An observational study in Influenza, Human, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by GlaxoSmithKline · Observational
This pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance study using passive surveillance enhanced with a reporting card system to report adverse events of interest (AEIs) after Flu vaccination.
This is the third pilot study following, EPI-FLU-045 VS UK [NCT02567721] and EPI-FLU-046 VS UK [NCT02893878] studies, carried out in the 2 previous influenza seasons (2015/2016 and 2016/2017). This study will collect data about vaccination status and adverse events following influenza immunisation (AEFI) on a weekly basis, from 01 September 2017 onwards, using a customized Adverse Drug Reaction (ADR) Cards and data from Electronic Health Records system for a period of approximately 13 weeks.
Registered patients in up to 10 general practices in UK immunized against seasonal influenza at the beginning of 2017/18 season.
Exclusion Criteria:
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017.
Other: Enhanced vaccine safety surveillance
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017.
Other: Enhanced vaccine safety surveillance
Volunteered subjects who received influenza vaccination (GSK or non-GSK not known) in 10 volunteer GP practices between 01 September and 30 November 2017.
Other: Enhanced vaccine safety surveillance
Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system.
Also known as: Data collection
Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group
The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea and, vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
The weekly incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card; * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine. Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card; * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine. Vaccination of the subjects happened between week 35 and week 48 of the year 2017.
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial oedema and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from General Practitioners (GPs). The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
SAEs reported here are derived from 2 sources of data - ADR cards and SAE routinely collected from GPs. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
"subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 data sources - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years, and \>65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with seasonal influenza vaccine Vaccination of subjects happened between weeks 35 and 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 data sources - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and \>65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
AEIs reported are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and \>65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhea, and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator = the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator = the number of subjects from the denominator who reported any AEIs in EHR (routine data collection + card-based ADR reporting system) within 7 days following vaccination with seasonal influenza vaccine Vaccination happened between weeks 35 and 48, of 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and \>65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhea, and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection + ADR) within 7 days following vaccination with seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48, 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea and vomiting. The cumulative incidence rates of AEIs expressed as a cumulative percentage of subjects, were estimated as follows: The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system); The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine. Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48 of 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48 of 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48 of 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
"SAEs reported here are derived from 2 sources of data - ADR cards and SAEs routinely collected from GPs. SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017"
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
SAEs reported here are derived from 2 sources of data - ADR cards and SAEs routinely collected from GPs. SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system)within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system) Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
| Milestone | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Started | 16433 | 3310 | 4196 |
| Completed | 16433 | 3310 | 4196 |
| Not completed | 0 | 0 | 0 |
The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Week 37 | 10.10 (8.53 to 11.84) | 0.00 (0.00 to 70.76) | 12.50 (1.55 to 38.35) |
| Week 38 | 7.69 (5.94 to 9.77) | 14.29 (0.00 to 90.97) | 12.50 (1.50 to 38.73) |
| Week 39 | 7.97 (7.16 to 8.84) | 0.00 (0.00 to 3.85) | 4.17 (0.11 to 21.12) |
| Week 40 | 8.22 (4.92 to 12.73) | 4.75 (2.74 to 7.60) | 0.00 (0.00 to 11.22) |
| Week 41 | 6.40 (4.45 to 8.86) | 3.25 (1.08 to 7.37) | 1.79 (0.05 to 9.55) |
| Week 42 | 3.74 (1.74 to 6.93) | 1.25 (0.36 to 3.06) | 0.00 (0.00 to 19.51) |
| Week 43 | 4.64 (1.86 to 9.38) | 2.65 (0.69 to 6.81) | 0.00 (0.00 to 15.44) |
| Week 44 | 4.40 (1.33 to 10.39) | 3.66 (0.70 to 10.72) | 0.00 (0.00 to 11.57) |
| Week 45 | 3.75 (1.64 to 7.25) | 2.24 (0.20 to 8.71) | 1.92 (0.62 to 4.41) |
| Week 46 | 4.29 (1.59 to 9.10) | 1.89 (0.08 to 9.13) | 0.00 (0.00 to 17.65) |
| Week 47 | 1.55 (0.22 to 5.19) | 0.64 (0.02 to 3.50) | 0.00 (0.00 to 8.60) |
| Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Week 35-37 | 10.09 (8.52 to 11.84) | 0.00 (0.00 to 60.24) | 10.53 (1.30 to 33.14) |
| Week 35-38 | 8.83 (7.25 to 10.63) | 9.09 (0.08 to 47.67) | 11.43 (3.20 to 26.74) |
| Week 35-39 | 8.45 (7.37 to 9.64) | 0.95 (0.02 to 5.19) | 8.47 (2.81 to 18.68) |
| Week 35-40 | 8.41 (7.29 to 9.63) | 3.85 (2.14 to 6.33) | 5.56 (1.83 to 12.49) |
| Week 35-41 | 8.15 (7.00 to 9.43) | 3.59 (1.96 to 5.98) | 4.11 (1.52 to 8.73) |
| Week 35-42 | 7.87 (6.68 to 9.19) | 2.79 (1.49 to 4.74) | 3.68 (1.36 to 7.84) |
| Week 35-43 | 7.75 (6.54 to 9.12) | 2.76 (1.38 to 4.90) | 3.24 (1.20 to 6.93) |
| Week 35-44 | 7.59 (6.36 to 8.97) | 2.97 (1.29 to 5.75) | 2.79 (1.03 to 5.97) |
| Week 35-45 | 7.48 (6.25 to 8.86) | 2.85 (1.32 to 5.30) | 2.31 (1.16 to 4.10) |
| Week 35-46 | 7.41 (6.13 to 8.86) | 2.75 (1.14 to 5.52) | 2.22 (1.11 to 3.94) |
| Week 35-47 | 7.31 (6.03 to 8.78) | 2.64 (1.05 to 5.39) | 2.05 (1.03 to 3.64) |
| Week 35-48 | 7.25 (5.95 to 8.73) | 2.55 (1.01 to 5.23) | 2.01 (1.01 to 3.58) |
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Week 37 | 0.45 (0.20 to 0.85) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 20.59) |
| Week 38 | 0.51 (0.15 to 1.26) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 20.59) |
| Week 39 | 0.46 (0.20 to 0.92) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 14.25) |
| Week 40 | 0.34 (0.12 to 0.77) | 1.19 (0.09 to 4.96) | 0.00 (0.00 to 11.22) |
| Week 41 | 0.36 (0.13 to 0.79) | 0.59 (0.07 to 2.12) | 0.00 (0.00 to 6.38) |
| Week 42 | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 0.92) | 0.00 (0.00 to 19.51) |
| Week 43 | 0.40 (0.05 to 1.47) | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 15.44) |
| Week 44 | 0.27 (0.02 to 1.20) | 0.43 (0.05 to 1.55) | 0.00 (0.00 to 11.57) |
| Week 45 | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.91) | 0.38 (0.01 to 2.12) |
| Week 46 | 0.57 (0.03 to 2.58) | 0.00 (0.00 to 1.39) | 0.00 (0.00 to 17.65) |
| Week 47 | 0.39 (0.00 to 2.82) | 0.00 (0.00 to 2.32) | 0.00 (0.00 to 8.60) |
| Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Week 35-37 | 0.45 (0.20 to 0.85) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 17.65) |
| Week 35-38 | 0.48 (0.26 to 0.80) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 10.00) |
| Week 35-39 | 0.47 (0.24 to 0.83) | 0.00 (0.00 to 3.45) | 0.00 (0.00 to 6.06) |
| Week 35-40 | 0.45 (0.25 to 0.73) | 0.90 (0.03 to 4.68) | 0.00 (0.00 to 4.02) |
| Week 35-41 | 0.44 (0.27 to 0.68) | 0.77 (0.16 to 2.23) | 0.00 (0.00 to 2.49) |
| Week 35-42 | 0.41 (0.24 to 0.65) | 0.51 (0.08 to 1.67) | 0.00 (0.00 to 2.24) |
| Week 35-43 | 0.41 (0.24 to 0.64) | 0.38 (0.05 to 1.38) | 0.00 (0.00 to 1.97) |
| Week 35-44 | 0.40 (0.24 to 0.63) | 0.40 (0.09 to 1.08) | 0.00 (0.00 to 1.70) |
| Week 35-45 | 0.39 (0.23 to 0.62) | 0.33 (0.07 to 0.94) | 0.21 (0.01 to 1.16) |
| Week 35-46 | 0.39 (0.23 to 0.64) | 0.30 (0.06 to 0.87) | 0.20 (0.01 to 1.12) |
| Week 35-47 | 0.39 (0.23 to 0.63) | 0.28 (0.06 to 0.83) | 0.19 (0.00 to 1.04) |
| Week 35-48 | 0.39 (0.23 to 0.62) | 0.27 (0.05 to 0.80) | 0.18 (0.00 to 1.02) |
Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Week 37 | 1.87 (0.78 to 3.72) | 0.00 (0.00 to 70.76) | 6.25 (0.16 to 30.23) |
| Week 38 | 1.61 (0.84 to 2.79) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 20.59) |
| Week 39 | 1.90 (1.23 to 2.79) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 14.25) |
| Week 40 | 1.95 (0.77 to 4.02) | 0.30 (0.00 to 1.82) | 0.00 (0.00 to 11.22) |
| Week 41 | 1.45 (0.93 to 2.15) | 0.89 (0.15 to 2.82) | 0.00 (0.00 to 6.38) |
| Week 42 | 0.55 (0.09 to 1.78) | 0.50 (0.06 to 1.79) | 0.00 (0.00 to 19.51) |
| Week 43 | 0.40 (0.04 to 1.50) | 0.79 (0.06 to 3.28) | 0.00 (0.00 to 15.44) |
| Week 44 | 1.20 (0.25 to 3.43) | 0.65 (0.08 to 2.28) | 0.00 (0.00 to 11.57) |
| Week 45 | 0.66 (0.05 to 2.76) | 0.50 (0.00 to 3.52) | 0.00 (0.00 to 1.40) |
| Week 46 | 1.43 (0.20 to 4.82) | 1.14 (0.09 to 4.61) | 0.00 (0.00 to 17.65) |
| Week 47 | 1.16 (0.06 to 5.45) | 0.00 (0.00 to 2.32) | 0.00 (0.00 to 8.60) |
| Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Week 35-37 | 1.86 (0.78 to 3.72) | 0.00 (0.00 to 60.24) | 5.26 (0.13 to 26.03) |
| Week 35-38 | 1.73 (0.99 to 2.81) | 0.00 (0.00 to 28.49) | 2.86 (0.07 to 14.92) |
| Week 35-39 | 1.80 (1.14 to 2.71) | 0.00 (0.00 to 3.45) | 1.69 (0.02 to 10.67) |
| Week 35-40 | 1.83 (1.17 to 2.71) | 0.23 (0.01 to 1.25) | 1.11 (0.02 to 6.81) |
| Week 35-41 | 1.78 (1.20 to 2.54) | 0.51 (0.04 to 2.05) | 0.68 (0.01 to 4.24) |
| Week 35-42 | 1.70 (1.19 to 2.36) | 0.51 (0.06 to 1.89) | 0.61 (0.01 to 3.64) |
| Week 35-43 | 1.66 (1.17 to 2.28) | 0.58 (0.06 to 2.17) | 0.54 (0.01 to 3.14) |
| Week 35-44 | 1.63 (1.17 to 2.21) | 0.59 (0.08 to 2.05) | 0.47 (0.01 to 2.73) |
| Week 35-45 | 1.61 (1.16 to 2.17) | 0.58 (0.12 to 1.65) | 0.21 (0.00 to 1.82) |
| Week 35-46 | 1.60 (1.17 to 2.14) | 0.63 (0.13 to 1.83) | 0.20 (0.00 to 1.74) |
| Week 35-47 | 1.59 (1.17 to 2.12) | 0.60 (0.12 to 1.74) | 0.19 (0.00 to 1.59) |
| Week 35-48 | 1.58 (1.16 to 2.10) | 0.58 (0.12 to 1.68) | 0.18 (0.00 to 1.57) |
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Any, Week 37 | 3.89 (3.16 to 4.74) | 0.00 (0.00 to 70.76) | 6.25 (0.03 to 39.17) |
| Any, Week 38 | 2.97 (2.02 to 4.19) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 20.59) |
| Any, Week 39 | 2.94 (2.41 to 3.55) | 0.00 (0.00 to 3.85) | 4.17 (0.11 to 21.12) |
| Any, Week 40 | 2.43 (1.76 to 3.27) | 1.48 (0.36 to 4.00) | 0.00 (0.00 to 11.22) |
| Any, Week 41 | 1.75 (1.18 to 2.50) | 1.18 (0.19 to 3.76) | 0.00 (0.00 to 6.38) |
| Any, Week 42 | 1.54 (0.53 to 3.43) | 0.25 (0.01 to 1.38) | 0.00 (0.00 to 19.51) |
| Any, Week 43 | 1.81 (0.54 to 4.39) | 1.06 (0.08 to 4.36) | 0.00 (0.00 to 15.44) |
| Any, Week 44 | 1.60 (0.67 to 3.18) | 1.29 (0.09 to 5.42) | 0.00 (0.00 to 11.57) |
| Any, Week 45 | 1.10 (0.19 to 3.43) | 1.00 (0.15 to 3.24) | 0.38 (0.01 to 2.12) |
| Any, Week 46 | 0.57 (0.03 to 2.58) | 0.76 (0.01 to 5.22) | 0.00 (0.00 to 17.65) |
| Any, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.32) | 0.00 (0.00 to 8.60) |
| Any, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
| Drowsiness, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Drowsiness, Week 37 | 1.05 (0.62 to 1.68) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 20.59) |
| Drowsiness, Week 38 | 0.81 (0.29 to 1.76) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 20.59) |
| Drowsiness, Week 39 | 0.63 (0.32 to 1.12) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 14.25) |
| Drowsiness, Week 40 | 0.68 (0.37 to 1.14) | 0.30 (0.01 to 1.64) | 0.00 (0.00 to 11.22) |
| Drowsiness, Week 41 | 0.48 (0.20 to 0.98) | 0.59 (0.07 to 2.12) | 0.00 (0.00 to 6.38) |
| Drowsiness, Week 42 | 0.33 (0.02 to 1.52) | 0.00 (0.00 to 0.92) | 0.00 (0.00 to 19.51) |
| Drowsiness, Week 43 | 0.81 (0.01 to 5.29) | 0.26 (0.01 to 1.47) | 0.00 (0.00 to 15.44) |
| Drowsiness, Week 44 | 0.27 (0.02 to 1.18) | 0.43 (0.01 to 2.52) | 0.00 (0.00 to 11.57) |
| Drowsiness, Week 45 | 0.22 (0.00 to 1.58) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.40) |
| Drowsiness, Week 46 | 0.00 (0.00 to 1.05) | 0.38 (0.00 to 2.63) | 0.00 (0.00 to 17.65) |
| Drowsiness, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.32) | 0.00 (0.00 to 8.60) |
| Drowsiness, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
| Fatigue, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Fatigue, Week 37 | 2.11 (1.58 to 2.76) | 0.00 (0.00 to 70.76) | 6.25 (0.03 to 39.17) |
| Fatigue, Week 38 | 1.79 (1.16 to 2.65) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 20.59) |
| Fatigue, Week 39 | 1.58 (1.22 to 2.01) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 14.25) |
| Fatigue, Week 40 | 1.12 (0.54 to 2.05) | 0.59 (0.01 to 3.61) | 0.00 (0.00 to 11.22) |
| Fatigue, Week 41 | 1.09 (0.65 to 1.71) | 0.30 (0.01 to 1.64) | 0.00 (0.00 to 6.38) |
| Fatigue, Week 42 | 0.77 (0.08 to 2.92) | 0.00 (0.00 to 0.92) | 0.00 (0.00 to 19.51) |
| Fatigue, Week 43 | 0.81 (0.14 to 2.53) | 0.53 (0.04 to 2.19) | 0.00 (0.00 to 15.44) |
| Fatigue, Week 44 | 0.53 (0.15 to 1.36) | 0.65 (0.10 to 2.08) | 0.00 (0.00 to 11.57) |
| Fatigue, Week 45 | 0.88 (0.15 to 2.77) | 0.50 (0.02 to 2.39) | 0.38 (0.01 to 2.12) |
| Fatigue, Week 46 | 0.57 (0.03 to 2.58) | 0.00 (0.00 to 1.39) | 0.00 (0.00 to 17.65) |
| Fatigue, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.32) | 0.00 (0.00 to 8.60) |
| Fatigue, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
| Headache, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Headache, Week 37 | 2.19 (1.65 to 2.85) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 20.59) |
| Headache, Week 38 | 1.79 (0.90 to 3.18) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 20.59) |
| Headache, Week 39 | 1.68 (1.22 to 2.25) | 0.00 (0.00 to 3.85) | 4.17 (0.11 to 21.12) |
| Headache, Week 40 | 1.41 (0.88 to 2.14) | 0.89 (0.06 to 3.80) | 0.00 (0.00 to 11.22) |
| Headache, Week 41 | 0.91 (0.51 to 1.49) | 0.89 (0.15 to 2.82) | 0.00 (0.00 to 6.38) |
| Headache, Week 42 | 0.77 (0.24 to 1.82) | 0.25 (0.01 to 1.38) | 0.00 (0.00 to 19.51) |
| Headache, Week 43 | 1.21 (0.27 to 3.36) | 0.79 (0.06 to 3.28) | 0.00 (0.00 to 15.44) |
| Headache, Week 44 | 1.33 (0.52 to 2.78) | 0.65 (0.10 to 2.08) | 0.00 (0.00 to 11.57) |
| Headache, Week 45 | 0.88 (0.07 to 3.62) | 0.75 (0.07 to 2.91) | 0.38 (0.01 to 2.12) |
| Headache, Week 46 | 0.29 (0.00 to 2.15) | 0.38 (0.00 to 2.63) | 0.00 (0.00 to 17.65) |
| Headache, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.32) | 0.00 (0.00 to 8.60) |
| Headache, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
| Irritability, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Irritability, Week 37 | 0.36 (0.14 to 0.76) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 20.59) |
| Irritability, Week 38 | 0.26 (0.09 to 0.56) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 20.59) |
| Irritability, Week 39 | 0.34 (0.12 to 0.76) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 14.25) |
| Irritability, Week 40 | 0.15 (0.03 to 0.43) | 0.00 (0.00 to 1.09) | 0.00 (0.00 to 11.22) |
| Irritability, Week 41 | 0.12 (0.01 to 0.44) | 0.00 (0.00 to 1.09) | 0.00 (0.00 to 6.38) |
| Irritability, Week 42 | 0.11 (0.00 to 0.80) | 0.25 (0.01 to 1.38) | 0.00 (0.00 to 19.51) |
| Irritability, Week 43 | 0.20 (0.00 to 1.34) | 0.26 (0.01 to 1.47) | 0.00 (0.00 to 15.44) |
| Irritability, Week 44 | 0.00 (0.00 to 0.49) | 0.43 (0.01 to 2.52) | 0.00 (0.00 to 11.57) |
| Irritability, Week 45 | 0.22 (0.00 to 1.58) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.40) |
| Irritability, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 1.39) | 0.00 (0.00 to 17.65) |
| Irritability, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.32) | 0.00 (0.00 to 8.60) |
| Irritability, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
| Malaise, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Malaise, Week 37 | 0.04 (0.00 to 0.25) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 20.59) |
| Malaise, Week 38 | 0.00 (0.00 to 0.14) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 20.59) |
| Malaise, Week 39 | 0.00 (0.00 to 0.09) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 14.25) |
| Malaise, Week 40 | 0.00 (0.00 to 0.18) | 0.00 (0.00 to 1.09) | 0.00 (0.00 to 11.22) |
| Malaise, Week 41 | 0.00 (0.00 to 0.22) | 0.00 (0.00 to 1.09) | 0.00 (0.00 to 6.38) |
| Malaise, Week 42 | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 0.92) | 0.00 (0.00 to 19.51) |
| Malaise, Week 43 | 0.00 (0.00 to 0.74) | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 15.44) |
| Malaise, Week 44 | 0.00 (0.00 to 0.49) | 0.00 (0.00 to 0.79) | 0.00 (0.00 to 11.57) |
| Malaise, Week 45 | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.40) |
| Malaise, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 1.39) | 0.00 (0.00 to 17.65) |
| Malaise, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.32) | 0.00 (0.00 to 8.60) |
| Malaise, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Any, Week 35-37 | 3.89 (3.15 to 4.74) | 0.00 (0.00 to 60.24) | 5.26 (0.06 to 29.55) |
| Any, Week 35-38 | 3.41 (2.58 to 4.40) | 0.00 (0.00 to 28.49) | 2.86 (0.02 to 18.52) |
| Any, Week 35-39 | 3.20 (2.47 to 4.07) | 0.00 (0.00 to 3.45) | 3.39 (0.41 to 11.71) |
| Any, Week 35-40 | 3.06 (2.39 to 3.85) | 1.13 (0.37 to 2.62) | 2.22 (0.27 to 7.80) |
| Any, Week 35-41 | 2.89 (2.24 to 3.67) | 1.15 (0.34 to 2.80) | 1.37 (0.17 to 4.86) |
| Any, Week 35-42 | 2.81 (2.14 to 3.60) | 0.85 (0.27 to 2.00) | 1.23 (0.15 to 4.36) |
| Any, Week 35-43 | 2.77 (2.10 to 3.59) | 0.90 (0.21 to 2.44) | 1.08 (0.13 to 3.85) |
| Any, Week 35-44 | 2.71 (2.04 to 3.54) | 0.99 (0.19 to 2.96) | 0.93 (0.11 to 3.32) |
| Any, Week 35-45 | 2.67 (2.00 to 3.47) | 0.99 (0.27 to 2.50) | 0.63 (0.13 to 1.83) |
| Any, Week 35-46 | 2.62 (1.95 to 3.45) | 0.97 (0.22 to 2.68) | 0.61 (0.13 to 1.76) |
| Any, Week 35-47 | 2.58 (1.91 to 3.41) | 0.91 (0.20 to 2.56) | 0.56 (0.12 to 1.63) |
| Any, Week 35-48 | 2.56 (1.89 to 3.38) | 0.88 (0.20 to 2.48) | 0.55 (0.11 to 1.60) |
| Drowsiness, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Drowsiness, Week 35-37 | 1.05 (0.62 to 1.68) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 17.65) |
| Drowsiness, Week 35-38 | 0.92 (0.49 to 1.59) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 10.00) |
| Drowsiness, Week 35-39 | 0.79 (0.42 to 1.36) | 0.00 (0.00 to 3.45) | 0.00 (0.00 to 6.06) |
| Drowsiness, Week 35-40 | 0.77 (0.43 to 1.28) | 0.23 (0.01 to 1.25) | 0.00 (0.00 to 4.02) |
| Drowsiness, Week 35-41 | 0.74 (0.41 to 1.23) | 0.38 (0.08 to 1.12) | 0.00 (0.00 to 2.49) |
| Drowsiness, Week 35-42 | 0.71 (0.38 to 1.21) | 0.25 (0.05 to 0.74) | 0.00 (0.00 to 2.24) |
| Drowsiness, Week 35-43 | 0.71 (0.36 to 1.26) | 0.26 (0.07 to 0.66) | 0.00 (0.00 to 1.97) |
| Drowsiness, Week 35-44 | 0.69 (0.34 to 1.24) | 0.30 (0.06 to 0.89) | 0.00 (0.00 to 1.70) |
| Drowsiness, Week 35-45 | 0.68 (0.34 to 1.21) | 0.25 (0.04 to 0.78) | 0.00 (0.00 to 0.77) |
| Drowsiness, Week 35-46 | 0.66 (0.33 to 1.19) | 0.26 (0.04 to 0.90) | 0.00 (0.00 to 0.74) |
| Drowsiness, Week 35-47 | 0.65 (0.32 to 1.17) | 0.25 (0.03 to 0.86) | 0.00 (0.00 to 0.69) |
| Drowsiness, Week 35-48 | 0.65 (0.32 to 1.16) | 0.24 (0.03 to 0.83) | 0.00 (0.00 to 0.67) |
| Fatigue, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Fatigue, Week 35-37 | 2.11 (1.58 to 2.76) | 0.00 (0.00 to 60.24) | 5.26 (0.06 to 29.55) |
| Fatigue, Week 35-38 | 1.94 (1.46 to 2.54) | 0.00 (0.00 to 28.49) | 2.86 (0.02 to 18.52) |
| Fatigue, Week 35-39 | 1.78 (1.37 to 2.28) | 0.00 (0.00 to 3.45) | 1.69 (0.01 to 12.12) |
| Fatigue, Week 35-40 | 1.66 (1.27 to 2.13) | 0.45 (0.01 to 2.35) | 1.11 (0.01 to 7.73) |
| Fatigue, Week 35-41 | 1.59 (1.20 to 2.06) | 0.38 (0.03 to 1.54) | 0.68 (0.02 to 3.76) |
| Fatigue, Week 35-42 | 1.54 (1.14 to 2.02) | 0.25 (0.03 to 0.95) | 0.61 (0.02 to 3.37) |
| Fatigue, Week 35-43 | 1.51 (1.13 to 1.98) | 0.32 (0.03 to 1.21) | 0.54 (0.01 to 2.97) |
| Fatigue, Week 35-44 | 1.46 (1.09 to 1.92) | 0.40 (0.06 to 1.30) | 0.47 (0.01 to 2.56) |
| Fatigue, Week 35-45 | 1.45 (1.09 to 1.88) | 0.41 (0.14 to 0.95) | 0.42 (0.05 to 1.51) |
| Fatigue, Week 35-46 | 1.43 (1.05 to 1.89) | 0.37 (0.11 to 0.91) | 0.40 (0.05 to 1.45) |
| Fatigue, Week 35-47 | 1.40 (1.03 to 1.86) | 0.35 (0.10 to 0.87) | 0.37 (0.05 to 1.34) |
| Fatigue, Week 35-48 | 1.39 (1.02 to 1.85) | 0.34 (0.10 to 0.84) | 0.37 (0.04 to 1.32) |
| Headache, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Headache, Week 35-37 | 2.19 (1.64 to 2.85) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 17.65) |
| Headache, Week 35-38 | 1.98 (1.25 to 2.97) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 10.00) |
| Headache, Week 35-39 | 1.85 (1.24 to 2.64) | 0.00 (0.00 to 3.45) | 1.69 (0.04 to 9.09) |
| Headache, Week 35-40 | 1.77 (1.24 to 2.44) | 0.68 (0.08 to 2.44) | 1.11 (0.03 to 6.04) |
| Headache, Week 35-41 | 1.66 (1.16 to 2.29) | 0.77 (0.14 to 2.32) | 0.68 (0.01 to 4.40) |
| Headache, Week 35-42 | 1.60 (1.12 to 2.21) | 0.59 (0.13 to 1.69) | 0.61 (0.01 to 4.02) |
| Headache, Week 35-43 | 1.59 (1.11 to 2.20) | 0.64 (0.12 to 1.95) | 0.54 (0.00 to 3.67) |
| Headache, Week 35-44 | 1.57 (1.10 to 2.19) | 0.64 (0.12 to 1.93) | 0.47 (0.00 to 3.34) |
| Headache, Week 35-45 | 1.55 (1.09 to 2.15) | 0.66 (0.17 to 1.73) | 0.42 (0.05 to 1.51) |
| Headache, Week 35-46 | 1.53 (1.06 to 2.12) | 0.63 (0.14 to 1.78) | 0.40 (0.05 to 1.45) |
| Headache, Week 35-47 | 1.50 (1.04 to 2.09) | 0.60 (0.13 to 1.70) | 0.37 (0.05 to 1.34) |
| Headache, Week 35-48 | 1.49 (1.03 to 2.08) | 0.58 (0.13 to 1.64) | 0.37 (0.04 to 1.32) |
| Irritability, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Irritability, Week 35-37 | 0.36 (0.14 to 0.76) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 17.65) |
| Irritability, Week 35-38 | 0.31 (0.14 to 0.60) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 10.00) |
| Irritability, Week 35-39 | 0.32 (0.17 to 0.56) | 0.00 (0.00 to 3.45) | 0.00 (0.00 to 6.06) |
| Irritability, Week 35-40 | 0.29 (0.16 to 0.47) | 0.00 (0.00 to 0.83) | 0.00 (0.00 to 4.02) |
| Irritability, Week 35-41 | 0.27 (0.15 to 0.45) | 0.00 (0.00 to 0.47) | 0.00 (0.00 to 2.49) |
| Irritability, Week 35-42 | 0.26 (0.14 to 0.45) | 0.08 (0.00 to 0.47) | 0.00 (0.00 to 2.24) |
| Irritability, Week 35-43 | 0.26 (0.13 to 0.46) | 0.13 (0.01 to 0.48) | 0.00 (0.00 to 1.97) |
| Irritability, Week 35-44 | 0.24 (0.12 to 0.44) | 0.20 (0.02 to 0.82) | 0.00 (0.00 to 1.70) |
| Irritability, Week 35-45 | 0.24 (0.13 to 0.42) | 0.16 (0.01 to 0.71) | 0.00 (0.00 to 0.77) |
| Irritability, Week 35-46 | 0.24 (0.12 to 0.42) | 0.15 (0.01 to 0.67) | 0.00 (0.00 to 0.74) |
| Irritability, Week 35-47 | 0.23 (0.12 to 0.41) | 0.14 (0.01 to 0.64) | 0.00 (0.00 to 0.69) |
| Irritability, Week 35-48 | 0.23 (0.12 to 0.41) | 0.14 (0.01 to 0.62) | 0.00 (0.00 to 0.67) |
| Malaise, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Malaise, Week 35-37 | 0.04 (0.00 to 0.25) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 17.65) |
| Malaise, Week 35-38 | 0.02 (0.00 to 0.12) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 10.00) |
| Malaise, Week 35-39 | 0.01 (0.00 to 0.07) | 0.00 (0.00 to 3.45) | 0.00 (0.00 to 6.06) |
| Malaise, Week 35-40 | 0.01 (0.00 to 0.06) | 0.00 (0.00 to 0.83) | 0.00 (0.00 to 4.02) |
| Malaise, Week 35-41 | 0.01 (0.00 to 0.05) | 0.00 (0.00 to 0.47) | 0.00 (0.00 to 2.49) |
| Malaise, Week 35-42 | 0.01 (0.00 to 0.05) | 0.00 (0.00 to 0.31) | 0.00 (0.00 to 2.24) |
| Malaise, Week 35-43 | 0.01 (0.00 to 0.04) | 0.00 (0.00 to 0.24) | 0.00 (0.00 to 1.97) |
| Malaise, Week 35-44 | 0.01 (0.00 to 0.04) | 0.00 (0.00 to 0.18) | 0.00 (0.00 to 1.70) |
| Malaise, Week 35-45 | 0.01 (0.00 to 0.04) | 0.00 (0.00 to 0.15) | 0.00 (0.00 to 0.77) |
| Malaise, Week 35-46 | 0.01 (0.00 to 0.04) | 0.00 (0.00 to 0.14) | 0.00 (0.00 to 0.74) |
| Malaise, Week 35-47 | 0.01 (0.00 to 0.04) | 0.00 (0.00 to 0.13) | 0.00 (0.00 to 0.69) |
| Malaise, Week 35-48 | 0.01 (0.00 to 0.04) | 0.00 (0.00 to 0.13) | 0.00 (0.00 to 0.67) |
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Any, Week 37 | 5.76 (4.81 to 6.83) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 20.59) |
| Any, Week 38 | 3.88 (2.99 to 4.95) | 14.29 (0.00 to 90.97) | 6.25 (0.16 to 30.23) |
| Any, Week 39 | 4.23 (3.63 to 4.89) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 14.25) |
| Any, Week 40 | 4.57 (2.77 to 7.05) | 2.67 (0.48 to 8.06) | 0.00 (0.00 to 11.22) |
| Any, Week 41 | 3.32 (2.19 to 4.81) | 2.07 (0.75 to 4.49) | 0.00 (0.00 to 6.38) |
| Any, Week 42 | 2.09 (0.95 to 3.94) | 0.50 (0.06 to 1.79) | 0.00 (0.00 to 19.51) |
| Any, Week 43 | 2.62 (0.83 to 6.10) | 1.85 (0.66 to 4.07) | 0.00 (0.00 to 15.44) |
| Any, Week 44 | 2.40 (0.64 to 6.09) | 2.16 (0.63 to 5.25) | 0.00 (0.00 to 11.57) |
| Any, Week 45 | 1.77 (0.54 to 4.23) | 1.00 (0.01 to 6.97) | 1.92 (0.62 to 4.41) |
| Any, Week 46 | 1.43 (0.41 to 3.52) | 1.14 (0.01 to 7.76) | 0.00 (0.00 to 17.65) |
| Any, Week 47 | 1.55 (0.22 to 5.19) | 0.64 (0.02 to 3.50) | 0.00 (0.00 to 8.60) |
| Any, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Any, Week 35-37 | 5.76 (4.81 to 6.83) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 17.65) |
| Any, Week 35-38 | 4.77 (3.99 to 5.65) | 9.09 (0.08 to 47.67) | 2.86 (0.05 to 16.10) |
| Any, Week 35-39 | 4.53 (3.96 to 5.16) | 0.95 (0.02 to 5.19) | 1.69 (0.04 to 9.09) |
| Any, Week 35-40 | 4.54 (3.88 to 5.27) | 2.26 (0.44 to 6.66) | 1.11 (0.03 to 6.04) |
| Any, Week 35-41 | 4.38 (3.71 to 5.14) | 2.18 (0.80 to 4.71) | 0.68 (0.01 to 4.40) |
| Any, Week 35-42 | 4.23 (3.53 to 5.03) | 1.61 (0.58 to 3.50) | 0.61 (0.01 to 4.02) |
| Any, Week 35-43 | 4.18 (3.44 to 5.02) | 1.67 (0.84 to 2.95) | 0.54 (0.00 to 3.67) |
| Any, Week 35-44 | 4.09 (3.35 to 4.94) | 1.78 (0.96 to 2.99) | 0.47 (0.00 to 3.34) |
| Any, Week 35-45 | 4.02 (3.28 to 4.88) | 1.65 (0.83 to 2.91) | 1.26 (0.46 to 2.72) |
| Any, Week 35-46 | 3.97 (3.19 to 4.86) | 1.60 (0.80 to 2.85) | 1.21 (0.45 to 2.62) |
| Any, Week 35-47 | 3.93 (3.16 to 4.82) | 1.55 (0.77 to 2.77) | 1.12 (0.41 to 2.42) |
| Any, Week 35-48 | 3.89 (3.12 to 4.79) | 1.49 (0.73 to 2.69) | 1.10 (0.40 to 2.38) |
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Any, Week 37 | 2.03 (1.29 to 3.03) | 0.00 (0.00 to 70.76) | 6.25 (0.03 to 39.17) |
| Any, Week 38 | 1.65 (0.95 to 2.65) | 14.29 (0.00 to 90.97) | 0.00 (0.00 to 20.59) |
| Any, Week 39 | 1.34 (0.81 to 2.08) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 14.25) |
| Any, Week 40 | 1.36 (0.80 to 2.16) | 1.19 (0.32 to 3.01) | 0.00 (0.00 to 11.22) |
| Any, Week 41 | 1.15 (0.62 to 1.94) | 0.59 (0.07 to 2.12) | 0.00 (0.00 to 6.38) |
| Any, Week 42 | 0.66 (0.19 to 1.63) | 0.00 (0.00 to 0.92) | 0.00 (0.00 to 19.51) |
| Any, Week 43 | 0.40 (0.04 to 1.61) | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 15.44) |
| Any, Week 44 | 0.40 (0.08 to 1.16) | 0.43 (0.01 to 2.52) | 0.00 (0.00 to 11.57) |
| Any, Week 45 | 1.32 (0.22 to 4.18) | 1.00 (0.15 to 3.24) | 0.38 (0.01 to 2.12) |
| Any, Week 46 | 0.86 (0.06 to 3.72) | 0.00 (0.00 to 1.39) | 0.00 (0.00 to 17.65) |
| Any, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.32) | 0.00 (0.00 to 8.60) |
| Any, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea and, vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Any, Week 35-37 | 2.03 (1.29 to 3.03) | 0.00 (0.00 to 60.24) | 5.26 (0.06 to 29.55) |
| Any, Week 35-38 | 1.83 (1.33 to 2.44) | 9.09 (0.08 to 47.67) | 2.86 (0.02 to 18.52) |
| Any, Week 35-39 | 1.61 (1.11 to 2.26) | 0.95 (0.02 to 5.19) | 1.69 (0.01 to 12.12) |
| Any, Week 35-40 | 1.57 (1.15 to 2.07) | 1.13 (0.37 to 2.62) | 1.11 (0.01 to 7.73) |
| Any, Week 35-41 | 1.51 (1.12 to 1.99) | 0.90 (0.35 to 1.87) | 0.68 (0.02 to 3.76) |
| Any, Week 35-42 | 1.46 (1.09 to 1.91) | 0.59 (0.24 to 1.23) | 0.61 (0.02 to 3.37) |
| Any, Week 35-43 | 1.42 (1.05 to 1.88) | 0.45 (0.16 to 1.01) | 0.54 (0.01 to 2.97) |
| Any, Week 35-44 | 1.37 (1.01 to 1.81) | 0.44 (0.10 to 1.22) | 0.47 (0.01 to 2.56) |
| Any, Week 35-45 | 1.37 (1.03 to 1.78) | 0.54 (0.21 to 1.12) | 0.42 (0.05 to 1.51) |
| Any, Week 35-46 | 1.36 (1.02 to 1.76) | 0.48 (0.17 to 1.07) | 0.40 (0.05 to 1.45) |
| Any, Week 35-47 | 1.34 (1.00 to 1.74) | 0.46 (0.16 to 1.03) | 0.37 (0.05 to 1.34) |
| Any, Week 35-48 | 1.32 (0.99 to 1.73) | 0.44 (0.15 to 1.00) | 0.37 (0.04 to 1.32) |
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Any, Week 37 | 0.65 (0.01 to 4.33) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 20.59) |
| Any, Week 38 | 0.55 (0.07 to 1.92) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 20.59) |
| Any, Week 39 | 0.36 (0.03 to 1.54) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 14.25) |
| Any, Week 40 | 0.39 (0.06 to 1.28) | 0.59 (0.01 to 3.61) | 0.00 (0.00 to 11.22) |
| Any, Week 41 | 0.24 (0.05 to 0.70) | 0.59 (0.07 to 2.12) | 0.00 (0.00 to 6.38) |
| Any, Week 42 | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 0.92) | 0.00 (0.00 to 19.51) |
| Any, Week 43 | 0.20 (0.00 to 1.37) | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 15.44) |
| Any, Week 44 | 0.27 (0.02 to 1.20) | 0.65 (0.01 to 3.77) | 0.00 (0.00 to 11.57) |
| Any, Week 45 | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.91) | 0.38 (0.01 to 2.12) |
| Any, Week 46 | 0.29 (0.00 to 2.10) | 0.00 (0.00 to 1.39) | 0.00 (0.00 to 17.65) |
| Any, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.32) | 0.00 (0.00 to 8.60) |
| Any, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Any, Week 35-37 | 0.65 (0.01 to 4.33) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 17.65) |
| Any, Week 35-38 | 0.60 (0.03 to 2.83) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 10.00) |
| Any, Week 35-39 | 0.49 (0.03 to 2.23) | 0.00 (0.00 to 3.45) | 0.00 (0.00 to 6.06) |
| Any, Week 35-40 | 0.48 (0.03 to 2.05) | 0.45 (0.01 to 2.35) | 0.00 (0.00 to 4.02) |
| Any, Week 35-41 | 0.45 (0.04 to 1.81) | 0.51 (0.04 to 2.05) | 0.00 (0.00 to 2.49) |
| Any, Week 35-42 | 0.42 (0.03 to 1.73) | 0.34 (0.04 to 1.26) | 0.00 (0.00 to 2.24) |
| Any, Week 35-43 | 0.41 (0.03 to 1.67) | 0.26 (0.03 to 0.97) | 0.00 (0.00 to 1.97) |
| Any, Week 35-44 | 0.40 (0.04 to 1.58) | 0.35 (0.03 to 1.43) | 0.00 (0.00 to 1.70) |
| Any, Week 35-45 | 0.39 (0.04 to 1.54) | 0.29 (0.02 to 1.24) | 0.21 (0.01 to 1.16) |
| Any, Week 35-46 | 0.39 (0.03 to 1.55) | 0.26 (0.02 to 1.17) | 0.20 (0.01 to 1.12) |
| Any, Week 35-47 | 0.38 (0.03 to 1.53) | 0.25 (0.01 to 1.11) | 0.19 (0.00 to 1.04) |
| Any, Week 35-48 | 0.38 (0.03 to 1.51) | 0.24 (0.01 to 1.08) | 0.18 (0.00 to 1.02) |
The weekly incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Week 37 | 0.53 (0.23 to 1.04) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 20.59) |
| Week 38 | 0.29 (0.10 to 0.67) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 20.59) |
| Week 39 | 0.19 (0.08 to 0.38) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 14.25) |
| Week 40 | 0.44 (0.20 to 0.83) | 0.00 (0.00 to 1.09) | 0.00 (0.00 to 11.22) |
| Week 41 | 0.12 (0.01 to 0.44) | 0.30 (0.01 to 1.64) | 0.00 (0.00 to 6.38) |
| Week 42 | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 0.92) | 0.00 (0.00 to 19.51) |
| Week 43 | 0.40 (0.03 to 1.69) | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 15.44) |
| Week 44 | 0.40 (0.02 to 1.80) | 0.00 (0.00 to 0.79) | 0.00 (0.00 to 11.57) |
| Week 45 | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.40) |
| Week 46 | 0.29 (0.00 to 2.08) | 0.00 (0.00 to 1.39) | 0.00 (0.00 to 17.65) |
| Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.32) | 0.00 (0.00 to 8.60) |
| Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Week 35-37 | 0.53 (0.23 to 1.04) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 17.65) |
| Week 35-38 | 0.40 (0.17 to 0.80) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 10.00) |
| Week 35-39 | 0.31 (0.17 to 0.53) | 0.00 (0.00 to 3.45) | 0.00 (0.00 to 6.06) |
| Week 35-40 | 0.33 (0.22 to 0.48) | 0.00 (0.00 to 0.83) | 0.00 (0.00 to 4.02) |
| Week 35-41 | 0.31 (0.20 to 0.44) | 0.13 (0.00 to 0.71) | 0.00 (0.00 to 2.49) |
| Week 35-42 | 0.29 (0.19 to 0.41) | 0.08 (0.00 to 0.47) | 0.00 (0.00 to 2.24) |
| Week 35-43 | 0.29 (0.20 to 0.41) | 0.06 (0.00 to 0.36) | 0.00 (0.00 to 1.97) |
| Week 35-44 | 0.30 (0.21 to 0.41) | 0.05 (0.00 to 0.28) | 0.00 (0.00 to 1.70) |
| Week 35-45 | 0.29 (0.20 to 0.40) | 0.04 (0.00 to 0.23) | 0.00 (0.00 to 0.77) |
| Week 35-46 | 0.29 (0.20 to 0.40) | 0.04 (0.00 to 0.21) | 0.00 (0.00 to 0.74) |
| Week 35-47 | 0.28 (0.20 to 0.39) | 0.04 (0.00 to 0.20) | 0.00 (0.00 to 0.69) |
| Week 35-48 | 0.28 (0.20 to 0.39) | 0.03 (0.00 to 0.19) | 0.00 (0.00 to 0.67) |
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Any, Week 37 | 3.65 (2.94 to 4.47) | 0.00 (0.00 to 70.76) | 6.25 (0.16 to 30.23) |
| Any, Week 38 | 2.82 (2.12 to 3.67) | 0.00 (0.00 to 40.96) | 6.25 (0.01 to 45.43) |
| Any, Week 39 | 2.55 (2.04 to 3.14) | 0.00 (0.00 to 3.85) | 4.17 (0.11 to 21.12) |
| Any, Week 40 | 2.19 (1.60 to 2.92) | 1.19 (0.02 to 7.15) | 0.00 (0.00 to 11.22) |
| Any, Week 41 | 1.99 (1.37 to 2.79) | 0.00 (0.00 to 1.09) | 0.00 (0.00 to 6.38) |
| Any, Week 42 | 1.54 (0.59 to 3.23) | 0.25 (0.01 to 1.38) | 0.00 (0.00 to 19.51) |
| Any, Week 43 | 2.82 (1.31 to 5.26) | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 15.44) |
| Any, Week 44 | 1.60 (0.39 to 4.27) | 1.08 (0.02 to 6.23) | 0.00 (0.00 to 11.57) |
| Any, Week 45 | 1.32 (0.26 to 3.91) | 0.25 (0.01 to 1.38) | 0.38 (0.01 to 2.12) |
| Any, Week 46 | 0.86 (0.17 to 2.52) | 0.38 (0.00 to 2.63) | 0.00 (0.00 to 17.65) |
| Any, Week 47 | 0.39 (0.00 to 2.82) | 0.00 (0.00 to 2.32) | 0.00 (0.00 to 8.60) |
| Any, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Any, Week 35-37 | 3.65 (2.94 to 4.47) | 0.00 (0.00 to 60.24) | 5.26 (0.13 to 26.03) |
| Any, Week 35-38 | 3.21 (2.56 to 3.98) | 0.00 (0.00 to 28.49) | 5.71 (0.61 to 20.03) |
| Any, Week 35-39 | 2.92 (2.35 to 3.58) | 0.00 (0.00 to 3.45) | 5.08 (1.06 to 14.15) |
| Any, Week 35-40 | 2.79 (2.32 to 3.32) | 0.90 (0.03 to 4.68) | 3.33 (0.69 to 9.43) |
| Any, Week 35-41 | 2.69 (2.21 to 3.23) | 0.51 (0.04 to 2.05) | 2.05 (0.42 to 5.91) |
| Any, Week 35-42 | 2.61 (2.12 to 3.18) | 0.42 (0.05 to 1.57) | 1.84 (0.38 to 5.28) |
| Any, Week 35-43 | 2.62 (2.12 to 3.19) | 0.32 (0.03 to 1.21) | 1.62 (0.34 to 4.67) |
| Any, Week 35-44 | 2.57 (2.08 to 3.13) | 0.49 (0.04 to 2.04) | 1.40 (0.26 to 4.21) |
| Any, Week 35-45 | 2.53 (2.05 to 3.10) | 0.45 (0.03 to 1.94) | 0.84 (0.14 to 2.67) |
| Any, Week 35-46 | 2.50 (2.01 to 3.06) | 0.45 (0.03 to 1.99) | 0.81 (0.14 to 2.56) |
| Any, Week 35-47 | 2.46 (1.98 to 3.02) | 0.42 (0.02 to 1.90) | 0.75 (0.14 to 2.27) |
| Any, Week 35-48 | 2.44 (1.96 to 3.00) | 0.41 (0.02 to 1.84) | 0.73 (0.13 to 2.24) |
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Any, Week 37 | 0.28 (0.11 to 0.58) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 20.59) |
| Any, Week 38 | 0.26 (0.10 to 0.53) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 20.59) |
| Any, Week 39 | 0.17 (0.04 to 0.44) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 14.25) |
| Any, Week 40 | 0.00 (0.00 to 0.18) | 0.30 (0.00 to 1.82) | 0.00 (0.00 to 11.22) |
| Any, Week 41 | 0.18 (0.03 to 0.59) | 0.30 (0.01 to 1.64) | 1.79 (0.05 to 9.55) |
| Any, Week 42 | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 0.92) | 0.00 (0.00 to 19.51) |
| Any, Week 43 | 0.00 (0.00 to 0.74) | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 15.44) |
| Any, Week 44 | 0.13 (0.00 to 1.05) | 0.00 (0.00 to 0.79) | 0.00 (0.00 to 11.57) |
| Any, Week 45 | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.40) |
| Any, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 1.39) | 0.00 (0.00 to 17.65) |
| Any, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.32) | 0.00 (0.00 to 8.60) |
| Any, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Any, Week 35-37 | 0.28 (0.11 to 0.58) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 17.65) |
| Any, Week 35-38 | 0.27 (0.15 to 0.45) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 10.00) |
| Any, Week 35-39 | 0.23 (0.12 to 0.39) | 0.00 (0.00 to 3.45) | 0.00 (0.00 to 6.06) |
| Any, Week 35-40 | 0.18 (0.09 to 0.34) | 0.23 (0.01 to 1.25) | 0.00 (0.00 to 4.02) |
| Any, Week 35-41 | 0.18 (0.10 to 0.31) | 0.26 (0.02 to 1.03) | 0.68 (0.02 to 3.76) |
| Any, Week 35-42 | 0.17 (0.09 to 0.29) | 0.17 (0.02 to 0.63) | 0.61 (0.02 to 3.37) |
| Any, Week 35-43 | 0.17 (0.09 to 0.28) | 0.13 (0.01 to 0.48) | 0.54 (0.01 to 2.97) |
| Any, Week 35-44 | 0.16 (0.09 to 0.28) | 0.10 (0.01 to 0.41) | 0.47 (0.01 to 2.56) |
| Any, Week 35-45 | 0.16 (0.09 to 0.27) | 0.08 (0.01 to 0.35) | 0.21 (0.01 to 1.16) |
| Any, Week 35-46 | 0.16 (0.08 to 0.27) | 0.07 (0.00 to 0.33) | 0.20 (0.01 to 1.12) |
| Any, Week 35-47 | 0.15 (0.08 to 0.26) | 0.07 (0.00 to 0.32) | 0.19 (0.00 to 1.04) |
| Any, Week 35-48 | 0.15 (0.08 to 0.26) | 0.07 (0.00 to 0.31) | 0.18 (0.00 to 1.02) |
The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card; * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine. Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Week 37 | 0.00 (0.00 to 0.15) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 20.59) |
| Week 38 | 0.00 (0.00 to 0.14) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 20.59) |
| Week 39 | 0.00 (0.00 to 0.09) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 14.25) |
| Week 40 | 0.00 (0.00 to 0.18) | 0.00 (0.00 to 1.09) | 0.00 (0.00 to 11.22) |
| Week 41 | 0.00 (0.00 to 0.22) | 0.00 (0.00 to 1.09) | 0.00 (0.00 to 6.38) |
| Week 42 | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 0.92) | 0.00 (0.00 to 19.51) |
| Week 43 | 0.00 (0.00 to 0.74) | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 15.44) |
| Week 44 | 0.00 (0.00 to 0.49) | 0.00 (0.00 to 0.79) | 0.00 (0.00 to 11.57) |
| Week 45 | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.40) |
| Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 1.39) | 0.00 (0.00 to 17.65) |
| Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.32) | 0.00 (0.00 to 8.60) |
| Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 30.85) |
The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card; * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine. Vaccination of the subjects happened between week 35 and week 48 of the year 2017.
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| Week 35-37 | 0.00 (0.00 to 0.15) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 17.65) |
| Week 35-38 | 0.00 (0.00 to 0.07) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 10.00) |
| Week 35-39 | 0.00 (0.00 to 0.04) | 0.00 (0.00 to 3.45) | 0.00 (0.00 to 6.06) |
| Week 35-40 | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.83) | 0.00 (0.00 to 4.02) |
| Week 35-41 | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.47) | 0.00 (0.00 to 2.49) |
| Week 35-42 | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.31) | 0.00 (0.00 to 2.24) |
| Week 35-43 | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.24) | 0.00 (0.00 to 1.97) |
| Week 35-44 | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.18) | 0.00 (0.00 to 1.70) |
| Week 35-45 | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.15) | 0.00 (0.00 to 0.77) |
| Week 35-46 | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.14) | 0.00 (0.00 to 0.74) |
| Week 35-47 | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.13) | 0.00 (0.00 to 0.69) |
| Week 35-48 | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.13) | 0.00 (0.00 to 0.67) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 3.38 (1.37 to 6.84) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 1.63 (0.02 to 10.28) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.52 (0.00 to 3.94) | 0.00 (0.00 to 60.24) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 1.97 (0.07 to 9.78) | 0.00 (0.00 to 24.71) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 3.21) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 36.94) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 40 | 33.33 (0.00 to 100) | 14.29 (3.05 to 36.34) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 28.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | — |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 1.06 (0.02 to 5.93) | — |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.99 (0.00 to 10.54) | — |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 84.19) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 7.14 (0.02 to 44.90) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 11.11 (0.19 to 51.19) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 1.25 (0.03 to 6.77) | 1.46 (0.30 to 4.22) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18-65 years, Week 37 | 9.87 (6.92 to 13.55) | 0.00 (0.00 to 84.19) | 22.22 (2.81 to 60.01) |
| 18-65 years, Week 38 | 7.45 (4.89 to 10.79) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 45.93) |
| 18-65 years, Week 39 | 8.48 (7.08 to 10.06) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 52.18) |
| 18-65 years, Week 40 | 8.37 (4.12 to 14.76) | 6.78 (1.88 to 16.46) | 0.00 (0.00 to 33.63) |
| 18-65 years, Week 41 | 4.88 (2.78 to 7.88) | 4.44 (1.22 to 10.99) | 0.00 (0.00 to 30.85) |
| 18-65 years, Week 42 | 3.67 (1.25 to 8.20) | 0.00 (0.00 to 3.48) | 0.00 (0.00 to 60.24) |
| 18-65 years, Week 43 | 4.59 (1.48 to 10.46) | 6.03 (2.46 to 12.04) | 0.00 (0.00 to 24.71) |
| 18-65 years, Week 44 | 3.83 (1.31 to 8.54) | 8.97 (0.36 to 37.68) | 0.00 (0.00 to 36.94) |
| 18-65 years, Week 45 | 2.25 (0.60 to 5.75) | 1.82 (0.00 to 93.05) | 5.88 (0.72 to 19.68) |
| 18-65 years, Week 46 | 4.93 (1.73 to 10.77) | 8.00 (0.74 to 28.24) | 0.00 (0.00 to 60.24) |
| 18-65 years, Week 47 | 2.74 (0.36 to 9.27) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 21.80) |
| 18-65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 37 | 10.27 (8.88 to 11.79) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 40.96) |
| >65 years, Week 38 | 7.90 (6.31 to 9.74) | 16.67 (0.00 to 91.51) | 20.00 (1.06 to 65.28) |
| >65 years, Week 39 | 7.74 (6.52 to 9.12) | 0.00 (0.00 to 70.76) | 5.88 (0.15 to 28.69) |
| >65 years, Week 40 | 8.15 (5.16 to 12.10) | 2.44 (0.06 to 12.86) | 0.00 (0.00 to 26.46) |
| >65 years, Week 41 | 7.43 (5.38 to 9.96) | 6.33 (2.09 to 14.16) | 33.33 (0.00 to 99.94) |
| >65 years, Week 42 | 3.85 (1.67 to 7.46) | 6.15 (1.70 to 15.01) | 0.00 (0.00 to 52.18) |
| >65 years, Week 43 | 4.74 (1.88 to 9.68) | 3.70 (0.00 to 98.52) | 0.00 (0.00 to 70.76) |
| >65 years, Week 44 | 4.88 (1.08 to 13.29) | 7.81 (0.00 to 63.88) | 0.00 (0.00 to 60.24) |
| >65 years, Week 45 | 5.41 (2.08 to 11.19) | 16.22 (0.00 to 99.95) | 0.00 (0.00 to 16.84) |
| >65 years, Week 46 | 3.51 (0.58 to 10.84) | 2.70 (0.00 to 99.94) | 0.00 (0.00 to 45.93) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 3.70 (0.00 to 99.88) | 0.00 (0.00 to 70.76) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 84.19) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 2.59 (0.63 to 6.88) | 0.00 (0.00 to 45.93) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 2.29 (0.33 to 7.54) | 0.00 (0.00 to 40.96) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 1.71 (0.25 to 5.63) | 0.00 (0.00 to 28.49) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 1.38 (0.15 to 5.09) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 1.51 (0.26 to 4.71) | 0.00 (0.00 to 11.94) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 1.32 (0.20 to 4.30) | 0.00 (0.00 to 11.22) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 1.19 (0.18 to 3.94) | 0.00 (0.00 to 9.74) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 1.13 (0.16 to 3.75) | 0.00 (0.00 to 8.04) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 1.10 (0.16 to 3.67) | 0.00 (0.00 to 7.40) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 35-40 | 3.70 (0.00 to 39.49) | 7.32 (0.90 to 24.00) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 35-41 | 3.45 (0.00 to 35.58) | 4.29 (0.36 to 16.39) | 0.00 (0.00 to 21.80) |
| 6 - 12 years, Week 35-42 | 2.94 (0.00 to 26.56) | 3.19 (0.28 to 12.23) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-43 | 2.86 (0.00 to 25.94) | 2.52 (0.21 to 9.89) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-44 | 2.44 (0.00 to 20.29) | 1.88 (0.24 to 6.46) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-45 | 2.38 (0.00 to 19.99) | 1.59 (0.07 to 7.48) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-46 | 2.13 (0.00 to 17.04) | 1.37 (0.05 to 6.77) | 0.00 (0.00 to 16.11) |
| 6 - 12 years, Week 35-47 | 2.13 (0.00 to 17.04) | 1.31 (0.05 to 6.49) | 0.00 (0.00 to 11.22) |
| 6 - 12 years, Week 35-48 | 2.08 (0.00 to 16.23) | 1.25 (0.04 to 6.39) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 2.63 (0.01 to 18.97) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 2.22 (0.02 to 14.79) | 7.14 (0.04 to 41.49) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 35-41 | 1.82 (0.01 to 12.25) | 3.23 (0.01 to 24.14) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-42 | 1.69 (0.02 to 10.77) | 2.08 (0.02 to 13.45) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-43 | 1.64 (0.02 to 10.46) | 1.64 (0.01 to 11.31) | 0.00 (0.00 to 10.28) |
| 13 - 17 years, Week 35-44 | 1.61 (0.02 to 10.31) | 1.16 (0.01 to 8.31) | 0.00 (0.00 to 9.03) |
| 13 - 17 years, Week 35-45 | 1.43 (0.02 to 9.07) | 1.20 (0.15 to 4.28) | 1.23 (0.25 to 3.55) |
| 13 - 17 years, Week 35-46 | 1.32 (0.01 to 8.53) | 1.12 (0.14 to 4.00) | 1.22 (0.25 to 3.52) |
| 13 - 17 years, Week 35-47 | 1.22 (0.01 to 8.11) | 1.09 (0.13 to 3.89) | 1.20 (0.25 to 3.45) |
| 13 - 17 years, Week 35-48 | 1.16 (0.01 to 7.70) | 1.09 (0.13 to 3.87) | 1.20 (0.25 to 3.45) |
| 18 - 65 years, Week 35-37 | 9.87 (6.92 to 13.55) | 0.00 (0.00 to 84.19) | 22.22 (2.81 to 60.01) |
| 18 - 65 years, Week 35-38 | 8.56 (6.27 to 11.34) | 0.00 (0.00 to 70.76) | 13.33 (1.66 to 40.46) |
| 18 - 65 years, Week 35-39 | 8.52 (7.40 to 9.75) | 0.00 (0.00 to 45.93) | 10.00 (1.23 to 31.70) |
| 18 - 65 years, Week 35-40 | 8.49 (7.19 to 9.94) | 6.15 (1.70 to 15.01) | 6.90 (0.85 to 22.77) |
| 18 - 65 years, Week 35-41 | 7.97 (6.82 to 9.23) | 5.16 (2.25 to 9.92) | 5.13 (0.63 to 17.32) |
| 18 - 65 years, Week 35-42 | 7.64 (6.47 to 8.95) | 3.09 (1.34 to 6.00) | 4.65 (0.57 to 15.81) |
| 18 - 65 years, Week 35-43 | 7.51 (6.29 to 8.88) | 4.00 (2.26 to 6.51) | 3.57 (0.44 to 12.31) |
| 18 - 65 years, Week 35-44 | 7.29 (6.02 to 8.73) | 4.86 (3.07 to 7.26) | 3.13 (0.38 to 10.84) |
| 18 - 65 years, Week 35-45 | 7.09 (5.82 to 8.52) | 4.53 (2.89 to 6.72) | 4.08 (1.12 to 10.12) |
| 18 - 65 years, Week 35-46 | 7.00 (5.66 to 8.54) | 4.84 (3.21 to 6.96) | 3.92 (1.08 to 9.74) |
| 18 - 65 years, Week 35-47 | 6.89 (5.57 to 8.42) | 4.53 (3.01 to 6.52) | 3.42 (0.94 to 8.52) |
| 18 - 65 years, Week 35-48 | 6.79 (5.46 to 8.33) | 4.32 (2.87 to 6.22) | 3.31 (0.91 to 8.25) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 35-37 | 10.26 (8.87 to 11.78) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 30.85) |
| >65 years, Week 35-38 | 9.04 (7.70 to 10.54) | 12.50 (0.10 to 60.63) | 10.00 (0.88 to 34.70) |
| >65 years, Week 35-39 | 8.49 (7.30 to 9.80) | 9.09 (0.21 to 41.85) | 8.11 (1.70 to 21.91) |
| >65 years, Week 35-40 | 8.43 (7.22 to 9.77) | 3.85 (0.47 to 13.21) | 6.12 (1.28 to 16.87) |
| >65 years, Week 35-41 | 8.31 (7.08 to 9.68) | 5.34 (2.18 to 10.70) | 7.69 (2.14 to 18.54) |
| >65 years, Week 35-42 | 8.04 (6.77 to 9.47) | 5.61 (2.83 to 9.82) | 7.02 (1.95 to 17.00) |
| >65 years, Week 35-43 | 7.95 (6.66 to 9.39) | 5.05 (2.56 to 8.85) | 6.67 (1.85 to 16.20) |
| >65 years, Week 35-44 | 7.81 (6.57 to 9.21) | 5.57 (3.11 to 9.11) | 6.25 (1.73 to 15.24) |
| >65 years, Week 35-45 | 7.76 (6.52 to 9.16) | 6.61 (6.61 to 9.61) | 4.76 (0.69 to 15.23) |
| >65 years, Week 35-46 | 7.71 (6.45 to 9.14) | 6.27 (4.13 to 9.05) | 4.44 (0.54 to 15.14) |
| >65 years, Week 35-47 | 7.63 (6.35 to 9.08) | 6.11 (4.06 to 8.76) | 4.30 (0.52 to 14.72) |
| >65 years, Week 35-48 | 7.59 (6.31 to 9.05) | 5.82 (3.87 to 8.35) | 4.21 (0.49 to 14.59) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 1.45 (0.30 to 4.18) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.91) | 0.00 (0.00 to 60.24) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.49 (0.01 to 2.71) | 0.00 (0.00 to 24.71) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 3.21) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 36.94) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 4.76 (0.03 to 29.74) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 28.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | — |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.85) | — |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.59) | — |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 84.19) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 0.49 (0.01 to 2.69) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 37 | 0.56 (0.15 to 1.42) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 38 | 0.81 (0.13 to 2.66) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 45.93) |
| 18 - 65 years, Week 39 | 0.57 (0.24 to 1.11) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 52.18) |
| 18 - 65 years, Week 40 | 0.54 (0.05 to 2.16) | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 41 | 1.04 (0.02 to 1.39) | 0.00 (0.00 to 4.02) | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 42 | 0.00 (0.00 to 1.04) | 0.00 (0.00 to 3.48) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 43 | 0.46 (0.01 to 2.96) | 0.00 (0.00 to 3.13) | 0.00 (0.00 to 24.71) |
| 18 - 65 years, Week 44 | 0.32 (0.01 to 1.77) | 0.00 (0.00 to 4.62) | 0.00 (0.00 to 36.94) |
| 18 - 65 years, Week 45 | 0.00 (0.00 to 1.65) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 10.28) |
| 18 - 65 years, Week 46 | 0.45 (0.00 to 3.36) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 47 | 0.68 (0.00 to 4.94) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 37 | 0.40 (0.16 to 0.83) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 40.96) |
| >65 years, Week 38 | 0.38 (0.15 to 0.78) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 30.85) |
| >65 years, Week 39 | 0.41 (0.12 to 1.01) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 19.51) |
| >65 years, Week 40 | 0.23 (0.05 to 0.67) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 26.46) |
| >65 years, Week 41 | 0.40 (0.09 to 1.11) | 2.53 (0.31 to 8.85) | 0.00 (0.00 to 70.76) |
| >65 years, Week 42 | 0.00 (0.00 to 0.67) | 0.00 (0.00 to 5.52) | 0.00 (0.00 to 52.18) |
| >65 years, Week 43 | 0.36 (0.00 to 2.44) | 0.00 (0.00 to 4.45) | 0.00 (0.00 to 70.76) |
| >65 years, Week 44 | 0.23 (0.01 to 1.29) | 1.56 (0.00 to 64.84) | 0.00 (0.00 to 60.24) |
| >65 years, Week 45 | 0.00 (0.00 to 1.65) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 16.84) |
| >65 years, Week 46 | 0.88 (0.01 to 6.20) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 45.93) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 70.76) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 84.19) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 1.11 (0.14 to 3.88) | 0.00 (0.00 to 45.93) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.76 (0.06 to 3.15) | 0.00 (0.00 to 40.96) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.51 (0.02 to 2.44) | 0.00 (0.00 to 28.49) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.41 (0.01 to 2.18) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.43 (0.04 to 1.68) | 0.00 (0.00 to 11.94) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.38 (0.03 to 1.53) | 0.00 (0.00 to 11.22) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.34 (0.03 to 1.41) | 0.00 (0.00 to 9.74) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.32 (0.02 to 1.34) | 0.00 (0.00 to 8.04) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.31 (0.02 to 1.31) | 0.00 (0.00 to 7.40) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 2.44 (0.03 to 14.54) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 1.43 (0.01 to 9.35) | 0.00 (0.00 to 21.80) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 1.06 (0.01 to 7.27) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.84 (0.01 to 5.77) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.47 (0.00 to 3.56) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.32 (0.00 to 2.62) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.27 (0.00 to 2.31) | 0.00 (0.00 to 16.11) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.26 (0.00 to 2.22) | 0.00 (0.00 to 11.22) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.25 (0.00 to 2.15) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 10.28) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 9.03) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 2.20) | 0.41 (0.01 to 2.26) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.00 (0.00 to 2.05) | 0.41 (0.01 to 2.24) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 2.00) | 0.40 (0.01 to 2.20) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 1.98) | 0.40 (0.01 to 2.20) |
| 18 - 65 years, Week 35-37 | 0.56 (0.15 to 1.42) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 35-38 | 0.70 (0.22 to 1.64) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 35-39 | 0.63 (0.26 to 1.29) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 16.84) |
| 18 - 65 years, Week 35-40 | 0.62 (0.28 to 1.17) | 0.00 (0.00 to 5.52) | 0.00 (0.00 to 11.94) |
| 18 - 65 years, Week 35-41 | 0.57 (0.29 to 1.02) | 0.00 (0.00 to 2.35) | 0.00 (0.00 to 9.03) |
| 18 - 65 years, Week 35-42 | 0.53 (0.26 to 0.97) | 0.00 (0.00 to 1.41) | 0.00 (0.00 to 8.22) |
| 18 - 65 years, Week 35-43 | 0.53 (0.25 to 0.97) | 0.00 (0.00 to 0.98) | 0.00 (0.00 to 6.38) |
| 18 - 65 years, Week 35-44 | 0.51 (0.25 to 0.94) | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 5.60) |
| 18 - 65 years, Week 35-45 | 0.49 (0.24 to 0.90) | 0.00 (0.00 to 0.72) | 0.00 (0.00 to 3.69) |
| 18 - 65 years, Week 35-46 | 0.49 (0.22 to 0.94) | 0.00 (0.00 to 0.66) | 0.00 (0.00 to 3.55) |
| 18 - 65 years, Week 35-47 | 0.50 (0.24 to 0.91) | 0.00 (0.00 to 0.62) | 0.00 (0.00 to 3.10) |
| 18 - 65 years, Week 35-48 | 0.49 (0.24 to 0.89) | 0.00 (0.00 to 0.59) | 0.00 (0.00 to 3.00) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 35-37 | 0.40 (0.16 to 0.83) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 30.85) |
| >65 years, Week 35-38 | 0.39 (0.21 to 0.65) | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 16.84) |
| >65 years, Week 35-39 | 0.40 (0.22 to 0.66) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 9.49) |
| >65 years, Week 35-40 | 0.37 (0.22 to 0.58) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 7.25) |
| >65 years, Week 35-41 | 0.37 (0.24 to 0.55) | 1.53 (0.19 to 5.41) | 0.00 (0.00 to 6.85) |
| >65 years, Week 35-42 | 0.35 (0.22 to 0.53) | 1.02 (0.12 to 3.64) | 0.00 (0.00 to 6.27) |
| >65 years, Week 35-43 | 0.35 (0.22 to 0.54) | 0.72 (0.09 to 2.58) | 0.00 (0.00 to 5.96) |
| >65 years, Week 35-44 | 0.35 (0.21 to 0.53) | 0.88 (0.18 to 2.55) | 0.00 (0.00 to 5.60) |
| >65 years, Week 35-45 | 0.34 (0.21 to 0.52) | 0.79 (0.16 to 2.30) | 0.00 (0.00 to 4.30) |
| >65 years, Week 35-46 | 0.34 (0.21 to 0.54) | 0.72 (0.15 to 2.10) | 0.00 (0.00 to 4.02) |
| >65 years, Week 35-47 | 0.34 (0.20 to 0.54) | 0.68 (0.14 to 1.97) | 0.00 (0.00 to 3.89) |
| >65 years, Week 35-48 | 0.34 (0.20 to 0.53) | 0.65 (0.13 to 1.88) | 0.00 (0.00 to 3.81) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 1.77) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.91) | 0.00 (0.00 to 60.24) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.00 (0.00 to 1.80) | 0.00 (0.00 to 24.71) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 3.21) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 36.94) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 28.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | — |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.85) | — |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.59) | — |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 84.19) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 0.00 (0.00 to 1.78) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 37 | 3.06 (1.93 to 4.60) | 0.00 (0.00 to 84.19) | 11.11 (0.19 to 51.19) |
| 18 - 65 years, Week 38 | 3.03 (1.36 to 5.75) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 45.93) |
| 18 - 65 years, Week 39 | 2.12 (1.26 to 3.33) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 52.18) |
| 18 - 65 years, Week 40 | 3.10 (0.67 to 8.64) | 1.69 (0.04 to 9.09) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 41 | 1.26 (0.55 to 2.47) | 2.22 (0.27 to 7.80) | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 42 | 0.85 (0.06 to 3.52) | 0.00 (0.00 to 3.48) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 43 | 0.46 (0.01 to 2.96) | 1.72 (0.11 to 7.43) | 0.00 (0.00 to 24.71) |
| 18 - 65 years, Week 44 | 2.24 (0.76 to 5.02) | 1.28 (0.03 to 6.94) | 0.00 (0.00 to 36.94) |
| 18 - 65 years, Week 45 | 0.00 (0.00 to 1.65) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 10.28) |
| 18 - 65 years, Week 46 | 2.24 (0.30 to 7.65) | 4.00 (0.49 to 13.71) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 47 | 2.05 (0.10 to 9.40) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 37 | 1.38 (0.31 to 3.85) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 40.96) |
| >65 years, Week 38 | 0.97 (0.53 to 1.63) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 30.85) |
| >65 years, Week 39 | 1.80 (1.19 to 2.60) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 19.51) |
| >65 years, Week 40 | 1.31 (0.44 to 2.97) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 26.46) |
| >65 years, Week 41 | 1.59 (0.91 to 2.56) | 1.27 (0.03 to 6.85) | 0.00 (0.00 to 70.76) |
| >65 years, Week 42 | 0.37 (0.00 to 2.82) | 3.08 (0.37 to 10.68) | 0.00 (0.00 to 52.18) |
| >65 years, Week 43 | 0.36 (0.00 to 2.55) | 1.23 (0.00 to 73.92) | 0.00 (0.00 to 70.76) |
| >65 years, Week 44 | 0.47 (0.02 to 2.39) | 3.13 (0.00 to 46.96) | 0.00 (0.00 to 60.24) |
| >65 years, Week 45 | 1.35 (0.09 to 5.79) | 5.41 (0.00 to 99.64) | 0.00 (0.00 to 16.84) |
| >65 years, Week 46 | 0.00 (0.00 to 3.18) | 2.70 (0.00 to 99.94) | 0.00 (0.00 to 45.93) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 70.76) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 84.19) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 45.93) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.93) | 0.00 (0.00 to 40.96) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 0.63) | 0.00 (0.00 to 28.49) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.51) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 11.94) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.35) | 0.00 (0.00 to 11.22) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.31) | 0.00 (0.00 to 9.74) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.30) | 0.00 (0.00 to 8.04) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.29) | 0.00 (0.00 to 7.40) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 21.80) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.17) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 1.00) | 0.00 (0.00 to 16.11) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 11.22) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 0.92) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 10.28) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 9.03) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 2.20) | 0.00 (0.00 to 1.50) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.00 (0.00 to 2.05) | 0.00 (0.00 to 1.49) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 2.00) | 0.00 (0.00 to 1.46) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 1.98) | 0.00 (0.00 to 1.46) |
| 18 - 65 years, Week 35-37 | 3.06 (1.93 to 4.60) | 0.00 (0.00 to 84.19) | 11.11 (0.19 to 51.19) |
| 18 - 65 years, Week 35-38 | 3.04 (1.83 to 4.73) | 0.00 (0.00 to 70.76) | 6.67 (0.17 to 31.95) |
| 18 - 65 years, Week 35-39 | 2.61 (1.61 to 3.97) | 0.00 (0.00 to 45.93) | 5.00 (0.10 to 26.11) |
| 18 - 65 years, Week 35-40 | 2.70 (1.52 to 4.42) | 1.54 (0.04 to 8.28) | 3.45 (0.05 to 19.42) |
| 18 - 65 years, Week 35-41 | 2.49 (1.48 to 3.92) | 1.94 (0.40 to 5.55) | 2.56 (0.05 to 14.20) |
| 18 - 65 years, Week 35-42 | 2.37 (1.44 to 3.67) | 1.16 (0.24 to 3.35) | 2.33 (0.06 to 12.41) |
| 18 - 65 years, Week 35-43 | 2.29 (1.39 to 3.52) | 1.33 (0.43 to 3.08) | 1.79 (0.05 to 9.55) |
| 18 - 65 years, Week 35-44 | 2.28 (1.44 to 3.43) | 1.32 (0.49 to 2.86) | 1.56 (0.04 to 8.40) |
| 18 - 65 years, Week 35-45 | 2.19 (1.38 to 3.30) | 1.18 (0.43 to 2.55) | 1.02 (0.02 to 5.93) |
| 18 - 65 years, Week 35-46 | 2.19 (1.41 to 3.25) | 1.43 (0.62 to 2.81) | 0.98 (0.02 to 5.69) |
| 18 - 65 years, Week 35-47 | 2.19 (1.43 to 3.20) | 1.34 (0.58 to 2.63) | 0.85 (0.02 to 4.96) |
| 18 - 65 years, Week 35-48 | 2.16 (1.41 to 3.16) | 1.28 (0.55 to 2.51) | 0.83 (0.01 to 4.93) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 35-37 | 1.38 (0.31 to 3.85) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 30.85) |
| >65 years, Week 35-38 | 1.17 (0.47 to 2.42) | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 16.84) |
| >65 years, Week 35-39 | 1.44 (0.82 to 2.34) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 9.49) |
| >65 years, Week 35-40 | 1.42 (0.87 to 2.16) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 7.25) |
| >65 years, Week 35-41 | 1.44 (0.94 to 2.10) | 0.76 (0.02 to 4.18) | 0.00 (0.00 to 6.85) |
| >65 years, Week 35-42 | 1.37 (0.93 to 1.94) | 1.53 (0.32 to 4.41) | 0.00 (0.00 to 6.27) |
| >65 years, Week 35-43 | 1.34 (0.92 to 1.89) | 1.44 (0.39 to 3.66) | 0.00 (0.00 to 5.96) |
| >65 years, Week 35-44 | 1.30 (0.90 to 1.83) | 1.76 (0.65 to 3.79) | 0.00 (0.00 to 5.60) |
| >65 years, Week 35-45 | 1.31 (0.90 to 1.83) | 2.12 (0.92 to 4.13) | 0.00 (0.00 to 4.30) |
| >65 years, Week 35-46 | 1.29 (0.89 to 1.81) | 2.17 (1.00 to 4.08) | 0.00 (0.00 to 4.02) |
| >65 years, Week 35-47 | 1.28 (0.88 to 1.79) | 2.04 (0.94 to 3.83) | 0.00 (0.00 to 3.89) |
| >65 years, Week 35-48 | 1.27 (0.88 to 1.78) | 1.94 (0.89 to 3.65) | 0.00 (0.00 to 3.81) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 1.77) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.91) | 0.00 (0.00 to 60.24) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.49 (0.01 to 2.71) | 0.00 (0.00 to 24.71) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 3.21) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 36.94) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 9.52 (1.17 to 30.38) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 28.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | — |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.85) | — |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.99 (0.00 to 10.54) | — |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 84.19) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 0.49 (0.01 to 2.69) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 37 | 3.76 (2.09 to 6.18) | 0.00 (0.00 to 84.19) | 11.11 (0.03 to 62.14) |
| 18 - 65 years, Week 38 | 3.26 (1.90 to 5.19) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 45.93) |
| 18 - 65 years, Week 39 | 3.75 (2.61 to 5.18) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 52.18) |
| 18 - 65 years, Week 40 | 2.56 (1.55 to 3.98) | 3.39 (0.41 to 11.71) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 41 | 1.42 (0.65 to 2.67) | 2.22 (0.27 to 7.80) | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 42 | 2.54 (0.87 to 5.70) | 0.00 (0.00 to 3.48) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 43 | 0.46 (0.00 to 3.13) | 1.72 (0.11 to 7.43) | 0.00 (0.00 to 24.71) |
| 18 - 65 years, Week 44 | 1.60 (0.48 to 3.84) | 5.13 (0.23 to 22.68) | 0.00 (0.00 to 36.94) |
| 18 - 65 years, Week 45 | 0.90 (0.09 to 3.43) | 1.82 (0.00 to 93.05) | 0.00 (0.00 to 10.28) |
| 18 - 65 years, Week 46 | 0.45 (0.00 to 3.36) | 4.00 (0.00 to 40.02) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 47 | 0.00 (0.00 to 2.49) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 37 | 3.98 (3.11 to 5.01) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 40.96) |
| >65 years, Week 38 | 2.87 (2.06 to 3.88) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 30.85) |
| >65 years, Week 39 | 2.54 (1.78 to 3.51) | 0.00 (0.00 to 70.76) | 5.88 (0.15 to 28.69) |
| >65 years, Week 40 | 2.38 (1.49 to 3.59) | 2.44 (0.06 to 12.86) | 0.00 (0.00 to 26.46) |
| >65 years, Week 41 | 1.98 (1.17 to 3.13) | 2.53 (0.31 to 8.85) | 0.00 (0.00 to 70.76) |
| >65 years, Week 42 | 0.92 (0.11 to 3.23) | 1.54 (0.04 to 8.28) | 0.00 (0.00 to 52.18) |
| >65 years, Week 43 | 2.92 (1.11 to 6.13) | 2.47 (0.00 to 93.58) | 0.00 (0.00 to 70.76) |
| >65 years, Week 44 | 1.63 (0.53 to 3.74) | 1.56 (0.00 to 64.84) | 0.00 (0.00 to 60.24) |
| >65 years, Week 45 | 1.35 (0.11 to 5.51) | 5.41 (0.03 to 33.24) | 0.00 (0.00 to 16.84) |
| >65 years, Week 46 | 0.88 (0.01 to 6.20) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 45.93) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 70.76) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 84.19) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | 2Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 45.93) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.93) | 0.00 (0.00 to 40.96) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 0.63) | 0.00 (0.00 to 28.49) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.51) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.11 (0.00 to 0.78) | 0.00 (0.00 to 11.94) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.09 (0.00 to 0.70) | 0.00 (0.00 to 11.22) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.09 (0.00 to 0.62) | 0.00 (0.00 to 9.74) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.08 (0.00 to 0.58) | 0.00 (0.00 to 8.04) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.08 (0.00 to 0.56) | 0.00 (0.00 to 7.40) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 4.88 (0.60 to 16.53) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 2.86 (0.34 to 10.06) | 0.00 (0.00 to 21.80) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 2.13 (0.26 to 7.48) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 1.68 (0.20 to 5.94) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.94 (0.07 to 3.94) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.96 (0.02 to 5.20) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.82 (0.02 to 4.69) | 0.00 (0.00 to 16.11) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.79 (0.02 to 4.50) | 0.00 (0.00 to 11.22) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.75 (0.01 to 4.41) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 10.28) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 9.03) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 2.20) | 0.41 (0.01 to 2.26) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.00 (0.00 to 2.05) | 0.41 (0.01 to 2.24) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 2.00) | 0.40 (0.01 to 2.20) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 1.98) | 0.40 (0.01 to 2.20) |
| 18 - 65 years, Week 35-37 | 3.76 (2.09 to 6.18) | 0.00 (0.00 to 84.19) | 11.11 (0.03 to 62.14) |
| 18 - 65 years, Week 35-38 | 3.49 (2.10 to 5.41) | 0.00 (0.00 to 70.76) | 6.67 (0.04 to 38.91) |
| 18 - 65 years, Week 35-39 | 3.61 (2.61 to 4.85) | 0.00 (0.00 to 45.93) | 5.00 (0.03 to 30.57) |
| 18 - 65 years, Week 35-40 | 3.40 (2.60 to 4.37) | 3.08 (0.37 to 10.68) | 3.45 (0.05 to 19.42) |
| 18 - 65 years, Week 35-41 | 3.11 (2.30 to 4.11) | 2.58 (0.71 to 6.48) | 2.56 (0.06 to 13.56) |
| 18 - 65 years, Week 35-42 | 3.07 (2.29 to 4.02) | 1.54 (0.42 to 3.91) | 2.33 (0.05 to 12.95) |
| 18 - 65 years, Week 35-43 | 2.95 (2.17 to 3.92) | 1.60 (0.59 to 3.45) | 1.79 (0.03 to 10.14) |
| 18 - 65 years, Week 35-44 | 2.87 (2.10 to 3.83) | 2.21 (1.06 to 4.02) | 1.56 (0.02 to 9.62) |
| 18 - 65 years, Week 35-45 | 2.79 (2.05 to 3.71) | 2.17 (1.09 to 3.84) | 1.02 (0.03 to 5.55) |
| 18 - 65 years, Week 35-46 | 2.70 (1.95 to 3.65) | 2.33 (1.25 to 3.95) | 0.98 (0.02 to 5.34) |
| 18 - 65 years, Week 35-47 | 2.63 (1.89 to 3.57) | 2.18 (1.17 to 3.70) | 0.85 (0.02 to 4.67) |
| 18 - 65 years, Week 35-48 | 2.60 (1.85 to 3.53) | 2.08 (1.11 to 3.53) | 0.83 (0.02 to 4.52) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 35-37 | 3.98 (3.11 to 5.01) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 30.85) |
| >65 years, Week 35-38 | 3.40 (2.73 to 4.19) | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 16.84) |
| >65 years, Week 35-39 | 3.04 (2.29 to 3.95) | 0.00 (0.00 to 28.49) | 2.70 (0.07 to 14.16) |
| >65 years, Week 35-40 | 2.92 (2.19 to 3.83) | 1.92 (0.05 to 10.26) | 2.04 (0.05 to 10.85) |
| >65 years, Week 35-41 | 2.81 (2.11 to 3.67) | 2.29 (0.47 to 6.55) | 1.92 (0.05 to 10.26) |
| >65 years, Week 35-42 | 2.70 (1.98 to 3.59) | 2.04 (0.56 to 5.14) | 1.75 (0.04 to 9.39) |
| >65 years, Week 35-43 | 2.71 (1.98 to 3.61) | 2.17 (0.80 to 4.65) | 1.67 (0.04 to 8.94) |
| >65 years, Week 35-44 | 2.66 (1.94 to 3.56) | 2.05 (0.83 to 4.18) | 1.56 (0.04 to 8.40) |
| >65 years, Week 35-45 | 2.63 (1.92 to 3.52) | 2.38 (1.09 to 4.47) | 1.19 (0.02 to 7.24) |
| >65 years, Week 35-46 | 2.61 (1.89 to 3.51) | 2.17 (1.00 to 4.08) | 1.11 (0.01 to 7.09) |
| >65 years, Week 35-47 | 2.58 (1.86 to 3.49) | 2.04 (0.91 to 3.89) | 1.08 (0.01 to 6.96) |
| >65 years, Week 35-48 | 2.57 (1.85 to 3.47) | 1.94 (0.84 to 3.79) | 1.05 (0.01 to 6.88) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 2.90 (1.07 to 6.20) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 1.63 (0.02 to 10.28) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.52 (0.00 to 3.94) | 0.00 (0.00 to 60.24) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 1.97 (0.07 to 9.78) | 0.00 (0.00 to 24.71) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 3.21) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 36.94) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 40 | 33.33 (0.00 to 100) | 9.52 (1.17 to 30.38) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 28.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | — |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 1.06 (0.02 to 5.93) | — |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.59) | — |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 84.19) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 7.14 (0.02 to 44.90) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 11.11 (0.19 to 51.19) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 1.46 (0.30 to 4.22) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 37 | 5.98 (3.78 to 8.93) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 38 | 3.38 (2.06 to 5.20) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 45.93) |
| 18 - 65 years, Week 39 | 4.66 (3.43 to 6.18) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 52.18) |
| 18 - 65 years, Week 40 | 3.24 (2.01 to 4.91) | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 41 | 2.52 (1.45 to 4.06) | 2.22 (0.27 to 7.80) | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 42 | 1.69 (0.61 to 3.69) | 0.00 (0.00 to 3.48) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 43 | 1.83 (0.30 to 5.81) | 5.17 (1.92 to 10.92) | 0.00 (0.00 to 24.71) |
| 18 - 65 years, Week 44 | 1.60 (0.52 to 3.69) | 1.28 (0.03 to 6.94) | 0.00 (0.00 to 36.94) |
| 18 - 65 years, Week 45 | 1.80 (0.46 to 4.69) | 1.82 (0.00 to 93.05) | 5.88 (0.72 to 19.68) |
| 18 - 65 years, Week 46 | 1.35 (0.21 to 4.35) | 6.00 (0.00 to 54.61) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 47 | 2.74 (0.36 to 9.27) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 37 | 5.71 (4.66 to 6.91) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 40.96) |
| >65 years, Week 38 | 4.17 (3.29 to 5.20) | 16.67 (0.00 to 91.51) | 10.00 (0.25 to 44.50) |
| >65 years, Week 39 | 4.00 (2.98 to 5.25) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 19.51) |
| >65 years, Week 40 | 5.30 (2.90 to 8.81) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 26.46) |
| >65 years, Week 41 | 3.87 (2.34 to 5.97) | 3.80 (0.79 to 10.70) | 0.00 (0.00 to 70.76) |
| >65 years, Week 42 | 2.38 (0.86 to 5.17) | 1.54 (0.04 to 8.28) | 0.00 (0.00 to 52.18) |
| >65 years, Week 43 | 3.28 (1.32 to 6.67) | 1.23 (0.00 to 73.92) | 0.00 (0.00 to 70.76) |
| >65 years, Week 44 | 3.02 (0.48 to 9.57) | 6.25 (0.14 to 30.86) | 0.00 (0.00 to 60.24) |
| >65 years, Week 45 | 1.80 (0.29 to 5.74) | 8.11 (0.00 to 99.99) | 0.00 (0.00 to 16.84) |
| >65 years, Week 46 | 1.75 (0.12 to 7.34) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 45.93) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 3.70 (0.00 to 99.88) | 0.00 (0.00 to 70.76) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 84.19) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 2.22 (0.58 to 5.73) | 0.00 (0.00 to 45.93) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 2.04 (0.32 to 6.56) | 0.00 (0.00 to 40.96) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 1.54 (0.25 to 4.89) | 0.00 (0.00 to 28.49) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 1.24 (0.15 to 4.43) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 1.40 (0.25 to 4.31) | 0.00 (0.00 to 11.94) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 1.23 (0.20 to 3.94) | 0.00 (0.00 to 11.22) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 1.11 (0.17 to 3.60) | 0.00 (0.00 to 9.74) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 1.05 (0.16 to 3.42) | 0.00 (0.00 to 8.04) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 1.02 (0.16 to 3.35) | 0.00 (0.00 to 7.40) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 35-40 | 3.70 (0.00 to 39.49) | 4.88 (0.60 to 16.53) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 35-41 | 3.45 (0.00 to 35.58) | 2.86 (0.34 to 10.06) | 0.00 (0.00 to 21.80) |
| 6 - 12 years, Week 35-42 | 2.94 (0.00 to 26.56) | 2.13 (0.26 to 7.48) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-43 | 2.86 (0.00 to 25.94) | 1.68 (0.20 to 5.94) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-44 | 2.44 (0.00 to 20.29) | 1.41 (0.26 to 4.26) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-45 | 2.38 (0.00 to 19.99) | 0.96 (0.08 to 3.79) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-46 | 2.13 (0.00 to 17.04) | 0.82 (0.06 to 3.47) | 0.00 (0.00 to 16.11) |
| 6 - 12 years, Week 35-47 | 2.13 (0.00 to 17.04) | 0.79 (0.06 to 3.32) | 0.00 (0.00 to 11.22) |
| 6 - 12 years, Week 35-48 | 2.08 (0.00 to 16.23) | 0.75 (0.05 to 3.29) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 2.63 (0.01 to 18.97) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 2.22 (0.02 to 14.79) | 7.14 (0.04 to 41.49) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 35-41 | 1.82 (0.01 to 12.25) | 3.23 (0.01 to 24.14) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-42 | 1.69 (0.02 to 10.77) | 2.08 (0.02 to 13.45) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-43 | 1.64 (0.02 to 10.46) | 1.64 (0.01 to 11.31) | 0.00 (0.00 to 10.28) |
| 13 - 17 years, Week 35-44 | 1.61 (0.02 to 10.31) | 1.16 (0.01 to 8.31) | 0.00 (0.00 to 9.03) |
| 13 - 17 years, Week 35-45 | 1.43 (0.02 to 9.07) | 0.60 (0.00 to 5.27) | 1.23 (0.25 to 3.55) |
| 13 - 17 years, Week 35-46 | 1.32 (0.01 to 8.53) | 0.56 (0.00 to 4.82) | 1.22 (0.25 to 3.52) |
| 13 - 17 years, Week 35-47 | 1.22 (0.01 to 8.11) | 0.55 (0.00 to 4.69) | 1.20 (0.25 to 3.45) |
| 13 - 17 years, Week 35-48 | 1.16 (0.01 to 7.70) | 0.54 (0.00 to 4.66) | 1.20 (0.25 to 3.45) |
| 18 - 65 years, Week 35-37 | 5.98 (3.78 to 8.93) | 0.0 (0.0 to 84.19) | 0.0 (0.0 to 33.63) |
| 18 - 65 years, Week 35-38 | 4.56 (3.03 to 6.56) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 35-39 | 4.61 (3.81 to 5.53) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 16.84) |
| 18 - 65 years, Week 35-40 | 4.34 (3.70 to 5.06) | 0.00 (0.00 to 5.52) | 0.00 (0.00 to 11.94) |
| 18 - 65 years, Week 35-41 | 4.07 (3.51 to 4.70) | 1.29 (0.16 to 4.58) | 0.00 (0.00 to 9.03) |
| 18 - 65 years, Week 35-42 | 3.90 (3.28 to 4.59) | 0.77 (0.09 to 2.76) | 0.00 (0.00 to 8.22) |
| 18 - 65 years, Week 35-43 | 3.80 (3.19 to 4.50) | 2.13 (0.93 to 4.16) | 0.00 (0.00 to 6.38) |
| 18 - 65 years, Week 35-44 | 3.67 (3.08 to 4.34) | 1.99 (0.91 to 3.74) | 0.00 (0.00 to 5.60) |
| 18 - 65 years, Week 35-45 | 3.60 (3.03 to 4.23) | 1.97 (0.95 to 3.59) | 2.04 (0.14 to 8.50) |
| 18 - 65 years, Week 35-46 | 3.51 (2.96 to 4.13) | 2.33 (1.25 to 3.95) | 1.96 (0.13 to 8.26) |
| 18 - 65 years, Week 35-47 | 3.49 (2.98 to 4.06) | 2.18 (1.17 to 3.70) | 1.71 (0.11 to 7.37) |
| 18 - 65 years, Week 35-48 | 3.44 (2.93 to 4.00) | 2.08 (1.11 to 3.53) | 1.65 (0.12 to 6.86) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 35-37 | 5.71 (4.66 to 6.90) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 30.85) |
| >65 years, Week 35-38 | 4.91 (4.23 to 5.67) | 12.50 (0.10 to 60.63) | 5.00 (0.13 to 24.87) |
| >65 years, Week 35-39 | 4.52 (3.80 to 5.34) | 9.09 (0.21 to 41.85) | 2.70 (0.07 to 14.16) |
| >65 years, Week 35-40 | 4.66 (3.75 to 5.71) | 1.92 (0.05 to 10.26) | 2.04 (0.05 to 10.85) |
| >65 years, Week 35-41 | 4.56 (3.64 to 5.65) | 3.05 (0.84 to 7.63) | 1.92 (0.05 to 10.26) |
| >65 years, Week 35-42 | 4.43 (3.48 to 5.56) | 2.55 (0.83 to 5.85) | 1.75 (0.04 to 9.39) |
| >65 years, Week 35-43 | 4.40 (3.43 to 5.55) | 2.17 (0.80 to 4.65) | 1.67 (0.04 to 8.94) |
| >65 years, Week 35-44 | 4.34 (3.40 to 5.45) | 2.93 (1.42 to 5.33) | 1.56 (0.04 to 8.40) |
| >65 years, Week 35-45 | 4.28 (3.34 to 5.40) | 3.44 (1.84 to 5.81) | 1.19 (0.02 to 7.24) |
| >65 years, Week 35-46 | 4.26 (3.30 to 5.39) | 3.13 (1.68 to 5.30) | 1.11 (0.01 to 7.09) |
| >65 years, Week 35-47 | 4.21 (3.25 to 5.36) | 3.17 (1.74 to 5.26) | 1.08 (0.01 to 6.96) |
| >65 years, Week 35-48 | 4.19 (3.23 to 5.34) | 3.02 (1.66 to 5.01) | 1.05 (0.01 to 6.88) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.97 (0.12 to 3.45) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.91) | 0.00 (0.00 to 60.24) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.00 (0.00 to 1.80) | 0.00 (0.00 to 24.71) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 3.21) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 36.94) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 28.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | — |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.85) | — |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.99 (0.00 to 10.54) | — |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 84.19) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 1.25 (0.03 to 6.77) | 0.49 (0.01 to 2.69) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 37 | 1.95 (0.56 to 4.80) | 0.00 (0.00 to 84.19) | 11.11 (0.03 to 62.14) |
| 18 - 65 years, Week 38 | 1.63 (0.59 to 3.56) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 45.93) |
| 18 - 65 years, Week 39 | 1.77 (0.70 to 3.63) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 52.18) |
| 18 - 65 years, Week 40 | 1.62 (0.46 to 4.04) | 3.39 (0.41 to 11.71) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 41 | 0.94 (0.35 to 2.05) | 0.00 (0.00 to 4.02) | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 42 | 0.85 (0.12 to 2.86) | 0.00 (0.00 to 3.48) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 43 | 0.00 (0.00 to 1.68) | 0.00 (0.00 to 3.13) | 0.00 (0.00 to 24.71) |
| 18 - 65 years, Week 44 | 0.32 (0.00 to 2.44) | 1.28 (0.03 to 6.94) | 0.00 (0.00 to 36.94) |
| 18 - 65 years, Week 45 | 0.00 (0.00 to 1.65) | 1.82 (0.00 to 93.05) | 0.00 (0.00 to 10.28) |
| 18 - 65 years, Week 46 | 0.00 (0.00 to 1.64) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 47 | 0.00 (0.00 to 2.49) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 37 | 2.08 (0.98 to 3.85) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 40.96) |
| >65 years, Week 38 | 1.68 (1.10 to 2.44) | 16.67 (0.00 to 91.51) | 0.00 (0.00 to 30.85) |
| >65 years, Week 39 | 1.12 (0.73 to 1.66) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 19.51) |
| >65 years, Week 40 | 1.23 (0.52 to 2.45) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 26.46) |
| >65 years, Week 41 | 1.29 (0.59 to 2.43) | 2.53 (0.31 to 8.85) | 0.00 (0.00 to 70.76) |
| >65 years, Week 42 | 0.55 (0.09 to 1.80) | 0.00 (0.00 to 5.52) | 0.00 (0.00 to 52.18) |
| >65 years, Week 43 | 0.73 (0.06 to 2.90) | 0.00 (0.00 to 4.45) | 0.00 (0.00 to 70.76) |
| >65 years, Week 44 | 0.47 (0.06 to 1.67) | 1.56 (0.00 to 64.84) | 0.00 (0.00 to 60.24) |
| >65 years, Week 45 | 2.70 (0.54 to 7.83) | 2.70 (0.00 to 93.12) | 0.00 (0.00 to 16.84) |
| >65 years, Week 46 | 2.63 (0.20 to 10.66) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 45.93) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 70.76) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 84.19) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 0.74 (0.09 to 2.65) | 0.00 (0.00 to 45.93) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.51 (0.04 to 2.11) | 0.00 (0.00 to 40.96) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.34 (0.02 to 1.63) | 0.00 (0.00 to 28.49) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.28 (0.01 to 1.46) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.22 (0.00 to 1.24) | 0.00 (0.00 to 11.94) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.19 (0.00 to 1.12) | 0.00 (0.00 to 11.22) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.17 (0.00 to 1.04) | 0.00 (0.00 to 9.74) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.16 (0.00 to 0.99) | 0.00 (0.00 to 8.04) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.16 (0.00 to 0.97) | 0.00 (0.00 to 7.40) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 21.80) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.32 (0.00 to 2.62) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.27 (0.00 to 2.31) | 0.00 (0.00 to 16.11) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.26 (0.00 to 2.22) | 0.00 (0.00 to 11.22) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.25 (0.00 to 2.15) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 10.28) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 9.03) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.60 (0.02 to 3.31) | 0.41 (0.01 to 2.26) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.56 (0.01 to 3.09) | 0.41 (0.01 to 2.24) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.55 (0.01 to 3.01) | 0.40 (0.01 to 2.20) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.54 (0.01 to 2.99) | 0.40 (0.01 to 2.20) |
| 18 - 65 years, Week 35-37 | 1.95 (0.56 to 4.80) | 0.00 (0.00 to 84.19) | 11.11 (0.03 to 62.14) |
| 18 - 65 years, Week 35-38 | 1.77 (0.60 to 4.01) | 0.00 (0.00 to 70.76) | 6.67 (0.04 to 38.91) |
| 18 - 65 years, Week 35-39 | 1.77 (0.84 to 3.26) | 0.00 (0.00 to 45.93) | 5.00 (0.03 to 30.57) |
| 18 - 65 years, Week 35-40 | 1.74 (0.99 to 2.82) | 3.08 (0.37 to 10.68) | 3.45 (0.05 to 19.42) |
| 18 - 65 years, Week 35-41 | 1.63 (0.95 to 2.58) | 1.29 (0.16 to 4.58) | 2.56 (0.06 to 13.56) |
| 18 - 65 years, Week 35-42 | 1.57 (0.93 to 2.47) | 0.77 (0.09 to 2.76) | 2.33 (0.05 to 12.95) |
| 18 - 65 years, Week 35-43 | 1.50 (0.87 to 2.40) | 0.53 (0.06 to 1.91) | 1.79 (0.03 to 10.14) |
| 18 - 65 years, Week 35-44 | 1.43 (0.81 to 2.32) | 0.66 (0.14 to 1.92) | 1.56 (0.02 to 9.62) |
| 18 - 65 years, Week 35-45 | 1.37 (0.77 to 2.24) | 0.79 (0.21 to 2.00) | 1.02 (0.03 to 5.55) |
| 18 - 65 years, Week 35-46 | 1.32 (0.73 to 2.17) | 0.72 (0.20 to 1.83) | 0.98 (0.02 to 5.34) |
| 18 - 65 years, Week 35-47 | 1.28 (0.71 to 2.12) | 0.67 (0.18 to 1.71) | 0.85 (0.02 to 4.67) |
| 18 - 65 years, Week 35-48 | 1.26 (0.70 to 2.09) | 0.64 (0.17 to 1.63) | 0.83 (0.02 to 4.52) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 35-37 | 2.07 (0.98 to 3.84) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 30.85) |
| >65 years, Week 35-38 | 1.87 (1.45 to 2.37) | 12.50 (0.10 to 60.63) | 0.00 (0.00 to 16.84) |
| >65 years, Week 35-39 | 1.55 (1.15 to 2.04) | 9.09 (0.21 to 41.85) | 0.00 (0.00 to 9.49) |
| >65 years, Week 35-40 | 1.50 (1.11 to 1.97) | 1.92 (0.05 to 10.26) | 0.00 (0.00 to 7.25) |
| >65 years, Week 35-41 | 1.47 (1.10 to 1.93) | 2.29 (0.47 to 6.55) | 0.00 (0.00 to 6.85) |
| >65 years, Week 35-42 | 1.42 (1.07 to 1.83) | 1.53 (0.32 to 4.41) | 0.00 (0.00 to 6.27) |
| >65 years, Week 35-43 | 1.40 (1.06 to 1.81) | 1.08 (0.22 to 3.13) | 0.00 (0.00 to 5.96) |
| >65 years, Week 35-44 | 1.35 (1.04 to 1.73) | 1.17 (0.32 to 2.98) | 0.00 (0.00 to 5.60) |
| >65 years, Week 35-45 | 1.38 (1.09 to 1.73) | 1.32 (0.43 to 3.06) | 0.00 (0.00 to 4.30) |
| >65 years, Week 35-46 | 1.40 (1.09 to 1.77) | 1.20 (0.39 to 2.79) | 0.00 (0.00 to 4.02) |
| >65 years, Week 35-47 | 1.38 (1.08 to 1.75) | 1.13 (0.37 to 2.62) | 0.00 (0.00 to 3.89) |
| >65 years, Week 35-48 | 1.38 (1.07 to 1.74) | 1.08 (0.35 to 2.50) | 0.00 (0.00 to 3.81) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial oedema and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 1.77) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.91) | 0.00 (0.00 to 60.24) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.00 (0.00 to 1.80) | 0.00 (0.00 to 24.71) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 3.21) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 36.94) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 28.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | — |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.85) | — |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.59) | — |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 84.19) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 0.00 (0.00 to 1.78) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 37 | 0.56 (0.01 to 3.49) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 38 | 0.70 (0.06 to 2.79) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 45.93) |
| 18 - 65 years, Week 39 | 0.71 (0.05 to 3.00) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 52.18) |
| 18 - 65 years, Week 40 | 0.27 (0.03 to 0.97) | 3.39 (0.41 to 11.71) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 41 | 0.31 (0.01 to 1.85) | 1.11 (0.03 to 6.04) | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 42 | 0.00 (0.00 to 1.04) | 0.00 (0.00 to 3.48) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 43 | 0.00 (0.00 to 1.68) | 0.00 (0.00 to 3.13) | 0.00 (0.00 to 24.71) |
| 18 - 65 years, Week 44 | 0.00 (0.00 to 1.17) | 3.85 (0.18 to 17.30) | 0.00 (0.00 to 36.94) |
| 18 - 65 years, Week 45 | 0.00 (0.00 to 1.65) | 0.00 (0.00 to 6.49) | 2.94 (0.07 to 15.33) |
| 18 - 65 years, Week 46 | 0.45 (0.00 to 3.36) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 47 | 0.00 (0.00 to 2.49) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 37 | 0.69 (0.01 to 4.78) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 40.96) |
| >65 years, Week 38 | 0.49 (0.08 to 1.58) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 30.85) |
| >65 years, Week 39 | 0.19 (0.02 to 0.74) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 19.51) |
| >65 years, Week 40 | 0.46 (0.03 to 2.06) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 26.46) |
| >65 years, Week 41 | 0.20 (0.01 to 0.94) | 1.27 (0.03 to 6.85) | 0.00 (0.00 to 70.76) |
| >65 years, Week 42 | 0.00 (0.00 to 0.67) | 0.00 (0.00 to 5.52) | 0.00 (0.00 to 52.18) |
| >65 years, Week 43 | 0.36 (0.00 to 2.55) | 0.00 (0.00 to 4.45) | 0.00 (0.00 to 70.76) |
| >65 years, Week 44 | 0.47 (0.02 to 2.39) | 0.00 (0.00 to 5.60) | 0.00 (0.00 to 60.24) |
| >65 years, Week 45 | 0.00 (0.00 to 1.65) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 16.84) |
| >65 years, Week 46 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 45.93) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 70.76) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 84.19) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35- 40 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 45.93) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.93) | 0.00 (0.00 to 40.96) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 0.63) | 0.00 (0.00 to 28.49) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.51) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 11.94) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.35) | 0.00 (0.00 to 11.22) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.31) | 0.00 (0.00 to 9.74) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.30) | 0.00 (0.00 to 8.04) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.29) | 0.00 (0.00 to 7.40) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 21.80) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.17) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 1.00) | 0.00 (0.00 to 16.11) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 11.22) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 0.92) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 10.28) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 9.03) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 2.20) | 0.00 (0.00 to 1.50) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.00 (0.00 to 2.05) | 0.00 (0.00 to 1.49) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 2.00) | 0.00 (0.00 to 1.46) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 1.98) | 0.00 (0.00 to 1.46) |
| 18 - 65 years, Week 35-37 | 0.56 (0.01 to 3.49) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 35-38 | 0.63 (0.03 to 2.94) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 35-39 | 0.67 (0.04 to 2.90) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 16.84) |
| 18 - 65 years, Week 35-40 | 0.59 (0.05 to 2.39) | 3.08 (0.37 to 10.68) | 0.00 (0.00 to 11.94) |
| 18 - 65 years, Week 35-41 | 0.55 (0.06 to 2.08) | 1.94 (0.40 to 5.55) | 0.00 (0.00 to 9.03) |
| 18 - 65 years, Week 35-42 | 0.51 (0.05 to 1.97) | 1.16 (0.24 to 3.35) | 0.00 (0.00 to 8.22) |
| 18 - 65 years, Week 35-43 | 0.49 (0.05 to 1.91) | 0.80 (0.17 to 2.32) | 0.00 (0.00 to 6.38) |
| 18 - 65 years, Week 35-44 | 0.46 (0.04 to 1.82) | 1.32 (0.49 to 2.86) | 0.00 (0.00 to 5.60) |
| 18 - 65 years, Week 35-45 | 0.44 (0.04 to 1.76) | 1.18 (0.43 to 2.55) | 1.02 (0.03 to 5.55) |
| 18 - 65 years, Week 35-46 | 0.44 (0.04 to 1.80) | 1.08 (0.40 to 2.33) | 0.98 (0.02 to 5.34) |
| 18 - 65 years, Week 35-47 | 0.43 (0.03 to 1.76) | 1.01 (0.37 to 2.18) | 0.85 (0.02 to 4.67) |
| 18 - 65 years, Week 35-48 | 0.42 (0.03 to 1.73) | 0.96 (0.35 to 2.08) | 0.83 (0.02 to 4.52) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 35-37 | 0.69 (0.01 to 4.78) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 30.85) |
| >65 years, Week 35-38 | 0.59 (0.03 to 2.82) | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 16.84) |
| >65 years, Week 35-39 | 0.42 (0.02 to 1.91) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 9.49) |
| >65 years, Week 35-40 | 0.42 (0.02 to 1.92) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 7.25) |
| >65 years, Week 35-41 | 0.40 (0.03 to 1.71) | 0.76 (0.02 to 4.18) | 0.00 (0.00 to 6.85) |
| >65 years, Week 35-42 | 0.37 (0.02 to 1.63) | 0.51 (0.01 to 2.81) | 0.00 (0.00 to 6.27) |
| >65 years, Week 35-43 | 0.37 (0.03 to 1.57) | 0.36 (0.01 to 1.99) | 0.00 (0.00 to 5.96) |
| >65 years, Week 35-44 | 0.38 (0.03 to 1.49) | 0.29 (0.01 to 1.62) | 0.00 (0.00 to 5.60) |
| >65 years, Week 35-45 | 0.37 (0.03 to 1.46) | 0.26 (0.01 to 1.47) | 0.00 (0.00 to 4.30) |
| >65 years, Week 35-46 | 0.36 (0.03 to 1.45) | 0.24 (0.01 to 1.34) | 0.00 (0.00 to 4.02) |
| >65 years, Week 35-47 | 0.36 (0.03 to 1.43) | 0.23 (0.01 to 1.25) | 0.00 (0.00 to 3.89) |
| >65 years, Week 35-48 | 0.36 (0.03 to 1.43) | 0.22 (0.01 to 1.19) | 0.00 (0.00 to 3.81) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 1.77) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.91) | 0.00 (0.00 to 60.24) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.00 (0.00 to 1.80) | 0.00 (0.00 to 24.71) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 3.21) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 36.94) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 28.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | — |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.85) | — |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.59) | — |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 84.19) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 0.00 (0.00 to 1.78) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 37 | 0.28 (0.00 to 1.80) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 38 | 0.47 (0.07 to 1.58) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 45.93) |
| 18 - 65 years, Week 39 | 0.35 (0.11 to 0.82) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 52.18) |
| 18 - 65 years, Week 40 | 0.54 (0.15 to 1.38) | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 41 | 0.00 (0.00 to 0.58) | 0.00 (0.00 to 4.02) | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 42 | 0.00 (0.00 to 1.04) | 0.00 (0.00 to 3.48) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 43 | 0.92 (0.08 to 3.71) | 0.00 (0.00 to 3.13) | 0.00 (0.00 to 24.71) |
| 18 - 65 years, Week 44 | 0.64 (0.06 to 2.51) | 0.00 (0.00 to 4.62) | 0.00 (0.00 to 36.94) |
| 18 - 65 years, Week 45 | 0.00 (0.00 to 1.65) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 10.28) |
| 18 - 65 years, Week 46 | 0.45 (0.00 to 3.27) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 47 | 0.00 (0.00 to 2.49) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 37 | 0.63 (0.28 to 1.22) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 40.96) |
| >65 years, Week 38 | 0.22 (0.04 to 0.68) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 30.85) |
| >65 years, Week 39 | 0.11 (0.02 to 0.36) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 19.51) |
| >65 years, Week 40 | 0.38 (0.12 to 0.89) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 26.46) |
| >65 years, Week 41 | 0.20 (0.02 to 0.71) | 1.27 (0.03 to 6.85) | 0.00 (0.00 to 70.76) |
| >65 years, Week 42 | 0.00 (0.00 to 0.67) | 0.00 (0.00 to 5.52) | 0.00 (0.00 to 52.18) |
| >65 years, Week 43 | 0.00 (0.00 to 1.34) | 0.00 (0.00 to 4.45) | 0.00 (0.00 to 70.76) |
| >65 years, Week 44 | 0.23 (0.01 to 1.29) | 0.00 (0.00 to 5.60) | 0.00 (0.00 to 60.24) |
| >65 years, Week 45 | 0.00 (0.00 to 1.65) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 16.84) |
| >65 years, Week 46 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 45.93) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 70.76) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 84.19) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 45.93) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.93) | 0.00 (0.00 to 40.96) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 0.63) | 0.00 (0.00 to 28.49) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.51) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 11.94) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.35) | 0.00 (0.00 to 11.22) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.31) | 0.00 (0.00 to 9.74) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.30) | 0.00 (0.00 to 8.04) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.29) | 0.00 (0.00 to 7.40) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 21.80) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.17) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 1.00) | 0.00 (0.00 to 16.11) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 11.22) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 0.92) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 10.28) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 9.03) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 2.20) | 0.00 (0.00 to 1.50) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.00 (0.00 to 2.05) | 0.00 (0.00 to 1.49) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 2.00) | 0.00 (0.00 to 1.46) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 1.98) | 0.00 (0.00 to 1.46) |
| 18 - 65 years, Week 35-37 | 0.28 (0.00 to 1.80) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 35-38 | 0.38 (0.12 to 0.89) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 35-39 | 0.37 (0.18 to 0.66) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 16.84) |
| 18 - 65 years, Week 35-40 | 0.40 (0.22 to 0.67) | 0.00 (0.00 to 5.52) | 0.00 (0.00 to 11.94) |
| 18 - 65 years, Week 35-41 | 0.34 (0.19 to 0.57) | 0.00 (0.00 to 2.35) | 0.00 (0.00 to 9.03) |
| 18 - 65 years, Week 35-42 | 0.32 (0.18 to 0.52) | 0.00 (0.00 to 1.41) | 0.00 (0.00 to 8.22) |
| 18 - 65 years, Week 35-43 | 0.34 (0.20 to 0.55) | 0.00 (0.00 to 0.98) | 0.00 (0.00 to 6.38) |
| 18 - 65 years, Week 35-44 | 0.36 (0.22 to 0.57) | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 5.60) |
| 18 - 65 years, Week 35-45 | 0.35 (0.21 to 0.55) | 0.00 (0.00 to 0.72) | 0.00 (0.00 to 3.69) |
| 18 - 65 years, Week 35-46 | 0.35 (0.21 to 0.54) | 0.00 (0.00 to 0.66) | 0.00 (0.00 to 3.55) |
| 18 - 65 years, Week 35-47 | 0.34 (0.21 to 0.53) | 0.00 (0.00 to 0.62) | 0.00 (0.00 to 3.10) |
| 18 - 65 years, Week 35-48 | 0.34 (0.21 to 0.52) | 0.00 (0.00 to 0.59) | 0.00 (0.00 to 3.00) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 35-37 | 0.63 (0.28 to 1.22) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 30.85) |
| >65 years, Week 35-38 | 0.42 (0.18 to 0.82) | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 16.84) |
| >65 years, Week 35-39 | 0.29 (0.13 to 0.56) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 9.49) |
| >65 years, Week 35-40 | 0.30 (0.16 to 0.54) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 7.25) |
| >65 years, Week 35-41 | 0.29 (0.15 to 0.50) | 0.76 (0.02 to 4.18) | 0.00 (0.00 to 6.85) |
| >65 years, Week 35-42 | 0.27 (0.15 to 0.47) | 0.51 (0.01 to 2.81) | 0.00 (0.00 to 6.27) |
| >65 years, Week 35-43 | 0.27 (0.14 to 0.45) | 0.36 (0.01 to 1.99) | 0.00 (0.00 to 5.96) |
| >65 years, Week 35-44 | 0.26 (0.15 to 0.43) | 0.29 (0.01 to 1.62) | 0.00 (0.00 to 5.60) |
| >65 years, Week 35-45 | 0.26 (0.15 to 0.42) | 0.26 (0.01 to 1.47) | 0.00 (0.00 to 4.30) |
| >65 years, Week 35-46 | 0.26 (0.14 to 0.42) | 0.24 (0.01 to 1.34) | 0.00 (0.00 to 4.02) |
| >65 years, Week 35-47 | 0.25 (0.14 to 0.42) | 0.23 (0.01 to 1.25) | 0.00 (0.00 to 3.89) |
| >65 years, Week 35-48 | 0.25 (0.14 to 0.41) | 0.22 (0.01 to 1.19) | 0.00 (0.00 to 3.81) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 1.77) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.91) | 0.00 (0.00 to 60.24) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.00 (0.00 to 1.80) | 0.00 (0.00 to 24.71) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 3.21) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 36.94) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 28.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | — |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.85) | — |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.59) | — |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 84.19) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 0.49 (0.01 to 2.69) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 37 | 4.59 (3.10 to 6.51) | 0.00 (0.00 to 84.19) | 11.11 (0.19 to 51.19) |
| 18 - 65 years, Week 38 | 2.91 (1.89 to 4.27) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 45.93) |
| 18 - 65 years, Week 39 | 2.76 (1.88 to 3.89) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 52.18) |
| 18 - 65 years, Week 40 | 2.56 (1.55 to 3.98) | 5.08 (1.06 to 14.15) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 41 | 1.57 (0.76 to 2.88) | 0.00 (0.00 to 4.02) | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 42 | 1.69 (0.36 to 4.79) | 0.00 (0.00 to 3.48) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 43 | 3.67 (1.60 to 7.10) | 0.00 (0.00 to 3.13) | 0.00 (0.00 to 24.71) |
| 18 - 65 years, Week 44 | 1.28 (0.25 to 3.78) | 3.85 (0.18 to 17.30) | 0.00 (0.00 to 36.94) |
| 18 - 65 years, Week 45 | 0.90 (0.09 to 3.43) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 10.28) |
| 18 - 65 years, Week 46 | 1.35 (0.24 to 4.12) | 2.00 (0.00 to 21.99) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 47 | 0.68 (0.00 to 4.94) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 37 | 3.29 (2.50 to 4.24) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 40.96) |
| >65 years, Week 38 | 2.81 (2.04 to 3.78) | 0.00 (0.00 to 45.93) | 10.00 (0.00 to 75.66) |
| >65 years, Week 39 | 2.47 (1.82 to 3.27) | 0.00 (0.00 to 70.76) | 5.88 (0.15 to 28.69) |
| >65 years, Week 40 | 2.00 (0.99 to 3.58) | 2.44 (0.06 to 12.86) | 0.00 (0.00 to 26.46) |
| >65 years, Week 41 | 2.28 (1.18 to 3.95) | 0.00 (0.00 to 4.56) | 0.00 (0.00 to 70.76) |
| >65 years, Week 42 | 1.47 (0.49 to 3.33) | 1.54 (0.04 to 8.28) | 0.00 (0.00 to 52.18) |
| >65 years, Week 43 | 2.19 (0.81 to 4.71) | 0.00 (0.00 to 4.45) | 0.00 (0.00 to 70.76) |
| >65 years, Week 44 | 1.86 (0.16 to 7.37) | 3.13 (0.00 to 88.31) | 0.00 (0.00 to 60.24) |
| >65 years, Week 45 | 1.80 (0.09 to 8.23) | 2.70 (0.00 to 99.67) | 0.00 (0.00 to 16.84) |
| >65 years, Week 46 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 45.93) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 70.76) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 84.19) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 45.93) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.93) | 0.00 (0.00 to 40.96) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 0.63) | 0.00 (0.00 to 28.49) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.51) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 11.94) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.35) | 0.00 (0.00 to 11.22) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.31) | 0.00 (0.00 to 9.74) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.30) | 0.00 (0.00 to 8.04) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.29) | 0.00 (0.00 to 7.40) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 21.80) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.17) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 1.00) | 0.00 (0.00 to 16.11) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 11.22) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 0.92) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to —) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 10.28) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 9.03) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 2.20) | 0.41 (0.01 to 2.26) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.00 (0.00 to 2.05) | 0.41 (0.01 to 2.24) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 2.00) | 0.40 (0.01 to 2.20) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 1.98) | 0.40 (0.01 to 2.20) |
| 18 - 65 years, Week 35-37 | 4.59 (3.10 to 6.51) | 0.00 (0.00 to 84.19) | 11.11 (0.19 to 51.19) |
| 18 - 65 years, Week 35-38 | 3.68 (2.63 to 4.99) | 0.00 (0.00 to 70.76) | 6.67 (0.17 to 31.95) |
| 18 - 65 years, Week 35-39 | 3.24 (2.55 to 4.06) | 0.00 (0.00 to 45.93) | 5.00 (0.10 to 26.11) |
| 18 - 65 years, Week 35-40 | 3.11 (2.57 to 3.71) | 4.62 (0.96 to 12.90) | 3.45 (0.05 to 19.42) |
| 18 - 65 years, Week 35-41 | 2.88 (2.39 to 3.45) | 1.94 (0.40 to 5.55) | 2.56 (0.05 to 14.20) |
| 18 - 65 years, Week 35-42 | 2.79 (2.24 to 3.45) | 1.16 (0.24 to 3.35) | 2.33 (0.06 to 12.41) |
| 18 - 65 years, Week 35-43 | 2.83 (2.28 to 3.48) | 0.80 (0.17 to 2.32) | 1.79 (0.05 to 9.55) |
| 18 - 65 years, Week 35-44 | 2.74 (2.15 to 3.45) | 1.32 (0.49 to 2.86) | 1.56 (0.04 to 8.40) |
| 18 - 65 years, Week 35-45 | 2.67 (2.11 to 3.33) | 1.18 (0.43 to 2.55) | 1.02 (0.02 to 5.93) |
| 18 - 65 years, Week 35-46 | 2.61 (2.07 to 3.26) | 1.25 (0.51 to 2.57) | 0.98 (0.02 to 5.69) |
| 18 - 65 years, Week 35-47 | 2.57 (2.04 to 3.19) | 1.17 (0.45 to 2.47) | 0.85 (0.02 to 4.96) |
| 18 - 65 years, Week 35-48 | 2.53 (2.00 to 3.14) | 1.12 (0.41 to 2.41) | 0.83 (0.01 to 4.93) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 35-37 | 3.29 (2.50 to 4.24) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 30.85) |
| >65 years, Week 35-38 | 3.04 (2.48 to 3.70) | 0.00 (0.00 to 36.94) | 5.00 (0.01 to 35.33) |
| >65 years, Week 35-39 | 2.80 (2.21 to 3.50) | 0.00 (0.00 to 28.49) | 5.41 (0.66 to 18.19) |
| >65 years, Week 35-40 | 2.66 (2.14 to 3.27) | 1.92 (0.05 to 10.26) | 4.08 (0.50 to 13.98) |
| >65 years, Week 35-41 | 2.61 (2.09 to 3.23) | 0.76 (0.02 to 4.18) | 3.85 (0.47 to 13.21) |
| >65 years, Week 35-42 | 2.55 (2.02 to 3.16) | 1.02 (0.12 to 3.64) | 3.51 (0.43 to 12.11) |
| >65 years, Week 35-43 | 2.54 (2.01 to 3.16) | 0.72 (0.09 to 2.58) | 3.33 (0.41 to 11.53) |
| >65 years, Week 35-44 | 2.51 (2.04 to 3.05) | 1.17 (0.32 to 2.98) | 3.13 (0.35 to 11.09) |
| >65 years, Week 35-45 | 2.49 (2.01 to 3.05) | 1.32 (0.43 to 3.06) | 2.38 (0.15 to 10.17) |
| >65 years, Week 35-46 | 2.46 (1.98 to 3.02) | 1.20 (0.30 to 3.22) | 2.22 (0.12 to 9.92) |
| >65 years, Week 35-47 | 2.44 (1.96 to 3.00) | 1.13 (0.24 to 3.21) | 2.15 (0.11 to 9.70) |
| >65 years, Week 35-48 | 2.42 (1.94 to 2.99) | 1.08 (0.22 to 3.13) | 2.11 (0.11 to 9.58) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 1.77) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.91) | 0.00 (0.00 to 60.24) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.00 (0.00 to 1.80) | 0.00 (0.00 to 24.71) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 3.21) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 36.94) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 28.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | — |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.85) | — |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.59) | — |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 84.19) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 0.00 (0.00 to 1.78) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 37 | 0.28 (0.03 to 1.00) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 38 | 0.35 (0.04 to 1.25) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 45.93) |
| 18 - 65 years, Week 39 | 0.14 (0.00 to 0.86) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 52.18) |
| 18 - 65 years, Week 40 | 0.00 (0.00 to 0.50) | 1.69 (0.04 to 9.09) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 41 | 0.16 (0.00 to 0.93) | 1.11 (0.03 to 6.04) | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 42 | 0.00 (0.00 to 1.04) | 0.00 (0.00 to 3.48) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 43 | 0.00 (0.00 to 1.68) | 0.00 (0.00 to 3.13) | 0.00 (0.00 to 24.71) |
| 18 - 65 years, Week 44 | 0.00 (0.00 to 1.17) | 0.00 (0.00 to 4.62) | 0.00 (0.00 to 36.94) |
| 18 - 65 years, Week 45 | 0.00 (0.00 to 1.65) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 10.28) |
| 18 - 65 years, Week 46 | 0.00 (0.00 to 1.64) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 47 | 0.00 (0.00 to 2.49) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 37 | 0.29 (0.09 to 0.67) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 40.96) |
| >65 years, Week 38 | 0.22 (0.05 to 0.59) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 30.85) |
| >65 years, Week 39 | 0.19 (0.06 to 0.44) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 19.51) |
| >65 years, Week 40 | 0.00 (0.00 to 0.28) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 26.46) |
| >65 years, Week 41 | 0.20 (0.00 to 1.21) | 0.00 (0.00 to 4.56) | 33.33 (0.00 to 99.94) |
| >65 years, Week 42 | 0.00 (0.00 to 0.67) | 0.00 (0.00 to 5.52) | 0.00 (0.00 to 52.18) |
| >65 years, Week 43 | 0.00 (0.00 to 1.34) | 0.00 (0.00 to 4.45) | 0.00 (0.00 to 70.76) |
| >65 years, Week 44 | 0.23 (0.00 to 1.90) | 0.00 (0.00 to 5.60) | 0.00 (0.00 to 60.24) |
| >65 years, Week 45 | 0.00 (0.00 to 1.65) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 16.84) |
| >65 years, Week 46 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 45.93) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 70.76) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 84.19) |
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 45.93) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.93) | 0.00 (0.00 to 40.96) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 0.63) | 0.00 (0.00 to 28.49) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.51) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 11.94) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.35) | 0.00 (0.00 to 11.22) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.31) | 0.00 (0.00 to 9.74) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.30) | 0.00 (0.00 to 8.04) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.29) | 0.00 (0.00 to 7.40) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 21.80) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.17) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 1.00) | 0.00 (0.00 to 16.11) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 11.22) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 0.92) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 10.28) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 9.03) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 2.20) | 0.00 (0.00 to 1.50) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.00 (0.00 to 2.05) | 0.00 (0.00 to 1.49) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 2.00) | 0.00 (0.00 to 1.46) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 1.98) | 0.00 (0.00 to 1.46) |
| 18 - 65 years, Week 35-37 | 0.28 (0.03 to 1.00) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 35-38 | 0.32 (0.07 to 0.89) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 35-39 | 0.23 (0.07 to 0.57) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 16.84) |
| 18 - 65 years, Week 35-40 | 0.19 (0.05 to 0.51) | 1.54 (0.04 to 8.28) | 0.00 (0.00 to 11.94) |
| 18 - 65 years, Week 35-41 | 0.18 (0.05 to 0.45) | 1.29 (0.16 to 4.58) | 0.00 (0.00 to 9.03) |
| 18 - 65 years, Week 35-42 | 0.17 (0.05 to 0.43) | 0.77 (0.09 to 2.76) | 0.00 (0.00 to 8.22) |
| 18 - 65 years, Week 35-43 | 0.16 (0.04 to 0.41) | 0.53 (0.06 to 1.91) | 0.00 (0.00 to 6.38) |
| 18 - 65 years, Week 35-44 | 0.15 (0.04 to 0.39) | 0.44 (0.05 to 1.59) | 0.00 (0.00 to 5.60) |
| 18 - 65 years, Week 35-45 | 0.15 (0.04 to 0.38) | 0.39 (0.05 to 1.41) | 0.00 (0.00 to 3.69) |
| 18 - 65 years, Week 35-46 | 0.14 (0.04 to 0.36) | 0.36 (0.04 to 1.29) | 0.00 (0.00 to 3.55) |
| 18 - 65 years, Week 35-47 | 0.14 (0.04 to 0.36) | 0.34 (0.04 to 1.21) | 0.00 (0.00 to 3.10) |
| 18 - 65 years, Week 35-48 | 0.13 (0.04 to 0.35) | 0.32 (0.04 to 1.15) | 0.00 (0.00 to 3.00) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 35-37 | 0.29 (0.09 to 0.67) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 30.85) |
| >65 years, Week 35-38 | 0.25 (0.11 to 0.48) | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 16.84) |
| >65 years, Week 35-39 | 0.22 (0.12 to 0.39) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 9.49) |
| >65 years, Week 35-40 | 0.19 (0.09 to 0.33) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 7.25) |
| >65 years, Week 35-41 | 0.19 (0.10 to 0.31) | 0.00 (0.00 to 2.78) | 1.92 (0.00 to 15.59) |
| >65 years, Week 35-42 | 0.18 (0.09 to 0.30) | 0.00 (0.00 to 1.86) | 1.75 (0.00 to 13.94) |
| >65 years, Week 35-43 | 0.17 (0.09 to 0.29) | 0.00 (0.00 to 1.32) | 1.67 (0.00 to 13.08) |
| >65 years, Week 35-44 | 0.17 (0.09 to 0.29) | 0.00 (0.00 to 1.08) | 1.56 (0.01 to 11.81) |
| >65 years, Week 35-45 | 0.17 (0.09 to 0.29) | 0.00 (0.00 to 0.97) | 1.19 (0.00 to 9.68) |
| >65 years, Week 35-46 | 0.17 (0.09 to 0.29) | 0.00 (0.00 to 0.88) | 1.11 (0.00 to 9.22) |
| >65 years, Week 35-47 | 0.17 (0.09 to 0.28) | 0.00 (0.00 to 0.83) | 1.08 (0.00 to 8.81) |
| >65 years, Week 35-48 | 0.16 (0.09 to 0.28) | 0.00 (0.00 to 0.79) | 1.05 (0.00 to 8.66) |
SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 1.77) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.91) | 0.00 (0.00 to 60.24) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.00 (0.00 to 1.80) | 0.00 (0.00 to 24.71) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 3.21) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 36.94) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 28.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | — |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.85) | — |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.59) | — |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 84.19) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 0.00 (0.00 to 1.78) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 37 | 0.00 (0.00 to 0.51) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 38 | 0.00 (0.00 to 0.43) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 45.93) |
| 18 - 65 years, Week 39 | 0.00 (0.00 to 0.26) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 52.18) |
| 18 - 65 years, Week 40 | 0.00 (0.00 to 0.50) | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 41 | 0.00 (0.00 to 0.58) | 0.00 (0.00 to 4.02) | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 42 | 0.00 (0.00 to 1.04) | 0.00 (0.00 to 3.48) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 43 | 0.00 (0.00 to 1.68) | 0.00 (0.00 to 3.13) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 44 | 0.00 (0.00 to 1.17) | 0.00 (0.00 to 4.62) | 0.00 (0.00 to 36.94) |
| 18 - 65 years, Week 45 | 0.00 (0.00 to 1.65) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 10.28) |
| 18 - 65 years, Week 46 | 0.00 (0.00 to 1.64) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 60.24) |
| 18 - 65 years, Week 47 | 0.00 (0.00 to 2.49) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 37 | 0.00 (0.00 to 0.21) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 40.96) |
| >65 years, Week 38 | 0.00 (0.00 to 0.20) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 30.85) |
| >65 years, Week 39 | 0.00 (0.00 to 0.14) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 19.51) |
| >65 years, Week 40 | 0.00 (0.00 to 0.28) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 26.46) |
| >65 years, Week 41 | 0.00 (0.00 to 0.36) | 0.00 (0.00 to 4.56) | 0.00 (0.00 to 70.76) |
| >65 years, Week 42 | 0.00 (0.00 to 0.67) | 0.00 (0.00 to 5.52) | 0.00 (0.00 to 52.18) |
| >65 years, Week 43 | 0.00 (0.00 to 1.34) | 0.00 (0.00 to 4.45) | 0.00 (0.00 to 70.76) |
| >65 years, Week 44 | 0.00 (0.00 to 0.85) | 0.00 (0.00 to 5.60) | 0.00 (0.00 to 60.24) |
| >65 years, Week 45 | 0.00 (0.00 to 1.65) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 16.84) |
| >65 years, Week 46 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 45.93) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 70.76) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 84.19) |
SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 45.93) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.93) | 0.00 (0.00 to 40.96) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 0.63) | 0.00 (0.00 to 28.49) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.51) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 11.94) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.35) | 0.00 (0.00 to 11.22) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.31) | 0.00 (0.00 to 9.74) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.30) | 0.00 (0.00 to 8.04) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.29) | 0.00 (0.00 to 7.40) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.84) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 21.80) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.17) | 0.00 (0.00 to 17.65) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 1.00) | 0.00 (0.00 to 16.11) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 11.22) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 0.92) | 0.00 (0.00 to 11.22) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.58) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 10.28) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 9.03) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 2.20) | 0.00 (0.00 to 1.50) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.00 (0.00 to 2.05) | 0.00 (0.00 to 1.49) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 2.00) | 0.00 (0.00 to 1.46) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 1.98) | 0.00 (0.00 to 1.46) |
| 18 - 65 years, Week 35-37 | 0.00 (0.00 to 0.51) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 33.63) |
| 18 - 65 years, Week 35-38 | 0.00 (0.00 to 0.23) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 21.80) |
| 18 - 65 years, Week 35-39 | 0.00 (0.00 to 0.12) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 16.84) |
| 18 - 65 years, Week 35-40 | 0.00 (0.00 to 0.10) | 0.00 (0.00 to 5.52) | 0.00 (0.00 to 11.94) |
| 18 - 65 years, Week 35-41 | 0.00 (0.00 to 0.08) | 0.00 (0.00 to 2.35) | 0.00 (0.00 to 9.03) |
| 18 - 65 years, Week 35-42 | 0.00 (0.00 to 0.08) | 0.00 (0.00 to 1.41) | 0.00 (0.00 to 8.22) |
| 18 - 65 years, Week 35-43 | 0.00 (0.00 to 0.07) | 0.00 (0.00 to 0.98) | 0.00 (0.00 to 6.38) |
| 18 - 65 years, Week 35-44 | 0.00 (0.00 to 0.07) | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 5.60) |
| 18 - 65 years, Week 35-45 | 0.00 (0.00 to 0.07) | 0.00 (0.00 to 0.72) | 0.00 (0.00 to 3.69) |
| 18 - 65 years, Week 35-46 | 0.00 (0.00 to 0.06) | 0.00 (0.00 to 0.66) | 0.00 (0.00 to 3.55) |
| 18 - 65 years, Week 35-47 | 0.00 (0.00 to 0.06) | 0.00 (0.00 to 0.62) | 0.00 (0.00 to 3.10) |
| 18 - 65 years, Week 35-48 | 0.00 (0.00 to 0.06) | 0.00 (0.00 to 0.59) | 0.00 (0.00 to 3.00) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| >65 years, Week 35-37 | 0.00 (0.00 to 0.21) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 30.85) |
| >65 years, Week 35-38 | 0.00 (0.00 to 0.10) | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 16.84) |
| >65 years, Week 35-39 | 0.00 (0.00 to 0.06) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 9.49) |
| >65 years, Week 35-40 | 0.00 (0.00 to 0.05) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 7.25) |
| >65 years, Week 35-41 | 0.00 (0.00 to 0.04) | 0.00 (0.00 to 2.78) | 0.00 (0.00 to 6.85) |
| >65 years, Week 35-42 | 0.00 (0.00 to 0.04) | 0.00 (0.00 to 1.86) | 0.00 (0.00 to 6.27) |
| >65 years, Week 35-43 | 0.00 (0.00 to 0.04) | 0.00 (0.00 to 1.32) | 0.00 (0.00 to 5.96) |
| >65 years, Week 35-44 | 0.00 (0.00 to 0.04) | 0.00 (0.00 to 1.08) | 0.00 (0.00 to 5.60) |
| >65 years, Week 35-45 | 0.00 (0.00 to 0.04) | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 4.30) |
| >65 years, Week 35-46 | 0.00 (0.00 to 0.04) | 0.00 (0.00 to 0.88) | 0.00 (0.00 to 4.02) |
| >65 years, Week 35-47 | 0.00 (0.00 to 0.04) | 0.00 (0.00 to 0.83) | 0.00 (0.00 to 3.89) |
| >65 years, Week 35-48 | 0.00 (0.00 to 0.04) | 0.00 (0.00 to 0.79) | 0.00 (0.00 to 3.81) |
The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 37 | 9.94 (8.24 to 11.87) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 26.46) |
| At risk, Week 38 | 7.56 (5.85 to 9.58) | 14.29 (0.00 to 90.97) | 15.38 (1.47 to 48.44) |
| At risk, Week 39 | 7.79 (6.95 to 8.69) | 0.00 (0.00 to 4.06) | 4.17 (0.11 to 21.12) |
| At risk, Week 40 | 8.14 (4.89 to 12.57) | 5.14 (2.97 to 8.22) | 0.00 (0.00 to 12.77) |
| At risk, Week 41 | 6.43 (4.46 to 8.92) | 3.67 (1.08 to 8.82) | 2.78 (0.07 to 14.53) |
| At risk, Week 42 | 4.13 (1.91 to 7.68) | 1.42 (0.35 to 3.82) | 0.00 (0.00 to 21.80) |
| At risk, Week 43 | 4.72 (2.00 to 9.26) | 2.15 (0.66 to 5.09) | 0.00 (0.00 to 23.16) |
| At risk, Week 44 | 4.41 (1.31 to 10.49) | 2.92 (0.61 to 8.30) | 0.00 (0.00 to 11.94) |
| At risk, Week 45 | 3.69 (1.48 to 7.50) | 2.32 (0.05 to 12.57) | 0.00 (0.00 to 8.22) |
| At risk, Week 46 | 2.60 (0.72 to 6.52) | 0.87 (0.00 to 6.67) | 0.00 (0.00 to 24.71) |
| At risk, Week 47 | 1.42 (0.26 to 4.32) | 0.73 (0.02 to 4.06) | 0.00 (0.00 to 10.58) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 33.63) |
| Not at risk, Week 37 | 12.78 (7.63 to 19.67) | — | 50.00 (0.00 to 100) |
| Not at risk, Week 38 | 9.70 (5.40 to 15.75) | — | 0.00 (0.00 to 70.76) |
| Not at risk, Week 39 | 10.00 (6.17 to 15.10) | 0.00 (0.00 to 52.18) | — |
| Not at risk, Week 40 | 9.14 (4.45 to 16.21) | 0.00 (0.00 to 13.23) | 0.00 (0.00 to 60.24) |
| Not at risk, Week 41 | 6.10 (1.66 to 15.01) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 16.84) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.15) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 84.19) |
| Not at risk, Week 43 | 3.92 (0.34 to 14.93) | 5.77 (0.44 to 22.18) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 44 | 4.35 (0.91 to 12.18) | 9.43 (2.00 to 25.09) | 0.00 (0.00 to 97.50) |
| Not at risk, Week 45 | 4.05 (0.64 to 12.73) | 2.00 (0.10 to 9.21) | 2.29 (0.75 to 5.27) |
| Not at risk, Week 46 | 9.88 (2.59 to 24.02) | 8.57 (1.80 to 23.06) | 0.00 (0.00 to 45.93) |
| Not at risk, Week 47 | 2.17 (0.01 to 16.04) | 0.00 (0.00 to 16.84) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 97.50) |
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 35-37 | 9.94 (8.23 to 11.87) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 21.80) |
| At risk, Week 35-38 | 8.70 (7.07 to 10.56) | 9.09 (0.08 to 47.67) | 7.14 (0.68 to 25.29) |
| At risk, Week 35-39 | 8.30 (7.13 to 9.59) | 1.00 (0.03 to 5.45) | 5.77 (1.21 to 15.95) |
| At risk, Week 35-40 | 8.27 (7.09 to 9.57) | 4.14 (2.39 to 6.61) | 3.80 (0.70 to 11.27) |
| At risk, Week 35-41 | 8.04 (6.86 to 9.36) | 3.94 (2.11 to 6.65) | 3.48 (0.88 to 9.02) |
| At risk, Week 35-42 | 7.79 (6.57 to 9.16) | 3.11 (1.57 to 5.47) | 3.08 (0.70 to 8.37) |
| At risk, Week 35-43 | 7.69 (6.44 to 9.09) | 2.88 (1.38 to 5.25) | 2.78 (0.61 to 7.71) |
| At risk, Week 35-44 | 7.53 (6.28 to 8.94) | 2.89 (1.24 to 5.66) | 2.31 (0.45 to 6.76) |
| At risk, Week 35-45 | 7.43 (6.19 to 8.83) | 2.81 (1.19 to 5.54) | 1.85 (0.31 to 5.77) |
| At risk, Week 35-46 | 7.34 (6.07 to 8.78) | 2.62 (0.98 to 5.58) | 1.75 (0.28 to 5.54) |
| At risk, Week 35-47 | 7.26 (5.97 to 8.72) | 2.51 (0.91 to 5.45) | 1.53 (0.27 to 4.71) |
| At risk, Week 35-48 | 7.20 (5.91 to 8.67) | 2.43 (0.88 to 5.28) | 1.48 (0.25 to 4.61) |
| Not at risk, Week 35-37 | 12.78 (7.63 to 19.67) | — | 50.00 (0.00 to 100) |
| Not at risk, Week 35-38 | 11.07 (7.75 to 15.20) | — | 28.57 (3.67 to 70.96) |
| Not at risk, Week 35-39 | 10.50 (7.61 to 14.02) | 0.00 (0.00 to 52.18) | 28.57 (3.67 to 70.96) |
| Not at risk, Week 35-40 | 10.21 (7.67 to 13.25) | 0.00 (0.00 to 11.22) | 18.18 (1.26 to 58.58) |
| Not at risk, Week 35-41 | 9.52 (7.05 to 12.50) | 0.00 (0.00 to 5.21) | 6.45 (0.79 to 21.42) |
| Not at risk, Week 35-42 | 8.74 (6.60 to 11.30) | 0.00 (0.00 to 3.05) | 6.06 (0.74 to 20.23) |
| Not at risk, Week 35-43 | 8.52 (6.46 to 10.98) | 1.75 (0.36 to 5.04) | 4.88 (0.60 to 16.53) |
| Not at risk, Week 35-44 | 8.28 (6.26 to 10.68) | 3.57 (1.55 to 6.92) | 4.76 (0.58 to 16.16) |
| Not at risk, Week 35-45 | 8.03 (6.11 to 10.32) | 3.09 (1.49 to 5.60) | 2.69 (1.09 to 5.47) |
| Not at risk, Week 35-46 | 8.14 (6.25 to 10.38) | 3.62 (1.94 to 6.11) | 2.63 (1.06 to 5.35) |
| Not at risk, Week 35-47 | 7.94 (6.10 to 10.13) | 3.43 (1.84 to 5.79) | 2.55 (1.03 to 5.19) |
| Not at risk, Week 35-48 | 7.77 (5.90 to 9.99) | 3.29 (1.76 to 5.56) | 2.55 (1.03 to 5.17) |
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 37 | 0.39 (0.17 to 0.76) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 26.46) |
| At risk, Week 38 | 0.43 (0.13 to 1.05) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 24.71) |
| At risk, Week 39 | 0.48 (0.21 to 0.91) | 0.00 (0.00 to 4.06) | 0.00 (0.00 to 14.25) |
| At risk, Week 40 | 0.27 (0.09 to 0.62) | 1.29 (0.12 to 4.97) | 0.00 (0.00 to 12.77) |
| At risk, Week 41 | 0.40 (0.15 to 0.87) | 0.67 (0.08 to 2.39) | 0.00 (0.00 to 9.74) |
| At risk, Week 42 | 0.00 (0.00 to 0.45) | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 21.80) |
| At risk, Week 43 | 0.45 (0.05 to 1.63) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 23.16) |
| At risk, Week 44 | 0.29 (0.02 to 1.34) | 0.49 (0.06 to 1.75) | 0.00 (0.00 to 11.94) |
| At risk, Week 45 | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 1.21) | 0.00 (0.00 to 8.22) |
| At risk, Week 46 | 0.37 (0.00 to 2.71) | 0.00 (0.00 to 1.60) | 0.00 (0.00 to 24.71) |
| At risk, Week 47 | 0.47 (0.00 to 3.37) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 10.58) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 33.63) |
| Not at risk, Week 37 | 1.50 (0.18 to 5.33) | — | 0.00 (0.00 to 60.24) |
| Not at risk, Week 38 | 1.82 (0.30 to 5.77) | — | 0.00 (0.00 to 70.76) |
| Not at risk, Week 39 | 0.29 (0.01 to 1.63) | 0.00 (0.00 to 52.18) | — |
| Not at risk, Week 40 | 1.14 (0.02 to 6.55) | 0.00 (0.00 to 13.23) | 0.00 (0.00 to 60.24) |
| Not at risk, Week 41 | 0.00 (0.00 to 2.22) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 16.84) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.15) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 84.19) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.98) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 0.00 (0.00 to 6.72) | 0.00 (0.00 to 97.50) |
| Not at risk, Week 45 | 0.00 (0.00 to 4.86) | 0.00 (0.00 to 3.62) | 0.46 (0.01 to 2.53) |
| Not at risk, Week 46 | 1.23 (0.00 to 9.48) | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 45.93) |
| Not at risk, Week 47 | 0.00 (0.00 to 7.71) | 0.00 (0.00 to 16.84) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 97.50) |
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 35-37 | 0.39 (0.17 to 0.76) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 21.80) |
| At risk, Week 35-38 | 0.41 (0.24 to 0.65) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 12.34) |
| At risk, Week 35-39 | 0.44 (0.24 to 0.74) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 6.85) |
| At risk, Week 35-40 | 0.41 (0.24 to 0.66) | 0.97 (0.04 to 4.78) | 0.00 (0.00 to 4.56) |
| At risk, Week 35-41 | 0.41 (0.26 to 0.61) | 0.84 (0.19 to 2.34) | 0.00 (0.00 to 3.16) |
| At risk, Week 35-42 | 0.38 (0.24 to 0.58) | 0.56 (0.10 to 1.79) | 0.00 (0.00 to 2.80) |
| At risk, Week 35-43 | 0.38 (0.24 to 0.58) | 0.43 (0.06 to 1.50) | 0.00 (0.00 to 2.53) |
| At risk, Week 35-44 | 0.38 (0.24 to 0.57) | 0.44 (0.11 to 1.20) | 0.00 (0.00 to 2.11) |
| At risk, Week 35-45 | 0.37 (0.23 to 0.56) | 0.38 (0.08 to 1.09) | 0.00 (0.00 to 1.69) |
| At risk, Week 35-46 | 0.37 (0.23 to 0.56) | 0.34 (0.07 to 1.01) | 0.00 (0.00 to 1.60) |
| At risk, Week 35-47 | 0.37 (0.23 to 0.56) | 0.32 (0.06 to 0.96) | 0.00 (0.00 to 1.40) |
| At risk, Week 35-48 | 0.37 (0.23 to 0.55) | 0.31 (0.06 to 0.94) | 0.00 (0.00 to 1.35) |
| Not at risk, Week 35-37 | 1.50 (0.18 to 5.33) | — | 0.00 (0.00 to 60.24) |
| Not at risk, Week 35-38 | 1.68 (0.36 to 4.74) | — | 0.00 (0.00 to 40.96) |
| Not at risk, Week 35-39 | 0.94 (0.20 to 2.69) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 40.96) |
| Not at risk, Week 35-40 | 0.98 (0.24 to 2.64) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 28.49) |
| Not at risk, Week 35-41 | 0.82 (0.19 to 2.27) | 0.00 (0.00 to 5.21) | 0.00 (0.00 to 11.22) |
| Not at risk, Week 35-42 | 0.75 (0.16 to 2.14) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 10.58) |
| Not at risk, Week 35-43 | 0.72 (0.15 to 2.08) | 0.00 (0.00 to 2.13) | 0.00 (0.00 to 8.60) |
| Not at risk, Week 35-44 | 0.68 (0.13 to 2.01) | 0.00 (0.00 to 1.63) | 0.00 (0.00 to 8.41) |
| Not at risk, Week 35-45 | 0.64 (0.12 to 1.91) | 0.00 (0.00 to 1.13) | 0.38 (0.01 to 2.12) |
| Not at risk, Week 35-46 | 0.67 (0.11 to 2.18) | 0.00 (0.00 to 1.02) | 0.38 (0.01 to 2.08) |
| Not at risk, Week 35-47 | 0.65 (0.10 to 2.10) | 0.00 (0.00 to 0.97) | 0.36 (0.01 to 2.02) |
| Not at risk, Week 35-48 | 0.64 (0.10 to 2.06) | 0.00 (0.00 to 0.93) | 0.36 (0.01 to 2.01) |
Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 37 | 1.67 (0.58 to 3.73) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 26.46) |
| At risk, Week 38 | 1.33 (0.65 to 2.40) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 24.71) |
| At risk, Week 39 | 1.77 (1.24 to 2.46) | 0.00 (0.00 to 4.06) | 0.00 (0.00 to 14.25) |
| At risk, Week 40 | 1.70 (0.72 to 3.39) | 0.32 (0.00 to 2.12) | 0.00 (0.00 to 12.77) |
| At risk, Week 41 | 1.54 (0.98 to 2.30) | 1.00 (0.14 to 3.40) | 0.00 (0.00 to 9.74) |
| At risk, Week 42 | 0.61 (0.10 to 1.96) | 0.57 (0.07 to 2.07) | 0.00 (0.00 to 21.80) |
| At risk, Week 43 | 0.45 (0.05 to 1.67) | 0.61 (0.04 to 2.66) | 0.00 (0.00 to 23.16) |
| At risk, Week 44 | 0.88 (0.13 to 2.95) | 0.49 (0.06 to 1.75) | 0.00 (0.00 to 11.94) |
| At risk, Week 45 | 0.79 (0.07 to 3.18) | 0.66 (0.00 to 4.57) | 0.00 (0.00 to 8.22) |
| At risk, Week 46 | 0.74 (0.09 to 2.70) | 0.44 (0.00 to 3.38) | 0.00 (0.00 to 24.71) |
| At risk, Week 47 | 0.94 (0.05 to 4.24) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 10.58) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 33.63) |
| Not at risk, Week 37 | 5.26 (1.54 to 12.59) | — | 25.00 (0.00 to 100) |
| Not at risk, Week 38 | 6.06 (2.82 to 11.16) | — | 0.00 (0.00 to 70.76) |
| Not at risk, Week 39 | 3.24 (1.06 to 7.38) | 0.00 (0.00 to 52.18) | — |
| Not at risk, Week 40 | 4.57 (1.62 to 9.92) | 0.00 (0.00 to 13.23) | 0.00 (0.00 to 60.24) |
| Not at risk, Week 41 | 0.61 (0.00 to 4.32) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 16.84) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.15) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 84.19) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.98) | 1.92 (0.05 to 10.26) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 44 | 4.35 (0.91 to 12.18) | 1.89 (0.05 to 10.07) | 0.00 (0.00 to 97.50) |
| Not at risk, Week 45 | 0.00 (0.00 to 4.86) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 1.68) |
| Not at risk, Week 46 | 3.70 (0.08 to 40) | 5.71 (0.70 to 19.16) | 0.00 (0.00 to 45.93) |
| Not at risk, Week 47 | 2.17 (0.01 to 16.04) | 0.00 (0.00 to 16.84) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 97.50) |
Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 35-37 | 1.67 (0.58 to 3.72) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 21.80) |
| At risk, Week 35-38 | 1.49 (0.78 to 2.57) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 12.34) |
| At risk, Week 35-39 | 1.61 (1.02 to 2.42) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 6.85) |
| At risk, Week 35-40 | 1.63 (1.05 to 2.41) | 0.24 (0.01 to 1.35) | 0.00 (0.00 to 4.56) |
| At risk, Week 35-41 | 1.62 (1.10 to 2.29) | 0.56 (0.04 to 2.40) | 0.00 (0.00 to 3.16) |
| At risk, Week 35-42 | 1.55 (1.10 to 2.13) | 0.56 (0.05 to 2.26) | 0.00 (0.00 to 2.80) |
| At risk, Week 35-43 | 1.52 (1.08 to 2.07) | 0.58 (0.05 to 2.32) | 0.00 (0.00 to 2.53) |
| At risk, Week 35-44 | 1.49 (1.07 to 2.01) | 0.56 (0.07 to 1.99) | 0.00 (0.00 to 2.11) |
| At risk, Week 35-45 | 1.47 (1.06 to 1.98) | 0.57 (0.11 to 1.73) | 0.00 (0.00 to 1.69) |
| At risk, Week 35-46 | 1.45 (1.05 to 1.96) | 0.56 (0.09 to 1.81) | 0.00 (0.00 to 1.60) |
| At risk, Week 35-47 | 1.45 (1.05 to 1.95) | 0.53 (0.08 to 1.72) | 0.00 (0.00 to 1.40) |
| At risk, Week 35-48 | 1.44 (1.04 to 1.93) | 0.51 (0.08 to 1.66) | 0.00 (0.00 to 1.35) |
| Not at risk, Week 35-37 | 5.26 (1.54 to 12.59) | — | 25.00 (0.00 to 100) |
| Not at risk, Week 35-38 | 5.70 (2.72 to 10.36) | — | 14.29 (0.04 to 71.51) |
| Not at risk, Week 35-39 | 4.39 (1.96 to 8.34) | 0.00 (0.00 to 52.18) | 14.29 (0.04 to 71.51) |
| Not at risk, Week 35-40 | 4.43 (2.31 to 7.59) | 0.00 (0.00 to 11.22) | 9.09 (0.00 to 65.53) |
| Not at risk, Week 35-41 | 3.79 (2.04 to 6.37) | 0.00 (0.00 to 5.21) | 3.23 (0.00 to 33.66) |
| Not at risk, Week 35-42 | 3.48 (1.94 to 5.72) | 0.00 (0.00 to 3.05) | 3.03 (0.00 to 26.51) |
| Not at risk, Week 35-43 | 3.32 (1.89 to 5.37) | 0.58 (0.01 to 3.22) | 2.44 (0.01 to 17.96) |
| Not at risk, Week 35-44 | 3.38 (2.04 to 5.24) | 0.89 (0.11 to 3.19) | 2.38 (0.01 to 17.83) |
| Not at risk, Week 35-45 | 3.18 (1.93 to 4.92) | 0.62 (0.07 to 2.21) | 0.38 (0.00 to 5.26) |
| Not at risk, Week 35-46 | 3.21 (2.16 to 4.59) | 1.11 (0.30 to 2.83) | 0.38 (0.00 to 4.72) |
| Not at risk, Week 35-47 | 3.18 (2.14 to 4.52) | 1.06 (0.29 to 2.68) | 0.36 (0.00 to 4.34) |
| Not at risk, Week 35-48 | 3.11 (2.09 to 4.44) | 1.01 (0.28 to 2.57) | 0.36 (0.00 to 4.33) |
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 37 | 3.86 (3.11 to 4.72) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 26.46) |
| At risk, Week 38 | 2.96 (2.02 to 4.19) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 24.71) |
| At risk, Week 39 | 2.78 (2.18 to 3.49) | 0.00 (0.00 to 4.06) | 4.17 (0.11 to 21.12) |
| At risk, Week 40 | 2.39 (1.75 to 3.19) | 1.61 (0.31 to 4.76) | 0.00 (0.00 to 12.77) |
| At risk, Week 41 | 1.74 (0.95 to 2.92) | 1.33 (0.18 to 4.53) | 0.00 (0.00 to 9.74) |
| At risk, Week 42 | 1.70 (0.59 to 3.80) | 0.28 (0.01 to 1.58) | 0.00 (0.00 to 21.80) |
| At risk, Week 43 | 2.02 (0.63 to 4.79) | 0.92 (0.06 to 3.98) | 0.00 (0.00 to 23.16) |
| At risk, Week 44 | 1.76 (0.74 to 3.52) | 0.97 (0.09 to 3.76) | 0.00 (0.00 to 11.94) |
| At risk, Week 45 | 1.06 (0.19 to 3.22) | 0.99 (0.06 to 4.45) | 0.00 (0.00 to 8.22) |
| At risk, Week 46 | 0.37 (0.00 to 2.71) | 0.44 (0.00 to 3.38) | 0.00 (0.00 to 24.71) |
| At risk, Week 47 | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 10.58) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 33.63) |
| Not at risk, Week 37 | 4.51 (1.67 to 9.56) | — | 25.00 (0.00 to 99.42) |
| Not at risk, Week 38 | 3.03 (0.99 to 6.93) | — | 0.00 (0.00 to 70.76) |
| Not at risk, Week 39 | 4.71 (1.62 to 10.38) | 0.00 (0.00 to 52.18) | — |
| Not at risk, Week 40 | 2.86 (0.76 to 7.27) | 0.00 (0.00 to 13.23) | 0.00 (0.00 to 60.24) |
| Not at risk, Week 41 | 1.83 (0.23 to 6.42) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 16.84) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.15) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 84.19) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.98) | 1.92 (0.05 to 10.26) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 3.77 (0.17 to 17.08) | 0.00 (0.00 to 97.50) |
| Not at risk, Week 45 | 1.35 (0.01 to 9.52) | 1.00 (0.00 to 15.27) | 0.46 (0.01 to 2.53) |
| Not at risk, Week 46 | 1.23 (0.00 to 9.48) | 2.86 (0.07 to 14.92) | 0.00 (0.00 to 45.93) |
| Not at risk, Week 47 | 0.00 (0.00 to 7.71) | 0.00 (0.00 to 16.84) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 97.50) |
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 35-37 | 3.86 (3.11 to 4.72) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 21.80) |
| At risk, Week 35-38 | 3.39 (2.57 to 4.38) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 12.34) |
| At risk, Week 35-39 | 3.12 (2.36 to 4.04) | 0.00 (0.00 to 3.62) | 1.92 (0.05 to 10.26) |
| At risk, Week 35-40 | 2.99 (2.29 to 3.84) | 1.22 (0.37 to 2.91) | 1.27 (0.03 to 6.85) |
| At risk, Week 35-41 | 2.84 (2.15 to 3.67) | 1.27 (0.33 to 3.30) | 0.87 (0.01 to 5.18) |
| At risk, Week 35-42 | 2.77 (2.07 to 3.61) | 0.94 (0.25 to 2.41) | 0.77 (0.01 to 4.74) |
| At risk, Week 35-43 | 2.74 (2.04 to 3.61) | 0.94 (0.20 to 2.67) | 0.69 (0.01 to 4.39) |
| At risk, Week 35-44 | 2.69 (1.98 to 3.57) | 0.94 (0.18 to 2.86) | 0.58 (0.00 to 3.95) |
| At risk, Week 35-45 | 2.65 (1.95 to 3.51) | 0.95 (0.20 to 2.71) | 0.46 (0.00 to 3.33) |
| At risk, Week 35-46 | 2.61 (1.91 to 3.48) | 0.90 (0.16 to 2.77) | 0.44 (0.00 to 3.19) |
| At risk, Week 35-47 | 2.57 (1.87 to 3.44) | 0.85 (0.15 to 2.63) | 0.38 (0.00 to 2.86) |
| At risk, Week 35-48 | 2.55 (1.86 to 3.42) | 0.82 (0.15 to 2.54) | 0.37 (0.00 to 2.79) |
| Not at risk, Week 35-37 | 4.51 (1.67 to 9.56) | — | 25.00 (0.00 to 99.42) |
| Not at risk, Week 35-38 | 3.69 (1.86 to 6.51) | — | 14.29 (0.35 to 58.19) |
| Not at risk, Week 35-39 | 4.23 (2.22 to 7.23) | 0.00 (0.00 to 52.18) | 14.29 (0.35 to 58.19) |
| Not at risk, Week 35-40 | 3.94 (2.30 to 6.24) | 0.00 (0.00 to 11.22) | 9.09 (0.05 to 50.77) |
| Not at risk, Week 35-41 | 3.58 (1.95 to 5.98) | 0.00 (0.00 to 5.21) | 3.23 (0.08 to 16.70) |
| Not at risk, Week 35-42 | 3.29 (1.78 to 5.51) | 0.00 (0.00 to 3.05) | 3.03 (0.08 to 15.76) |
| Not at risk, Week 35-43 | 3.14 (1.71 to 5.26) | 0.58 (0.01 to 3.22) | 2.44 (0.06 to 12.86) |
| Not at risk, Week 35-44 | 2.96 (1.57 to 5.02) | 1.34 (0.28 to 3.86) | 2.38 (0.06 to 12.57) |
| Not at risk, Week 35-45 | 2.86 (1.59 to 4.72) | 1.23 (0.34 to 3.13) | 0.77 (0.09 to 2.75) |
| Not at risk, Week 35-46 | 2.76 (1.49 to 4.66) | 1.39 (0.45 to 3.22) | 0.75 (0.09 to 2.69) |
| Not at risk, Week 35-47 | 2.67 (1.43 to 4.54) | 1.32 (0.43 to 3.05) | 0.73 (0.09 to 2.61) |
| Not at risk, Week 35-48 | 2.61 (1.39 to 4.45) | 1.27 (0.41 to 2.93) | 0.73 (0.09 to 2.60) |
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 37 | 5.62 (4.72 to 6.63) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 26.46) |
| At risk, Week 38 | 3.86 (2.98 to 4.91) | 14.29 (0.00 to 90.97) | 7.69 (0.19 to 36.03) |
| At risk, Week 39 | 4.03 (3.26 to 4.91) | 0.00 (0.00 to 4.06) | 0.00 (0.00 to 14.25) |
| At risk, Week 40 | 4.68 (2.70 to 7.49) | 2.89 (0.64 to 8.00) | 0.00 (0.00 to 12.77) |
| At risk, Week 41 | 3.35 (2.14 to 4.97) | 2.33 (0.79 to 5.27) | 0.00 (0.00 to 9.74) |
| At risk, Week 42 | 2.31 (1.05 to 4.37) | 0.57 (0.07 to 2.04) | 0.00 (0.00 to 21.80) |
| At risk, Week 43 | 2.92 (0.97 to 6.65) | 1.53 (0.50 to 3.54) | 0.00 (0.00 to 23.16) |
| At risk, Week 44 | 2.50 (0.55 to 6.92) | 1.95 (0.53 to 4.90) | 0.00 (0.00 to 11.94) |
| At risk, Week 45 | 1.32 (0.35 to 3.40) | 1.32 (0.01 to 9.00) | 0.00 (0.00 to 8.22) |
| At risk, Week 46 | 0.74 (0.05 to 3.22) | 0.44 (0.00 to 3.38) | 0.00 (0.00 to 24.71) |
| At risk, Week 47 | 1.42 (0.26 to 4.32) | 0.73 (0.02 to 4.06) | 0.00 (0.00 to 10.58) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 33.63) |
| Not at risk, Week 37 | 8.27 (4.20 to 14.32) | — | 0.00 (0.00 to 60.24) |
| Not at risk, Week 38 | 4.24 (1.72 to 8.55) | — | 0.00 (0.00 to 70.76) |
| Not at risk, Week 39 | 6.47 (2.73 to 12.64) | 0.00 (0.00 to 52.18) | — |
| Not at risk, Week 40 | 3.43 (1.27 to 7.31) | 0.00 (0.00 to 13.23) | 0.00 (0.00 to 60.24) |
| Not at risk, Week 41 | 3.05 (1.00 to 6.97) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 16.84) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.15) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 84.19) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.98) | 3.85 (0.30 to 15.08) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 44 | 1.45 (0.01 to 10.55) | 3.77 (0.46 to 12.98) | 0.00 (0.00 to 97.50) |
| Not at risk, Week 45 | 4.05 (0.64 to 12.73) | 0.00 (0.00 to 3.62) | 2.29 (0.75 to 5.27) |
| Not at risk, Week 46 | 3.70 (0.77 to 10.44) | 5.71 (0.70 to 19.16) | 0.00 (0.00 to 45.93) |
| Not at risk, Week 47 | 2.17 (0.01 to 16.04) | 0.00 (0.00 to 16.84) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 97.50) |
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 35-37 | 5.61 (4.71 to 6.62) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 21.80) |
| At risk, Week 35-38 | 4.69 (3.96 to 5.53) | 9.09 (0.08 to 47.67) | 3.57 (0.08 to 18.86) |
| At risk, Week 35-39 | 4.40 (3.75 to 5.13) | 1.00 (0.03 to 5.45) | 1.92 (0.05 to 10.26) |
| At risk, Week 35-40 | 4.45 (3.71 to 5.30) | 2.43 (0.53 to 6.77) | 1.27 (0.03 to 6.85) |
| At risk, Week 35-41 | 4.32 (3.56 to 5.18) | 2.39 (0.94 to 4.93) | 0.87 (0.01 to 5.18) |
| At risk, Week 35-42 | 4.19 (3.41 to 5.09) | 1.79 (0.69 to 3.74) | 0.77 (0.01 to 4.74) |
| At risk, Week 35-43 | 4.15 (3.34 to 5.08) | 1.73 (0.81 to 3.22) | 0.69 (0.01 to 4.39) |
| At risk, Week 35-44 | 4.07 (3.27 to 4.99) | 1.78 (0.91 to 3.13) | 0.58 (0.00 to 3.95) |
| At risk, Week 35-45 | 3.99 (3.20 to 4.92) | 1.71 (0.79 to 3.23) | 0.46 (0.00 to 3.33) |
| At risk, Week 35-46 | 3.93 (3.12 to 4.89) | 1.59 (0.71 to 3.05) | 0.44 (0.00 to 3.19) |
| At risk, Week 35-47 | 3.90 (3.09 to 4.85) | 1.54 (0.69 to 2.96) | 0.38 (0.00 to 2.86) |
| At risk, Week 35-48 | 3.87 (3.06 to 4.82) | 1.49 (0.66 to 2.87) | 0.37 (0.00 to 2.79) |
| Not at risk, Week 35-37 | 8.27 (4.20 to 14.32) | — | 0.00 (0.00 to 60.24) |
| Not at risk, Week 35-38 | 6.04 (3.59 to 9.43) | — | 0.00 (0.00 to 40.96) |
| Not at risk, Week 35-39 | 6.27 (3.96 to 9.35) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 40.96) |
| Not at risk, Week 35-40 | 5.66 (3.70 to 8.24) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 28.49) |
| Not at risk, Week 35-41 | 5.22 (3.64 to 7.22) | 0.00 (0.00 to 5.21) | 0.00 (0.00 to 11.22) |
| Not at risk, Week 35-42 | 4.79 (3.37 to 6.59) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 10.58) |
| Not at risk, Week 35-43 | 4.57 (3.25 to 6.23) | 1.17 (0.14 to 4.16) | 0.00 (0.00 to 8.60) |
| Not at risk, Week 35-44 | 4.39 (3.15 to 5.94) | 1.79 (0.49 to 4.51) | 0.00 (0.00 to 8.41) |
| Not at risk, Week 35-45 | 4.37 (3.26 to 5.72) | 1.23 (0.34 to 3.13) | 1.92 (0.63 to 4.43) |
| Not at risk, Week 35-46 | 4.33 (3.31 to 5.56) | 1.67 (0.62 to 3.60) | 1.88 (0.61 to 4.33) |
| Not at risk, Week 35-47 | 4.26 (3.26 to 5.46) | 1.58 (0.58 to 3.41) | 1.82 (0.60 to 4.21) |
| Not at risk, Week 35-48 | 4.17 (3.19 to 5.34) | 1.52 (0.56 to 3.28) | 1.82 (0.59 to 4.19) |
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 37 | 2.01 (1.33 to 2.93) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 26.46) |
| At risk, Week 38 | 1.64 (0.89 to 2.75) | 14.29 (0.00 to 90.97) | 0.00 (0.00 to 24.71) |
| At risk, Week 39 | 1.27 (0.80 to 1.92) | 0.00 (0.00 to 4.06) | 0.00 (0.00 to 14.25) |
| At risk, Week 40 | 1.44 (0.87 to 2.23) | 1.29 (0.35 to 3.26) | 0.00 (0.00 to 12.77) |
| At risk, Week 41 | 1.14 (0.58 to 2.01) | 0.67 (0.08 to 2.39) | 0.00 (0.00 to 9.74) |
| At risk, Week 42 | 0.73 (0.21 to 1.82) | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 21.80) |
| At risk, Week 43 | 0.45 (0.04 to 1.77) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 23.16) |
| At risk, Week 44 | 0.44 (0.09 to 1.28) | 0.24 (0.00 to 1.50) | 0.00 (0.00 to 11.94) |
| At risk, Week 45 | 1.58 (0.27 to 4.95) | 0.66 (0.00 to 4.57) | 0.00 (0.00 to 8.22) |
| At risk, Week 46 | 1.12 (0.07 to 4.86) | 0.00 (0.00 to 1.60) | 0.00 (0.00 to 24.71) |
| At risk, Week 47 | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 10.58) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 33.63) |
| Not at risk, Week 37 | 2.26 (0.23 to 8.42) | — | 25.00 (0.00 to 99.42) |
| Not at risk, Week 38 | 1.82 (0.21 to 6.56) | — | 0.00 (0.00 to 70.76) |
| Not at risk, Week 39 | 2.06 (0.68 to 4.71) | 0.00 (0.00 to 52.18) | — |
| Not at risk, Week 40 | 0.57 (0.01 to 3.31) | 0.00 (0.00 to 13.23) | 0.00 (0.00 to 60.24) |
| Not at risk, Week 41 | 1.22 (0.03 to 6.81) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 16.84) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.15) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 84.19) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.98) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 1.89 (0.05 to 10.07) | 0.00 (0.00 to 97.50) |
| Not at risk, Week 45 | 0.00 (0.00 to 4.86) | 2.00 (0.10 to 9.21) | 0.46 (0.01 to 2.53) |
| Not at risk, Week 46 | 0.00 (0.00 to 4.45) | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 45.93) |
| Not at risk, Week 47 | 0.00 (0.00 to 7.71) | 0.00 (0.00 to 16.84) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 97.50) |
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 35-37 | 2.01 (1.33 to 2.93) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 21.80) |
| At risk, Week 35-38 | 1.82 (1.39 to 2.33) | 9.09 (0.08 to 47.67) | 0.00 (0.00 to 12.34) |
| At risk, Week 35-39 | 1.58 (1.12 to 2.15) | 1.00 (0.03 to 5.45) | 0.00 (0.00 to 6.85) |
| At risk, Week 35-40 | 1.55 (1.17 to 2.02) | 1.22 (0.40 to 2.82) | 0.00 (0.00 to 4.56) |
| At risk, Week 35-41 | 1.50 (1.12 to 1.96) | 0.98 (0.35 to 2.17) | 0.00 (0.00 to 3.16) |
| At risk, Week 35-42 | 1.45 (1.09 to 1.90) | 0.66 (0.23 to 1.46) | 0.00 (0.00 to 2.80) |
| At risk, Week 35-43 | 1.42 (1.06 to 1.86) | 0.50 (0.16 to 1.20) | 0.00 (0.00 to 2.53) |
| At risk, Week 35-44 | 1.37 (1.02 to 1.80) | 0.44 (0.10 to 1.25) | 0.00 (0.00 to 2.11) |
| At risk, Week 35-45 | 1.38 (1.05 to 1.77) | 0.48 (0.17 to 1.06) | 0.00 (0.00 to 1.69) |
| At risk, Week 35-46 | 1.37 (1.05 to 1.77) | 0.43 (0.13 to 1.02) | 0.00 (0.00 to 1.60) |
| At risk, Week 35-47 | 1.35 (1.03 to 1.75) | 0.41 (0.12 to 0.97) | 0.00 (0.00 to 1.40) |
| At risk, Week 35-48 | 1.34 (1.02 to 1.73) | 0.39 (0.12 to 0.94) | 0.00 (0.00 to 1.35) |
| Not at risk, Week 35-37 | 2.26 (0.23 to 8.42) | — | 25.00 (0.00 to 99.42) |
| Not at risk, Week 35-38 | 2.01 (0.38 to 6.01) | — | 14.29 (0.35 to 58.19) |
| Not at risk, Week 35-39 | 2.04 (0.66 to 4.71) | 0.00 (0.00 to 52.18) | 14.29 (0.35 to 58.19) |
| Not at risk, Week 35-40 | 1.72 (0.58 to 3.91) | 0.00 (0.00 to 11.22) | 9.09 (0.05 to 50.77) |
| Not at risk, Week 35-41 | 1.64 (0.64 to 3.41) | 0.00 (0.00 to 5.21) | 3.23 (0.08 to 16.70) |
| Not at risk, Week 35-42 | 1.50 (0.57 to 3.19) | 0.00 (0.00 to 3.05) | 3.03 (0.08 to 15.76) |
| Not at risk, Week 35-43 | 1.43 (0.54 to 3.05) | 0.00 (0.00 to 2.13) | 2.44 (0.06 to 12.86) |
| Not at risk, Week 35-44 | 1.35 (0.49 to 2.96) | 0.45 (0.01 to 2.46) | 2.38 (0.06 to 12.57) |
| Not at risk, Week 35-45 | 1.27 (0.45 to 2.80) | 0.93 (0.19 to 2.68) | 0.77 (0.09 to 2.75) |
| Not at risk, Week 35-46 | 1.19 (0.41 to 2.69) | 0.84 (0.17 to 2.42) | 0.75 (0.09 to 2.69) |
| Not at risk, Week 35-47 | 1.16 (0.39 to 2.61) | 0.79 (0.16 to 2.30) | 0.73 (0.09 to 2.61) |
| Not at risk, Week 35-48 | 1.13 (0.39 to 2.55) | 0.76 (0.16 to 2.20) | 0.73 (0.09 to 2.60) |
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 37 | 0.64 (0.01 to 4.30) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 26.46) |
| At risk, Week 38 | 0.51 (0.05 to 1.93) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 24.71) |
| At risk, Week 39 | 0.29 (0.02 to 1.34) | 0.00 (0.00 to 4.06) | 0.00 (0.00 to 14.25) |
| At risk, Week 40 | 0.43 (0.06 to 1.40) | 0.64 (0.01 to 4.22) | 0.00 (0.00 to 12.77) |
| At risk, Week 41 | 0.20 (0.04 to 0.60) | 0.67 (0.08 to 2.39) | 0.00 (0.00 to 9.74) |
| At risk, Week 42 | 0.00 (0.00 to 0.45) | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 21.80) |
| At risk, Week 43 | 0.22 (0.00 to 1.52) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 23.16) |
| At risk, Week 44 | 0.29 (0.02 to 1.34) | 0.24 (0.00 to 1.50) | 0.00 (0.00 to 11.94) |
| At risk, Week 45 | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 1.21) | 0.00 (0.00 to 8.22) |
| At risk, Week 46 | 0.37 (0.00 to 2.68) | 0.00 (0.00 to 1.60) | 0.00 (0.00 to 24.71) |
| At risk, Week 47 | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 10.58) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 33.63) |
| Not at risk, Week 37 | 0.75 (0.01 to 5.16) | — | 0.00 (0.00 to 60.24) |
| Not at risk, Week 38 | 1.21 (0.15 to 4.31) | — | 0.00 (0.00 to 70.76) |
| Not at risk, Week 39 | 1.18 (0.17 to 3.93) | 0.00 (0.00 to 52.18) | — |
| Not at risk, Week 40 | 0.00 (0.00 to 2.09) | 0.00 (0.00 to 13.23) | 0.00 (0.00 to 60.24) |
| Not at risk, Week 41 | 0.61 (0.01 to 3.69) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 16.84) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.15) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 84.19) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.98) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 3.77 (0.17 to 17.08) | 0.00 (0.00 to 97.50) |
| Not at risk, Week 45 | 0.00 (0.00 to 4.86) | 0.00 (0.00 to 3.62) | 0.46 (0.01 to 2.53) |
| Not at risk, Week 46 | 0.00 (0.00 to 4.45) | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 45.93) |
| Not at risk, Week 47 | 0.00 (0.00 to 7.71) | 0.00 (0.00 to 16.84) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 97.50) |
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 35-37 | 0.64 (0.01 to 4.30) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 21.80) |
| At risk, Week 35-38 | 0.57 (0.02 to 2.84) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 12.34) |
| At risk, Week 35-39 | 0.45 (0.02 to 2.15) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 6.85) |
| At risk, Week 35-40 | 0.45 (0.03 to 1.99) | 0.49 (0.01 to 2.67) | 0.00 (0.00 to 4.56) |
| At risk, Week 35-41 | 0.42 (0.03 to 1.77) | 0.56 (0.04 to 2.40) | 0.00 (0.00 to 3.16) |
| At risk, Week 35-42 | 0.39 (0.03 to 1.68) | 0.38 (0.03 to 1.51) | 0.00 (0.00 to 2.80) |
| At risk, Week 35-43 | 0.38 (0.03 to 1.63) | 0.29 (0.02 to 1.16) | 0.00 (0.00 to 2.53) |
| At risk, Week 35-44 | 0.38 (0.03 to 1.54) | 0.28 (0.02 to 1.22) | 0.00 (0.00 to 2.11) |
| At risk, Week 35-45 | 0.37 (0.03 to 1.50) | 0.24 (0.01 to 1.12) | 0.00 (0.00 to 1.69) |
| At risk, Week 35-46 | 0.37 (0.03 to 1.52) | 0.21 (0.01 to 1.06) | 0.00 (0.00 to 1.60) |
| At risk, Week 35-47 | 0.36 (0.03 to 1.50) | 0.20 (0.01 to 1.01) | 0.00 (0.00 to 1.40) |
| At risk, Week 35-48 | 0.36 (0.03 to 1.49) | 0.20 (0.01 to 0.97) | 0.00 (0.00 to 1.35) |
| Not at risk, Week 35-37 | 0.75 (0.01 to 5.16) | — | 0.00 (0.00 to 60.24) |
| Not at risk, Week 35-38 | 1.01 (0.18 to 3.13) | — | 0.00 (0.00 to 40.96) |
| Not at risk, Week 35-39 | 1.10 (0.21 to 3.29) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 40.96) |
| Not at risk, Week 35-40 | 0.86 (0.12 to 2.89) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 28.49) |
| Not at risk, Week 35-41 | 0.82 (0.15 to 2.52) | 0.00 (0.00 to 5.21) | 0.00 (0.00 to 11.22) |
| Not at risk, Week 35-42 | 0.75 (0.12 to 2.39) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 10.58) |
| Not at risk, Week 35-43 | 0.72 (0.11 to 2.31) | 0.00 (0.00 to 2.13) | 0.00 (0.00 to 8.60) |
| Not at risk, Week 35-44 | 0.68 (0.10 to 2.23) | 0.89 (0.11 to 3.19) | 0.00 (0.00 to 8.41) |
| Not at risk, Week 35-45 | 0.64 (0.09 to 2.11) | 0.62 (0.07 to 2.21) | 0.38 (0.01 to 2.12) |
| Not at risk, Week 35-46 | 0.60 (0.09 to 2.01) | 0.56 (0.07 to 2.00) | 0.38 (0.01 to 2.08) |
| Not at risk, Week 35-47 | 0.58 (0.08 to 1.94) | 0.53 (0.06 to 1.89) | 0.36 (0.01 to 2.02) |
| Not at risk, Week 35-48 | 0.56 (0.08 to 1.89) | 0.51 (0.06 to 1.82) | 0.36 (0.01 to 2.01) |
The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 37 | 0.51 (0.23 to 1.00) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 26.46) |
| At risk, Week 38 | 0.23 (0.08 to 0.53) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 24.71) |
| At risk, Week 39 | 0.16 (0.06 to 0.35) | 0.00 (0.00 to 4.06) | 0.00 (0.00 to 14.25) |
| At risk, Week 40 | 0.48 (0.22 to 0.91) | 0.00 (0.00 to 1.18) | 0.00 (0.00 to 12.77) |
| At risk, Week 41 | 0.13 (0.02 to 0.48) | 0.33 (0.01 to 1.84) | 0.00 (0.00 to 9.74) |
| At risk, Week 42 | 0.00 (0.00 to 0.45) | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 21.80) |
| At risk, Week 43 | 0.45 (0.03 to 1.87) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 23.16) |
| At risk, Week 44 | 0.44 (0.03 to 2.00) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 11.94) |
| At risk, Week 45 | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 1.21) | 0.00 (0.00 to 8.22) |
| At risk, Week 46 | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 1.60) | 0.00 (0.00 to 24.71) |
| At risk, Week 47 | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 10.58) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 33.63) |
| Not at risk, Week 37 | 0.75 (0.01 to 4.87) | — | 0.00 (0.00 to 60.24) |
| Not at risk, Week 38 | 1.21 (0.10 to 4.88) | — | 0.00 (0.00 to 70.76) |
| Not at risk, Week 39 | 0.59 (0.05 to 2.42) | 0.00 (0.00 to 52.18) | — |
| Not at risk, Week 40 | 0.00 (0.00 to 2.09) | 0.00 (0.00 to 13.23) | 0.00 (0.00 to 60.24) |
| Not at risk, Week 41 | 0.00 (0.00 to 2.22) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 16.84) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.15) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 84.19) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.98) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 0.00 (0.00 to 6.72) | 0.00 (0.00 to 97.50) |
| Not at risk, Week 45 | 0.00 (0.00 to 4.86) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 1.68) |
| Not at risk, Week 46 | 1.23 (0.01 to 8.69) | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 45.93) |
| Not at risk, Week 47 | 0.00 (0.00 to 7.71) | 0.00 (0.00 to 16.84) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 97.50) |
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 35-37 | 0.51 (0.23 to 1.00) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 21.80) |
| At risk, Week 35-38 | 0.37 (0.16 to 0.72) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 12.34) |
| At risk, Week 35-39 | 0.28 (0.15 to 0.47) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 6.85) |
| At risk, Week 35-40 | 0.31 (0.21 to 0.46) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 4.56) |
| At risk, Week 35-41 | 0.29 (0.19 to 0.42) | 0.14 (0.00 to 0.78) | 0.00 (0.00 to 3.16) |
| At risk, Week 35-42 | 0.27 (0.18 to 0.39) | 0.09 (0.00 to 0.52) | 0.00 (0.00 to 2.80) |
| At risk, Week 35-43 | 0.28 (0.19 to 0.40) | 0.07 (0.00 to 0.40) | 0.00 (0.00 to 2.53) |
| At risk, Week 35-44 | 0.29 (0.19 to 0.41) | 0.06 (0.00 to 0.31) | 0.00 (0.00 to 2.11) |
| At risk, Week 35-45 | 0.28 (0.19 to 0.40) | 0.05 (0.00 to 0.26) | 0.00 (0.00 to 1.69) |
| At risk, Week 35-46 | 0.27 (0.18 to 0.39) | 0.04 (0.00 to 0.24) | 0.00 (0.00 to 1.60) |
| At risk, Week 35-47 | 0.27 (0.18 to 0.38) | 0.04 (0.00 to 0.23) | 0.00 (0.00 to 1.40) |
| At risk, Week 35-48 | 0.27 (0.18 to 0.38) | 0.04 (0.00 to 0.22) | 0.00 (0.00 to 1.35) |
| Not at risk, Week 35-37 | 0.75 (0.01 to 4.87) | — | 0.00 (0.00 to 60.24) |
| Not at risk, Week 35-38 | 1.01 (0.21 to 2.91) | — | 0.00 (0.00 to 40.96) |
| Not at risk, Week 35-39 | 0.78 (0.21 to 2.02) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 40.96) |
| Not at risk, Week 35-40 | 0.62 (0.18 to 1.53) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 28.49) |
| Not at risk, Week 35-41 | 0.51 (0.15 to 1.26) | 0.00 (0.00 to 5.21) | 0.00 (0.00 to 11.22) |
| Not at risk, Week 35-42 | 0.47 (0.14 to 1.14) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 10.58) |
| Not at risk, Week 35-43 | 0.45 (0.14 to 1.07) | 0.00 (0.00 to 2.13) | 0.00 (0.00 to 8.60) |
| Not at risk, Week 35-44 | 0.42 (0.13 to 1.02) | 0.00 (0.00 to 1.63) | 0.00 (0.00 to 8.41) |
| Not at risk, Week 35-45 | 0.40 (0.12 to 0.96) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 1.41) |
| Not at risk, Week 35-46 | 0.45 (0.16 to 0.97) | 0.00 (0.00 to 1.02) | 0.00 (0.00 to 1.38) |
| Not at risk, Week 35-47 | 0.43 (0.16 to 0.94) | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 1.34) |
| Not at risk, Week 35-48 | 0.42 (0.16 to 0.92) | 0.00 (0.00 to 0.93) | 0.00 (0.00 to 1.33) |
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 37 | 3.51 (2.79 to 4.37) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 26.46) |
| At risk, Week 38 | 2.81 (2.03 to 3.78) | 0.00 (0.00 to 40.96) | 7.69 (0.00 to 57.26) |
| At risk, Week 39 | 2.41 (1.90 to 3.02) | 0.00 (0.00 to 4.06) | 4.17 (0.11 to 21.12) |
| At risk, Week 40 | 2.02 (1.37 to 2.88) | 1.29 (0.01 to 8.32) | 0.00 (0.00 to 12.77) |
| At risk, Week 41 | 1.94 (1.20 to 2.96) | 0.00 (0.00 to 1.22) | 0.00 (0.00 to 9.74) |
| At risk, Week 42 | 1.70 (0.66 to 3.56) | 0.28 (0.01 to 1.58) | 0.00 (0.00 to 21.80) |
| At risk, Week 43 | 2.70 (1.36 to 4.75) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 23.16) |
| At risk, Week 44 | 1.76 (0.42 to 4.74) | 0.97 (0.01 to 5.90) | 0.00 (0.00 to 11.94) |
| At risk, Week 45 | 1.32 (0.17 to 4.62) | 0.33 (0.00 to 2.45) | 0.00 (0.00 to 8.22) |
| At risk, Week 46 | 0.37 (0.01 to 2.19) | 0.00 (0.00 to 1.60) | 0.00 (0.00 to 24.71) |
| At risk, Week 47 | 0.47 (0.00 to 3.37) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 10.58) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 33.63) |
| Not at risk, Week 37 | 6.02 (2.38 to 12.21) | — | 25.00 (0.00 to 100) |
| Not at risk, Week 38 | 3.03 (0.99 to 6.93) | — | 0.00 (0.00 to 70.76) |
| Not at risk, Week 39 | 4.12 (1.40 to 9.18) | 0.00 (0.00 to 52.18) | — |
| Not at risk, Week 40 | 4.00 (1.42 to 8.69) | 0.00 (0.00 to 13.23) | 0.00 (0.00 to 60.24) |
| Not at risk, Week 41 | 4.00 (1.42 to 8.69) | 0.00 (0.00 to 13.23) | 0.00 (0.00 to 60.24) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.15) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 84.19) |
| Not at risk, Week 43 | 3.92 (0.34 to 14.93) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 1.89 (1.89 to 10.07) | 0.00 (0.00 to 97.50) |
| Not at risk, Week 45 | 1.35 (0.01 to 9.52) | 0.00 (0.00 to 3.62) | 0.46 (0.01 to 2.53) |
| Not at risk, Week 46 | 2.47 (0.07 to 12.65) | 2.86 (0.07 to 14.92) | 0.00 (0.00 to 45.93) |
| Not at risk, Week 47 | 0.00 (0.00 to 7.71) | 0.00 (0.00 to 16.84) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 97.50) |
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 35-37 | 3.51 (2.78 to 4.37) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 21.80) |
| At risk, Week 35-38 | 3.14 (2.41 to 4.03) | 0.00 (0.00 to 28.49) | 3.57 (0.01 to 24.71) |
| At risk, Week 35-39 | 2.82 (2.20 to 3.57) | 0.00 (0.00 to 3.62) | 3.85 (0.47 to 13.21) |
| At risk, Week 35-40 | 2.68 (2.19 to 3.25) | 0.97 (0.02 to 5.30) | 2.53 (0.31 to 8.85) |
| At risk, Week 35-41 | 2.59 (2.08 to 3.18) | 0.56 (0.04 to 2.40) | 1.74 (0.17 to 6.55) |
| At risk, Week 35-42 | 2.53 (2.01 to 3.15) | 0.47 (0.04 to 1.88) | 1.54 (0.15 to 5.92) |
| At risk, Week 35-43 | 2.54 (2.02 to 3.14) | 0.36 (0.03 to 1.45) | 1.39 (0.12 to 5.49) |
| At risk, Week 35-44 | 2.50 (2.00 to 3.09) | 0.50 (0.03 to 2.19) | 1.16 (0.08 to 4.94) |
| At risk, Week 35-45 | 2.47 (1.97 to 3.06) | 0.48 (0.02 to 2.24) | 0.93 (0.05 to 4.23) |
| At risk, Week 35-46 | 2.43 (1.93 to 3.01) | 0.43 (0.02 to 2.12) | 0.87 (0.04 to 4.08) |
| At risk, Week 35-47 | 2.40 (1.91 to 2.98) | 0.41 (0.02 to 2.01) | 0.76 (0.05 to 3.40) |
| At risk, Week 35-48 | 2.38 (1.89 to 2.96) | 0.39 (0.02 to 1.94) | 0.74 (0.04 to 3.35) |
| Not at risk, Week 35-37 | 6.02 (2.38 to 12.21) | — | 25.00 (0.00 to 100) |
| Not at risk, Week 35-38 | 4.36 (2.34 to 7.34) | — | 14.29 (0.04 to 71.51) |
| Not at risk, Week 35-39 | 4.23 (2.26 to 7.15) | 0.00 (0.00 to 52.18) | 14.29 (0.04 to 71.51) |
| Not at risk, Week 35-40 | 4.18 (2.41 to 6.71) | 0.00 (0.00 to 11.22) | 9.09 (0.00 to 65.53) |
| Not at risk, Week 35-41 | 3.89 (2.35 to 6.02) | 0.00 (0.00 to 5.21) | 3.23 (0.00 to 33.66) |
| Not at risk, Week 35-42 | 3.57 (2.21 to 5.44) | 0.00 (0.00 to 3.05) | 3.03 (0.00 to 26.51) |
| Not at risk, Week 35-43 | 3.59 (2.28 to 5.36) | 0.00 (0.00 to 2.13) | 2.44 (0.01 to 17.96) |
| Not at risk, Week 35-44 | 3.38 (2.18 to 4.99) | 0.45 (0.01 to 2.46) | 2.38 (0.01 to 17.83) |
| Not at risk, Week 35-45 | 3.26 (2.14 to 4.75) | 0.31 (0.01 to 1.71) | 0.77 (0.04 to 3.45) |
| Not at risk, Week 35-46 | 3.21 (2.19 to 4.53) | 0.56 (0.07 to 2.00) | 0.75 (0.06 to 3.14) |
| Not at risk, Week 35-47 | 3.10 (2.08 to 4.45) | 0.53 (0.06 to 1.89) | 0.73 (0.06 to 2.93) |
| Not at risk, Week 35-48 | 3.04 (2.01 to 4.38) | 0.51 (0.06 to 1.82) | 0.73 (0.06 to 2.92) |
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 37 | 0.21 (0.07 to 0.50) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 26.46) |
| At risk, Week 38 | 0.23 (0.08 to 0.51) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 24.71) |
| At risk, Week 39 | 0.19 (0.05 to 0.50) | 0.00 (0.00 to 4.06) | 0.00 (0.00 to 14.25) |
| At risk, Week 40 | 0.00 (0.00 to 0.20) | 0.32 (0.00 to 2.12) | 0.00 (0.00 to 12.77) |
| At risk, Week 41 | 0.20 (0.03 to 0.66) | 0.33 (0.01 to 1.84) | 2.78 (0.07 to 14.53) |
| At risk, Week 42 | 0.00 (0.00 to 0.45) | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 21.80) |
| At risk, Week 43 | 0.00 (0.00 to 0.83) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 23.16) |
| At risk, Week 44 | 0.15 (0.00 to 1.16) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 11.94) |
| At risk, Week 45 | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 1.21) | 0.00 (0.00 to 8.22) |
| At risk, Week 46 | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 1.60) | 0.00 (0.00 to 24.71) |
| At risk, Week 47 | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 10.58) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 33.63) |
| Not at risk, Week 37 | 1.50 (0.18 to 5.33) | — | 0.00 (0.00 to 60.24) |
| Not at risk, Week 38 | 0.61 (0.01 to 4.01) | — | 0.00 (0.00 to 70.76) |
| Not at risk, Week 39 | 0.00 (0.00 to 1.08) | 0.00 (0.00 to 52.18) | — |
| Not at risk, Week 40 | 0.00 (0.00 to 2.09) | 0.00 (0.00 to 13.23) | 0.00 (0.00 to 60.24) |
| Not at risk, Week 41 | 0.00 (0.00 to 2.22) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 16.84) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.15) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 84.19) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.98) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 0.00 (0.00 to 6.72) | 0.00 (0.00 to 97.50) |
| Not at risk, Week 45 | 0.00 (0.00 to 4.86) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 1.68) |
| Not at risk, Week 46 | 0.00 (0.00 to 4.45) | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 45.93) |
| Not at risk, Week 47 | 0.00 (0.00 to 7.71) | 0.00 (0.00 to 16.84) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 97.50) |
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 35-37 | 0.21 (0.07 to 0.50) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 21.80) |
| At risk, Week 35-38 | 0.22 (0.11 to 0.40) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 12.34) |
| At risk, Week 35-39 | 0.21 (0.09 to 0.40) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 6.85) |
| At risk, Week 35-40 | 0.17 (0.07 to 0.34) | 0.24 (0.01 to 1.35) | 0.00 (0.00 to 4.56) |
| At risk, Week 35-41 | 0.17 (0.09 to 0.31) | 0.28 (0.02 to 1.20) | 0.87 (0.02 to 5.09) |
| At risk, Week 35-42 | 0.16 (0.08 to 0.30) | 0.19 (0.02 to 0.76) | 0.77 (0.01 to 4.61) |
| At risk, Week 35-43 | 0.16 (0.08 to 0.29) | 0.14 (0.01 to 0.58) | 0.69 (0.01 to 4.07) |
| At risk, Week 35-44 | 0.16 (0.08 to 0.29) | 0.11 (0.01 to 0.49) | 0.58 (0.01 to 3.18) |
| At risk, Week 35-45 | 0.15 (0.07 to 0.28) | 0.10 (0.00 to 0.45) | 0.46 (0.01 to 2.55) |
| At risk, Week 35-46 | 0.15 (0.07 to 0.27) | 0.09 (0.00 to 0.42) | 0.44 (0.01 to 2.41) |
| At risk, Week 35-47 | 0.15 (0.07 to 0.27) | 0.08 (0.00 to 0.40) | 0.38 (0.01 to 2.11) |
| At risk, Week 35-48 | 0.15 (0.07 to 0.27) | 0.08 (0.00 to 0.39) | 0.37 (0.01 to 2.04) |
| Not at risk, Week 35-37 | 1.50 (0.18 to 5.33) | — | 0.00 (0.00 to 60.24) |
| Not at risk, Week 35-38 | 1.01 (0.13 to 3.49) | — | 0.00 (0.00 to 40.96) |
| Not at risk, Week 35-39 | 0.47 (0.04 to 1.84) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 40.96) |
| Not at risk, Week 35-40 | 0.37 (0.03 to 1.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 28.49) |
| Not at risk, Week 35-41 | 0.31 (0.02 to 1.26) | 0.00 (0.00 to 5.21) | 0.00 (0.00 to 11.22) |
| Not at risk, Week 35-42 | 0.28 (0.02 to 1.15) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 10.58) |
| Not at risk, Week 35-43 | 0.27 (0.02 to 1.08) | 0.00 (0.00 to 2.13) | 0.00 (0.00 to 8.60) |
| Not at risk, Week 35-44 | 0.25 (0.02 to 1.03) | 0.00 (0.00 to 1.63) | 0.00 (0.00 to 8.41) |
| Not at risk, Week 35-45 | 0.24 (0.02 to 0.97) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 1.41) |
| Not at risk, Week 35-46 | 0.22 (0.02 to 0.90) | 0.00 (0.00 to 1.02) | 0.00 (0.00 to 1.38) |
| Not at risk, Week 35-47 | 0.22 (0.02 to 0.88) | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 1.34) |
| Not at risk, Week 35-48 | 0.21 (0.02 to 0.86) | 0.00 (0.00 to 0.93) | 0.00 (0.00 to 1.33) |
The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 37 | 0.00 (0.00 to 0.16) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 26.46) |
| At risk, Week 38 | 0.00 (0.00 to 0.14) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 24.71) |
| At risk, Week 39 | 0.00 (0.00 to 0.10) | 0.00 (0.00 to 4.06) | 0.00 (0.00 to 14.25) |
| At risk, Week 40 | 0.00 (0.00 to 0.20) | 0.00 (0.00 to 1.18) | 0.00 (0.00 to 12.77) |
| At risk, Week 41 | 0.00 (0.00 to 0.25) | 0.00 (0.00 to 1.22) | 0.00 (0.00 to 9.74) |
| At risk, Week 42 | 0.00 (0.00 to 0.45) | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 21.80) |
| At risk, Week 43 | 0.00 (0.00 to 0.83) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 23.16) |
| At risk, Week 44 | 0.00 (0.00 to 0.54) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 11.94) |
| At risk, Week 45 | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 1.21) | 0.00 (0.00 to 8.22) |
| At risk, Week 46 | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 1.60) | 0.00 (0.00 to 24.71) |
| At risk, Week 47 | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 10.58) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 33.63) |
| Not at risk, Week 37 | 0.00 (0.00 to 2.74) | — | 0.00 (0.00 to 60.24) |
| Not at risk, Week 38 | 0.00 (0.00 to 2.21) | — | 0.00 (0.00 to 70.76) |
| Not at risk, Week 39 | 0.00 (0.00 to 1.08) | 0.00 (0.00 to 52.18) | — |
| Not at risk, Week 40 | 0.00 (0.00 to 2.09) | 0.00 (0.00 to 13.23) | 0.00 (0.00 to 60.24) |
| Not at risk, Week 41 | 0.00 (0.00 to 2.22) | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 16.84) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.15) | 0.00 (0.00 to 7.11) | 0.00 (0.00 to 84.19) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.98) | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 0.00 (0.00 to 6.72) | 0.00 (0.00 to 97.50) |
| Not at risk, Week 45 | 0.00 (0.00 to 4.86) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 1.68) |
| Not at risk, Week 46 | 0.00 (0.00 to 4.45) | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 45.93) |
| Not at risk, Week 47 | 0.00 (0.00 to 7.71) | 0.00 (0.00 to 16.84) | 0.00 (0.00 to 36.94) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 97.50) |
The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 70.76) |
| At risk, Week 35-37 | 0.00 (0.00 to 0.16) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 21.80) |
| At risk, Week 35-38 | 0.00 (0.00 to 0.08) | 0.00 (0.00 to 28.49) | 0.00 (0.00 to 12.34) |
| At risk, Week 35-39 | 0.00 (0.00 to 0.04) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 6.85) |
| At risk, Week 35-40 | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 4.56) |
| At risk, Week 35-41 | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.52) | 0.00 (0.00 to 3.16) |
| At risk, Week 35-42 | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.35) | 0.00 (0.00 to 2.80) |
| At risk, Week 35-43 | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.27) | 0.00 (0.00 to 2.53) |
| At risk, Week 35-44 | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.20) | 0.00 (0.00 to 2.11) |
| At risk, Week 35-45 | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.18) | 0.00 (0.00 to 1.69) |
| At risk, Week 35-46 | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.16) | 0.00 (0.00 to 1.60) |
| At risk, Week 35-47 | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.15) | 0.00 (0.00 to 1.40) |
| At risk, Week 35-48 | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.14) | 0.00 (0.00 to 1.35) |
| Not at risk, Week 35-37 | 0.00 (0.00 to 2.74) | — | 0.00 (0.00 to 60.24) |
| Not at risk, Week 35-38 | 0.00 (0.00 to 1.23) | — | 0.00 (0.00 to 40.96) |
| Not at risk, Week 35-39 | 0.00 (0.00 to 0.58) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 40.96) |
| Not at risk, Week 35-40 | 0.00 (0.00 to 0.45) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 28.49) |
| Not at risk, Week 35-41 | 0.00 (0.00 to 0.38) | 0.00 (0.00 to 5.21) | 0.00 (0.00 to 11.22) |
| Not at risk, Week 35-42 | 0.00 (0.00 to 0.35) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 10.58) |
| Not at risk, Week 35-43 | 0.00 (0.00 to 0.33) | 0.00 (0.00 to 2.13) | 0.00 (0.00 to 8.60) |
| Not at risk, Week 35-44 | 0.00 (0.00 to 0.31) | 0.00 (0.00 to 1.63) | 0.00 (0.00 to 8.41) |
| Not at risk, Week 35-45 | 0.00 (0.00 to 0.29) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 1.41) |
| Not at risk, Week 35-46 | 0.00 (0.00 to 0.28) | 0.00 (0.00 to 1.02) | 0.00 (0.00 to 1.38) |
| Not at risk, Week 35-47 | 0.00 (0.00 to 0.27) | 0.00 (0.00 to 0.97) | 0.00 (0.00 to 1.34) |
| Not at risk, Week 35-48 | 0.00 (0.00 to 0.26) | 0.00 (0.00 to 0.93) | 0.00 (0.00 to 1.33) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from General Practitioners (GPs). The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 1.64 (0.00 to 15.62) |
| Week 37 | 11.63 (9.72 to 13.77) | 0.00 (0.00 to 52.18) | 1.28 (0.40 to 3.00) |
| Week 38 | 10.01 (7.49 to 13.03) | 10.00 (0.00 to 74.36) | 1.48 (0.64 to 2.89) |
| Week 39 | 10.03 (8.81 to 11.36) | 1.89 (0.23 to 6.65) | 2.26 (0.90 to 4.64) |
| Week 40 | 9.97 (6.19 to 14.98) | 7.31 (4.79 to 10.60) | 1.54 (0.46 to 3.74) |
| Week 41 | 8.58 (6.13 to 11.61) | 5.54 (2.93 to 9.41) | 0.50 (0.06 to 1.86) |
| Week 42 | 5.26 (2.93 to 8.62) | 2.18 (1.00 to 4.11) | 1.66 (0.21 to 5.75) |
| Week 43 | 6.01 (2.73 to 11.23) | 4.45 (2.19 to 7.95) | 1.83 (0.38 to 5.25) |
| Week 44 | 6.00 (2.35 to 12.24) | 5.94 (1.76 to 14.05) | 0.36 (0.04 to 1.28) |
| Week 45 | 6.59 (3.97 to 10.20) | 3.23 (0.38 to 11.32) | 4.00 (2.04 to 6.98) |
| Week 46 | 7.43 (3.88 to 12.65) | 1.56 (0.13 to 6.27) | 3.09 (0.24 to 12.26) |
| Week 47 | 4.26 (1.74 to 8.55) | 3.16 (1.04 to 7.23) | 1.51 (0.16 to 5.60) |
| Week 48 | 0.00 (0.00 to 2.51) | 5.00 (1.06 to 13.81) | 0.00 (0.00 to 8.41) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Week 37 | 0.45 (0.20 to 0.85) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Week 38 | 0.54 (0.19 to 1.23) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Week 39 | 0.51 (0.21 to 1.04) | 0.00 (0.00 to 3.42) | 0.21 (0.00 to 1.50) |
| Week 40 | 0.44 (0.11 to 1.19) | 1.46 (0.41 to 3.63) | 0.00 (0.00 to 0.63) |
| Week 41 | 0.36 (0.13 to 0.78) | 0.58 (0.07 to 2.09) | 0.00 (0.00 to 0.92) |
| Week 42 | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Week 43 | 0.40 (0.05 to 1.46) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Week 44 | 0.27 (0.02 to 1.20) | 0.42 (0.05 to 1.53) | 0.00 (0.00 to 0.66) |
| Week 45 | 0.22 (0.00 to 1.60) | 0.00 (0.00 to 0.91) | 0.29 (0.01 to 1.58) |
| Week 46 | 0.57 (0.03 to 2.58) | 0.17 (0.00 to 1.71) | 0.00 (0.00 to 3.73) |
| Week 47 | 0.39 (0.00 to 2.82) | 0.63 (0.01 to 4.02) | 0.00 (0.00 to 1.84) |
| Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Week 37 | 1.91 (0.82 to 3.74) | 0.00 (0.00 to 52.18) | 0.21 (0.01 to 1.18) |
| Week 38 | 1.63 (0.89 to 2.75) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Week 39 | 1.94 (1.31 to 2.77) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Week 40 | 1.94 (0.77 to 4.02) | 0.29 (0.00 to 1.78) | 0.00 (0.00 to 0.63) |
| Week 41 | 1.44 (0.93 to 2.14) | 0.87 (0.16 to 2.69) | 0.00 (0.00 to 0.92) |
| Week 42 | 0.55 (0.09 to 1.78) | 0.49 (0.06 to 1.74) | 0.00 (0.00 to 1.52) |
| Week 43 | 0.40 (0.04 to 1.49) | 0.79 (0.06 to 3.25) | 0.00 (0.00 to 2.22) |
| Week 44 | 1.20 (0.25 to 3.43) | 0.64 (0.08 to 2.26) | 0.00 (0.00 to 0.66) |
| Week 45 | 0.88 (0.15 to 2.76) | 0.50 (0.00 to 3.52) | 0.00 (0.00 to 1.05) |
| Week 46 | 1.43 (0.20 to 4.82) | 0.52 (0.01 to 3.35) | 0.00 (0.00 to 3.73) |
| Week 47 | 1.16 (0.06 to 5.45) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Any, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Any, Week 37 | 4.01 (3.23 to 4.92) | 0.00 (0.00 to 52.18) | 0.21 (0.00 to 1.80) |
| Any, Week 38 | 3.19 (2.35 to 4.23) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Any, Week 39 | 3.30 (2.61 to 4.12) | 0.94 (0.02 to 5.14) | 0.41 (0.05 to 1.48) |
| Any, Week 40 | 2.72 (2.06 to 3.52) | 2.34 (0.64 to 5.88) | 0.00 (0.00 to 0.63) |
| Any, Week 41 | 1.98 (1.37 to 2.77) | 1.17 (0.21 to 3.57) | 0.00 (0.00 to 0.92) |
| Any, Week 42 | 1.64 (0.58 to 3.64) | 0.49 (0.06 to 1.74) | 0.00 (0.00 to 1.52) |
| Any, Week 43 | 2.00 (0.73 to 4.36) | 1.05 (0.08 to 4.32) | 0.00 (0.00 to 2.22) |
| Any, Week 44 | 1.87 (0.74 to 3.85) | 1.70 (0.20 to 6.03) | 0.00 (0.00 to 0.66) |
| Any, Week 45 | 1.54 (0.33 to 4.38) | 1.49 (0.27 to 4.57) | 1.43 (0.47 to 3.30) |
| Any, Week 46 | 1.14 (0.31 to 2.91) | 0.35 (0.00 to 3.20) | 0.00 (0.00 to 3.73) |
| Any, Week 47 | 0.39 (0.01 to 2.41) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Any, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Drowsiness, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Drowsiness, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Drowsiness, Week 37 | 1.05 (0.62 to 1.68) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Drowsiness, Week 38 | 0.80 (0.29 to 1.75) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Drowsiness, Week 39 | 0.63 (0.32 to 1.12) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Drowsiness, Week 40 | 0.68 (0.37 to 1.14) | 0.29 (0.01 to 1.62) | 0.00 (0.00 to 0.63) |
| Drowsiness, Week 41 | 0.54 (0.25 to 1.02) | 0.58 (0.07 to 2.09) | 0.00 (0.00 to 0.92) |
| Drowsiness, Week 42 | 0.33 (0.02 to 1.52) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Drowsiness, Week 43 | 0.80 (0.01 to 5.27) | 0.26 (0.01 to 1.45) | 0.00 (0.00 to 2.22) |
| Drowsiness, Week 44 | 0.27 (0.02 to 1.18) | 0.42 (0.01 to 2.49) | 0.00 (0.00 to 0.66) |
| Drowsiness, Week 45 | 0.22 (0.00 to 1.58) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.05) |
| Drowsiness, Week 46 | 0.00 (0.00 to 1.05) | 0.17 (0.00 to 1.61) | 0.00 (0.00 to 3.73) |
| Drowsiness, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Drowsiness, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Fatigue, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Fatigue, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Fatigue, Week 37 | 2.19 (1.65 to 2.85) | 0.00 (0.00 to 52.18) | 0.21 (0.00 to 1.80) |
| Fatigue, Week 38 | 1.89 (1.33 to 2.59) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Fatigue, Week 39 | 1.80 (1.40 to 2.27) | 0.00 (0.00 to 3.42) | 0.21 (0.00 to 1.29) |
| Fatigue, Week 40 | 1.17 (0.60 to 2.03) | 0.58 (0.01 to 3.53) | 0.00 (0.00 to 0.63) |
| Fatigue, Week 41 | 1.20 (0.73 to 1.85) | 0.29 (0.01 to 1.61) | 0.00 (0.00 to 0.92) |
| Fatigue, Week 42 | 0.77 (0.08 to 2.91) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Fatigue, Week 43 | 0.80 (0.14 to 2.52) | 0.52 (0.04 to 2.17) | 0.00 (0.00 to 2.22) |
| Fatigue, Week 44 | 0.67 (0.22 to 1.55) | 0.64 (0.10 to 2.06) | 0.00 (0.00 to 0.66) |
| Fatigue, Week 45 | 1.10 (0.19 to 3.42) | 0.50 (0.02 to 2.38) | 0.29 (0.01 to 1.58) |
| Fatigue,Week 46 | 1.14 (0.31 to 2.91) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Fatigue,Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Fatigue,Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Headache, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Headache, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Headache, Week 37 | 2.27 (1.61 to 3.11) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Headache, Week 38 | 1.92 (1.11 to 3.08) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Headache, Week 39 | 1.92 (1.29 to 2.73) | 0.94 (0.02 to 5.14) | 0.21 (0.00 to 1.15) |
| Headache, Week 40 | 1.60 (1.02 to 2.40) | 1.46 (0.07 to 6.71) | 0.00 (0.00 to 0.63) |
| Headache, Week 41 | 0.96 (0.55 to 1.55) | 0.87 (0.16 to 2.69) | 0.00 (0.00 to 0.92) |
| Headache, Week 42 | 0.88 (0.22 to 2.35) | 0.24 (0.01 to 1.34) | 0.00 (0.00 to 1.52) |
| Headache, Week 43 | 1.40 (0.43 to 3.37) | 0.79 (0.06 to 3.25) | 0.00 (0.00 to 2.22) |
| Headache, Week 44 | 1.47 (0.61 to 2.94) | 1.06 (0.26 to 2.85) | 0.00 (0.00 to 0.66) |
| Headache, Week 45 | 1.32 (0.17 to 4.59) | 0.99 (0.16 to 3.22) | 1.43 (0.47 to 3.30) |
| Headache, Week 46 | 0.29 (0.00 to 2.15) | 0.17 (0.00 to 1.61) | 0.00 (0.00 to 3.73) |
| Headache, Week 47 | 0.39 (0.01 to 2.41) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Headache, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Irritability, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Irritability, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Irritability, Week 37 | 0.41 (0.19 to 0.74) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Irritability, Week 38 | 0.25 (0.09 to 0.55) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Irritability, Week 39 | 0.36 (0.11 to 0.88) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Irritability, Week 40 | 0.15 (0.03 to 0.43) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.63) |
| Irritability, Week 41 | 0.12 (0.01 to 0.43) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.92) |
| Irritability, Week 42 | 0.11 (0.00 to 0.79) | 0.24 (0.01 to 1.34) | 0.00 (0.00 to 1.52) |
| Irritability, Week 43 | 0.20 (0.00 to 1.33) | 0.26 (0.01 to 1.45) | 0.00 (0.00 to 2.22) |
| Irritability, Week 44 | 0.00 (0.00 to 0.49) | 0.42 (0.01 to 2.49) | 0.00 (0.00 to 0.66) |
| Irritability, Week 45 | 0.44 (0.00 to 3.14) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.05) |
| Irritability, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Irritability, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Irritability, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Malaise, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Malaise, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Malaise, Week 37 | 0.04 (0.00 to 0.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Malaise, Week 38 | 0.00 (0.00 to 0.13) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Malaise, Week 39 | 0.00 (0.00 to 0.09) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Malaise, Week 40 | 0.05 (0.00 to 0.28) | 0.29 (0.01 to 1.62) | 0.00 (0.00 to 0.63) |
| Malaise, Week 41 | 0.06 (0.00 to 0.37) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.92) |
| Malaise, Week 42 | 0.00 (0.00 to 0.40) | 0.24 (0.01 to 1.34) | 0.00 (0.00 to 1.52) |
| Malaise, Week 43 | 0.00 (0.00 to 0.74) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Malaise, Week 44 | 0.00 (0.00 to 0.49) | 0.00 (0.00 to 0.78) | 0.00 (0.00 to 0.66) |
| Malaise, Week 45 | 0.00 (0.00 to 0.81) | 0.25 (0.00 to 1.77) | 0.00 (0.00 to 1.05) |
| Malaise, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Malaise, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Malaise, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Any, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 1.64 (0.00 to 15.62) |
| Any, Week 37 | 6.45 (5.26 to 7.80) | 0.00 (0.00 to 52.18) | 0.64 (0.07 to 2.39) |
| Any, Week 38 | 4.86 (3.59 to 6.42) | 10.00 (0.00 to 74.36) | 0.55 (0.03 to 2.54) |
| Any, Week 39 | 4.98 (4.33 to 5.69) | 0.94 (0.02 to 5.14) | 1.23 (0.34 to 3.12) |
| Any, Week 40 | 5.30 (3.29 to 8.02) | 4.09 (2.26 to 6.77) | 1.03 (0.37 to 2.23) |
| Any, Week 41 | 4.68 (3.48 to 6.15) | 3.79 (2.03 to 6.39) | 0.25 (0.00 to 1.66) |
| Any, Week 42 | 2.52 (1.40 to 4.15) | 0.73 (0.15 to 2.13) | 1.66 (0.21 to 5.75) |
| Any, Week 43 | 2.81 (0.88 to 6.58) | 2.88 (1.17 to 5.84) | 0.00 (0.00 to 2.22) |
| Any, Week 44 | 3.07 (1.08 to 6.74) | 3.61 (1.41 to 7.45) | 0.36 (0.04 to 1.28) |
| Any, Week 45 | 2.20 (0.63 to 5.41) | 1.24 (0.05 to 6.01) | 2.29 (0.99 to 4.45) |
| Any, Week 46 | 2.86 (1.09 to 6.01) | 0.69 (0.02 to 3.73) | 0.00 (0.00 to 3.73) |
| Any, Week 47 | 2.71 (0.51 to 8.06) | 1.27 (0.15 to 4.50) | 1.51 (0.16 to 5.60) |
| Any, Week 48 | 0.00 (0.00 to 2.51) | 2.00 (0.24 to 7.04) | 0.00 (0.00 to 8.41) |
| Conjunctivitis, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Conjunctivitis, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Conjunctivitis, Week 37 | 0.24 (0.09 to 0.53) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Conjunctivitis, Week 38 | 0.51 (0.18 to 1.14) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Conjunctivitis, Week 39 | 0.32 (0.17 to 0.55) | 0.00 (0.00 to 3.42) | 0.21 (0.00 to 1.56) |
| Conjunctivitis, Week 40 | 0.34 (0.14 to 0.70) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.63) |
| Conjunctivitis, Week 41 | 0.42 (0.09 to 1.19) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.92) |
| Conjunctivitis, Week 42 | 0.11 (0.00 to 0.79) | 0.24 (0.01 to 1.34) | 0.41 (0.00 to 3.24) |
| Conjunctivitis, Week 43 | 0.20 (0.00 to 1.33) | 0.26 (0.01 to 1.45) | 0.00 (0.00 to 2.22) |
| Conjunctivitis, Week 44 | 0.53 (0.11 to 1.53) | 0.21 (0.00 to 1.46) | 0.18 (0.00 to 0.99) |
| Conjunctivitis, Week 45 | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.91) | 0.57 (0.07 to 2.05) |
| Conjunctivitis, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Conjunctivitis, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Conjunctivitis, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Coryza, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Coryza, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Coryza, Week 37 | 1.38 (0.75 to 2.32) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Coryza, Week 38 | 0.94 (0.50 to 1.62) | 0.00 (0.00 to 30.85) | 0.18 (0.00 to 1.36) |
| Coryza, Week 39 | 1.24 (0.85 to 1.75) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Coryza, Week 40 | 1.02 (0.63 to 1.56) | 1.46 (0.48 to 3.38) | 0.00 (0.00 to 0.63) |
| Coryza, Week 41 | 1.26 (0.70 to 2.10) | 0.29 (0.01 to 1.61) | 0.00 (0.00 to 0.92) |
| Coryza, Week 42 | 0.44 (0.12 to 1.12) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Coryza, Week 43 | 0.60 (0.04 to 2.61) | 0.79 (0.16 to 2.31) | 0.00 (0.00 to 2.22) |
| Coryza, Week 44 | 0.67 (0.11 to 2.15) | 0.42 (0.05 to 1.53) | 0.00 (0.00 to 0.66) |
| Coryza, Week 45 | 0.44 (0.00 to 3.14) | 0.25 (0.00 to 1.77) | 0.29 (0.01 to 1.58) |
| Coryza, Week 46 | 0.86 (0.14 to 2.76) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Coryza, Week 47 | 0.78 (0.08 to 2.99) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Coryza, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Cough, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Cough, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 1.64 (0.00 to 15.62) |
| Cough, Week 37 | 2.31 (1.64 to 3.16) | 0.00 (0.00 to 52.18) | 0.64 (0.07 to 2.39) |
| Cough, Week 38 | 1.96 (1.36 to 2.72) | 0.00 (0.00 to 30.85) | 0.18 (0.00 to 1.36) |
| Cough, Week 39 | 2.31 (1.87 to 2.81) | 0.94 (0.02 to 5.14) | 1.03 (0.19 to 3.09) |
| Cough, Week 40 | 1.65 (0.74 to 3.18) | 2.63 (1.13 to 5.16) | 0.85 (0.22 to 2.25) |
| Cough, Week 41 | 2.04 (1.17 to 3.29) | 2.04 (0.82 to 4.16) | 0.25 (0.00 to 1.66) |
| Cough, Week 42 | 1.10 (0.53 to 2.01) | 0.24 (0.00 to 2.15) | 0.41 (0.00 to 3.45) |
| Cough, Week 43 | 1.20 (0.26 to 3.40) | 1.83 (0.74 to 3.74) | 0.00 (0.00 to 2.22) |
| Cough, Week 44 | 1.33 (0.59 to 2.58) | 2.12 (0.63 to 5.12) | 0.00 (0.00 to 0.66) |
| Cough, Week 45 | 1.32 (0.24 to 4.00) | 0.99 (0.06 to 4.42) | 0.86 (0.18 to 2.48) |
| Cough, Week 46 | 2.29 (0.91 to 4.69) | 0.35 (0.00 to 3.20) | 0.00 (0.00 to 3.73) |
| Cough, Week 47 | 1.55 (0.15 to 5.98) | 0.00 (0.00 to 2.31) | 1.01 (0.05 to 4.78) |
| Cough, Week 48 | 0.00 (0.00 to 2.51) | 2.00 (0.24 to 7.04) | 0.00 (0.00 to 8.41) |
| Epistaxis, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Epistaxis, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Epistaxis, Week 37 | 0.08 (0.00 to 0.48) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Epistaxis, Week 38 | 0.04 (0.00 to 0.27) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Epistaxis, Week 39 | 0.12 (0.02 to 0.39) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Epistaxis, Week 40 | 0.15 (0.02 to 0.50) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.63) |
| Epistaxis, Week 41 | 0.06 (0.00 to 0.37) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.92) |
| Epistaxis, Week 42 | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Epistaxis, Week 43 | 0.00 (0.00 to 0.74) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Epistaxis, Week 44 | 0.27 (0.03 to 0.96) | 0.00 (0.00 to 0.78) | 0.00 (0.00 to 0.66) |
| Epistaxis, Week 45 | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.05) |
| Epistaxis, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Epistaxis, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Epistaxis, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Hoarseness, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Hoarseness, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Hoarseness, Week 37 | 1.09 (0.72 to 1.59) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Hoarseness, Week 38 | 0.83 (0.46 to 1.40) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Hoarseness, Week 39 | 0.53 (0.34 to 0.81) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Hoarseness, Week 40 | 0.49 (0.23 to 0.89) | 0.29 (0.01 to 1.62) | 0.00 (0.00 to 0.63) |
| Hoarseness, Week 41 | 0.54 (0.12 to 1.53) | 0.58 (0.07 to 2.09) | 0.00 (0.00 to 0.92) |
| Hoarseness, Week 42 | 0.22 (0.02 to 0.86) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Hoarseness, Week 43 | 0.80 (0.15 to 2.43) | 0.26 (0.01 to 1.45) | 0.00 (0.00 to 2.22) |
| Hoarseness, Week 44 | 0.27 (0.02 to 1.20) | 0.21 (0.00 to 1.25) | 0.00 (0.00 to 0.66) |
| Hoarseness, Week 45 | 0.66 (0.00 to 4.69) | 0.00 (0.00 to 0.91) | 0.29 (0.01 to 1.58) |
| Hoarseness, Week 46 | 0.29 (0.00 to 1.91) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Hoarseness, Week 47 | 0.39 (0.00 to 2.82) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Hoarseness, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Nasal congestion, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Nasal congestion, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Nasal congestion, Week 37 | 1.34 (0.92 to 1.87) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Nasal congestion, Week 38 | 0.91 (0.51 to 1.49) | 0.00 (0.00 to 30.85) | 0.18 (0.00 to 1.36) |
| Nasal congestion, Week 39 | 0.95 (0.62 to 1.39) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Nasal congestion, Week 40 | 0.88 (0.37 to 1.74) | 0.58 (0.04 to 2.49) | 0.00 (0.00 to 0.63) |
| Nasal congestion, Week 41 | 0.48 (0.21 to 0.94) | 0.87 (0.16 to 2.69) | 0.00 (0.00 to 0.92) |
| Nasal congestion, Week 42 | 0.44 (0.02 to 2.19) | 0.00 (0.00 to 0.89) | 0.41 (0.00 to 3.20) |
| Nasal congestion, Week 43 | 0.20 (0.00 to 1.37) | 0.79 (0.16 to 2.28) | 0.00 (0.00 to 2.22) |
| Nasal congestion, Week 44 | 0.27 (0.03 to 0.96) | 0.21 (0.00 to 1.46) | 0.00 (0.00 to 0.66) |
| Nasal congestion, Week 45 | 0.88 (0.14 to 2.81) | 0.25 (0.00 to 1.77) | 0.29 (0.01 to 1.58) |
| Nasal congestion, Week 46 | 0.86 (0.12 to 2.94) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Nasal congestion, Week 47 | 0.78 (0.05 to 3.40) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Nasal congestion, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Oropharyngeal pain, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Oropharyngeal pain, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Oropharyngeal pain, Week 37 | 2.27 (1.64 to 3.06) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Oropharyngeal pain, Week 38 | 1.38 (0.79 to 2.22) | 0.00 (0.00 to 30.85) | 0.18 (0.00 to 1.28) |
| Oropharyngeal pain, Week 39 | 1.58 (1.22 to 2.01) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Oropharyngeal pain, Week 40 | 1.02 (0.48 to 1.91) | 0.29 (0.00 to 1.78) | 0.17 (0.00 to 1.48) |
| Oropharyngeal pain, Week 41 | 1.20 (0.54 to 2.29) | 0.87 (0.16 to 2.69) | 0.00 (0.00 to 0.92) |
| Oropharyngeal pain, Week 42 | 0.44 (0.07 to 1.43) | 0.24 (0.00 to 2.05) | 0.41 (0.00 to 3.14) |
| Oropharyngeal pain, Week 43 | 0.60 (0.05 to 2.44) | 0.52 (0.04 to 2.17) | 0.00 (0.00 to 2.22) |
| Oropharyngeal pain, Week 44 | 0.93 (0.22 to 2.56) | 0.64 (0.01 to 3.72) | 0.18 (0.00 to 0.99) |
| Oropharyngeal pain, Week 45 | 0.88 (0.03 to 4.37) | 0.50 (0.00 to 3.52) | 0.57 (0.07 to 2.05) |
| Oropharyngeal pain, Week 46 | 0.29 (0.00 to 1.91) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Oropharyngeal pain, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.50 (0.00 to 3.77) |
| Oropharyngeal pain, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Rhinorrhoea, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Rhinorrhoea, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Rhinorrhoea, Week 37 | 3.28 (2.18 to 4.74) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Rhinorrhoea, Week 38 | 2.43 (1.71 to 3.35) | 10.00 (0.00 to 74.36) | 0.00 (0.00 to 0.68) |
| Rhinorrhoea, Week 39 | 2.26 (1.68 to 2.97) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Rhinorrhoea, Week 40 | 2.43 (1.31 to 4.10) | 1.17 (0.22 to 3.53) | 0.00 (0.00 to 0.63) |
| Rhinorrhoea, Week 41 | 1.92 (1.19 to 2.92) | 1.75 (0.64 to 3.79) | 0.00 (0.00 to 0.92) |
| Rhinorrhoea, Week 42 | 0.99 (0.33 to 2.27) | 0.49 (0.06 to 1.74) | 0.00 (0.00 to 1.52) |
| Rhinorrhoea, Week 43 | 2.00 (0.48 to 5.36) | 1.57 (0.58 to 3.39) | 0.00 (0.00 to 2.22) |
| Rhinorrhoea, Week 44 | 1.47 (0.37 to 3.86) | 1.06 (0.25 to 2.89) | 0.00 (0.00 to 0.66) |
| Rhinorrhoea, Week 45 | 1.32 (0.38 to 3.24) | 0.50 (0.00 to 3.52) | 0.86 (0.18 to 2.48) |
| Rhinorrhoea, Week 46 | 1.14 (0.27 to 3.12) | 0.17 (0.00 to 1.61) | 0.00 (0.00 to 3.73) |
| Rhinorrhoea, Week 47 | 1.16 (0.06 to 5.45) | 0.63 (0.02 to 3.48) | 0.00 (0.00 to 1.84) |
| Rhinorrhoea, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Wheezing, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Wheezing, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Wheezing, Week 37 | 0.93 (0.59 to 1.40) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Wheezing, Week 38 | 0.58 (0.29 to 1.02) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Wheezing, Week 39 | 0.41 (0.24 to 0.67) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Wheezing, Week 40 | 0.63 (0.25 to 1.33) | 0.29 (0.01 to 1.62) | 0.00 (0.00 to 0.63) |
| Wheezing, Week 41 | 0.30 (0.08 to 0.78) | 0.58 (0.07 to 2.09) | 0.00 (0.00 to 0.92) |
| Wheezing, Week 42 | 0.22 (0.01 to 1.06) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Wheezing, Week 43 | 0.20 (0.00 to 1.46) | 0.52 (0.04 to 2.17) | 0.00 (0.00 to 2.22) |
| Wheezing, Week 44 | 0.27 (0.03 to 0.96) | 1.06 (0.20 to 3.19) | 0.00 (0.00 to 0.66) |
| Wheezing, Week 45 | 0.22 (0.00 to 1.58) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.05) |
| Wheezing, Week 46 | 0.00 (0.00 to 1.05) | 0.35 (0.04 to 1.25) | 0.00 (0.00 to 3.73) |
| Wheezing, Week 47 | 0.39 (0.01 to 2.44) | 0.63 (0.01 to 3.88) | 0.00 (0.00 to 1.84) |
| Wheezing, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Any, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Any, Week 37 | 2.11 (1.30 to 3.22) | 0.00 (0.00 to 52.18) | 0.21 (0.00 to 1.80) |
| Any, Week 38 | 1.81 (1.08 to 2.84) | 10.00 (0.00 to 74.36) | 0.00 (0.00 to 0.68) |
| Any, Week 39 | 1.51 (0.99 to 2.19) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Any, Week 40 | 1.46 (0.88 to 2.27) | 1.17 (0.32 to 2.97) | 0.00 (0.00 to 0.63) |
| Any, Week 41 | 1.26 (0.63 to 2.24) | 0.58 (0.07 to 2.09) | 0.00 (0.00 to 0.92) |
| Any, Week 42 | 1.10 (0.46 to 2.18) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Any, Week 43 | 0.80 (0.22 to 2.04) | 0.00 (0.00 to 0.96) | 0.61 (0.00 to 4.42) |
| Any, Week 44 | 0.67 (0.22 to 1.55) | 0.42 (0.01 to 2.49) | 0.00 (0.00 to 0.66) |
| Any, Week 45 | 1.98 (0.63 to 4.60) | 0.99 (0.15 to 3.23) | 0.86 (0.18 to 2.48) |
| Any, Week 46 | 1.43 (0.18 to 5.01) | 0.17 (0.00 to 1.48) | 1.03 (0.01 to 6.91) |
| Any, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Any, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Decreased appetite, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Decreased appetite, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Decreased appetite, Week 37 | 0.73 (0.43 to 1.15) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Decreased appetite, Week 38 | 0.47 (0.25 to 0.81) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Decreased appetite, Week 39 | 0.46 (0.19 to 0.94) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Decreased appetite, Week 40 | 0.34 (0.12 to 0.75) | 1.17 (0.32 to 2.97) | 0.00 (0.00 to 0.63) |
| Decreased appetite, Week 41 | 0.48 (0.13 to 1.23) | 0.29 (0.01 to 1.61) | 0.00 (0.00 to 0.92) |
| Decreased appetite, Week 42 | 0.22 (0.01 to 0.95) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Decreased appetite, Week 43 | 0.00 (0.00 to 0.74) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Decreased appetite, Week 44 | 0.13 (0.00 to 1.01) | 0.00 (0.00 to 0.78) | 0.00 (0.00 to 0.66) |
| Decreased appetite, Week 45 | 0.66 (0.09 to 2.22) | 0.25 (0.00 to 1.77) | 0.00 (0.00 to 1.05) |
| Decreased appetite, Week 46 | 0.57 (0.04 to 2.38) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Decreased appetite, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Decreased appetite, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Diarrhoea, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Diarrhoea, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Diarrhoea, Week 37 | 0.97 (0.58 to 1.54) | 0.00 (0.00 to 52.18) | 0.21 (0.00 to 1.80) |
| Diarrhoea, Week 38 | 0.76 (0.46 to 1.18) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Diarrhoea, Week 39 | 0.68 (0.45 to 0.98) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Diarrhoea, Week 40 | 0.68 (0.25 to 1.47) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.63) |
| Diarrhoea, Week 41 | 0.66 (0.28 to 1.30) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.92) |
| Diarrhoea, Week 42 | 0.44 (0.12 to 1.12) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Diarrhoea, Week 43 | 0.40 (0.04 to 1.55) | 0.00 (0.00 to 0.96) | 0.61 (0.00 to 4.42) |
| Diarrhoea, Week 44 | 0.27 (0.01 to 1.27) | 0.21 (0.00 to 1.25) | 0.00 (0.00 to 0.66) |
| Diarrhoea, Week 45 | 0.66 (0.05 to 2.70) | 0.25 (0.01 to 1.37) | 0.29 (0.01 to 1.58) |
| Diarrhoea, Week 46 | 0.86 (0.07 to 3.46) | 0.00 (0.00 to 0.64) | 1.03 (0.01 to 6.91) |
| Diarrhoea, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Diarrhoea, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Nausea, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Nausea, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Nausea, Week 37 | 0.97 (0.49 to 1.72) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Nausea, Week 38 | 1.05 (0.43 to 2.14) | 10 (0 to 74.36) | 0.00 (0.00 to 0.68) |
| Nausea, Week 39 | 0.78 (0.35 to 1.50) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Nausea, Week 40 | 0.53 (0.23 to 1.05) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.63) |
| Nausea, Week 41 | 0.54 (0.25 to 1.02) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.92) |
| Nausea, Week 42 | 0.33 (0.02 to 1.47) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Nausea, Week 43 | 0.40 (0.04 to 1.61) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Nausea, Week 44 | 0.53 (0.15 to 1.36) | 0.21 (0.00 to 1.25) | 0.00 (0.00 to 0.66) |
| Nausea, Week 45 | 0.88 (0.12 to 3.05) | 0.50 (0.02 to 2.38) | 0.29 (0.01 to 1.58) |
| Nausea, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Nausea, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Nausea, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Vomiting, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Vomiting, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Vomiting, Week 37 | 0.12 (0.02 to 0.38) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Vomiting, Week 38 | 0.22 (0.08 to 0.48) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Vomiting, Week 39 | 0.19 (0.08 to 0.38) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Vomiting, Week 40 | 0.05 (0.00 to 0.28) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.63) |
| Vomiting, Week 41 | 0.30 (0.05 to 0.92) | 0.29 (0.01 to 1.61) | 0.00 (0.00 to 0.92) |
| Vomiting, Week 42 | 0.33 (0.03 to 1.37) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Vomiting, Week 43 | 0.20 (0.00 to 1.32) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Vomiting, Week 44 | 0.13 (0.00 to 1.05) | 0.00 (0.00 to 0.78) | 0.00 (0.00 to 0.66) |
| Vomiting, Week 45 | 0.44 (0.01 to 2.73) | 0.00 (0.00 to 0.91) | 0.57 (0.07 to 2.05) |
| Vomiting, Week 46 | 0.00 (0.00 to 1.05) | 0.17 (0.00 to 1.48) | 0.00 (0.00 to 3.73) |
| Vomiting, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Vomiting, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Any, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Any, Week 37 | 0.69 (0.01 to 4.09) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Any, Week 38 | 0.58 (0.07 to 2.10) | 0.00 (0.00 to 30.85) | 0.18 (0.00 to 1.06) |
| Any, Week 39 | 0.41 (0.04 to 1.65) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Any, Week 40 | 0.44 (0.05 to 1.59) | 0.58 (0.01 to 3.53) | 0.00 (0.00 to 0.63) |
| Any, Week 41 | 0.24 (0.05 to 0.69) | 0.87 (0.16 to 2.69) | 0.00 (0.00 to 0.92) |
| Any, Week 42 | 0.00 (0.00 to 0.40) | 0.24 (0.00 to 1.97) | 0.00 (0.00 to 1.52) |
| Any, Week 43 | 0.20 (0.00 to 1.37) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Any, Week 44 | 0.27 (0.02 to 1.20) | 0.64 (0.01 to 3.72) | 0.00 (0.00 to 0.66) |
| Any, Week 45 | 0.22 (0.00 to 1.58) | 0.00 (0.00 to 0.91) | 0.29 (0.01 to 1.58) |
| Any, Week 46 | 0.29 (0.00 to 2.10) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Any, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Any, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Anaphylactic reactions, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Anaphylactic reactions, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Anaphylactic reactions, Week 37 | 0.61 (0.01 to 4.06) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Anaphylactic reactions, Week 38 | 0.44 (0.01 to 2.53) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Anaphylactic reactions, Week 39 | 0.29 (0.01 to 1.48) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Anaphylactic reactions, Week 40 | 0.19 (0.00 to 1.58) | 0.58 (0.01 to 3.53) | 0.00 (0.00 to 0.63) |
| Anaphylactic reactions, Week 41 | 0.00 (0.00 to 0.22) | 0.58 (0.07 to 2.09) | 0.00 (0.00 to 0.92) |
| Anaphylactic reactions, Week 42 | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Anaphylactic reactions, Week 43 | 0.20 (0.00 to 1.37) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Anaphylactic reactions, Week 44 | 0.00 (0.00 to 0.49) | 0.64 (0.01 to 3.72) | 0.00 (0.00 to 0.66) |
| Anaphylactic reactions, Week 45 | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.91) | 0.29 (0.01 to 1.58) |
| Anaphylactic reactions, Week 46 | 0.29 (0.00 to 2.10) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Anaphylactic reactions, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Anaphylactic reactions, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Facial oedema, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Facial oedema, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Facial oedema, Week 37 | 0.04 (0.00 to 0.27) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Facial oedema, Week 38 | 0.07 (0.01 to 0.26) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Facial oedema, Week 39 | 0.05 (0.00 to 0.20) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Facial oedema, Week 40 | 0.00 (0.00 to 0.18) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.63) |
| Facial oedema, Week 41 | 0.06 (0.00 to 0.45) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.92) |
| Facial oedema, Week 42 | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Facial oedema, Week 43 | 0.00 (0.00 to 0.74) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Facial oedema, Week 44 | 0.13 (0.00 to 0.74) | 0.00 (0.00 to 0.78) | 0.00 (0.00 to 0.66) |
| Facial oedema, Week 45 | 0.22 (0.00 to 1.58) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.05) |
| Facial oedema, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Facial oedema, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Facial oedema, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Hypersensitivity reactions, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Hypersensitivity reactions, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Hypersensitivity reactions, Week 37 | 0.08 (0.01 to 0.29) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Hypersensitivity reactions, Week 38 | 0.11 (0.02 to 0.36) | 0.00 (0.00 to 30.85) | 0.18 (0.00 to 1.06) |
| Hypersensitivity reactions, Week 39 | 0.07 (0.02 to 0.21) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Hypersensitivity reactions, Week 40 | 0.24 (0.08 to 0.57) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.63) |
| Hypersensitivity reactions, Week 41 | 0.24 (0.05 to 0.69) | 0.29 (0.01 to 1.61) | 0.00 (0.00 to 0.92) |
| Hypersensitivity reactions, Week 42 | 0.00 (0.00 to 0.40) | 0.24 (0.00 to 1.97) | 0.00 (0.00 to 1.52) |
| Hypersensitivity reactions, Week 43 | 0.00 (0.00 to 0.74) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Hypersensitivity reactions, Week 44 | 0.13 (0.00 to 0.74) | 0.00 (0.00 to 0.78) | 0.00 (0.00 to 0.66) |
| Hypersensitivity reactions, Week 45 | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.05) |
| Hypersensitivity reactions, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Hypersensitivity reactions, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Hypersensitivity reactions, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Any, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Any, Week 37 | 0.77 (0.46 to 1.20) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Any, Week 38 | 0.54 (0.24 to 1.06) | 0.00 (0.00 to 30.85) | 0.37 (0.04 to 1.40) |
| Any, Week 39 | 0.36 (0.20 to 0.60) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Any, Week 40 | 0.58 (0.30 to 1.02) | 0.29 (0.01 to 1.62) | 0.17 (0.00 to 0.95) |
| Any, Week 41 | 0.12 (0.01 to 0.43) | 0.58 (0.07 to 2.09) | 0.00 (0.00 to 0.92) |
| Any, Week 42 | 0.11 (0.00 to 0.80) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Any, Week 43 | 0.60 (0.11 to 1.87) | 0.52 (0.06 to 1.88) | 0.00 (0.00 to 2.22) |
| Any, Week 44 | 0.53 (0.11 to 1.53) | 0.21 (0.00 to 1.27) | 0.00 (0.00 to 0.66) |
| Any, Week 45 | 0.22 (0.00 to 1.53) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.05) |
| Any, Week 46 | 0.57 (0.05 to 2.30) | 0.17 (0.00 to 1.59) | 0.00 (0.00 to 3.73) |
| Any, Week 47 | 0.00 (0.00 to 1.42) | 0.63 (0.02 to 3.48) | 0.00 (0.00 to 1.84) |
| Any, Week 48 | 0.00 (0.00 to 2.51) | 1.00 (0.01 to 6.22) | 0.00 (0.00 to 8.41) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Any, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Any, Week 37 | 4.26 (3.33 to 5.34) | 0.00 (0.00 to 52.18) | 0.43 (0.05 to 1.53) |
| Any, Week 38 | 3.37 (2.47 to 4.50) | 0.00 (0.00 to 30.85) | 0.37 (0.04 to 1.33) |
| Any, Week 39 | 3.33 (2.78 to 3.95) | 0.00 (0.00 to 3.42) | 0.82 (0.22 to 2.09) |
| Any, Week 40 | 2.63 (1.91 to 3.52) | 1.17 (0.02 to 6.99) | 0.51 (0.06 to 1.86) |
| Any, Week 41 | 2.52 (1.82 to 3.39) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.92) |
| Any, Week 42 | 1.97 (0.86 to 3.84) | 0.49 (0.06 to 1.74) | 0.00 (0.00 to 1.52) |
| Any, Week 43 | 3.21 (1.38 to 6.25) | 0.26 (0.00 to 1.67) | 1.22 (0.15 to 4.34) |
| Any, Week 44 | 1.87 (0.67 to 4.07) | 1.27 (0.02 to 7.37) | 0.00 (0.00 to 0.66) |
| Any, Week 45 | 2.64 (1.12 to 5.21) | 0.50 (0.06 to 1.78) | 0.29 (0.01 to 1.58) |
| Any, Week 46 | 1.43 (0.47 to 3.30) | 0.17 (0.00 to 1.61) | 2.06 (0.24 to 7.40) |
| Any, Week 47 | 1.94 (0.49 to 5.06) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Any, Week 48 | 0.00 (0.00 to 2.51) | 2.00 (0.24 to 7.04) | 0.00 (0.00 to 8.41) |
| Arthropathy, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Arthropathy, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Arthropathy, Week 37 | 1.42 (0.99 to 1.97) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Arthropathy, Week 38 | 1.05 (0.62 to 1.67) | 0.00 (0.00 to 30.85) | 0.18 (0.00 to 1.06) |
| Arthropathy, Week 39 | 0.90 (0.55 to 1.38) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Arthropathy, Week 40 | 0.78 (0.24 to 1.86) | 0.88 (0.01 to 5.27) | 0.00 (0.00 to 0.63) |
| Arthropathy, Week 41 | 0.60 (0.28 to 1.11) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.92) |
| Arthropathy, Week 42 | 0.33 (0.06 to 0.99) | 0.24 (0.01 to 1.34) | 0.00 (0.00 to 1.52) |
| Arthropathy, Week 43 | 1.00 (0.26 to 2.61) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Arthropathy, Week 44 | 0.67 (0.12 to 2.05) | 0.64 (0.01 to 3.72) | 0.00 (0.00 to 0.66) |
| Arthropathy, Week 45 | 0.66 (0.04 to 2.96) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.05) |
| Arthropathy, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Arthropathy, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Arthropathy, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Muscle aches / myalgia, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Muscle aches / myalgia, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Muscle aches / myalgia, Week 37 | 3.77 (2.67 to 5.16) | 0.00 (0.00 to 52.18) | 0.43 (0.05 to 1.53) |
| Muscle aches / myalgia, Week 38 | 3.08 (2.31 to 4.03) | 0.00 (0.00 to 30.85) | 0.18 (0.00 to 1.14) |
| Muscle aches / myalgia, Week 39 | 2.96 (2.47 to 3.53) | 0.00 (0.00 to 3.42) | 0.82 (0.22 to 2.09) |
| Muscle aches / myalgia, Week 40 | 2.43 (1.74 to 3.29) | 1.17 (0.02 to 6.99) | 0.51 (0.06 to 1.86) |
| Muscle aches / myalgia, Week 41 | 2.34 (1.64 to 3.23) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.92) |
| Muscle aches / myalgia, Week 42 | 1.86 (0.75 to 3.80) | 0.49 (0.06 to 1.74) | 0.00 (0.00 to 1.52) |
| Muscle aches / myalgia, Week 43 | 3.01 (1.18 to 6.20) | 0.26 (0.00 to 1.67) | 1.22 (0.15 to 4.34) |
| Muscle aches / myalgia, Week 44 | 1.60 (0.66 to 3.22) | 1.27 (0.02 to 7.37) | 0.00 (0.00 to 0.66) |
| Muscle aches / myalgia, Week 45 | 2.42 (1.04 to 4.74) | 0.50 (0.06 to 1.78) | 0.29 (0.01 to 1.58) |
| Muscle aches / myalgia, Week 46 | 1.43 (0.47 to 3.30) | 0.17 (0.00 to 1.61) | 2.06 (0.24 to 7.40) |
| Muscle aches / myalgia, Week 47 | 1.94 (0.49 to 5.06) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Muscle aches / myalgia, Week 48 | 0.00 (0.00 to 2.51) | 2.00 (0.24 to 7.04) | 0.00 (0.00 to 8.41) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Any, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Any, Week 37 | 0.28 (0.11 to 0.58) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Any, Week 38 | 0.29 (0.13 to 0.57) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Any, Week 39 | 0.22 (0.06 to 0.57) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Any, Week 40 | 0.00 (0.00 to 0.18) | 0.29 (0.00 to 1.78) | 0.00 (0.00 to 0.63) |
| Any, Week 41 | 0.18 (0.03 to 0.59) | 0.29 (0.01 to 1.61) | 0.25 (0.00 to 1.69) |
| Any, Week 42 | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Any, Week 43 | 0.00 (0.00 to 0.74) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Any, Week 44 | 0.13 (0.00 to 1.05) | 0.00 (0.00 to 0.78) | 0.00 (0.00 to 0.66) |
| Any, Week 45 | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.05) |
| Any, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Any, Week 47 | 0.00 (0.00 to 1.42) | 0.63 (0.01 to 4.02) | 0.00 (0.00 to 1.84) |
| Any, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Bell's palsy, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Bell's palsy, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Bell's palsy, Week 37 | 0.00 (0.00 to 0.15) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Bell's palsy, Week 38 | 0.00 (0.00 to 0.13) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Bell's palsy, Week 39 | 0.02 (0.00 to 0.18) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Bell's palsy, Week 40 | 0.00 (0.00 to 0.18) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.63) |
| Bell's palsy, Week 41 | 0.00 (0.00 to 0.22) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.92) |
| Bell's palsy, Week 42 | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Bell's palsy, Week 43 | 0.00 (0.00 to 0.74) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Bell's palsy, Week 44 | 0.00 (0.00 to 0.49) | 0.00 (0.00 to 0.78) | 0.00 (0.00 to 0.66) |
| Bell's palsy, Week 45 | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.05) |
| Bell's palsy, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Bell's palsy, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Bell's palsy, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Guillain-Barre Syndrome, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Guillain-Barre Syndrome, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Guillain-Barre Syndrome, Week 37 | 0.00 (0.00 to 0.15) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Guillain-Barre Syndrome, Week 38 | 0.00 (0.00 to 0.13) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Guillain-Barre Syndrome, Week 39 | 0.00 (0.00 to 0.09) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Guillain-Barre Syndrome, Week 40 | 0.00 (0.00 to 0.18) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.63) |
| Guillain-Barre Syndrome, Week 41 | 0.00 (0.00 to 0.22) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.92) |
| Guillain-Barre Syndrome, Week 42 | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Guillain-Barre Syndrome, Week 43 | 0.00 (0.00 to 0.74) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Guillain-Barre Syndrome, Week 44 | 0.00 (0.00 to 0.49) | 0.00 (0.00 to 0.78) | 0.00 (0.00 to 0.66) |
| Guillain-Barre Syndrome, Week 45 | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.05) |
| Guillain-Barre Syndrome, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Guillain-Barre Syndrome, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Guillain-Barre Syndrome, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Peripheral tremor, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Peripheral tremor, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Peripheral tremor, Week 37 | 0.24 (0.09 to 0.53) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Peripheral tremor, Week 38 | 0.29 (0.13 to 0.57) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Peripheral tremor, Week 39 | 0.19 (0.04 to 0.56) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Peripheral tremor, Week 40 | 0.00 (0.00 to 0.18) | 0.29 (0.00 to 1.78) | 0.00 (0.00 to 0.63) |
| Peripheral tremor, Week 41 | 0.18 (0.03 to 0.59) | 0.29 (0.01 to 1.61) | 0.00 (0.00 to 0.92) |
| Peripheral tremor, Week 42 | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Peripheral tremor, Week 43 | 0.00 (0.00 to 0.74) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Peripheral tremor, Week 44 | 0.13 (0.00 to 1.05) | 0.00 (0.00 to 0.78) | 0.00 (0.00 to 0.66) |
| Peripheral tremor, Week 45 | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.05) |
| Peripheral tremor, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Peripheral tremor, Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.00 (0.00 to 1.84) |
| Peripheral tremor, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
| Seizure/Febrile convulsions, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| Seizure/Febrile convulsions, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| Seizure/Febrile convulsions, Week 37 | 0.04 (0.00 to 0.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.78) |
| Seizure/Febrile convulsions, Week 38 | 0.00 (0.00 to 0.13) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.68) |
| Seizure/Febrile convulsions, Week 39 | 0.00 (0.00 to 0.09) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| Seizure/Febrile convulsions, Week 40 | 0.00 (0.00 to 0.18) | 0.00 (0.00 to 1.07) | 0.00 (0.00 to 0.63) |
| Seizure/Febrile convulsions, Week 41 | 0.00 (0.00 to 0.22) | 0.00 (0.00 to 1.07) | 0.25 (0.00 to 1.69) |
| Seizure/Febrile convulsions, Week 42 | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 0.89) | 0.00 (0.00 to 1.52) |
| Seizure/Febrile convulsions, Week 43 | 0.00 (0.00 to 0.74) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| Seizure/Febrile convulsions, Week 44 | 0.00 (0.00 to 0.49) | 0.00 (0.00 to 0.78) | 0.00 (0.00 to 0.66) |
| Seizure/Febrile convulsions, Week 45 | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 1.05) |
| Seizure/Febrile convulsions, Week 46 | 0.00 (0.00 to 1.05) | 0.00 (0.00 to 0.64) | 0.00 (0.00 to 3.73) |
| Seizure/Febrile convulsions, Week 47 | 0.00 (0.00 to 1.42) | 0.63 (0.01 to 4.02) | 0.00 (0.00 to 1.84) |
| Seizure/Febrile convulsions, Week 48 | 0.00 (0.00 to 2.51) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
SAEs reported here are derived from 2 sources of data - ADR cards and SAE routinely collected from GPs. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At Week 35 | — | — | 0.00 (0.00 to 97.50) |
| At Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.87) |
| At Week 37 | 0.12 (0.02 to 0.37) | 0.00 (0.00 to 52.18) | 0.21 (0.00 to 1.71) |
| At Week 38 | 0.18 (0.04 to 0.52) | 0.00 (0.00 to 30.85) | 0.37 (0.04 to 1.33) |
| At Week 39 | 0.07 (0.01 to 0.22) | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 0.76) |
| At Week 40 | 0.19 (0.04 to 0.60) | 0.00 (0.00 to 1.07) | 0.17 (0.00 to 1.29) |
| At Week 41 | 0.12 (0.01 to 0.55) | 0.00 (0.00 to 1.07) | 0.50 (0.04 to 2.05) |
| At Week 42 | 0.00 (0.00 to 0.40) | 0.24 (0.01 to 1.34) | 0.00 (0.00 to 1.52) |
| At Week 43 | 0.40 (0.01 to 2.45) | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 2.22) |
| At Week 44 | 0.27 (0.00 to 1.90) | 0.21 (0.00 to 1.46) | 0.36 (0.00 to 2.77) |
| At Week 45 | 0.22 (0.00 to 1.60) | 0.25 (0.00 to 1.77) | 0.00 (0.00 to 1.05) |
| At Week 46 | 0.57 (0.07 to 2.05) | 0.00 (0.00 to 0.64) | 1.03 (0.01 to 6.91) |
| At Week 47 | 0.00 (0.00 to 1.42) | 0.00 (0.00 to 2.31) | 0.50 (0.00 to 4.16) |
| At Week 48 | 0.69 (0.01 to 4.21) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 8.41) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 1.61 (0.00 to 14.32) |
| Week 35-37 | 11.63 (9.72 to 13.76) | 0.00 (0.00 to 45.93) | 1.32 (0.47 to 2.90) |
| Week 35-38 | 10.78 (8.92 to 12.86) | 6.25 (0.12 to 31.55) | 1.40 (0.78 to 2.30) |
| Week 35-39 | 10.45 (8.95 to 12.11) | 2.46 (0.33 to 8.32) | 1.67 (0.92 to 2.78) |
| Week 35-40 | 10.36 (8.58 to 12.37) | 6.03 (3.98 to 8.72) | 1.63 (0.82 to 2.89) |
| Week 35-41 | 10.13 (8.31 to 12.21) | 5.82 (3.69 to 8.68) | 1.46 (0.72 to 2.61) |
| Week 35-42 | 9.82 (7.97 to 11.93) | 4.59 (2.92 to 6.85) | 1.47 (0.74 to 2.61) |
| Week 35-43 | 9.69 (7.84 to 11.79) | 4.56 (2.86 to 6.86) | 1.49 (0.74 to 2.67) |
| Week 35-44 | 9.50 (7.65 to 11.63) | 4.87 (2.74 to 7.93) | 1.31 (0.69 to 2.24) |
| Week 35-45 | 9.42 (7.60 to 11.50) | 4.61 (2.45 to 7.80) | 1.56 (0.85 to 2.60) |
| Week 35-46 | 9.38 (7.54 to 11.48) | 4.03 (1.72 to 7.88) | 1.59 (0.92 to 2.56) |
| Week 35-47 | 9.30 (7.46 to 11.41) | 3.99 (1.72 to 7.76) | 1.59 (0.90 to 2.59) |
| Week 35-48 | 9.21 (7.37 to 11.34) | 4.02 (1.73 to 7.82) | 1.57 (0.89 to 2.56) |
"subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Week 35-37 | 0.45 (0.20 to 0.85) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Week 35-38 | 0.50 (0.29 to 0.80) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Week 35-39 | 0.50 (0.26 to 0.87) | 0.00 (0.00 to 2.98) | 0.06 (0.00 to 0.46) |
| Week 35-40 | 0.49 (0.29 to 0.79) | 1.08 (0.17 to 3.52) | 0.05 (0.00 to 0.34) |
| Week 35-41 | 0.47 (0.29 to 0.73) | 0.87 (0.27 to 2.05) | 0.04 (0.00 to 0.29) |
| Week 35-42 | 0.44 (0.26 to 0.70) | 0.57 (0.14 to 1.52) | 0.04 (0.00 to 0.26) |
| Week 35-43 | 0.44 (0.26 to 0.69) | 0.44 (0.09 to 1.27) | 0.03 (0.00 to 0.25) |
| Week 35-44 | 0.43 (0.26 to 0.68) | 0.43 (0.13 to 1.06) | 0.03 (0.00 to 0.21) |
| Week 35-45 | 0.43 (0.25 to 0.67) | 0.36 (0.10 to 0.94) | 0.05 (0.01 to 0.19) |
| Week 35-46 | 0.43 (0.25 to 0.69) | 0.33 (0.09 to 0.84) | 0.05 (0.01 to 0.18) |
| Week 35-47 | 0.43 (0.25 to 0.68) | 0.34 (0.12 to 0.77) | 0.05 (0.01 to 0.18) |
| Week 35-48 | 0.43 (0.25 to 0.67) | 0.33 (0.11 to 0.75) | 0.05 (0.01 to 0.18) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Week 35-37 | 1.90 (0.82 to 3.74) | 0.00 (0.00 to 45.93) | 0.19 (0.00 to 1.04) |
| Week 35-38 | 1.76 (1.04 to 2.79) | 0.00 (0.00 to 20.59) | 0.09 (0.00 to 0.53) |
| Week 35-39 | 1.84 (1.20 to 2.69) | 0.00 (0.00 to 2.98) | 0.06 (0.00 to 0.38) |
| Week 35-40 | 1.86 (1.23 to 2.70) | 0.22 (0.01 to 1.19) | 0.05 (0.00 to 0.30) |
| Week 35-41 | 1.81 (1.24 to 2.53) | 0.50 (0.05 to 1.94) | 0.04 (0.00 to 0.25) |
| Week 35-42 | 1.72 (1.23 to 2.35) | 0.49 (0.06 to 1.81) | 0.04 (0.00 to 0.24) |
| Week 35-43 | 1.68 (1.20 to 2.27) | 0.56 (0.06 to 2.09) | 0.03 (0.00 to 0.22) |
| Week 35-44 | 1.66 (1.21 to 2.21) | 0.58 (0.08 to 1.99) | 0.03 (0.00 to 0.19) |
| Week 35-45 | 1.63 (1.20 to 2.17) | 0.57 (0.12 to 1.61) | 0.03 (0.00 to 0.18) |
| Week 35-46 | 1.63 (1.21 to 2.14) | 0.56 (0.09 to 1.76) | 0.03 (0.00 to 0.18) |
| Week 35-47 | 1.62 (1.21 to 2.13) | 0.53 (0.09 to 1.68) | 0.02 (0.00 to 0.17) |
| Week 35-48 | 1.61 (1.20 to 2.11) | 0.51 (0.09 to 1.63) | 0.02 (0.00 to 0.17) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Any, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Any, Week 35-37 | 4.01 (3.23 to 4.92) | 0.00 (0.00 to 45.93) | 0.19 (0.00 to 1.60) |
| Any, Week 35-38 | 3.58 (2.78 to 4.53) | 0.00 (0.00 to 20.59) | 0.09 (0.00 to 0.77) |
| Any, Week 35-39 | 3.46 (2.70 to 4.35) | 0.82 (0.02 to 4.48) | 0.19 (0.04 to 0.57) |
| Any, Week 35-40 | 3.33 (2.63 to 4.15) | 1.94 (0.67 to 4.31) | 0.14 (0.03 to 0.41) |
| Any, Week 35-41 | 3.15 (2.48 to 3.95) | 1.61 (0.55 to 3.63) | 0.12 (0.02 to 0.34) |
| Any, Week 35-42 | 3.06 (2.37 to 3.88) | 1.23 (0.41 to 2.83) | 0.11 (0.02 to 0.31) |
| Any, Week 35-43 | 3.02 (2.32 to 3.85) | 1.19 (0.31 to 3.08) | 0.10 (0.02 to 0.30) |
| Any, Week 35-44 | 2.96 (2.26 to 3.81) | 1.30 (0.30 to 3.57) | 0.09 (0.02 to 0.25) |
| Any, Week 35-45 | 2.92 (2.23 to 3.75) | 1.33 (0.40 to 3.21) | 0.21 (0.02 to 0.75) |
| Any, Week 35-46 | 2.88 (2.18 to 3.73) | 1.15 (0.24 to 3.32) | 0.20 (0.02 to 0.73) |
| Any, Week 35-47 | 2.84 (2.15 to 3.68) | 1.09 (0.22 to 3.17) | 0.19 (0.02 to 0.70) |
| Any, Week 35-48 | 2.82 (2.13 to 3.66) | 1.06 (0.22 to 3.07) | 0.19 (0.02 to 0.70) |
| Drowsiness, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Drowsiness, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Drowsiness, Week 35-37 | 1.05 (0.62 to 1.68) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Drowsiness, Week 35-38 | 0.92 (0.48 to 1.59) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Drowsiness, Week 35-39 | 0.79 (0.42 to 1.36) | 0.00 (0.00 to 2.98) | 0.00 (0.00 to 0.24) |
| Drowsiness, Week 35-40 | 0.77 (0.43 to 1.28) | 0.22 (0.01 to 1.19) | 0.00 (0.00 to 0.17) |
| Drowsiness, Week 35-41 | 0.74 (0.41 to 1.23) | 0.37 (0.08 to 1.08) | 0.00 (0.00 to 0.15) |
| Drowsiness, Week 35-42 | 0.72 (0.38 to 1.21) | 0.25 (0.05 to 0.72) | 0.00 (0.00 to 0.13) |
| Drowsiness, Week 35-43 | 0.72 (0.37 to 1.26) | 0.25 (0.07 to 0.64) | 0.00 (0.00 to 0.13) |
| Drowsiness, Week 35-44 | 0.70 (0.35 to 1.24) | 0.29 (0.06 to 0.86) | 0.00 (0.00 to 0.11) |
| Drowsiness, Week 35-45 | 0.68 (0.34 to 1.21) | 0.24 (0.04 to 0.76) | 0.00 (0.00 to 0.10) |
| Drowsiness, Week 35-46 | 0.67 (0.34 to 1.19) | 0.23 (0.03 to 0.85) | 0.00 (0.00 to 0.09) |
| Drowsiness, Week 35-47 | 0.66 (0.33 to 1.17) | 0.22 (0.02 to 0.82) | 0.00 (0.00 to 0.09) |
| Drowsiness, Week 35-48 | 0.65 (0.33 to 1.16) | 0.21 (0.02 to 0.79) | 0.00 (0.00 to 0.09) |
| Fatigue, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Fatigue, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Fatigue, Week 35-37 | 2.19 (1.65 to 2.85) | 0.00 (0.00 to 45.93) | 0.19 (0.00 to 1.60) |
| Fatigue, Week 35-38 | 2.03 (1.57 to 2.58) | 0.00 (0.00 to 20.59) | 0.09 (0.00 to 0.77) |
| Fatigue, Week 35-39 | 1.93 (1.50 to 2.44) | 0.00 (0.00 to 2.98) | 0.13 (0.01 to 0.50) |
| Fatigue, Week 35-40 | 1.79 (1.40 to 2.26) | 0.43 (0.02 to 2.14) | 0.09 (0.01 to 0.38) |
| Fatigue, Week 35-41 | 1.71 (1.33 to 2.17) | 0.37 (0.04 to 1.45) | 0.08 (0.01 to 0.31) |
| Fatigue, Week 35-42 | 1.65 (1.26 to 2.13) | 0.25 (0.03 to 0.91) | 0.07 (0.01 to 0.28) |
| Fatigue, Week 35-43 | 1.62 (1.24 to 2.09) | 0.31 (0.03 to 0.31) | 0.07 (0.01 to 0.27) |
| Fatigue, Week 35-44 | 1.58 (1.20 to 2.04) | 0.39 (0.03 to 1.26) | 0.06 (0.01 to 0.21) |
| Fatigue, Week 35-45 | 1.56 (1.20 to 2.00) | 0.40 (0.13 to 0.93) | 0.08 (0.01 to 0.26) |
| Fatigue, Week 35-46 | 1.55 (1.18 to 2.01) | 0.33 (0.08 to 0.88) | 0.08 (0.01 to 0.26) |
| Fatigue, Week 35-47 | 1.53 (1.16 to 1.98) | 0.31 (0.08 to 0.84) | 0.07 (0.01 to 0.25) |
| Fatigue, Week 35-48 | 1.52 (1.14 to 1.97) | 0.30 (0.07 to 0.81) | 0.07 (0.01 to 0.24) |
| Headache, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Headache, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Headache, Week 35-37 | 2.27 (1.61 to 3.11) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Headache, Week 35-38 | 2.09 (1.36 to 3.06) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Headache, Week 35-39 | 2.01 (1.34 to 2.89) | 0.82 (0.02 to 4.48) | 0.06 (0.00 to 0.46) |
| Headache, Week 35-40 | 1.94 (1.34 to 2.71) | 1.29 (0.12 to 4.96) | 0.05 (0.00 to 0.28) |
| Headache, Week 35-41 | 1.81 (1.25 to 2.54) | 1.12 (0.18 to 3.56) | 0.04 (0.00 to 0.25) |
| Headache, Week 35-42 | 1.75 (1.20 to 2.46) | 0.82 (0.15 to 2.48) | 0.04 (0.00 to 0.23) |
| Headache, Week 35-43 | 1.74 (1.19 to 2.45) | 0.81 (0.14 to 2.56) | 0.03 (0.00 to 0.21) |
| Headache, Week 35-44 | 1.73 (1.19 to 2.42) | 0.87 (0.18 to 2.52) | 0.03 (0.00 to 0.19) |
| Headache, Week 35-45 | 1.72 (1.19 to 2.39) | 0.89 (0.21 to 2.41) | 0.16 (0.01 to 0.68) |
| Headache, Week 35-46 | 1.68 (1.16 to 2.36) | 0.75 (0.13 to 2.40) | 0.15 (0.01 to 0.66) |
| Headache, Week 35-47 | 1.66 (1.15 to 2.33) | 0.72 (0.12 to 2.29) | 0.14 (0.01 to 0.64) |
| Headache, Week 35-48 | 1.65 (1.14 to 2.31) | 0.69 (0.12 to 2.21) | 0.14 (0.01 to 0.63) |
| Irritability, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Irritability, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Irritability, Week 35-37 | 0.41 (0.19 to 0.74) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Irritability, Week 35-38 | 0.33 (0.15 to 0.61) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Irritability, Week 35-39 | 0.34 (0.16 to 0.63) | 0.00 (0.00 to 2.98) | 0.00 (0.00 to 0.24) |
| Irritability, Week 35-40 | 0.31 (0.16 to 0.53) | 0.00 (0.00 to 0.79) | 0.00 (0.00 to 0.17) |
| Irritability, Week 35-41 | 0.28 (0.14 to 0.50) | 0.00 (0.00 to 0.46) | 0.00 (0.00 to 0.15) |
| Irritability, Week 35-42 | 0.27 (0.13 to 0.50) | 0.08 (0.00 to 0.46) | 0.00 (0.00 to 0.13) |
| Irritability, Week 35-43 | 0.27 (0.13 to 0.50) | 0.12 (0.01 to 0.47) | 0.00 (0.00 to 0.13) |
| Irritability, Week 35-44 | 0.26 (0.12 to 0.48) | 0.19 (0.02 to 0.79) | 0.00 (0.00 to 0.11) |
| Irritability, Week 35-45 | 0.26 (0.13 to 0.47) | 0.16 (0.01 to 0.69) | 0.00 (0.00 to 0.10) |
| Irritability, Week 35-46 | 0.26 (0.13 to 0.46) | 0.13 (0.01 to 0.63) | 0.00 (0.00 to 0.09) |
| Irritability, Week 35-47 | 0.25 (0.13 to 0.45) | 0.12 (0.01 to 0.60) | 0.00 (0.00 to 0.09) |
| Irritability, Week 35-48 | 0.25 (0.12 to 0.45) | 0.12 (0.01 to 0.58) | 0.00 (0.00 to 0.09) |
| Malaise, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Malaise, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Malaise, Week 35-37 | 0.04 (0.00 to 0.25) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Malaise, Week 35-38 | 0.02 (0.00 to 0.11) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Malaise, Week 35-39 | 0.01 (0.00 to 0.07) | 0.00 (0.00 to 2.98) | 0.00 (0.00 to 0.24) |
| Malaise, Week 35-40 | 0.02 (0.00 to 0.07) | 0.22 (0.01 to 1.19) | 0.00 (0.00 to 0.17) |
| Malaise, Week 35-41 | 0.02 (0.00 to 0.07) | 0.12 (0.00 to 0.81) | 0.00 (0.00 to 0.15) |
| Malaise, Week 35-42 | 0.02 (0.00 to 0.06) | 0.16 (0.02 to 0.59) | 0.00 (0.00 to 0.13) |
| Malaise, Week 35-43 | 0.02 (0.00 to 0.06) | 0.12 (0.02 to 0.45) | 0.00 (0.00 to 0.13) |
| Malaise, Week 35-44 | 0.02 (0.00 to 0.06) | 0.10 (0.01 to 0.35) | 0.00 (0.00 to 0.11) |
| Malaise, Week 35-45 | 0.02 (0.00 to 0.06) | 0.12 (0.03 to 0.35) | 0.00 (0.00 to 0.10) |
| Malaise, Week 35-46 | 0.02 (0.00 to 0.05) | 0.10 (0.02 to 0.29) | 0.00 (0.00 to 0.09) |
| Malaise, Week 35-47 | 0.02 (0.00 to 0.05) | 0.09 (0.02 to 0.27) | 0.00 (0.00 to 0.09) |
| Malaise, Week 35-48 | 0.02 (0.00 to 0.05) | 0.09 (0.02 to 0.26) | 0.00 (0.00 to 0.09) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Any, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 1.61 (0.00 to 14.32) |
| Any, Week 35-37 | 6.44 (5.26 to 7.80) | 0.00 (0.00 to 45.93) | 0.75 (0.10 to 2.64) |
| Any, Week 35-38 | 5.61 (4.75 to 6.57) | 6.25 (0.12 to 31.55) | 0.65 (0.12 to 1.96) |
| Any, Week 35-39 | 5.33 (4.65 to 6.08) | 1.64 (0.20 to 5.80) | 0.83 (0.21 to 2.21) |
| Any, Week 35-40 | 5.33 (4.50 to 6.26) | 3.45 (1.92 to 5.68) | 0.89 (0.25 to 2.22) |
| Any, Week 35-41 | 5.24 (4.42 to 6.17) | 3.59 (2.39 to 5.17) | 0.79 (0.24 to 1.89) |
| Any, Week 35-42 | 5.07 (4.22 to 6.02) | 2.63 (1.70 to 3.86) | 0.86 (0.30 to 1.93) |
| Any, Week 35-43 | 4.99 (4.13 to 5.96) | 2.69 (1.78 to 3.87) | 0.81 (0.29 to 1.80) |
| Any, Week 35-44 | 4.89 (4.03 to 5.88) | 2.90 (1.86 to 4.29) | 0.74 (0.30 to 1.53) |
| Any, Week 35-45 | 4.82 (3.95 to 5.81) | 2.63 (1.49 to 4.26) | 0.88 (0.41 to 1.66) |
| Any, Week 35-46 | 4.77 (3.88 to 5.79) | 2.26 (1.08 to 4.15) | 0.86 (0.40 to 1.62) |
| Any, Week 35-47 | 4.74 (3.85 to 5.76) | 2.21 (1.08 to 4.00) | 0.89 (0.42 to 1.66) |
| Any, Week 35-48 | 4.70 (3.81 to 5.73) | 2.21 (1.07 to 4.00) | 0.88 (0.41 to 1.64) |
| Conjunctivitis, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Conjunctivitis, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Conjunctivitis, Week 35-37 | 0.24 (0.09 to 0.53) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Conjunctivitis, Week 35-38 | 0.38 (0.16 to 0.77) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Conjunctivitis, Week 35-39 | 0.35 (0.21 to 0.56) | 0.00 (0.00 to 2.98) | 0.06 (0.00 to 0.52) |
| Conjunctivitis, Week 35-40 | 0.35 (0.21 to 0.54) | 0.00 (0.00 to 0.79) | 0.05 (0.00 to 0.38) |
| Conjunctivitis, Week 35-41 | 0.36 (0.24 to 0.52) | 0.00 (0.00 to 0.46) | 0.04 (0.00 to 0.31) |
| Conjunctivitis, Week 35-42 | 0.34 (0.22 to 0.51) | 0.08 (0.00 to 0.46) | 0.07 (0.00 to 0.36) |
| Conjunctivitis, Week 35-43 | 0.34 (0.21 to 0.52) | 0.12 (0.01 to 0.47) | 0.07 (0.00 to 0.34) |
| Conjunctivitis, Week 35-44 | 0.35 (0.22 to 0.52) | 0.14 (0.03 to 0.42) | 0.09 (0.01 to 0.37) |
| Conjunctivitis, Week 35-45 | 0.34 (0.21 to 0.51) | 0.12 (0.03 to 0.35) | 0.13 (0.01 to 0.57) |
| Conjunctivitis, Week 35-46 | 0.33 (0.21 to 0.50) | 0.10 (0.02 to 0.29) | 0.13 (0.01 to 0.56) |
| Conjunctivitis, Week 35-47 | 0.33 (0.20 to 0.50) | 0.09 (0.02 to 0.27) | 0.12 (0.01 to 0.54) |
| Conjunctivitis, Week 35-48 | 0.32 (0.20 to 0.49) | 0.09 (0.02 to 0.26) | 0.12 (0.01 to 0.53) |
| Coryza, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Coryza, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Coryza, Week 35-37 | 1.38 (0.75 to 2.32) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Coryza, Week 35-38 | 1.15 (0.82 to 1.56) | 0.00 (0.00 to 20.59) | 0.09 (0.00 to 0.74) |
| Coryza, Week 35-39 | 1.19 (0.91 to 1.53) | 0.00 (0.00 to 2.98) | 0.06 (0.00 to 0.46) |
| Coryza, Week 35-40 | 1.16 (0.88 to 1.50) | 1.08 (0.34 to 2.54) | 0.05 (0.00 to 0.28) |
| Coryza, Week 35-41 | 1.17 (0.91 to 1.49) | 0.74 (0.27 to 1.61) | 0.04 (0.00 to 0.25) |
| Coryza, Week 35-42 | 1.12 (0.87 to 1.42) | 0.49 (0.15 to 1.19) | 0.04 (0.00 to 0.23) |
| Coryza, Week 35-43 | 1.11 (0.85 to 1.42) | 0.56 (0.20 to 1.25) | 0.03 (0.00 to 0.21) |
| Coryza, Week 35-44 | 1.08 (0.83 to 1.40) | 0.53 (0.25 to 0.99) | 0.03 (0.00 to 0.19) |
| Coryza, Week 35-45 | 1.07 (0.80 to 1.39) | 0.48 (0.20 to 1.00) | 0.05 (0.01 to 0.19) |
| Coryza, Week 35-46 | 1.06 (0.80 to 1.38) | 0.39 (0.14 to 0.87) | 0.05 (0.01 to 0.18) |
| Coryza, Week 35-47 | 1.06 (0.81 to 1.36) | 0.37 (0.13 to 0.83) | 0.05 (0.01 to 0.17) |
| Coryza, Week 35-48 | 1.05 (0.80 to 1.35) | 0.36 (0.13 to 0.80) | 0.05 (0.01 to 0.17) |
| Cough, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Cough, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 1.61 (0.00 to 14.32) |
| Cough, Week 35-37 | 2.31 (1.64 to 3.15) | 0.00 (0.00 to 45.93) | 0.75 (0.10 to 2.64) |
| Cough, Week 35-38 | 2.12 (1.61 to 2.76) | 0.00 (0.00 to 20.59) | 0.47 (0.10 to 1.32) |
| Cough, Week 35-39 | 2.21 (1.88 to 2.57) | 0.82 (0.02 to 4.48) | 0.64 (0.16 to 1.71) |
| Cough, Week 35-40 | 2.11 (1.71 to 2.57) | 2.16 (0.85 to 4.44) | 0.70 (0.17 to 1.89) |
| Cough, Week 35-41 | 2.10 (1.73 to 2.52) | 2.11 (1.18 to 3.45) | 0.63 (0.17 to 1.63) |
| Cough, Week 35-42 | 2.03 (1.66 to 2.46) | 1.48 (0.73 to 2.65) | 0.61 (0.18 to 1.49) |
| Cough, Week 35-43 | 2.00 (1.62 to 2.45) | 1.56 (0.97 to 2.37) | 0.58 (0.18 to 1.39) |
| Cough, Week 35-44 | 1.97 (1.59 to 2.41) | 1.69 (1.00 to 2.67) | 0.48 (0.13 to 1.23) |
| Cough, Week 35-45 | 1.95 (1.57 to 2.39) | 1.58 (0.84 to 2.67) | 0.52 (0.19 to 1.13) |
| Cough, Week 35-46 | 1.96 (1.58 to 2.40) | 1.34 (0.63 to 2.50) | 0.51 (0.18 to 1.11) |
| Cough, Week 35-47 | 1.95 (1.56 to 2.41) | 1.28 (0.60 to 2.36) | 0.53 (0.20 to 1.15) |
| Cough, Week 35-48 | 1.94 (1.54 to 2.39) | 1.30 (0.61 to 2.41) | 0.52 (0.19 to 1.14) |
| Epistaxis, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Epistaxis, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Epistaxis, Week 35-37 | 0.08 (0.00 to 0.48) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Epistaxis, Week 35-38 | 0.06 (0.00 to 0.37) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Epistaxis, Week 35-39 | 0.09 (0.02 to 0.23) | 0.00 (0.00 to 2.98) | 0.00 (0.00 to 0.24) |
| Epistaxis, Week 35-40 | 0.10 (0.04 to 0.21) | 0.00 (0.00 to 0.79) | 0.00 (0.00 to 0.17) |
| Epistaxis, Week 35-41 | 0.09 (0.04 to 0.19) | 0.00 (0.00 to 0.46) | 0.00 (0.00 to 0.15) |
| Epistaxis, Week 35-42 | 0.09 (0.04 to 0.17) | 0.00 (0.00 to 0.30) | 0.00 (0.00 to 0.13) |
| Epistaxis, Week 35-43 | 0.08 (0.04 to 0.16) | 0.00 (0.00 to 0.23) | 0.00 (0.00 to 0.13) |
| Epistaxis, Week 35-44 | 0.09 (0.04 to 0.18) | 0.00 (0.00 to 0.18) | 0.00 (0.00 to 0.11) |
| Epistaxis, Week 35-45 | 0.09 (0.04 to 0.18) | 0.00 (0.00 to 0.15) | 0.00 (0.00 to 0.10) |
| Epistaxis, Week 35-46 | 0.09 (0.04 to 0.18) | 0.00 (0.00 to 0.12) | 0.00 (0.00 to 0.09) |
| Epistaxis, Week 35-47 | 0.09 (0.04 to 0.17) | 0.00 (0.00 to 0.11) | 0.00 (0.00 to 0.09) |
| Epistaxis, Week 35-48 | 0.09 (0.04 to 0.17) | 0.00 (0.00 to 0.11) | 0.00 (0.00 to 0.09) |
| Hoarseness, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Hoarseness, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Hoarseness, Week 35-37 | 1.09 (0.72 to 1.59) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Hoarseness, Week 35-38 | 0.96 (0.71 to 1.26) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Hoarseness, Week 35-39 | 0.77 (0.60 to 0.97) | 0.00 (0.00 to 2.98) | 0.00 (0.00 to 0.24) |
| Hoarseness, Week 35-40 | 0.72 (0.57 to 0.89) | 0.22 (0.01 to 1.19) | 0.00 (0.00 to 0.17) |
| Hoarseness, Week 35-41 | 0.70 (0.55 to 0.87) | 0.37 (0.08 to 1.08) | 0.00 (0.00 to 0.15) |
| Hoarseness, Week 35-42 | 0.67 (0.53 to 0.82) | 0.25 (0.05 to 0.72) | 0.00 (0.00 to 0.13) |
| Hoarseness, Week 35-43 | 0.67 (0.53 to 0.84) | 0.25 (0.07 to 0.64) | 0.00 (0.00 to 0.13) |
| Hoarseness, Week 35-44 | 0.65 (0.52 to 0.81) | 0.24 (0.05 to 0.68) | 0.00 (0.00 to 0.11) |
| Hoarseness, Week 35-45 | 0.65 (0.51 to 0.82) | 0.20 (0.04 to 0.60) | 0.03 (0.00 to 0.15) |
| Hoarseness, Week 35-46 | 0.64 (0.50 to 0.81) | 0.16 (0.02 to 0.56) | 0.03 (0.00 to 0.15) |
| Hoarseness, Week 35-47 | 0.64 (0.51 to 0.80) | 0.16 (0.02 to 0.54) | 0.02 (0.00 to 0.14) |
| Hoarseness, Week 35-48 | 0.63 (0.50 to 0.79) | 0.15 (0.02 to 0.52) | 0.02 (0.00 to 0.14) |
| Nasal congestion, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Nasal congestion, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Nasal congestion, Week 35-37 | 1.34 (0.92 to 1.87) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Nasal congestion, Week 35-38 | 1.11 (0.81 to 1.48) | 0.00 (0.00 to 20.59) | 0.09 (0.00 to 0.74) |
| Nasal congestion, Week 35-39 | 1.04 (0.74 to 1.41) | 0.00 (0.00 to 2.98) | 0.06 (0.00 to 0.46) |
| Nasal congestion, Week 35-40 | 1.01 (0.72 to 1.37) | 0.43 (0.01 to 2.34) | 0.05 (0.00 to 0.28) |
| Nasal congestion, Week 35-41 | 0.94 (0.67 to 1.29) | 0.62 (0.20 to 1.44) | 0.04 (0.00 to 0.25) |
| Nasal congestion, Week 35-42 | 0.91 (0.65 to 1.23) | 0.41 (0.13 to 0.95) | 0.07 (0.01 to 0.29) |
| Nasal congestion, Week 35-43 | 0.88 (0.63 to 1.20) | 0.50 (0.22 to 0.98) | 0.07 (0.01 to 0.27) |
| Nasal congestion, Week 35-44 | 0.85 (0.61 to 1.17) | 0.43 (0.20 to 0.82) | 0.06 (0.00 to 0.24) |
| Nasal congestion, Week 35-45 | 0.85 (0.61 to 1.16) | 0.40 (0.18 to 0.79) | 0.08 (0.02 to 0.23) |
| Nasal congestion, Week 35-46 | 0.85 (0.62 to 1.15) | 0.33 (0.11 to 0.74) | 0.08 (0.02 to 0.22) |
| Nasal congestion, Week 35-47 | 0.85 (0.61 to 1.16) | 0.31 (0.11 to 0.70) | 0.07 (0.01 to 0.21) |
| Nasal congestion, Week 35-48 | 0.85 (0.60 to 1.15) | 0.30 (0.10 to 0.68) | 0.07 (0.01 to 0.21) |
| Oropharyngeal pain, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Oropharyngeal pain, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Oropharyngeal pain, Week 35-37 | 2.27 (1.64 to 3.06) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Oropharyngeal pain, Week 35-38 | 1.80 (1.29 to 2.44) | 0.00 (0.00 to 20.59) | 0.09 (0.00 to 0.67) |
| Oropharyngeal pain, Week 35-39 | 1.70 (1.31 to 2.17) | 0.00 (0.00 to 2.98) | 0.06 (0.00 to 0.46) |
| Oropharyngeal pain, Week 35-40 | 1.58 (1.16 to 2.10) | 0.22 (0.01 to 1.19) | 0.09 (0.00 to 0.44) |
| Oropharyngeal pain, Week 35-41 | 1.53 (1.15 to 2.00) | 0.50 (0.05 to 1.94) | 0.08 (0.00 to 0.36) |
| Oropharyngeal pain, Week 35-42 | 1.46 (1.07 to 1.94) | 0.41 (0.10 to 1.09) | 0.11 (0.02 to 0.34) |
| Oropharyngeal pain, Week 35-43 | 1.43 (1.04 to 1.91) | 0.44 (0.09 to 1.27) | 0.10 (0.02 to 0.31) |
| Oropharyngeal pain, Week 35-44 | 1.41 (1.02 to 1.88) | 0.48 (0.07 to 1.63) | 0.11 (0.02 to 0.33) |
| Oropharyngeal pain, Week 35-45 | 1.39 (1.01 to 1.87) | 0.48 (0.13 to 1.22) | 0.16 (0.02 to 0.51) |
| Oropharyngeal pain, Week 35-46 | 1.37 (0.99 to 1.84) | 0.39 (0.08 to 1.15) | 0.15 (0.02 to 0.49) |
| Oropharyngeal pain, Week 35-47 | 1.34 (0.97 to 1.82) | 0.37 (0.08 to 1.10) | 0.17 (0.02 to 0.60) |
| Oropharyngeal pain, Week 35-48 | 1.33 (0.96 to 1.80) | 0.36 (0.07 to 1.06) | 0.17 (0.02 to 0.59) |
| Rhinorrhoea, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Rhinorrhoea, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Rhinorrhoea, Week 35-37 | 3.28 (2.17 to 4.74) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Rhinorrhoea, Week 35-38 | 2.83 (2.07 to 3.78) | 6.25 (0.12 to 31.55) | 0.00 (0.00 to 0.34) |
| Rhinorrhoea, Week 35-39 | 2.58 (1.91 to 3.41) | 0.82 (0.02 to 4.48) | 0.00 (0.00 to 0.24) |
| Rhinorrhoea, Week 35-40 | 2.55 (1.91 to 3.34) | 1.08 (0.34 to 2.54) | 0.00 (0.00 to 0.17) |
| Rhinorrhoea, Week 35-41 | 2.47 (1.83 to 3.26) | 1.36 (0.66 to 2.48) | 0.00 (0.00 to 0.15) |
| Rhinorrhoea, Week 35-42 | 2.38 (1.74 to 3.16) | 1.07 (0.53 to 1.90) | 0.00 (0.00 to 0.13) |
| Rhinorrhoea, Week 35-43 | 2.36 (1.70 to 3.19) | 1.19 (0.70 to 1.88) | 0.00 (0.00 to 0.13) |
| Rhinorrhoea, Week 35-44 | 2.32 (1.67 to 3.13) | 1.16 (0.66 to 1.88) | 0.00 (0.00 to 0.11) |
| Rhinorrhoea, Week 35-45 | 2.29 (1.64 to 3.10) | 1.05 (0.54 to 1.83) | 0.08 (0.00 to 0.46) |
| Rhinorrhoea, Week 35-46 | 2.26 (1.61 to 3.09) | 0.88 (0.38 to 1.75) | 0.08 (0.00 to 0.45) |
| Rhinorrhoea, Week 35-47 | 2.25 (1.60 to 3.07) | 0.87 (0.37 to 1.74) | 0.07 (0.00 to 0.43) |
| Rhinorrhoea, Week 35-48 | 2.23 (1.58 to 3.05) | 0.85 (0.36 to 1.68) | 0.07 (0.00 to 0.42) |
| Wheezing, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Wheezing, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Wheezing, Week 35-37 | 0.93 (0.59 to 1.40) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Wheezing, Week 35-38 | 0.75 (0.46 to 1.14) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Wheezing, Week 35-39 | 0.60 (0.35 to 0.95) | 0.00 (0.00 to 2.98) | 0.00 (0.00 to 0.24) |
| Wheezing, Week 35-40 | 0.61 (0.35 to 0.97) | 0.22 (0.01 to 1.19) | 0.00 (0.00 to 0.17) |
| Wheezing, Week 35-41 | 0.57 (0.31 to 0.94) | 0.37 (0.08 to 1.08) | 0.00 (0.00 to 0.15) |
| Wheezing, Week 35-42 | 0.54 (0.31 to 0.89) | 0.25 (0.05 to 0.72) | 0.00 (0.00 to 0.13) |
| Wheezing, Week 35-43 | 0.53 (0.31 to 0.85) | 0.31 (0.09 to 0.77) | 0.00 (0.00 to 0.13) |
| Wheezing, Week 35-44 | 0.52 (0.31 to 0.81) | 0.48 (0.15 to 1.15) | 0.00 (0.00 to 0.11) |
| Wheezing, Week 35-45 | 0.51 (0.31 to 0.79) | 0.40 (0.11 to 1.02) | 0.00 (0.00 to 0.10) |
| Wheezing, Week 35-46 | 0.50 (0.30 to 0.78) | 0.39 (0.10 to 1.01) | 0.00 (0.00 to 0.09) |
| Wheezing, Week 35-47 | 0.50 (0.30 to 0.78) | 0.40 (0.13 to 0.95) | 0.00 (0.00 to 0.09) |
| Wheezing, Week 35-48 | 0.49 (0.30 to 0.77) | 0.39 (0.13 to 0.92) | 0.00 (0.00 to 0.09) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Any, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Any, Week 35-37 | 2.11 (2.11 to 1.30) | 0.00 (0.00 to 45.93) | 0.19 (0.00 to 1.60) |
| Any, Week 35-38 | 1.95 (1.40 to 2.64) | 6.25 (0.12 to 31.55) | 0.09 (0.00 to 0.77) |
| Any, Week 35-39 | 1.76 (1.23 to 2.42) | 0.82 (0.02 to 4.48) | 0.06 (0.00 to 0.52) |
| Any, Week 35-40 | 1.70 (1.28 to 2.22) | 1.08 (0.35 to 2.50) | 0.05 (0.00 to 0.38) |
| Any, Week 35-41 | 1.65 (1.24 to 2.14) | 0.87 (0.35 to 1.78) | 0.04 (0.00 to 0.31) |
| Any, Week 35-42 | 1.61 (1.22 to 2.08) | 0.57 (0.23 to 1.18) | 0.04 (0.00 to 0.28) |
| Any, Week 35-43 | 1.58 (1.20 to 2.05) | 0.44 (0.15 to 0.98) | 0.07 (0.00 to 0.53) |
| Any, Week 35-44 | 1.54 (1.17 to 1.98) | 0.43 (0.10 to 1.19) | 0.06 (0.00 to 0.37) |
| Any, Week 35-45 | 1.55 (1.21 to 1.96) | 0.53 (0.21 to 1.10) | 0.13 (0.00 to 0.76) |
| Any, Week 35-46 | 1.55 (1.21 to 1.95) | 0.46 (0.17 to 0.99) | 0.15 (0.01 to 0.69) |
| Any, Week 35-47 | 1.52 (1.19 to 1.92) | 0.44 (0.16 to 0.95) | 0.14 (0.01 to 0.66) |
| Any, Week 35-48 | 1.51 (1.18 to 1.90) | 0.42 (0.15 to 0.92) | 0.14 (0.01 to 0.66) |
| Decreased appetite, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Decreased appetite, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Decreased appetite, Week 35-37 | 0.73 (0.43 to 1.15) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Decreased appetite, Week 35-38 | 0.59 (0.40 to 0.84) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Decreased appetite, Week 35-39 | 0.54 (0.31 to 0.86) | 0.00 (0.00 to 2.98) | 0.00 (0.00 to 0.24) |
| Decreased appetite, Week 35-40 | 0.50 (0.30 to 0.77) | 0.86 (0.24 to 2.19) | 0.00 (0.00 to 0.17) |
| Decreased appetite, Week 35-41 | 0.50 (0.32 to 0.75) | 0.62 (0.20 to 1.44) | 0.00 (0.00 to 0.15) |
| Decreased appetite, Week 35-42 | 0.48 (0.31 to 0.72) | 0.41 (0.13 to 0.95) | 0.00 (0.00 to 0.13) |
| Decreased appetite, Week 35-43 | 0.46 (0.29 to 0.70) | 0.31 (0.10 to 0.73) | 0.00 (0.00 to 0.13) |
| Decreased appetite, Week 35-44 | 0.45 (0.28 to 0.68) | 0.24 (0.07 to 0.61) | 0.00 (0.00 to 0.11) |
| Decreased appetite, Week 35-45 | 0.45 (0.30 to 0.65) | 0.24 (0.09 to 0.53) | 0.00 (0.00 to 0.10) |
| Decreased appetite, Week 35-46 | 0.46 (0.30 to 0.66) | 0.20 (0.06 to 0.47) | 0.00 (0.00 to 0.09) |
| Decreased appetite, Week 35-47 | 0.45 (0.30 to 0.65) | 0.19 (0.06 to 0.45) | 0.00 (0.00 to 0.09) |
| Decreased appetite, Week 35-48 | 0.44 (0.30 to 0.64) | 0.18 (0.06 to 0.43) | 0.00 (0.00 to 0.09) |
| Diarrhoea, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Diarrhoea, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Diarrhoea, Week 35-37 | 0.97 (0.58 to 1.54) | 0.00 (0.00 to 45.93) | 0.19 (0.00 to 1.60) |
| Diarrhoea, Week 35-38 | 0.86 (0.63 to 1.15) | 0.00 (0.00 to 20.59) | 0.09 (0.00 to 0.77) |
| Diarrhoea, Week 35-39 | 0.78 (0.59 to 1.02) | 0.00 (0.00 to 2.98) | 0.06 (0.00 to 0.52) |
| Diarrhoea, Week 35-40 | 0.76 (0.60 to 0.95) | 0.00 (0.00 to 0.79) | 0.05 (0.00 to 0.38) |
| Diarrhoea, Week 35-41 | 0.75 (0.60 to 0.93) | 0.00 (0.00 to 0.46) | 0.04 (0.00 to 0.31) |
| Diarrhoea, Week 35-42 | 0.73 (0.59 to 0.90) | 0.00 (0.00 to 0.30) | 0.04 (0.00 to 0.28) |
| Diarrhoea, Week 35-43 | 0.72 (0.58 to 0.88) | 0.00 (0.00 to 0.23) | 0.07 (0.00 to 0.53) |
| Diarrhoea, Week 35-44 | 0.70 (0.56 to 0.85) | 0.05 (0.00 to 0.27) | 0.06 (0.00 to 0.37) |
| Diarrhoea, Week 35-45 | 0.70 (0.56 to 0.85) | 0.08 (0.01 to 0.34) | 0.06 (0.00 to 0.46) |
| Diarrhoea, Week 35-46 | 0.70 (0.56 to 0.86) | 0.07 (0.00 to 0.31) | 0.10 (0.01 to 0.41) |
| Diarrhoea, Week 35-47 | 0.69 (0.55 to 0.85) | 0.06 (0.00 to 0.30) | 0.10 (0.01 to 0.40) |
| Diarrhoea, Week 35-48 | 0.68 (0.55 to 0.84) | 0.06 (0.00 to 0.29) | 0.10 (0.01 to 0.39) |
| Nausea, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Nausea, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Nausea, Week 35-37 | 0.97 (0.49 to 1.72) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Nausea, Week 35-38 | 1.01 (0.49 to 1.86) | 6.25 (0.12 to 31.55) | 0.00 (0.00 to 0.34) |
| Nausea, Week 35-39 | 0.91 (0.46 to 1.61) | 0.82 (0.02 to 4.48) | 0.00 (0.00 to 0.24) |
| Nausea, Week 35-40 | 0.84 (0.45 to 1.43) | 0.22 (0.01 to 1.19) | 0.00 (0.00 to 0.17) |
| Nausea, Week 35-41 | 0.80 (0.44 to 1.34) | 0.12 (0.00 to 0.69) | 0.00 (0.00 to 0.15) |
| Nausea, Week 35-42 | 0.77 (0.42 to 1.29) | 0.08 (0.00 to 0.46) | 0.00 (0.00 to 0.13) |
| Nausea, Week 35-43 | 0.76 (0.42 to 1.27) | 0.06 (0.00 to 0.35) | 0.00 (0.00 to 0.13) |
| Nausea, Week 35-44 | 0.75 (0.42 to 1.22) | 0.10 (0.01 to 0.40) | 0.00 (0.00 to 0.11) |
| Nausea, Week 35-45 | 0.75 (0.44 to 1.19) | 0.16 (0.04 to 0.41) | 0.03 (0.00 to 0.15) |
| Nausea, Week 35-46 | 0.74 (0.43 to 1.17) | 0.13 (0.04 to 0.34) | 0.03 (0.00 to 0.15) |
| Nausea, Week 35-47 | 0.72 (0.42 to 1.15) | 0.12 (0.03 to 0.32) | 0.03 (0.00 to 0.14) |
| Nausea, Week 35-48 | 0.72 (0.42 to 1.14) | 0.12 (0.03 to 0.31) | 0.03 (0.00 to 0.14) |
| Vomiting, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Vomiting, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Vomiting, Week 35-37 | 0.12 (0.02 to 0.38) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Vomiting, Week 35-38 | 0.17 (0.08 to 0.33) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Vomiting, Week 35-39 | 0.18 (0.11 to 0.29) | 0.00 (0.00 to 2.98) | 0.00 (0.00 to 0.24) |
| Vomiting, Week 35-40 | 0.16 (0.09 to 0.25) | 0.00 (0.00 to 0.79) | 0.00 (0.00 to 0.17) |
| Vomiting, Week 35-41 | 0.18 (0.11 to 0.26) | 0.12 (0.00 to 0.69) | 0.00 (0.00 to 0.15) |
| Vomiting, Week 35-42 | 0.19 (0.12 to 0.27) | 0.08 (0.00 to 0.46) | 0.00 (0.00 to 0.13) |
| Vomiting, Week 35-43 | 0.19 (0.12 to 0.27) | 0.06 (0.00 to 0.35) | 0.00 (0.00 to 0.13) |
| Vomiting, Week 35-44 | 0.18 (0.12 to 0.27) | 0.05 (0.00 to 0.27) | 0.00 (0.00 to 0.11) |
| Vomiting, Week 35-45 | 0.19 (0.12 to 0.28) | 0.04 (0.00 to 0.22) | 0.05 (0.00 to 0.31) |
| Vomiting, Week 35-46 | 0.19 (0.12 to 0.28) | 0.07 (0.01 to 0.24) | 0.05 (0.00 to 0.30) |
| Vomiting, Week 35-47 | 0.18 (0.12 to 0.27) | 0.06 (0.01 to 0.22) | 0.05 (0.00 to 0.29) |
| Vomiting, Week 35-48 | 0.18 (0.12 to 0.27) | 0.06 (0.01 to 0.22) | 0.05 (0.00 to 0.28) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Any, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Any, Week 35-37 | 0.69 (0.01 to 4.09) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Any, Week 35-38 | 0.63 (0.04 to 2.86) | 0.00 (0.00 to 20.59) | 0.09 (0.00 to 0.53) |
| Any, Week 35-39 | 0.54 (0.04 to 2.29) | 0.00 (0.00 to 2.98) | 0.06 (0.00 to 0.37) |
| Any, Week 35-40 | 0.52 (0.04 to 2.16) | 0.43 (0.02 to 2.14) | 0.05 (0.00 to 0.29) |
| Any, Week 35-41 | 0.48 (0.04 to 1.91) | 0.62 (0.06 to 2.42) | 0.04 (0.00 to 0.24) |
| Any, Week 35-42 | 0.45 (0.04 to 1.82) | 0.49 (0.12 to 1.34) | 0.04 (0.00 to 0.22) |
| Any, Week 35-43 | 0.44 (0.04 to 1.76) | 0.37 (0.09 to 1.00) | 0.03 (0.00 to 0.20) |
| Any, Week 35-44 | 0.43 (0.04 to 1.68) | 0.43 (0.07 to 1.42) | 0.03 (0.00 to 0.18) |
| Any, Week 35-45 | 0.43 (0.04 to 1.63) | 0.36 (0.05 to 1.23) | 0.05 (0.01 to 0.19) |
| Any, Week 35-46 | 0.42 (0.04 to 1.63) | 0.29 (0.03 to 1.14) | 0.05 (0.01 to 0.18) |
| Any, Week 35-47 | 0.42 (0.04 to 1.61) | 0.28 (0.03 to 1.09) | 0.05 (0.01 to 0.17) |
| Any, Week 35-48 | 0.41 (0.04 to 1.59) | 0.27 (0.03 to 1.05) | 0.05 (0.01 to 0.17) |
| Anaphylactic reactions, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Anaphylactic reactions, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Anaphylactic reactions, Week 35-37 | 0.61 (0.01 to 4.06) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Anaphylactic reactions, Week 35-38 | 0.52 (0.01 to 3.09) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Anaphylactic reactions, Week 35-39 | 0.42 (0.01 to 2.37) | 0.00 (0.00 to 2.98) | 0.00 (0.00 to 0.24) |
| Anaphylactic reactions, Week 35-40 | 0.38 (0.01 to 2.25) | 0.43 (0.02 to 2.14) | 0.00 (0.00 to 0.17) |
| Anaphylactic reactions, Week 35-41 | 0.33 (0.00 to 2.04) | 0.50 (0.05 to 1.94) | 0.00 (0.00 to 0.15) |
| Anaphylactic reactions, Week 35-42 | 0.31 (0.00 to 1.93) | 0.33 (0.04 to 1.21) | 0.00 (0.00 to 0.13) |
| Anaphylactic reactions, Week 35-43 | 0.30 (0.00 to 1.86) | 0.25 (0.03 to 0.93) | 0.00 (0.00 to 0.13) |
| Anaphylactic reactions, Week 35-44 | 0.29 (0.00 to 1.78) | 0.34 (0.03 to 1.39) | 0.00 (0.00 to 0.11) |
| Anaphylactic reactions, Week 35-45 | 0.28 (0.00 to 1.74) | 0.28 (0.02 to 1.20) | 0.03 (0.00 to 0.15) |
| Anaphylactic reactions, Week 35-46 | 0.28 (0.00 to 1.74) | 0.23 (0.01 to 1.10) | 0.03 (0.00 to 0.15) |
| Anaphylactic reactions, Week 35-47 | 0.28 (0.00 to 1.72) | 0.22 (0.01 to 1.05) | 0.02 (0.00 to 0.14) |
| Anaphylactic reactions, Week 35-48 | 0.27 (0.00 to 1.70) | 0.21 (0.01 to 1.02) | 0.02 (0.00 to 0.14) |
| Facial oedema, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Facial oedema, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Facial oedema, Week 35-37 | 0.04 (0.00 to 0.27) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Facial oedema, Week 35-38 | 0.06 (0.01 to 0.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Facial oedema, Week 35-39 | 0.05 (0.01 to 0.17) | 0.00 (0.00 to 2.98) | 0.00 (0.00 to 0.24) |
| Facial oedema, Week 35-40 | 0.04 (0.01 to 0.15) | 0.00 (0.00 to 0.79) | 0.00 (0.00 to 0.17) |
| Facial oedema, Week 35-41 | 0.05 (0.01 to 0.14) | 0.00 (0.00 to 0.46) | 0.00 (0.00 to 0.15) |
| Facial oedema, Week 35-42 | 0.04 (0.01 to 0.13) | 0.00 (0.00 to 0.30) | 0.00 (0.00 to 0.13) |
| Facial oedema, Week 35-43 | 0.04 (0.01 to 0.12) | 0.00 (0.00 to 0.23) | 0.00 (0.00 to 0.13) |
| Facial oedema, Week 35-44 | 0.05 (0.01 to 0.12) | 0.00 (0.00 to 0.18) | 0.00 (0.00 to 0.11) |
| Facial oedema, Week 35-45 | 0.05 (0.02 to 0.12) | 0.00 (0.00 to 0.15) | 0.00 (0.00 to 0.10) |
| Facial oedema, Week 35-46 | 0.05 (0.02 to 0.12) | 0.00 (0.00 to 0.12) | 0.00 (0.00 to 0.09) |
| Facial oedema, Week 35-47 | 0.05 (0.02 to 0.11) | 0.00 (0.00 to 0.11) | 0.00 (0.00 to 0.09) |
| Facial oedema, Week 35-48 | 0.05 (0.02 to 0.11) | 0.00 (0.00 to 0.11) | 0.00 (0.00 to 0.09) |
| Hypersensitivity reactions, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Hypersensitivity reactions, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Hypersensitivity reactions, Week 35-37 | 0.08 (0.01 to 0.29) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Hypersensitivity reactions, Week 35-38 | 0.10 (0.03 to 0.23) | 0.00 (0.00 to 20.59) | 0.09 (0.00 to 0.53) |
| Hypersensitivity reactions, Week 35-39 | 0.09 (0.03 to 0.18) | 0.00 (0.00 to 2.98) | 0.06 (0.00 to 0.37) |
| Hypersensitivity reactions, Week 35-40 | 0.11 (0.05 to 0.23) | 0.00 (0.00 to 0.79) | 0.05 (0.00 to 0.29) |
| Hypersensitivity reactions, Week 35-41 | 0.13 (0.06 to 0.25) | 0.12 (0.00 to 0.69) | 0.04 (0.00 to 0.24) |
| Hypersensitivity reactions, Week 35-42 | 0.12 (0.06 to 0.23) | 0.16 (0.02 to 0.59) | 0.04 (0.00 to 0.22) |
| Hypersensitivity reactions, Week 35-43 | 0.12 (0.05 to 0.22) | 0.12 (0.02 to 0.45) | 0.03 (0.00 to 0.20) |
| Hypersensitivity reactions, Week 35-44 | 0.12 (0.06 to 0.21) | 0.10 (0.01 to 0.35) | 0.03 (0.00 to 0.18) |
| Hypersensitivity reactions, Week 35-45 | 0.11 (0.06 to 0.20) | 0.08 (0.01 to 0.29) | 0.03 (0.00 to 0.17) |
| Hypersensitivity reactions, Week 35-46 | 0.11 (0.06 to 0.20) | 0.07 (0.01 to 0.24) | 0.03 (0.00 to 0.16) |
| Hypersensitivity reactions, Week 35-47 | 0.11 (0.06 to 0.20) | 0.06 (0.01 to 0.22) | 0.02 (0.00 to 0.16) |
| Hypersensitivity reactions, Week 35-48 | 0.11 (0.06 to 0.19) | 0.06 (0.01 to 0.22) | 0.02 (0.00 to 0.15) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Week 35-37 | 0.77 (0.46 to 1.20) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Week 35-38 | 0.65 (0.38 to 1.04) | 0.00 (0.00 to 20.59) | 0.19 (0.02 to 0.69) |
| Week 35-39 | 0.52 (0.34 to 0.77) | 0.00 (0.00 to 2.98) | 0.13 (0.01 to 0.49) |
| Week 35-40 | 0.54 (0.38 to 0.73) | 0.22 (0.01 to 1.19) | 0.14 (0.03 to 0.41) |
| Week 35-41 | 0.48 (0.34 to 0.67) | 0.37 (0.08 to 1.08) | 0.12 (0.02 to 0.34) |
| Week 35-42 | 0.46 (0.33 to 0.62) | 0.25 (0.05 to 0.72) | 0.11 (0.02 to 0.31) |
| Week 35-43 | 0.46 (0.33 to 0.63) | 0.31 (0.10 to 0.73) | 0.10 (0.02 to 0.30) |
| Week 35-44 | 0.47 (0.34 to 0.63) | 0.29 (0.11 to 0.63) | 0.09 (0.02 to 0.26) |
| Week 35-45 | 0.46 (0.33 to 0.62) | 0.24 (0.09 to 0.53) | 0.08 (0.01 to 0.25) |
| Week 35-46 | 0.46 (0.33 to 0.63) | 0.23 (0.09 to 0.47) | 0.08 (0.01 to 0.24) |
| Week 35-47 | 0.45 (0.32 to 0.62) | 0.25 (0.11 to 0.49) | 0.07 (0.01 to 0.23) |
| Week 35-48 | 0.45 (0.32 to 0.62) | 0.27 (0.12 to 0.52) | 0.07 (0.01 to 0.23) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Any, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) |
| Any, Week 35-37 | 4.25 (3.33 to 5.34) | 0.00 (0.00 to 45.93) | 0.38 (0.05 to 1.35) |
| Any, Week 35-38 | 3.79 (2.92 to 4.83) | 0.00 (0.00 to 20.59) | 0.37 (0.10 to 0.96) |
| Any, Week 35-39 | 3.59 (2.91 to 4.37) | 0.00 (0.00 to 2.98) | 0.51 (0.22 to 1.01) |
| Any, Week 35-40 | 3.41 (2.80 to 4.12) | 0.86 (0.03 to 4.26) | 0.51 (0.21 to 1.03) |
| Any, Week 35-41 | 3.30 (2.70 to 3.99) | 0.50 (0.05 to 1.94) | 0.43 (0.16 to 0.93) |
| Any, Week 35-42 | 3.21 (2.58 to 3.94) | 0.49 (0.06 to 1.81) | 0.40 (0.15 to 0.86) |
| Any, Week 35-43 | 3.21 (2.57 to 3.97) | 0.44 (0.10 to 1.22) | 0.44 (0.17 to 0.92) |
| Any, Week 35-44 | 3.15 (2.50 to 3.91) | 0.63 (0.08 to 2.19) | 0.37 (0.12 to 0.88) |
| Any, Week 35-45 | 3.13 (2.51 to 3.85) | 0.61 (0.10 to 1.97) | 0.36 (0.13 to 0.81) |
| Any, Week 35-46 | 3.09 (2.48 to 3.81) | 0.52 (0.06 to 1.97) | 0.40 (0.16 to 0.83) |
| Any, Week 35-47 | 3.08 (2.46 to 3.79) | 0.50 (0.05 to 1.89) | 0.39 (0.15 to 0.80) |
| Any, Week 35-48 | 3.05 (2.43 to 3.77) | 0.54 (0.07 to 1.91) | 0.38 (0.15 to 0.80) |
| Arthropathy, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Arthropathy, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Arthropathy, Week 35-37 | 1.42 (0.99 to 1.97) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Arthropathy, Week 35-38 | 1.23 (0.81 to 1.77) | 0.00 (0.00 to 20.59) | 0.09 (0.00 to 0.53) |
| Arthropathy, Week 35-39 | 1.08 (0.70 to 1.59) | 0.00 (0.00 to 2.98) | 0.06 (0.00 to 0.37) |
| Arthropathy, Week 35-40 | 1.03 (0.66 to 1.52) | 0.65 (0.03 to 3.20) | 0.05 (0.00 to 0.29) |
| Arthropathy, Week 35-41 | 0.97 (0.63 to 1.43) | 0.37 (0.04 to 1.45) | 0.04 (0.00 to 0.24) |
| Arthropathy, Week 35-42 | 0.93 (0.61 to 1.36) | 0.33 (0.04 to 1.21) | 0.04 (0.00 to 0.22) |
| Arthropathy, Week 35-43 | 0.93 (0.61 to 1.37) | 0.25 (0.03 to 0.93) | 0.03 (0.00 to 0.20) |
| Arthropathy, Week 35-44 | 0.92 (0.60 to 1.34) | 0.34 (0.03 to 1.39) | 0.03 (0.00 to 0.18) |
| Arthropathy, Week 35-45 | 0.91 (0.60 to 1.32) | 0.28 (0.02 to 1.20) | 0.03 (0.00 to 0.17) |
| Arthropathy, Week 35-46 | 0.89 (0.58 to 1.30) | 0.23 (0.01 to 1.10) | 0.03 (0.00 to 0.16) |
| Arthropathy, Week 35-47 | 0.88 (0.57 to 1.28) | 0.22 (0.01 to 1.05) | 0.02 (0.00 to 0.16) |
| Arthropathy, Week 35-48 | 0.87 (0.57 to 1.27) | 0.21 (0.01 to 1.02) | 0.02 (0.00 to 0.15) |
| Myalgia, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Myalgia, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Myalgia, Week 35-37 | 3.77 (2.67 to 5.16) | 0.00 (0.00 to 45.93) | 0.38 (0.05 to 1.35) |
| Myalgia, Week 35-38 | 3.41 (2.53 to 4.48) | 0.00 (0.00 to 20.59) | 0.28 (0.06 to 0.83) |
| Myalgia, Week 35-39 | 3.21 (2.60 to 3.92) | 0.00 (0.00 to 2.98) | 0.45 (0.18 to 0.92) |
| Myalgia, Week 35-40 | 3.07 (2.51 to 3.72) | 0.86 (0.03 to 4.26) | 0.47 (0.17 to 1.01) |
| Myalgia, Week 35-41 | 2.98 (2.42 to 3.62) | 0.50 (0.05 to 1.94) | 0.39 (0.13 to 0.90) |
| Myalgia, Week 35-42 | 2.90 (2.33 to 3.58) | 0.49 (0.06 to 1.81) | 0.36 (0.12 to 0.84) |
| Myalgia, Week 35-43 | 2.91 (2.32 to 3.60) | 0.44 (0.10 to 1.22) | 0.41 (0.14 to 0.92) |
| Myalgia, Week 35-44 | 2.84 (2.25 to 3.54) | 0.63 (0.08 to 2.19) | 0.34 (0.09 to 0.87) |
| Myalgia, Week 35-45 | 2.83 (2.27 to 3.49) | 0.61 (0.10 to 1.97) | 0.34 (0.11 to 0.79) |
| Myalgia, Week 35-46 | 2.80 (2.24 to 3.45) | 0.52 (0.06 to 1.97) | 0.38 (0.14 to 0.82) |
| Myalgia, Week 35-47 | 2.79 (2.23 to 3.44) | 0.50 (0.05 to 1.89) | 0.36 (0.13 to 0.79) |
| Myalgia, Week 35-48 | 2.76 (2.20 to 3.42) | 0.54 (0.07 to 1.91) | 0.36 (0.13 to 0.78) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Any, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Any, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Any, Week 35-37 | 0.28 (0.11 to 0.58) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Any, Week 35-38 | 0.29 (0.16 to 0.47) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Any, Week 35-39 | 0.26 (0.15 to 0.41) | 0.00 (0.00 to 2.98) | 0.00 (0.00 to 0.24) |
| Any, Week 35-40 | 0.21 (0.11 to 0.36) | 0.22 (0.01 to 1.19) | 0.00 (0.00 to 0.17) |
| Any, Week 35-41 | 0.21 (0.12 to 0.33) | 0.25 (0.02 to 0.97) | 0.04 (0.00 to 0.31) |
| Any, Week 35-42 | 0.19 (0.11 to 0.32) | 0.16 (0.02 to 0.60) | 0.04 (0.00 to 0.28) |
| Any, Week 35-43 | 0.19 (0.10 to 0.31) | 0.12 (0.01 to 0.47) | 0.03 (0.00 to 0.27) |
| Any, Week 35-44 | 0.18 (0.10 to 0.31) | 0.10 (0.01 to 0.40) | 0.03 (0.00 to 0.18) |
| Any, Week 35-45 | 0.18 (0.10 to 0.30) | 0.08 (0.01 to 0.34) | 0.03 (0.00 to 0.15) |
| Any, Week 35-46 | 0.17 (0.10 to 0.29) | 0.07 (0.00 to 0.31) | 0.03 (0.00 to 0.15) |
| Any, Week 35-47 | 0.17 (0.09 to 0.29) | 0.09 (0.02 to 0.27) | 0.02 (0.00 to 0.14) |
| Any, Week 35-48 | 0.17 (0.09 to 0.29) | 0.09 (0.02 to 0.26) | 0.02 (0.00 to 0.14) |
| Bell's palsy, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Bell's palsy, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Bell's palsy, Week 35-37 | 0.00 (0.00 to 0.15) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Bell's palsy, Week 35-38 | 0.00 (0.00 to 0.07) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Bell's palsy, Week 35-39 | 0.01 (0.00 to 0.08) | 0.00 (0.00 to 2.98) | 0.00 (0.00 to 0.24) |
| Bell's palsy, Week 35-40 | 0.01 (0.00 to 0.06) | 0.00 (0.00 to 0.79) | 0.00 (0.00 to 0.17) |
| Bell's palsy, Week 35-41 | 0.01 (0.00 to 0.06) | 0.00 (0.00 to 0.46) | 0.00 (0.00 to 0.15) |
| Bell's palsy, Week 35-42 | 0.01 (0.00 to 0.05) | 0.00 (0.00 to 0.30) | 0.00 (0.00 to 0.13) |
| Bell's palsy, Week 35-43 | 0.01 (0.00 to 0.05) | 0.00 (0.00 to 0.23) | 0.00 (0.00 to 0.13) |
| Bell's palsy, Week 35-44 | 0.01 (0.00 to 0.05) | 0.00 (0.00 to 0.18) | 0.00 (0.00 to 0.11) |
| Bell's palsy, Week 35-45 | 0.01 (0.00 to 0.05) | 0.00 (0.00 to 0.15) | 0.00 (0.00 to 0.10) |
| Bell's palsy, Week 35-46 | 0.01 (0.00 to 0.05) | 0.00 (0.00 to 0.12) | 0.00 (0.00 to 0.09) |
| Bell's palsy, Week 35-47 | 0.01 (0.00 to 0.04) | 0.00 (0.00 to 0.11) | 0.00 (0.00 to 0.09) |
| Bell's palsy, Week 35-48 | 0.01 (0.00 to 0.04) | 0.00 (0.00 to 0.11) | 0.00 (0.00 to 0.09) |
| Guillain-Barre Syndrome, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Guillain-Barre Syndrome, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Guillain-Barre Syndrome, Week 35-37 | 0.00 (0.00 to 0.15) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Guillain-Barre Syndrome, Week 35-38 | 0.00 (0.00 to 0.07) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Guillain-Barre Syndrome, Week 35-39 | 0.00 (0.00 to 0.04) | 0.00 (0.00 to 2.98) | 0.00 (0.00 to 0.24) |
| Guillain-Barre Syndrome, Week 35-40 | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.79) | 0.00 (0.00 to 0.17) |
| Guillain-Barre Syndrome, Week 35-41 | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.46) | 0.00 (0.00 to 0.15) |
| Guillain-Barre Syndrome, Week 35-42 | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.30) | 0.00 (0.00 to 0.13) |
| Guillain-Barre Syndrome, Week 35-43 | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.23) | 0.00 (0.00 to 0.13) |
| Guillain-Barre Syndrome, Week 35-44 | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.18) | 0.00 (0.00 to 0.11) |
| Guillain-Barre Syndrome, Week 35-45 | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.15) | 0.00 (0.00 to 0.10) |
| Guillain-Barre Syndrome, Week 35-46 | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.12) | 0.00 (0.00 to 0.09) |
| Guillain-Barre Syndrome, Week 35-47 | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.11) | 0.00 (0.00 to 0.09) |
| Guillain-Barre Syndrome, Week 35-48 | 0.00 (0.00 to 0.02) | 0.00 (0.00 to 0.11) | 0.00 (0.00 to 0.09) |
| Peripheral tremor, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Peripheral tremor, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Peripheral tremor, Week 35-37 | 0.24 (0.09 to 0.53) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Peripheral tremor, Week 35-38 | 0.27 (0.15 to 0.45) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Peripheral tremor, Week 35-39 | 0.24 (0.12 to 0.41) | 0.00 (0.00 to 2.98) | 0.00 (0.00 to 0.24) |
| Peripheral tremor, Week 35-40 | 0.19 (0.09 to 0.35) | 0.22 (0.01 to 1.19) | 0.00 (0.00 to 0.17) |
| Peripheral tremor, Week 35-41 | 0.19 (0.10 to 0.32) | 0.25 (0.02 to 0.97) | 0.00 (0.00 to 0.15) |
| Peripheral tremor, Week 35-42 | 0.18 (0.09 to 0.31) | 0.16 (0.02 to 0.60) | 0.00 (0.00 to 0.13) |
| Peripheral tremor, Week 35-43 | 0.17 (0.09 to 0.30) | 0.12 (0.01 to 0.47) | 0.00 (0.00 to 0.13) |
| Peripheral tremor, Week 35-44 | 0.17 (0.09 to 0.30) | 0.10 (0.01 to 0.40) | 0.00 (0.00 to 0.11) |
| Peripheral tremor, Week 35-45 | 0.17 (0.09 to 0.29) | 0.08 (0.01 to 0.34) | 0.00 (0.00 to 0.10) |
| Peripheral tremor, Week 35-46 | 0.16 (0.08 to 0.28) | 0.07 (0.00 to 0.31) | 0.00 (0.00 to 0.09) |
| Peripheral tremor, Week 35-47 | 0.16 (0.08 to 0.28) | 0.06 (0.00 to 0.30) | 0.00 (0.00 to 0.09) |
| Peripheral tremor, Week 35-48 | 0.16 (0.08 to 0.28) | 0.06 (0.00 to 0.29) | 0.00 (0.00 to 0.09) |
| Seizure / Febrile convulsions, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Seizure / Febrile convulsions, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Seizure / Febrile convulsions, Week 35-37 | 0.04 (0.00 to 0.25) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.69) |
| Seizure / Febrile convulsions, Week 35-38 | 0.02 (0.00 to 0.11) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| Seizure / Febrile convulsions, Week 35-39 | 0.01 (0.00 to 0.07) | 0.00 (0.00 to 2.98) | 0.00 (0.00 to 0.24) |
| Seizure / Febrile convulsions, Week 35-40 | 0.01 (0.00 to 0.06) | 0.00 (0.00 to 0.79) | 0.00 (0.00 to 0.17) |
| Seizure / Febrile convulsions, Week 35-41 | 0.01 (0.00 to 0.05) | 0.00 (0.00 to 0.46) | 0.04 (0.00 to 0.31) |
| Seizure / Febrile convulsions, Week 35-42 | 0.01 (0.00 to 0.05) | 0.00 (0.00 to 0.30) | 0.04 (0.00 to 0.28) |
| Seizure / Febrile convulsions, Week 35-43 | 0.01 (0.00 to 0.04) | 0.00 (0.00 to 0.23) | 0.03 (0.00 to 0.27) |
| Seizure / Febrile convulsions, Week 35-44 | 0.01 (0.00 to 0.04) | 0.00 (0.00 to 0.18) | 0.03 (0.00 to 0.18) |
| Seizure / Febrile convulsions, Week 35-45 | 0.01 (0.00 to 0.04) | 0.00 (0.00 to 0.15) | 0.03 (0.00 to 0.15) |
| Seizure / Febrile convulsions, Week 35-46 | 0.01 (0.00 to 0.04) | 0.00 (0.00 to 0.12) | 0.03 (0.00 to 0.15) |
| Seizure / Febrile convulsions, Week 35-47 | 0.01 (0.00 to 0.04) | 0.03 (0.00 to 0.23) | 0.02 (0.00 to 0.14) |
| Seizure / Febrile convulsions, Week 35-48 | 0.01 (0.00 to 0.04) | 0.03 (0.00 to 0.22) | 0.02 (0.00 to 0.14) |
SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.78) |
| Week 35-37 | 0.12 (0.02 to 0.37) | 0.00 (0.00 to 45.93) | 0.19 (0.00 to 1.49) |
| Week 35-38 | 0.15 (0.06 to 0.34) | 0.00 (0.00 to 20.59) | 0.28 (0.06 to 0.81) |
| Week 35-39 | 0.12 (0.06 to 0.21) | 0.00 (0.00 to 2.98) | 0.19 (0.04 to 0.56) |
| Week 35-40 | 0.13 (0.07 to 0.22) | 0.00 (0.00 to 0.79) | 0.19 (0.03 to 0.57) |
| Week 35-41 | 0.13 (0.06 to 0.23) | 0.00 (0.00 to 0.46) | 0.24 (0.04 to 0.73) |
| Week 35-42 | 0.12 (0.06 to 0.22) | 0.08 (0.00 to 0.46) | 0.22 (0.04 to 0.65) |
| Week 35-43 | 0.13 (0.06 to 0.26) | 0.06 (0.00 to 0.35) | 0.20 (0.04 to 0.61) |
| Week 35-44 | 0.14 (0.05 to 0.30) | 0.10 (0.01 to 0.35) | 0.23 (0.06 to 0.62) |
| Week 35-45 | 0.14 (0.06 to 0.28) | 0.12 (0.01 to 0.44) | 0.21 (0.04 to 0.60) |
| Week 35-46 | 0.15 (0.06 to 0.31) | 0.10 (0.01 to 0.37) | 0.23 (0.06 to 0.59) |
| Week 35-47 | 0.15 (0.06 to 0.31) | 0.09 (0.01 to 0.35) | 0.24 (0.07 to 0.61) |
| Week 35-48 | 0.15 (0.06 to 0.33) | 0.09 (0.01 to 0.34) | 0.24 (0.07 to 0.60) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 1.59 (0.04 to 8.53) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 4.83 (2.34 to 8.70) | 0.00 (0.00 to 23.16) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 4.07 (0.99 to 10.69) | 0.00 (0.00 to 7.71) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 1.56 (0.29 to 4.72) | 5.88 (0.00 to 69.40) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 2.10 (0.43 to 6.01) | 20.00 (0.00 to 96.43) |
| 6 months to 5 years, Week 44 | — | 2.94 (0.10 to 14.43) | 0.00 (0.00 to 2.48) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 50.00 (1.26 to 98.74) | 0.99 (0.04 to 4.97) | 0.00 (0.00 to 30.85) |
| 6 months to 5 years, Week 47 | — | 1.39 (0.04 to 7.50) | 0.00 (0.00 to 9.03) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 40 | 33.33 (0.00 to 100) | 19.05 (3.24 to 49.67) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 41 | 50.00 (1.26 to 98.74) | 0.00 (0.00 to 11.57) | 0.00 (0.00 to 6.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 12.34) | 0.00 (0.00 to 14.82) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 40.96) |
| 6 - 12 years, Week 44 | 16.67 (0.02 to 81.43) | 2.02 (0.16 to 8.11) | 0.40 (0.01 to 2.22) |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.98 (0.00 to 10.39) | 0.00 (0.00 to 97.50) |
| 6 - 12 years, Week 46 | 20.00 (0.02 to 88.39) | 0.36 (0.01 to 2.02) | 0.00 (0.00 to 24.71) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 1.61 (0.00 to 29.53) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 7.14 (0.02 to 44.90) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 11.11 (0.19 to 51.19) | 50.00 (1.26 to 98.74) |
| 13 - 17 years, Week 41 | 10.00 (0.00 to 71.81) | 5.88 (0.02 to 38.78) | 0.00 (0.00 to 10.89) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 23.16) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 3.75 (0.78 to 10.57) | 4.39 (2.03 to 8.17) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 37 | 11.82 (9.20 to 14.88) | 0.00 (0.00 to 70.76) | 2.63 (0.72 to 6.60) |
| 18 - 65 years, Week 38 | 10.81 (7.35 to 15.18) | 0.00 (0.00 to 60.24) | 0.61 (0.01 to 3.60) |
| 18 - 65 years, Week 39 | 11.52 (9.90 to 13.30) | 10.00 (0.11 to 50.09) | 0.68 (0.00 to 4.80) |
| 18 - 65 years, Week 40 | 10.39 (5.89 to 16.65) | 11.11 (0.19 to 51.15) | 1.54 (0.32 to 4.43) |
| 18 - 65 years, Week 41 | 7.72 (4.87 to 11.50) | 6.38 (2.38 to 13.38) | 0.91 (0.02 to 5.16) |
| 18 - 65 years, Week 42 | 5.63 (2.28 to 11.30) | 1.82 (0.22 to 6.41) | 3.70 (0.50 to 12.30) |
| 18 - 65 years, Week 43 | 5.88 (1.87 to 13.42) | 7.56 (3.52 to 13.87) | 1.16 (0.03 to 6.31) |
| 18 - 65 years, Week 44 | 5.43 (2.05 to 11.35) | 17.72 (10.04 to 27.94) | 1.27 (0.03 to 7.12) |
| 18 - 65 years, Week 45 | 6.25 (3.31 to 10.57) | 3.64 (0.00 to 99.60) | 6.02 (1.48 to 15.53) |
| 18 - 65 years, Week 46 | 7.62 (4.08 to 12.77) | 7.84 (1.88 to 20.13) | 0.00 (0.00 to 8.81) |
| 18 - 65 years, Week 47 | 5.48 (1.98 to 11.73) | 7.69 (0.78 to 26.63) | 1.59 (0.01 to 11.07) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 10.34 (2.07 to 27.92) | 0.00 (0.00 to 12.34) |
| >65 years, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 1.96 (0.00 to 18.80) |
| >65 years, Week 37 | 11.64 (9.86 to 13.62) | 0.00 (0.00 to 84.19) | 0.63 (0.02 to 3.50) |
| >65 years, Week 38 | 9.77 (7.54 to 12.39) | 16.67 (0.00 to 91.51) | 1.86 (0.75 to 3.79) |
| >65 years, Week 39 | 9.31 (7.76 to 11.06) | 0.00 (0.00 to 40.96) | 2.97 (0.96 to 6.82) |
| >65 years, Week 40 | 9.75 (6.13 to 14.53) | 7.14 (1.50 to 19.48) | 1.37 (0.22 to 4.43) |
| >65 years, Week 41 | 9.04 (6.57 to 12.05) | 8.86 (3.64 to 17.41) | 0.65 (0.00 to 4.69) |
| >65 years, Week 42 | 5.12 (2.52 to 9.12) | 6.15 (1.70 to 15.01) | 0.00 (0.00 to 3.03) |
| >65 years, Week 43 | 6.20 (2.56 to 12.27) | 6.10 (0.00 to 86.17) | 1.54 (0.01 to 11.02) |
| >65 years, Week 44 | 6.28 (1.99 to 14.32) | 9.38 (3.52 to 19.30) | 0.00 (0.00 to 4.99) |
| >65 years, Week 45 | 7.21 (2.71 to 14.98) | 18.92 (0.00 to 100) | 0.00 (0.00 to 6.06) |
| >65 years, Week 46 | 6.14 (1.96 to 13.99) | 5.41 (0.00 to 68.00) | 9.38 (1.29 to 28.96) |
| >65 years, Week 47 | 2.83 (0.59 to 8.05) | 3.70 (0.00 to 99.88) | 3.33 (0.08 to 17.37) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 9.09 (0.00 to 100) | 0.00 (0.00 to 30.85) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 month to 5 years, Week 35-37 | — | — | 0.00 (0.00 to 97.50) |
| 6 month to 5 years, Week 35-38 | — | — | 0.00 (0.00 to 97.50) |
| 6 month to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 1.59 (0.04 to 8.53) | 0.00 (0.00 to 84.19) |
| 6 month to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 4.07 (1.83 to 7.72) | 0.00 (0.00 to 20.59) |
| 6 month to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 4.07 (1.86 to 7.64) | 0.00 (0.00 to 5.78) |
| 6 month to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 3.25 (1.55 to 5.94) | 1.27 (0.00 to 13.35) |
| 6 month to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 3.02 (1.53 to 5.32) | 2.38 (0.02 to 15.91) |
| 6 month to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 3.00 (1.44 to 5.47) | 0.87 (0.08 to 3.41) |
| 6 month to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 2.64 (1.20 to 4.98) | 0.86 (0.08 to 3.38) |
| 6 month to 5 years, Week 35-46 | 10.00 (0.14 to 48.28) | 2.37 (1.12 to 4.39) | 0.82 (0.08 to 3.22) |
| 6 month to 5 years, Week 35-47 | 10.00 (0.14 to 48.28) | 2.32 (1.14 to 4.17) | 0.71 (0.06 to 2.91) |
| 6 month to 5 years, Week 35-48 | 10.00 (0.14 to 48.28) | 2.27 (1.11 to 4.10) | 0.70 (0.06 to 2.86) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 35-40 | 3.70 (0.00 to 39.49) | 9.52 (0.71 to 34.64) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 35-41 | 6.90 (0.06 to 39.08) | 5.56 (0.29 to 23.48) | 0.00 (0.00 to 5.52) |
| 6 - 12 years, Week 35-42 | 5.88 (0.15 to 28.66) | 4.00 (0.25 to 16.69) | 0.00 (0.00 to 4.11) |
| 6 - 12 years, Week 35-43 | 5.71 (0.17 to 27.21) | 3.20 (0.17 to 14.11) | 0.00 (0.00 to 3.81) |
| 6 - 12 years, Week 35-44 | 7.32 (0.36 to 30.38) | 2.68 (0.32 to 9.40) | 0.29 (0.01 to 1.61) |
| 6 - 12 years, Week 35-45 | 7.14 (0.32 to 30.34) | 2.15 (0.11 to 9.76) | 0.29 (0.01 to 1.61) |
| 6 - 12 years, Week 35-46 | 8.51 (1.98 to 21.99) | 1.33 (0.10 to 5.51) | 0.28 (0.01 to 1.55) |
| 6 - 12 years, Week 35-47 | 8.51 (1.98 to 21.99) | 1.30 (0.10 to 5.37) | 0.48 (0.06 to 1.71) |
| 6 - 12 years, Week 35-48 | 8.33 (2.04 to 21.11) | 1.26 (0.09 to 5.27) | 0.48 (0.06 to 1.71) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 2.63 (0.01 to 18.97) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 2.22 (0.02 to 14.79) | 7.14 (0.04 to 41.49) | 33.33 (0.00 to 99.94) |
| 13 - 17 years, Week 35-41 | 3.64 (0.02 to 23.48) | 6.45 (0.34 to 26.78) | 2.86 (0.07 to 14.92) |
| 13 - 17 years, Week 35-42 | 3.39 (0.03 to 20.78) | 4.17 (0.48 to 14.52) | 2.86 (0.07 to 14.92) |
| 13 - 17 years, Week 35-43 | 3.28 (0.03 to 20.21) | 3.28 (0.33 to 12.04) | 2.78 (0.07 to 14.53) |
| 13 - 17 years, Week 35-44 | 3.23 (0.03 to 19.93) | 2.33 (0.22 to 8.82) | 2.00 (0.05 to 10.65) |
| 13 - 17 years, Week 35-45 | 2.86 (0.03 to 17.61) | 3.01 (0.99 to 6.89) | 3.92 (1.90 to 7.09) |
| 13 - 17 years, Week 35-46 | 2.63 (0.02 to 16.58) | 2.81 (0.92 to 6.43) | 3.89 (1.88 to 7.04) |
| 13 - 17 years, Week 35-47 | 2.44 (0.02 to 15.79) | 2.73 (0.89 to 6.26) | 3.82 (1.85 to 6.91) |
| 13 - 17 years, Week 35-48 | 2.33 (0.02 to 15.01) | 2.72 (0.89 to 6.23) | 3.82 (1.85 to 6.91) |
| 18 - 65 years, Weeks 35-36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Weeks 35-37 | 11.82 (9.20 to 14.88) | 0.00 (0.00 to 70.76) | 2.47 (0.68 to 6.20) |
| 18 - 65 years, Weeks 35-38 | 11.27 (8.66 to 14.35) | 0.00 (0.00 to 40.96) | 1.53 (0.50 to 3.54) |
| 18 - 65 years, Weeks 35-39 | 11.39 (9.78 to 13.16) | 5.88 (0.15 to 28.69) | 1.27 (0.44 to 2.84) |
| 18 - 65 years, Weeks 35-40 | 11.19 (9.16 to 13.49) | 10.00 (4.42 to 18.76) | 1.35 (0.62 to 2.54) |
| 18 - 65 years, Weeks 35-41 | 10.69 (8.73 to 12.91) | 8.05 (4.47 to 13.13) | 1.29 (0.62 to 2.35) |
| 18 - 65 years, Weeks 35-42 | 10.31 (8.26 to 12.66) | 5.63 (3.25 to 8.99) | 1.51 (0.81 to 2.57) |
| 18 - 65 years, Weeks 35-43 | 10.11 (8.02 to 12.52) | 6.20 (4.05 to 9.02) | 1.48 (0.81 to 2.47) |
| 18 - 65 years, Weeks 35-44 | 9.83 (7.72 to 12.29) | 8.09 (5.82 to 10.90) | 1.46 (0.73 to 2.61) |
| 18 - 65 years, Weeks 35-45 | 9.68 (7.60 to 12.11) | 7.64 (5.53 to 10.22) | 1.81 (0.67 to 3.87) |
| 18 - 65 years, Weeks 35-46 | 9.60 (7.52 to 12.04) | 7.65 (5.64 to 10.11) | 1.74 (0.65 to 3.73) |
| 18 - 65 years, Weeks 35-47 | 9.50 (7.43 to 11.92) | 7.66 (5.70 to 10.02) | 1.74 (0.70 to 3.55) |
| 18 - 65 years, Weeks 35-48 | 9.36 (7.29 to 11.78) | 7.77 (5.84 to 10.10) | 1.70 (0.69 to 3.46) |
| >65 years, Weeks 35-35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Weeks 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 1.92 (0.00 to 17.19) |
| >65 years, Weeks 35-37 | 11.64 (9.86 to 13.61) | 0.00 (0.00 to 70.76) | 0.81 (0.12 to 2.67) |
| >65 years, Weeks 35-38 | 10.67 (8.97 to 12.56) | 11.11 (0.03 to 62.14) | 1.34 (0.59 to 2.60) |
| >65 years, Weeks 35-39 | 10.09 (8.50 to 11.87) | 6.25 (0.16 to 30.23) | 1.85 (0.73 to 3.81) |
| >65 years, Weeks 35-40 | 10.03 (8.24 to 12.06) | 6.90 (1.91 to 16.73) | 1.73 (0.67 to 3.60) |
| >65 years, Weeks 35-41 | 9.91 (8.10 to 11.98) | 8.03 (4.08 to 13.91) | 1.62 (0.67 to 3.28) |
| >65 years, Weeks 35-42 | 9.63 (7.80 to 11.71) | 7.43 (4.22 to 11.95) | 1.51 (0.61 to 3.08) |
| >65 years, Weeks 35-43 | 9.53 (7.73 to 11.58) | 7.04 (4.35 to 10.67) | 1.51 (0.63 to 3.01) |
| >65 years, Weeks 35-44 | 9.39 (7.61 to 11.42) | 7.47 (4.94 to 10.76) | 1.45 (0.61 to 2.89) |
| >65 years, Weeks 35-45 | 9.34 (7.58 to 11.34) | 8.57 (5.97 to 11.83) | 1.41 (0.59 to 2.82) |
| >65 years, Weeks 35-46 | 9.30 (7.55 to 11.31) | 8.29 (5.84 to 11.35) | 1.54 (0.71 to 2.89) |
| >65 years, Weeks 35-47 | 9.24 (7.47 to 11.25) | 8.02 (5.68 to 10.93) | 1.57 (0.75 to 2.86) |
| >65 years, Weeks 35-48 | 9.19 (7.42 to 11.22) | 8.07 (5.77 to 10.91) | 1.56 (0.75 to 2.85) |
AEIs reported here are derived from 2 data sources - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years, and \>65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with seasonal influenza vaccine Vaccination of subjects happened between weeks 35 and 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 1.45 (0.30 to 4.18) | 0.00 (0.00 to 23.16) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 7.71) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.90) | 0.00 (0.00 to 19.51) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.49 (0.01 to 2.70) | 0.00 (0.00 to 2.48) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.49 (0.00 to 4.44) | 0.00 (0.00 to 30.85) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 9.03) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 4.76 (0.03 to 29.74) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.57) | 0.00 (0.00 to 6.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 12.34) | 0.00 (0.00 to 14.82) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 40.96) |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.66) | 0.00 (0.00 to 1.47) |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.55) | 0.00 (0.00 to 97.50) |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.34) | 0.00 (0.00 to 24.71) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 5.78) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 10.89) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 23.16) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 0.49 (0.01 to 2.69) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 37 | 0.56 (0.15 to 1.42) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 2.40) |
| 18 - 65 years, Week 38 | 0.81 (0.13 to 2.66) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 2.22) |
| 18 - 65 years, Week 39 | 0.71 (0.28 to 1.46) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 2.48) |
| 18 - 65 years, Week 40 | 0.81 (0.07 to 3.27) | 1.59 (0.04 to 8.63) | 0.00 (0.00 to 1.87) |
| 18 - 65 years, Week 41 | 0.31 (0.02 to 1.39) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 3.30) |
| 18 - 65 years, Week 42 | 0.00 (0.00 to 1.03) | 0.00 (0.00 to 3.30) | 0.00 (0.00 to 4.45) |
| 18 - 65 years, Week 43 | 0.45 (0.01 to 2.91) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 4.20) |
| 18 - 65 years, Week 44 | 0.32 (0.01 to 1.77) | 0.00 (0.00 to 4.56) | 0.00 (0.00 to 4.56) |
| 18 - 65 years, Week 45 | 0.45 (0.00 to 3.26) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 4.35) |
| 18 - 65 years, Week 46 | 0.45 (0.00 to 3.36) | 0.00 (0.00 to 6.98) | 0.00 (0.00 to 8.81) |
| 18 - 65 years, Week 47 | 0.68 (0.00 to 4.94) | 2.56 (0.00 to 25.31) | 0.00 (0.00 to 5.69) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 12.34) |
| >65 years, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.98) |
| >65 years, Week 37 | 0.40 (0.16 to 0.83) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 1.16) |
| >65 years, Week 38 | 0.43 (0.18 to 0.84) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.97) |
| >65 years, Week 39 | 0.41 (0.12 to 1.01) | 0.00 (0.00 to 40.96) | 0.30 (0.00 to 2.21) |
| >65 years, Week 40 | 0.23 (0.05 to 0.67) | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.01) |
| >65 years, Week 41 | 0.39 (0.09 to 1.11) | 2.53 (0.31 to 8.85) | 0.00 (0.00 to 2.35) |
| >65 years, Week 42 | 0.00 (0.00 to 0.67) | 0.00 (0.00 to 5.52) | 0.00 (0.00 to 3.03) |
| >65 years, Week 43 | 0.36 (0.00 to 2.44) | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 5.52) |
| >65 years, Week 44 | 0.23 (0.01 to 1.29) | 1.56 (0.00 to 64.84) | 0.00 (0.00 to 4.99) |
| >65 years, Week 45 | 0.00 (0.00 to 1.65) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 6.06) |
| >65 years, Week 46 | 0.88 (0.01 to 6.20) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 10.89) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 11.57) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 30.85) |
AEIs reported here are derived from 2 data sources - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and \>65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-38 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 1.11 (0.14 to 3.88) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.76 (0.06 to 3.15) | 0.00 (0.00 to 5.78) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.51 (0.02 to 2.44) | 0.00 (0.00 to 4.56) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.41 (0.01 to 2.18) | 0.00 (0.00 to 4.30) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.43 (0.04 to 1.68) | 0.00 (0.00 to 1.58) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.38 (0.03 to 1.53) | 0.00 (0.00 to 1.57) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.40 (0.06 to 1.29) | 0.00 (0.00 to 1.51) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.37 (0.06 to 1.22) | 0.00 (0.00 to 1.30) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.37 (0.06 to 1.19) | 0.00 (0.00 to 1.28) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 2.38 (0.03 to 14.41) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 1.39 (0.01 to 9.21) | 0.00 (0.00 to 5.52) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 1.00 (0.01 to 6.59) | 0.00 (0.00 to 4.11) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.80 (0.01 to 5.53) | 0.00 (0.00 to 3.81) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.45 (0.00 to 3.38) | 0.00 (0.00 to 1.07) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.31 (0.00 to 2.50) | 0.00 (0.00 to 1.06) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.17 (0.00 to 1.44) | 0.00 (0.00 to 1.03) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.16 (0.00 to 1.40) | 0.00 (0.00 to 0.87) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.16 (0.00 to 1.37) | 0.00 (0.00 to 0.87) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 70.76) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 9.74) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 7.11) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 2.20) | 0.39 (0.01 to 2.17) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.00 (0.00 to 2.05) | 0.39 (0.01 to 2.15) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 2.00) | 0.38 (0.01 to 2.11) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 1.98) | 0.38 (0.01 to 2.11) |
| 18 - 65 years, Week 35-36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 35-37 | 0.56 (0.15 to 1.42) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 2.25) |
| 18 - 65 years, Week 35-38 | 0.70 (0.22 to 1.64) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 1.13) |
| 18 - 65 years, Week 35-39 | 0.70 (0.28 to 1.45) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 0.78) |
| 18 - 65 years, Week 35-40 | 0.72 (0.33 to 1.37) | 1.25 (0.03 to 6.77) | 0.00 (0.00 to 0.55) |
| 18 - 65 years, Week 35-41 | 0.66 (0.33 to 1.18) | 0.57 (0.01 to 3.16) | 0.00 (0.00 to 0.47) |
| 18 - 65 years, Week 35-42 | 0.61 (0.30 to 1.12) | 0.35 (0.01 to 1.95) | 0.00 (0.00 to 0.43) |
| 18 - 65 years, Week 35-43 | 0.61 (0.29 to 1.13) | 0.25 (0.01 to 1.37) | 0.00 (0.00 to 0.39) |
| 18 - 65 years, Week 35-44 | 0.59 (0.28 to 1.08) | 0.21 (0.01 to 1.15) | 0.00 (0.00 to 0.36) |
| 18 - 65 years, Week 35-45 | 0.58 (0.28 to 1.07) | 0.19 (0.00 to 1.03) | 0.00 (0.00 to 0.33) |
| 18 - 65 years, Week 35-46 | 0.58 (0.26 to 1.10) | 0.17 (0.00 to 0.94) | 0.00 (0.00 to 0.32) |
| 18 - 65 years, Week 35-47 | 0.58 (0.28 to 1.06) | 0.32 (0.04 to 1.15) | 0.00 (0.00 to 0.30) |
| 18 - 65 years, Week 35-48 | 0.57 (0.28 to 1.05) | 0.30 (0.04 to 1.10) | 0.00 (0.00 to 0.30) |
| >65 years, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.85) |
| >65 years, Week 35-37 | 0.40 (0.16 to 0.83) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 0.99) |
| >65 years, Week 35-38 | 0.42 (0.23 to 0.68) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 0.49) |
| >65 years, Week 35-39 | 0.41 (0.25 to 0.65) | 0.00 (0.00 to 20.59) | 0.09 (0.00 to 0.67) |
| >65 years, Week 35-40 | 0.38 (0.24 to 0.58) | 0.00 (0.00 to 6.16) | 0.07 (0.00 to 0.52) |
| >65 years, Week 35-41 | 0.38 (0.25 to 0.56) | 1.46 (0.18 to 5.17) | 0.06 (0.00 to 0.47) |
| >65 years, Week 35-42 | 0.36 (0.23 to 0.54) | 0.99 (0.12 to 3.53) | 0.06 (0.00 to 0.43) |
| >65 years, Week 35-43 | 0.36 (0.22 to 0.55) | 0.70 (0.09 to 2.52) | 0.06 (0.00 to 0.42) |
| >65 years, Week 35-44 | 0.36 (0.22 to 0.54) | 0.86 (0.18 to 2.50) | 0.05 (0.00 to 0.40) |
| >65 years, Week 35-45 | 0.35 (0.22 to 0.53) | 0.78 (0.16 to 2.26) | 0.05 (0.00 to 0.39) |
| >65 years, Week 35-46 | 0.35 (0.22 to 0.55) | 0.71 (0.15 to 2.06) | 0.05 (0.00 to 0.38) |
| >65 years, Week 35-47 | 0.35 (0.21 to 0.54) | 0.67 (0.14 to 1.94) | 0.05 (0.00 to 0.37) |
| >65 years, Week 35-48 | 0.35 (0.21 to 0.54) | 0.64 (0.13 to 1.85) | 0.05 (0.00 to 0.37) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 1.77) | 0.00 (0.00 to 23.16) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 7.71) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.90) | 0.00 (0.00 to 19.51) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.00 (0.00 to 1.79) | 0.00 (0.00 to 2.48) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 1.80) | 0.00 (0.00 to 30.85) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 9.03) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.57) | 0.00 (0.00 to 6.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 12.34) | 0.00 (0.00 to 14.82) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 40.96) |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.66) | 0.00 (0.00 to 1.47) |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.55) | 0.00 (0.00 to 97.50) |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.34) | 0.00 (0.00 to 24.71) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 5.78) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 10.89) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 23.16) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 0.00 (0.00 to 1.78) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 37 | 3.06 (1.93 to 4.60) | 0.00 (0.00 to 70.76) | 0.66 (0.02 to 3.61) |
| 18 - 65 years, Week 38 | 3.14 (1.56 to 5.58) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 2.22) |
| 18 - 65 years, Week 39 | 2.19 (1.37 to 3.32) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 2.48) |
| 18 - 65 years, Week 40 | 3.10 (0.67 to 8.64) | 1.59 (0.04 to 8.63) | 0.00 (0.00 to 1.87) |
| 18 - 65 years, Week 41 | 1.26 (0.55 to 2.47) | 2.13 (0.26 to 7.48) | 0.00 (0.00 to 3.30) |
| 18 - 65 years, Week 42 | 0.85 (0.06 to 3.51) | 0.00 (0.00 to 3.30) | 0.00 (0.00 to 4.45) |
| 18 - 65 years, Week 43 | 0.45 (0.01 to 2.91) | 1.68 (0.20 to 5.94) | 0.00 (0.00 to 4.20) |
| 18 - 65 years, Week 44 | 2.24 (0.76 to 5.02) | 1.27 (0.03 to 6.85) | 0.00 (0.00 to 4.56) |
| 18 - 65 years, Week 45 | 0.45 (0.00 to 3.33) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 4.35) |
| 18 - 65 years, Week 46 | 2.24 (0.30 to 7.65) | 3.92 (0.48 to 13.46) | 0.00 (0.00 to 8.81) |
| 18 - 65 years, Week 47 | 2.05 (0.10 to 9.40) | 0.00 (0.00 to 9.03) | 0.00 (0.00 to 5.69) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 12.34) |
| >65 years, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.98) |
| >65 years, Week 37 | 1.44 (0.34 to 3.90) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 1.16) |
| >65 years, Week 38 | 0.96 (0.52 to 1.62) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.97) |
| >65 years, Week 39 | 1.83 (1.25 to 2.59) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 1.09) |
| >65 years, Week 40 | 1.30 (0.44 to 2.97) | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.01) |
| >65 years, Week 41 | 1.57 (0.90 to 2.54) | 1.27 (0.03 to 6.85) | 0.00 (0.00 to 2.35) |
| >65 years, Week 42 | 0.37 (0.00 to 2.81) | 3.08 (0.37 to 10.68) | 0.00 (0.00 to 3.03) |
| >65 years, Week 43 | 0.36 (0.00 to 2.55) | 1.22 (0.00 to 72.65) | 0.00 (0.00 to 5.52) |
| >65 years, Week 44 | 0.47 (0.02 to 2.39) | 3.13 (0.00 to 46.96) | 0.00 (0.00 to 4.99) |
| >65 years, Week 45 | 1.35 (0.09 to 5.79) | 5.41 (0.00 to 99.64) | 0.00 (0.00 to 6.06) |
| >65 years, Week 46 | 0.00 (0.00 to 3.18) | 2.70 (0.00 to 99.94) | 0.00 (0.00 to 10.89) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 11.57) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 30.85) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-38 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.93) | 0.00 (0.00 to 5.78) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 0.63) | 0.00 (0.00 to 4.56) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.51) | 0.00 (0.00 to 4.30) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 1.58) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.35) | 0.00 (0.00 to 1.57) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.29) | 0.00 (0.00 to 1.51) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.28) | 0.00 (0.00 to 1.30) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.27) | 0.00 (0.00 to 1.28) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 5.52) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 4.11) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 2.91) | 0.00 (0.00 to 3.81) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 1.63) | 0.00 (0.00 to 1.07) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 1.06) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.61) | 0.00 (0.00 to 1.03) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.60) | 0.00 (0.00 to 0.87) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 0.58) | 0.00 (0.00 to 0.87) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 70.76) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 9.74) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 7.11) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 2.20) | 0.00 (0.00 to 1.44) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.00 (0.00 to 2.05) | 0.00 (0.00 to 1.43) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 2.00) | 0.00 (0.00 to 1.40) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 1.98) | 0.00 (0.00 to 1.40) |
| 18 - 65 years, Week 35-36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 35-37 | 3.06 (1.93 to 4.60) | 0.00 (0.00 to 70.76) | 0.62 (0.02 to 3.39) |
| 18 - 65 years, Week 35-38 | 3.10 (1.96 to 4.65) | 0.00 (0.00 to 40.96) | 0.31 (0.01 to 1.70) |
| 18 - 65 years, Week 35-39 | 2.67 (1.74 to 3.92) | 0.00 (0.00 to 19.51) | 0.21 (0.00 to 1.23) |
| 18 - 65 years, Week 35-40 | 2.76 (1.61 to 4.38) | 1.25 (0.03 to 6.77) | 0.15 (0.00 to 0.95) |
| 18 - 65 years, Week 35-41 | 2.54 (1.56 to 3.90) | 1.72 (0.36 to 4.96) | 0.13 (0.00 to 0.83) |
| 18 - 65 years, Week 35-42 | 2.41 (1.50 to 3.66) | 1.06 (0.22 to 3.06) | 0.12 (0.00 to 0.77) |
| 18 - 65 years, Week 35-43 | 2.33 (1.45 to 3.52) | 1.24 (0.40 to 2.87) | 0.11 (0.00 to 0.71) |
| 18 - 65 years, Week 35-44 | 2.32 (1.50 to 3.42) | 1.24 (0.46 to 2.69) | 0.10 (0.00 to 0.66) |
| 18 - 65 years, Week 35-45 | 2.24 (1.46 to 3.28) | 1.12 (0.41 to 2.42) | 0.09 (0.00 to 0.61) |
| 18 - 65 years, Week 35-46 | 2.24 (1.48 to 3.25) | 1.36 (0.59 to 2.66) | 0.09 (0.00 to 0.59) |
| 18 - 65 years, Week 35-47 | 2.24 (1.50 to 3.20) | 1.28 (0.55 to 2.50) | 0.08 (0.00 to 0.57) |
| 18 - 65 years, Week 35-48 | 2.21 (1.48 to 3.16) | 1.22 (0.53 to 2.39) | 0.08 (0.00 to 0.56) |
| >65 years, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.85) |
| >65 years, Week 35-37 | 1.44 (0.34 to 3.89) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 0.99) |
| >65 years, Week 35-38 | 1.19 (0.49 to 2.42) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 0.49) |
| >65 years, Week 35-39 | 1.46 (0.86 to 2.33) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| >65 years, Week 35-40 | 1.44 (0.91 to 2.16) | 0.00 (0.00 to 6.16) | 0.00 (0.00 to 0.25) |
| >65 years, Week 35-41 | 1.45 (0.97 to 2.09) | 0.73 (0.02 to 4.00) | 0.00 (0.00 to 0.23) |
| >65 years, Week 35-42 | 1.39 (0.96 to 1.94) | 1.49 (0.31 to 4.28) | 0.00 (0.00 to 0.21) |
| >65 years, Week 35-43 | 1.36 (0.94 to 1.89) | 1.41 (0.39 to 3.57) | 0.00 (0.00 to 0.21) |
| >65 years, Week 35-44 | 1.32 (0.92 to 1.83) | 1.72 (0.64 to 3.71) | 0.00 (0.00 to 0.20) |
| >65 years, Week 35-45 | 1.32 (0.92 to 1.83) | 2.08 (0.90 to 4.05) | 0.00 (0.00 to 0.19) |
| >65 years, Week 35-46 | 1.31 (0.91 to 1.81) | 2.13 (0.98 to 4.01) | 0.00 (0.00 to 0.19) |
| >65 years, Week 35-47 | 1.29 (0.90 to 1.79) | 2.00 (0.92 to 3.77) | 0.00 (0.00 to 0.19) |
| >65 years, Week 35-48 | 1.29 (0.90 to 1.78) | 1.91 (0.88 to 3.60) | 0.00 (0.00 to 0.19) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.48 (0.01 to 2.66) | 0.00 (0.00 to 23.16) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 7.71) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.90) | 0.00 (0.00 to 19.51) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.49 (0.01 to 2.70) | 0.00 (0.00 to 2.48) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 1.80) | 0.00 (0.00 to 30.85) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 9.03) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 9.52 (1.17 to 30.38) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.57) | 0.00 (0.00 to 6.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 12.34) | 0.00 (0.00 to 14.82) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 40.96) |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.66) | 0.00 (0.00 to 1.47) |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.98 (0.00 to 10.39) | 0.00 (0.00 to 97.50) |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.34) | 0.00 (0.00 to 24.71) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 5.78) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 10.89) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 23.16) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 1.25 (0.03 to 6.77) | 1.95 (0.53 to 4.92) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 37 | 3.76 (2.09 to 6.18) | 0.00 (0.00 to 70.76) | 0.66 (0.00 to 5.33) |
| 18 - 65 years, Week 38 | 3.60 (2.41 to 5.17) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 2.22) |
| 18 - 65 years, Week 39 | 4.45 (3.38 to 5.75) | 10.00 (0.11 to 50.09) | 0.00 (0.00 to 2.48) |
| 18 - 65 years, Week 40 | 3.10 (1.98 to 4.62) | 4.76 (0.10 to 24.55) | 0.00 (0.00 to 1.87) |
| 18 - 65 years, Week 41 | 1.57 (0.76 to 2.88) | 2.13 (0.26 to 7.48) | 0.00 (0.00 to 3.30) |
| 18 - 65 years, Week 42 | 2.82 (0.89 to 6.58) | 0.91 (0.02 to 4.96) | 0.00 (0.00 to 4.45) |
| 18 - 65 years, Week 43 | 0.45 (0.00 to 3.10) | 1.68 (0.20 to 5.94) | 0.00 (0.00 to 4.20) |
| 18 - 65 years, Week 44 | 1.92 (0.71 to 4.13) | 7.59 (2.84 to 15.80) | 0.00 (0.00 to 4.56) |
| 18 - 65 years, Week 45 | 1.79 (0.26 to 5.92) | 1.82 (0.00 to 93.05) | 1.20 (0.03 to 6.53) |
| 18 - 65 years, Week 46 | 1.35 (0.28 to 3.89) | 3.92 (0.03 to 24.66) | 0.00 (0.00 to 8.81) |
| 18 - 65 years, Week 47 | 0.68 (0.02 to 3.78) | 0.00 (0.00 to 9.03) | 0.00 (0.00 to 5.69) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 12.34) |
| >65 years, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.98) |
| >65 years, Week 37 | 4.15 (3.26 to 5.20) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 1.16) |
| >65 years, Week 38 | 3.04 (2.26 to 4.01) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.97) |
| >65 years, Week 39 | 2.73 (1.86 to 3.85) | 0.00 (0.00 to 40.96) | 0.59 (0.07 to 2.13) |
| >65 years, Week 40 | 2.53 (1.58 to 3.83) | 4.76 (0.58 to 16.16) | 0.00 (0.00 to 1.01) |
| >65 years, Week 41 | 2.26 (1.44 to 3.37) | 2.53 (0.31 to 8.85) | 0.00 (0.00 to 2.35) |
| >65 years, Week 42 | 0.91 (0.11 to 3.23) | 1.54 (0.04 to 8.28) | 0.00 (0.00 to 3.03) |
| >65 years, Week 43 | 3.28 (1.50 to 6.18) | 2.44 (0.00 to 92.92) | 0.00 (0.00 to 5.52) |
| >65 years, Week 44 | 1.86 (0.54 to 4.58) | 1.56 (0.00 to 64.84) | 0.00 (0.00 to 4.99) |
| >65 years, Week 45 | 1.35 (0.11 to 5.51) | 8.11 (0.32 to 34.78) | 0.00 (0.00 to 6.06) |
| >65 years, Week 46 | 0.88 (0.01 to 6.20) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 10.89) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 11.57) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 30.85) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-38 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 0.37 (0.01 to 2.05) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.25 (0.01 to 1.41) | 0.00 (0.00 to 5.78) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.17 (0.00 to 0.95) | 0.00 (0.00 to 4.56) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.14 (0.00 to 0.76) | 0.00 (0.00 to 4.30) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.21 (0.03 to 0.77) | 0.00 (0.00 to 1.58) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.19 (0.02 to 0.69) | 0.00 (0.00 to 1.57) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.16 (0.02 to 0.60) | 0.00 (0.00 to 1.51) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.15 (0.02 to 0.57) | 0.00 (0.00 to 1.30) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.15 (0.02 to 0.55) | 0.00 (0.00 to 1.28) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 4.76 (0.58 to 16.16) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 2.78 (0.31 to 10.01) | 0.00 (0.00 to 5.52) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 2.00 (0.24 to 7.04) | 0.00 (0.00 to 4.11) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 1.60 (0.19 to 5.66) | 0.00 (0.00 to 3.81) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.89 (0.06 to 3.76) | 0.00 (0.00 to 1.07) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.92 (0.02 to 4.97) | 0.00 (0.00 to 1.06) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.50 (0.01 to 2.97) | 0.00 (0.00 to 1.03) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.49 (0.01 to 2.90) | 0.00 (0.00 to 0.87) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.47 (0.01 to 2.83) | 0.00 (0.00 to 0.87) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 70.76) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 9.74) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 7.11) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.60 (0.02 to 3.31) | 1.57 (0.43 to 3.97) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.56 (0.01 to 3.09) | 1.56 (0.43 to 3.94) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.55 (0.01 to 3.01) | 1.53 (0.42 to 3.86) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.54 (0.01 to 2.99) | 1.53 (0.42 to 3.86) |
| 18 - 65 years, Week 35-36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 35-37 | 3.76 (2.09 to 6.18) | 0.00 (0.00 to 70.76) | 0.62 (0.00 to 5.00) |
| 18 - 65 years, Week 35-38 | 3.67 (2.38 to 5.40) | 0.00 (0.00 to 40.96) | 0.31 (0.00 to 2.44) |
| 18 - 65 years, Week 35-39 | 4.04 (3.08 to 5.19) | 5.88 (0.15 to 28.69) | 0.21 (0.00 to 1.62) |
| 18 - 65 years, Week 35-40 | 3.86 (3.01 to 4.85) | 5.00 (1.38 to 12.31) | 0.15 (0.00 to 1.15) |
| 18 - 65 years, Week 35-41 | 3.52 (2.67 to 4.55) | 3.45 (1.28 to 7.35) | 0.13 (0.00 to 0.97) |
| 18 - 65 years, Week 35-42 | 3.47 (2.65 to 4.46) | 2.46 (1.00 to 5.01) | 0.12 (0.00 to 0.89) |
| 18 - 65 years, Week 35-43 | 3.34 (2.51 to 4.35) | 2.23 (1.03 to 4.20) | 0.11 (0.00 to 0.80) |
| 18 - 65 years, Week 35-44 | 3.25 (2.43 to 4.25) | 3.11 (1.75 to 5.08) | 0.10 (0.00 to 0.73) |
| 18 - 65 years, Week 35-45 | 3.19 (2.42 to 4.12) | 2.98 (1.71 to 4.79) | 0.18 (0.00 to 1.28) |
| 18 - 65 years, Week 35-46 | 3.12 (2.34 to 4.07) | 3.06 (1.82 to 4.80) | 0.17 (0.00 to 1.24) |
| 18 - 65 years, Week 35-47 | 3.06 (2.29 to 3.99) | 2.87 (1.71 to 4.50) | 0.17 (0.00 to 1.17) |
| 18 - 65 years, Week 35-48 | 3.01 (2.25 to 3.94) | 2.74 (1.63 to 4.30) | 0.16 (0.00 to 1.14) |
| >65 years, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.85) |
| >65 years, Week 35-37 | 4.15 (3.26 to 5.19) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 0.99) |
| >65 years, Week 35-38 | 3.57 (2.89 to 4.37) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 0.49) |
| >65 years, Week 35-39 | 3.22 (2.42 to 4.19) | 0.00 (0.00 to 20.59) | 0.18 (0.02 to 0.67) |
| >65 years, Week 35-40 | 3.10 (2.31 to 4.05) | 3.45 (0.42 to 11.91) | 0.14 (0.02 to 0.50) |
| >65 years, Week 35-41 | 3.00 (2.27 to 3.88) | 2.92 (0.80 to 7.31) | 0.12 (0.02 to 0.45) |
| >65 years, Week 35-42 | 2.87 (2.13 to 3.78) | 2.48 (0.81 to 5.68) | 0.12 (0.01 to 0.42) |
| >65 years, Week 35-43 | 2.89 (2.13 to 3.81) | 2.46 (1.00 to 5.01) | 0.11 (0.01 to 0.40) |
| >65 years, Week 35-44 | 2.84 (2.10 to 3.75) | 2.30 (0.97 to 4.55) | 0.11 (0.01 to 0.39) |
| >65 years, Week 35-45 | 2.81 (2.07 to 3.71) | 2.86 (1.43 to 5.05) | 0.10 (0.01 to 0.38) |
| >65 years, Week 35-46 | 2.79 (2.04 to 3.71) | 2.61 (1.31 to 4.62) | 0.10 (0.01 to 0.37) |
| >65 years, Week 35-47 | 2.76 (2.01 to 3.68) | 2.45 (1.23 to 4.34) | 0.10 (0.01 to 0.36) |
| >65 years, Week 35-48 | 2.74 (2.00 to 3.67) | 2.34 (1.17 to 4.14) | 0.10 (0.01 to 0.36) |
AEIs reported are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and \>65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhea, and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator = the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator = the number of subjects from the denominator who reported any AEIs in EHR (routine data collection + card-based ADR reporting system) within 7 days following vaccination with seasonal influenza vaccine Vaccination happened between weeks 35 and 48, of 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 1.59 (0.04 to 8.53) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 3.38 (1.37 to 6.84) | 0.00 (0.00 to 23.16) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 3.25 (0.68 to 9.19) | 0.00 (0.00 to 7.71) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 1.04 (0.07 to 4.40) | 5.88 (0.00 to 69.40) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.70 (0.00 to 5.22) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 2.45 (0.08 to 12.11) | 0.00 (0.00 to 2.48) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 50.00 (1.26 to 98.74) | 0.00 (0.00 to 1.80) | 0.00 (0.00 to 30.85) |
| 6 months to 5 years, Week 47 | — | 1.39 (0.04 to 7.50) | 0.00 (0.00 to 9.03) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 40 | 33.33 (0.00 to 100) | 14.29 (3.05 to 36.34) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 41 | 50.00 (1.26 to 98.74) | 0.00 (0.00 to 11.57) | 0.00 (0.00 to 6.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 12.34) | 0.00 (0.00 to 14.82) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 40.96) |
| 6 - 12 years, Week 44 | 16.67 (0.02 to 81.43) | 2.02 (0.16 to 8.11) | 0.40 (0.01 to 2.22) |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.55) | 0.00 (0.00 to 97.50) |
| 6 - 12 years, Week 46 | 20.00 (0.02 to 88.39) | 0.36 (0.01 to 2.02) | 0.00 (0.00 to 24.71) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 1.61 (0.00 to 29.53) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 7.14 (0.02 to 44.90) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 11.11 (0.19 to 51.19) | 50.00 (1.26 to 98.74) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 5.88 (0.02 to 38.78) | 0.00 (0.00 to 10.89) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 23.16) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 1.25 (0.03 to 6.77) | 1.95 (0.53 to 4.92) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 37 | 6.54 (4.34 to 9.38) | 0.00 (0.00 to 70.76) | 1.32 (0.12 to 5.14) |
| 18 - 65 years, Week 38 | 4.53 (2.66 to 7.17) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 2.22) |
| 18 - 65 years, Week 39 | 5.72 (4.51 to 7.15) | 0.00 (0.00 to 30.85) | 0.68 (0.00 to 4.80) |
| 18 - 65 years, Week 40 | 3.78 (2.49 to 5.47) | 1.59 (0.04 to 8.63) | 1.03 (0.12 to 3.66) |
| 18 - 65 years, Week 41 | 4.25 (2.70 to 6.33) | 4.26 (1.17 to 10.54) | 0.91 (0.02 to 5.16) |
| 18 - 65 years, Week 42 | 2.25 (0.95 to 4.48) | 0.00 (0.00 to 3.30) | 3.70 (0.50 to 12.30) |
| 18 - 65 years, Week 43 | 1.81 (0.29 to 5.76) | 6.72 (2.81 to 13.18) | 0.00 (0.00 to 4.20) |
| 18 - 65 years, Week 44 | 2.56 (0.98 to 5.37) | 6.33 (2.09 to 14.16) | 1.27 (0.03 to 7.12) |
| 18 - 65 years, Week 45 | 2.68 (0.66 to 7.09) | 1.82 (0.00 to 93.05) | 4.82 (1.32 to 11.92) |
| 18 - 65 years, Week 46 | 2.24 (0.43 to 6.60) | 5.88 (0.04 to 35.34) | 0.00 (0.00 to 8.81) |
| 18 - 65 years, Week 47 | 4.11 (0.70 to 12.51) | 0.00 (0.00 to 9.03) | 1.59 (0.01 to 11.07) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 6.90 (0.00 to 53.09) | 0.00 (0.00 to 12.34) |
| >65 years, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 1.96 (0.00 to 18.80) |
| >65 years, Week 37 | 6.46 (4.99 to 8.19) | 0.00 (0.00 to 84.19) | 0.32 (0.01 to 1.76) |
| >65 years, Week 38 | 5.07 (3.95 to 6.39) | 16.67 (0.00 to 91.51) | 0.80 (0.05 to 3.59) |
| >65 years, Week 39 | 4.60 (3.57 to 5.83) | 0.00 (0.00 to 40.96) | 1.48 (0.27 to 4.53) |
| >65 years, Week 40 | 6.14 (3.57 to 9.75) | 4.76 (0.58 to 16.16) | 0.82 (0.13 to 2.66) |
| >65 years, Week 41 | 4.91 (3.32 to 6.96) | 5.06 (1.40 to 12.46) | 0.00 (0.00 to 2.35) |
| >65 years, Week 42 | 2.74 (1.09 to 5.62) | 1.54 (0.04 to 8.28) | 0.00 (0.00 to 3.03) |
| >65 years, Week 43 | 3.65 (1.37 to 7.71) | 2.44 (0.00 to 92.92) | 0.00 (0.00 to 5.52) |
| >65 years, Week 44 | 3.26 (0.66 to 9.32) | 7.81 (0.28 to 34.30) | 0.00 (0.00 to 4.99) |
| >65 years, Week 45 | 1.80 (0.29 to 5.74) | 8.11 (0.00 to 99.99) | 0.00 (0.00 to 6.06) |
| >65 years, Week 46 | 2.63 (0.50 to 7.81) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 10.89) |
| >65 years, Week 47 | 0.94 (0.01 to 5.69) | 3.70 (0.00 to 99.88) | 3.33 (0.08 to 17.37) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 30.85) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and \>65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhea, and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection + ADR) within 7 days following vaccination with seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48, 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-38 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 1.59 (0.04 to 8.53) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 2.96 (1.29 to 5.75) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 3.05 (1.58 to 5.28) | 0.00 (0.00 to 5.78) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 2.39 (1.23 to 4.17) | 1.27 (0.00 to 13.35) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 2.06 (0.98 to 3.79) | 1.19 (0.00 to 12.33) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 2.15 (0.91 to 4.23) | 0.43 (0.00 to 4.99) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 1.89 (0.76 to 3.85) | 0.43 (0.00 to 4.96) |
| 6 months to 5 years, Week 35-46 | 10.00 (0.14 to 48.28) | 1.58 (0.58 to 3.43) | 0.41 (0.00 to 4.74) |
| 6 months to 5 years, Week 35-47 | 10.00 (0.14 to 48.28) | 1.57 (0.62 to 3.25) | 0.35 (0.00 to 4.00) |
| 6 months to 5 years, Week 35-48 | 10.00 (0.14 to 48.28) | 1.54 (0.61 to 3.18) | 0.35 (0.00 to 3.96) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 35-40 | 3.70 (0.00 to 39.49) | 7.14 (0.82 to 24.02) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 35-41 | 6.90 (0.06 to 39.08) | 4.17 (0.33 to 16.27) | 0.00 (0.00 to 5.52) |
| 6 - 12 years, Week 35-42 | 5.88 (0.15 to 28.66) | 3.00 (0.28 to 11.33) | 0.00 (0.00 to 4.11) |
| 6 - 12 years, Week 35-43 | 5.71 (0.17 to 27.21) | 2.40 (0.19 to 9.55) | 0.00 (0.00 to 3.81) |
| 6 - 12 years, Week 35-44 | 7.32 (0.36 to 30.38) | 2.23 (0.34 to 7.26) | 0.29 (0.01 to 1.61) |
| 6 - 12 years, Week 35-45 | 7.14 (0.32 to 30.34) | 1.53 (0.12 to 6.28) | 0.29 (0.01 to 1.60) |
| 6 - 12 years, Week 35-46 | 8.51 (1.98 to 21.99) | 1.00 (0.12 to 3.53) | 0.28 (0.01 to 1.55) |
| 6 - 12 years, Week 35-47 | 8.51 (1.98 to 21.99) | 0.98 (0.12 to 3.44) | 0.48 (0.06 to 1.71) |
| 6 - 12 years, Week 35-48 | 8.33 (2.04 to 21.11) | 0.95 (0.11 to 3.40) | 0.48 (0.06 to 1.71) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 2.63 (0.01 to 18.97) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 2.22 (0.02 to 14.79) | 7.14 (0.04 to 41.49) | 33.33 (0.00 to 99.94) |
| 13 - 17 years, Week 35-41 | 1.82 (0.01 to 12.25) | 6.45 (0.34 to 26.78) | 2.86 (0.07 to 14.92) |
| 13 - 17 years, Week 35-42 | 1.69 (0.02 to 10.77) | 4.17 (0.48 to 14.52) | 2.86 (0.07 to 14.92) |
| 13 - 17 years, Week 35-43 | 1.64 (0.02 to 10.46) | 3.28 (0.33 to 12.04) | 2.78 (0.07 to 14.53) |
| 13 - 17 years, Week 35-44 | 1.61 (0.02 to 10.31) | 2.33 (0.22 to 8.82) | 2.00 (0.05 to 10.65) |
| 13 - 17 years, Week 35-45 | 1.43 (0.02 to 9.07) | 1.81 (0.37 to 5.19) | 1.96 (0.64 to 4.52) |
| 13 - 17 years, Week 35-46 | 1.32 (0.01 to 8.53) | 1.69 (0.35 to 4.85) | 1.95 (0.63 to 4.48) |
| 13 - 17 years, Week 35-47 | 1.22 (0.01 to 8.11) | 1.64 (0.34 to 4.72) | 1.91 (0.62 to 4.40) |
| 13 - 17 years, Week 35-48 | 1.16 (0.01 to 7.70) | 1.63 (0.34 to 4.69) | 1.91 (0.62 to 4.40) |
| 18 - 65 years, Week 35-36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 35-37 | 6.54 (6.54 to 6.54) | 0.00 (0.00 to 70.76) | 1.23 (0.11 to 4.82) |
| 18 - 65 years, Week 35-38 | 5.45 (3.66 to 7.76) | 0.00 (0.00 to 40.96) | 0.61 (0.07 to 2.20) |
| 18 - 65 years, Week 35-39 | 5.58 (4.62 to 6.66) | 0.00 (0.00 to 19.51) | 0.63 (0.13 to 1.84) |
| 18 - 65 years, Week 35-40 | 5.22 (4.42 to 6.12) | 1.25 (0.03 to 6.77) | 0.75 (0.22 to 1.83) |
| 18 - 65 years, Week 35-41 | 5.08 (4.40 to 5.83) | 2.87 (0.94 to 6.58) | 0.77 (0.26 to 1.76) |
| 18 - 65 years, Week 35-42 | 4.87 (4.12 to 5.71) | 1.76 (0.57 to 4.06) | 1.05 (0.48 to 1.99) |
| 18 - 65 years, Week 35-43 | 4.73 (4.00 to 5.55) | 3.23 (1.43 to 6.19) | 0.95 (0.44 to 1.80) |
| 18 - 65 years, Week 35-44 | 4.60 (3.87 to 5.43) | 3.73 (1.60 to 7.30) | 0.98 (0.40 to 1.97) |
| 18 - 65 years, Week 35-45 | 4.52 (3.84 to 5.29) | 3.54 (1.54 to 6.85) | 1.26 (0.39 to 3.02) |
| 18 - 65 years, Week 35-46 | 4.43 (3.81 to 5.13) | 3.74 (2.33 to 5.67) | 1.22 (0.38 to 2.90) |
| 18 - 65 years, Week 35-47 | 4.43 (3.79 to 5.13) | 3.51 (2.21 to 5.26) | 1.24 (0.42 to 2.80) |
| 18 - 65 years, Week 35-48 | 4.36 (3.73 to 5.06) | 3.66 (2.31 to 5.48) | 1.21 (0.42 to 2.72) |
| >65 years, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 1.92 (0.00 to 17.19) |
| >65 years, Week 35-37 | 6.45 (4.99 to 8.19) | 0.00 (0.00 to 70.76) | 0.54 (0.07 to 1.94) |
| >65 years, Week 35-38 | 5.74 (4.95 to 6.61) | 11.11 (0.03 to 62.14) | 0.67 (0.10 to 2.22) |
| >65 years, Week 35-39 | 5.25 (4.38 to 6.23) | 6.25 (0.16 to 30.23) | 0.92 (0.15 to 2.98) |
| >65 years, Week 35-40 | 5.40 (4.33 to 6.66) | 5.17 (1.08 to 14.38) | 0.90 (0.16 to 2.77) |
| >65 years, Week 35-41 | 5.35 (4.25 to 6.63) | 5.11 (2.08 to 10.24) | 0.81 (0.14 to 2.52) |
| >65 years, Week 35-42 | 5.19 (4.07 to 6.51) | 3.96 (1.73 to 7.65) | 0.75 (0.13 to 2.36) |
| >65 years, Week 35-43 | 5.15 (4.02 to 6.47) | 3.52 (1.70 to 6.38) | 0.73 (0.13 to 2.28) |
| >65 years, Week 35-44 | 5.06 (3.96 to 6.37) | 4.31 (2.43 to 7.01) | 0.70 (0.12 to 2.19) |
| >65 years, Week 35-45 | 4.99 (3.89 to 6.29) | 4.68 (2.79 to 7.29) | 0.68 (0.12 to 2.12) |
| >65 years, Week 35-46 | 4.97 (3.85 to 6.28) | 4.27 (2.55 to 6.66) | 0.67 (0.12 to 2.09) |
| >65 years, Week 35-47 | 4.92 (3.81 to 6.24) | 4.23 (2.57 to 6.53) | 0.71 (0.16 to 1.97) |
| >65 years, Week 35-48 | 4.90 (3.79 to 6.22) | 4.03 (2.45 to 6.23) | 0.70 (0.16 to 1.96) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 month to 5 years, Week 37 | — | — | 0.00 (0.00 to 97.50) |
| 6 month to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 month to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.97 (0.12 to 3.45) | 0.00 (0.00 to 23.16) |
| 6 month to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 7.71) |
| 6 month to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.90) | 0.00 (0.00 to 19.51) |
| 6 month to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 20.00 (0.00 to 96.43) |
| 6 month to 5 years, Week 44 | — | 0.00 (0.00 to 1.79) | 0.00 (0.00 to 2.48) |
| 6 month to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 month to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.49 (0.00 to 3.54) | 0.00 (0.00 to 30.85) |
| 6 month to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 9.03) |
| 6 month to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.57) | 0.00 (0.00 to 6.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 12.34) | 0.00 (0.00 to 14.82) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 40.96) |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.66) | 0.00 (0.00 to 1.47) |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.98 (0.00 to 10.39) | 0.00 (0.00 to 97.50) |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.34) | 0.00 (0.00 to 24.71) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 5.78) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 10.89) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 23.16) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 1.25 (0.03 to 6.77) | 1.46 (0.30 to 4.22) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 37 | 1.95 (0.56 to 4.80) | 0.00 (0.00 to 70.76) | 0.66 (0.00 to 5.33) |
| 18 - 65 years, Week 38 | 1.98 (0.89 to 3.76) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 2.22) |
| 18 - 65 years, Week 39 | 1.98 (0.91 to 3.72) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 2.48) |
| 18 - 65 years, Week 40 | 1.62 (0.46 to 4.04) | 3.17 (0.07 to 16.81) | 0.00 (0.00 to 1.87) |
| 18 - 65 years, Week 41 | 1.10 (0.44 to 2.26) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 3.30) |
| 18 - 65 years, Week 42 | 1.41 (0.30 to 4.02) | 0.00 (0.00 to 3.30) | 0.00 (0.00 to 4.45) |
| 18 - 65 years, Week 43 | 0.45 (0.01 to 2.91) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 4.20) |
| 18 - 65 years, Week 44 | 0.64 (0.03 to 3.11) | 1.27 (0.03 to 6.85) | 0.00 (0.00 to 4.56) |
| 18 - 65 years, Week 45 | 1.34 (0.11 to 5.42) | 1.82 (0.00 to 93.05) | 0.00 (0.00 to 4.35) |
| 18 - 65 years, Week 46 | 0.00 (0.00 to 1.64) | 0.00 (0.00 to 6.98) | 0.00 (0.00 to 8.81) |
| 18 - 65 years, Week 47 | 0.00 (0.00 to 2.49) | 0.00 (0.00 to 9.03) | 0.00 (0.00 to 5.69) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 12.34) |
| >65 years, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.98) |
| >65 years, Week 37 | 2.19 (1.07 to 3.94) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 1.16) |
| >65 years, Week 38 | 1.76 (1.14 to 2.60) | 16.67 (0.00 to 91.51) | 0.00 (0.00 to 0.97) |
| >65 years, Week 39 | 1.27 (0.88 to 1.77) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 1.09) |
| >65 years, Week 40 | 1.38 (0.73 to 2.37) | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.01) |
| >65 years, Week 41 | 1.38 (0.56 to 2.81) | 2.53 (0.31 to 8.85) | 0.00 (0.00 to 2.35) |
| >65 years, Week 42 | 0.91 (0.24 to 2.35) | 0.00 (0.00 to 5.52) | 0.00 (0.00 to 3.03) |
| >65 years, Week 43 | 1.09 (0.21 to 3.24) | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 5.52) |
| >65 years, Week 44 | 0.70 (0.11 to 2.27) | 1.56 (0.00 to 64.84) | 0.00 (0.00 to 4.99) |
| >65 years, Week 45 | 2.70 (0.54 to 7.83) | 2.70 (0.00 to 93.12) | 0.00 (0.00 to 6.06) |
| >65 years, Week 46 | 4.39 (0.58 to 14.55) | 0.00 (0.00 to 9.49) | 3.13 (0.08 to 16.22) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 11.57) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 30.85) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea and vomiting. The cumulative incidence rates of AEIs expressed as a cumulative percentage of subjects, were estimated as follows: The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system); The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine. Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-38 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 0.74 (0.09 to 2.65) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.51 (0.04 to 2.11) | 0.00 (0.00 to 5.78) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.34 (0.02 to 1.63) | 0.00 (0.00 to 4.56) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.27 (0.01 to 1.45) | 1.19 (0.00 to 11.17) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.21 (0.00 to 1.24) | 0.43 (0.01 to 2.39) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.19 (0.00 to 1.12) | 0.43 (0.01 to 2.37) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.24 (0.03 to 0.87) | 0.41 (0.01 to 2.27) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.22 (0.03 to 0.83) | 0.35 (0.01 to 1.96) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.22 (0.02 to 0.82) | 0.35 (0.01 to 1.93) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 5.52) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 4.11) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 2.91) | 0.00 (0.00 to 3.81) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 1.63) | 0.00 (0.00 to 1.07) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.31 (0.00 to 2.50) | 0.00 (0.00 to 1.06) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.17 (0.00 to 1.44) | 0.00 (0.00 to 1.03) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.16 (0.00 to 1.40) | 0.00 (0.00 to 0.87) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.16 (0.00 to 1.37) | 0.00 (0.00 to 0.87) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 70.76) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 9.74) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 7.11) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.60 (0.02 to 3.31) | 1.18 (0.24 to 3.40) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.56 (0.01 to 3.09) | 1.17 (0.24 to 3.37) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.55 (0.01 to 3.01) | 1.15 (0.24 to 3.31) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.54 (0.01 to 2.99) | 1.15 (0.24 to 3.31) |
| 18 - 65 years, Week 35-36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 35-37 | 1.95 (0.56 to 4.80) | 0.00 (0.00 to 70.76) | 0.62 (0.00 to 5.00) |
| 18 - 65 years, Week 35-38 | 1.96 (0.76 to 4.10) | 0.00 (0.00 to 40.96) | 0.31 (0.00 to 2.44) |
| 18 - 65 years, Week 35-39 | 1.97 (1.01 to 3.45) | 0.00 (0.00 to 19.51) | 0.21 (0.00 to 1.62) |
| 18 - 65 years, Week 35-40 | 1.90 (1.14 to 2.97) | 2.50 (0.30 to 8.74) | 0.15 (0.00 to 1.15) |
| 18 - 65 years, Week 35-41 | 1.78 (1.09 to 2.76) | 1.15 (0.14 to 4.09) | 0.13 (0.00 to 0.97) |
| 18 - 65 years, Week 35-42 | 1.76 (1.09 to 2.68) | 0.70 (0.09 to 2.52) | 0.12 (0.00 to 0.89) |
| 18 - 65 years, Week 35-43 | 1.70 (1.04 to 2.61) | 0.50 (0.06 to 1.78) | 0.11 (0.00 to 0.80) |
| 18 - 65 years, Week 35-44 | 1.64 (0.99 to 2.53) | 0.62 (0.13 to 1.81) | 0.10 (0.00 to 0.73) |
| 18 - 65 years, Week 35-45 | 1.62 (1.00 to 2.48) | 0.74 (0.20 to 1.90) | 0.09 (0.00 to 0.64) |
| 18 - 65 years, Week 35-46 | 1.56 (0.96 to 2.40) | 0.68 (0.19 to 1.73) | 0.09 (0.00 to 0.62) |
| 18 - 65 years, Week 35-47 | 1.52 (0.93 to 2.34) | 0.64 (0.17 to 1.63) | 0.08 (0.00 to 0.59) |
| 18 - 65 years, Week 35-48 | 1.50 (0.92 to 2.30) | 0.61 (0.17 to 1.55) | 0.08 (0.00 to 0.57) |
| >65 years, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.85) |
| >65 years, Week 35-37 | 2.19 (1.07 to 3.94) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 0.99) |
| >65 years, Week 35-38 | 1.97 (1.53 to 2.49) | 11.11 (0.03 to 62.14) | 0.00 (0.00 to 0.49) |
| >65 years, Week 35-39 | 1.67 (1.29 to 2.12) | 6.25 (0.16 to 30.23) | 0.00 (0.00 to 0.34) |
| >65 years, Week 35-40 | 1.62 (1.28 to 2.03) | 1.72 (0.04 to 9.24) | 0.00 (0.00 to 0.25) |
| >65 years, Week 35-41 | 1.59 (1.24 to 2.01) | 2.19 (0.45 to 6.27) | 0.00 (0.00 to 0.23) |
| >65 years, Week 35-42 | 1.55 (1.22 to 1.94) | 1.49 (0.31 to 4.28) | 0.00 (0.00 to 0.21) |
| >65 years, Week 35-43 | 1.54 (1.21 to 1.93) | 1.06 (0.22 to 3.06) | 0.00 (0.00 to 0.21) |
| >65 years, Week 35-44 | 1.50 (1.20 to 1.86) | 1.15 (0.31 to 2.92) | 0.00 (0.00 to 0.20) |
| >65 years, Week 35-45 | 1.53 (1.23 to 1.88) | 1.30 (0.42 to 3.00) | 0.00 (0.00 to 0.19) |
| >65 years, Week 35-46 | 1.56 (1.24 to 1.93) | 1.18 (0.39 to 2.74) | 0.05 (0.00 to 0.38) |
| >65 years, Week 35-47 | 1.54 (1.23 to 1.91) | 1.11 (0.36 to 2.58) | 0.05 (0.00 to 0.37) |
| >65 years, Week 35-48 | 1.54 (1.22 to 1.90) | 1.06 (0.35 to 2.46) | 0.05 (0.00 to 0.37) |
AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 1.77) | 0.00 (0.00 to 23.16) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 7.71) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.52 (0.01 to 3.43) | 0.00 (0.00 to 19.51) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.00 (0.00 to 1.79) | 0.00 (0.00 to 2.48) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 1.80) | 0.00 (0.00 to 30.85) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 9.03) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.57) | 0.00 (0.00 to 6.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 12.34) | 0.00 (0.00 to 14.82) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 40.96) |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.66) | 0.00 (0.00 to 1.47) |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.55) | 0.00 (0.00 to 97.50) |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.34) | 0.00 (0.00 to 24.71) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 5.78) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 10.89) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 23.16) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 0.00 (0.00 to 1.78) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 37 | 0.70 (0.04 to 3.03) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 2.40) |
| 18 - 65 years, Week 38 | 0.81 (0.06 to 3.39) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 2.22) |
| 18 - 65 years, Week 39 | 0.78 (0.08 to 2.91) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 2.48) |
| 18 - 65 years, Week 40 | 0.27 (0.03 to 0.97) | 3.17 (0.07 to 16.81) | 0.00 (0.00 to 1.87) |
| 18 - 65 years, Week 41 | 0.31 (0.01 to 1.85) | 1.06 (0.03 to 5.79) | 0.00 (0.00 to 3.30) |
| 18 - 65 years, Week 42 | 0.00 (0.00 to 1.03) | 0.00 (0.00 to 3.30) | 0.00 (0.00 to 4.45) |
| 18 - 65 years, Week 43 | 0.00 (0.00 to 1.66) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 4.20) |
| 18 - 65 years, Week 44 | 0.00 (0.00 to 1.17) | 3.80 (0.62 to 11.76) | 0.00 (0.00 to 4.56) |
| 18 - 65 years, Week 45 | 0.45 (0.00 to 3.33) | 0.00 (0.00 to 6.49) | 1.20 (0.03 to 6.53) |
| 18 - 65 years, Week 46 | 0.45 (0.00 to 3.36) | 0.00 (0.00 to 6.98) | 0.00 (0.00 to 8.81) |
| 18 - 65 years, Week 47 | 0.00 (0.00 to 2.49) | 0.00 (0.00 to 9.03) | 0.00 (0.00 to 5.69) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 12.34) |
| >65 years, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.98) |
| >65 years, Week 37 | 0.69 (0.01 to 4.78) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 1.16) |
| >65 years, Week 38 | 0.48 (0.08 to 1.56) | 0.00 (0.00 to 45.93) | 0.27 (0.01 to 1.51) |
| >65 years, Week 39 | 0.22 (0.02 to 0.96) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 1.09) |
| >65 years, Week 40 | 0.54 (0.02 to 2.62) | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.01) |
| >65 years, Week 41 | 0.20 (0.01 to 0.93) | 2.53 (0.31 to 8.85) | 0.00 (0.00 to 2.35) |
| >65 years, Week 42 | 0.00 (0.00 to 0.67) | 0.00 (0.00 to 5.52) | 0.00 (0.00 to 3.03) |
| >65 years, Week 43 | 0.36 (0.00 to 2.55) | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 5.52) |
| >65 years, Week 44 | 0.47 (0.02 to 2.39) | 0.00 (0.00 to 5.60) | 0.00 (0.00 to 4.99) |
| >65 years, Week 45 | 0.00 (0.00 to 1.65) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 6.06) |
| >65 years, Week 46 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 10.89) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 11.57) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 30.85) |
AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48 of 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-38 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.93) | 0.00 (0.00 to 5.78) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.17 (0.00 to 1.26) | 0.00 (0.00 to 4.56) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.14 (0.00 to 1.01) | 0.00 (0.00 to 4.30) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.11 (0.00 to 0.77) | 0.00 (0.00 to 1.58) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.09 (0.00 to 0.68) | 0.00 (0.00 to 1.57) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.08 (0.00 to 0.58) | 0.00 (0.00 to 1.51) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.07 (0.00 to 0.56) | 0.00 (0.00 to 1.30) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.07 (0.00 to 0.54) | 0.00 (0.00 to 1.28) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 5.52) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 4.11) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 2.91) | 0.00 (0.00 to 3.81) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 1.63) | 0.00 (0.00 to 1.07) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 1.06) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.61) | 0.00 (0.00 to 1.03) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.60) | 0.00 (0.00 to 0.87) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 0.58) | 0.00 (0.00 to 0.87) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 70.76) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 9.74) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 7.11) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 2.20) | 0.00 (0.00 to 1.44) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.00 (0.00 to 2.05) | 0.00 (0.00 to 1.43) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 2.00) | 0.00 (0.00 to 1.40) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 1.98) | 0.00 (0.00 to 1.40) |
| 18 - 65 years, Week 35-36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 35-37 | 0.70 (0.04 to 3.03) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 2.25) |
| 18 - 65 years, Week 35-38 | 0.76 (0.06 to 3.10) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 1.13) |
| 18 - 65 years, Week 35-39 | 0.77 (0.08 to 2.90) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 0.78) |
| 18 - 65 years, Week 35-40 | 0.67 (0.08 to 2.42) | 2.50 (0.30 to 8.74) | 0.00 (0.00 to 0.55) |
| 18 - 65 years, Week 35-41 | 0.62 (0.08 to 2.13) | 1.72 (0.36 to 4.96) | 0.00 (0.00 to 0.47) |
| 18 - 65 years, Week 35-42 | 0.57 (0.07 to 2.02) | 1.06 (0.22 to 3.06) | 0.00 (0.00 to 0.43) |
| 18 - 65 years, Week 35-43 | 0.55 (0.07 to 1.95) | 0.74 (0.15 to 2.16) | 0.00 (0.00 to 0.39) |
| 18 - 65 years, Week 35-44 | 0.51 (0.06 to 1.87) | 1.24 (0.46 to 2.69) | 0.00 (0.00 to 0.36) |
| 18 - 65 years, Week 35-45 | 0.51 (0.07 to 1.79) | 1.12 (0.41 to 2.42) | 0.09 (0.00 to 0.64) |
| 18 - 65 years, Week 35-46 | 0.51 (0.06 to 1.83) | 1.02 (0.38 to 2.21) | 0.09 (0.00 to 0.62) |
| 18 - 65 years, Week 35-47 | 0.50 (0.06 to 1.78) | 0.96 (0.35 to 2.07) | 0.08 (0.00 to 0.59) |
| 18 - 65 years, Week 35-48 | 0.49 (0.06 to 1.76) | 0.91 (0.34 to 1.98) | 0.08 (0.00 to 0.57) |
| >65 years, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.85) |
| >65 years, Week 35-37 | 0.69 (0.01 to 4.77) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 0.99) |
| >65 years, Week 35-38 | 0.58 (0.03 to 2.80) | 0.00 (0.00 to 33.63) | 0.13 (0.00 to 0.74) |
| >65 years, Week 35-39 | 0.43 (0.02 to 2.00) | 2.00 (0.00 to 20.59) | 0.09 (0.00 to 0.52) |
| >65 years, Week 35-40 | 0.45 (0.02 to 2.08) | 0.00 (0.00 to 6.16) | 0.07 (0.00 to 0.41) |
| >65 years, Week 35-41 | 0.42 (0.03 to 1.85) | 1.46 (0.18 to 5.17) | 0.06 (0.00 to 0.37) |
| >65 years, Week 35-42 | 0.39 (0.02 to 1.77) | 0.99 (0.12 to 3.53) | 0.06 (0.00 to 0.34) |
| >65 years, Week 35-43 | 0.39 (0.03 to 1.71) | 0.70 (0.09 to 2.52) | 0.06 (0.00 to 0.33) |
| >65 years, Week 35-44 | 0.40 (0.03 to 1.62) | 0.57 (0.07 to 2.06) | 0.05 (0.00 to 0.32) |
| >65 years, Week 35-45 | 0.39 (0.03 to 1.59) | 0.52 (0.06 to 1.86) | 0.05 (0.00 to 0.31) |
| >65 years, Week 35-46 | 0.38 (0.03 to 1.57) | 0.47 (0.06 to 1.70) | 0.05 (0.00 to 0.31) |
| >65 years, Week 35-47 | 0.38 (0.03 to 1.57) | 0.45 (0.05 to 1.60) | 0.05 (0.00 to 0.30) |
| >65 years, Week 35-48 | 0.38 (0.03 to 1.57) | 0.42 (0.05 to 1.53) | 0.05 (0.00 to 0.30) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.48 (0.01 to 2.66) | 0.00 (0.00 to 23.16) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.81 (0.01 to 5.15) | 0.00 (0.00 to 7.71) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.90) | 0.00 (0.00 to 19.51) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 1.40 (0.17 to 4.96) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.49 (0.01 to 2.70) | 0.00 (0.00 to 2.48) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 1.80) | 0.00 (0.00 to 30.85) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 9.03) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.57) | 0.00 (0.00 to 6.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 12.34) | 0.00 (0.00 to 14.82) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 40.96) |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.66) | 0.00 (0.00 to 1.47) |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.55) | 0.00 (0.00 to 97.50) |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.34) | 0.00 (0.00 to 24.71) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 5.78) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 10.89) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 23.16) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 0.00 (0.00 to 1.78) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 37 | 0.97 (0.30 to 2.34) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 2.40) |
| 18 - 65 years, Week 38 | 0.93 (0.16 to 2.88) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 2.22) |
| 18 - 65 years, Week 39 | 0.57 (0.24 to 1.11) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 2.48) |
| 18 - 65 years, Week 40 | 0.67 (0.22 to 1.57) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 1.87) |
| 18 - 65 years, Week 41 | 0.00 (0.00 to 0.58) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 3.30) |
| 18 - 65 years, Week 42 | 0.00 (0.00 to 1.03) | 0.00 (0.00 to 3.30) | 0.00 (0.00 to 4.45) |
| 18 - 65 years, Week 43 | 0.90 (0.08 to 3.62) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 4.20) |
| 18 - 65 years, Week 44 | 0.64 (0.06 to 2.51) | 0.00 (0.00 to 4.56) | 0.00 (0.00 to 4.56) |
| 18 - 65 years, Week 45 | 0.00 (0.00 to 1.63) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 4.35) |
| 18 - 65 years, Week 46 | 0.90 (0.07 to 3.65) | 0.00 (0.00 to 6.98) | 0.00 (0.00 to 8.81) |
| 18 - 65 years, Week 47 | 0.00 (0.00 to 2.49) | 2.56 (0.06 to 13.48) | 0.00 (0.00 to 5.69) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 12.34) |
| >65 years, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.98) |
| >65 years, Week 37 | 0.69 (0.36 to 1.21) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 1.16) |
| >65 years, Week 38 | 0.37 (0.15 to 0.77) | 0.00 (0.00 to 45.93) | 0.53 (0.05 to 2.02) |
| >65 years, Week 39 | 0.26 (0.10 to 0.55) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 1.09) |
| >65 years, Week 40 | 0.54 (0.22 to 1.10) | 0.00 (0.00 to 8.41) | 0.27 (0.01 to 1.52) |
| >65 years, Week 41 | 0.20 (0.02 to 0.71) | 1.27 (0.03 to 6.85) | 0.00 (0.00 to 2.35) |
| >65 years, Week 42 | 0.18 (0.00 to 1.30) | 0.00 (0.00 to 5.52) | 0.00 (0.00 to 3.03) |
| >65 years, Week 43 | 0.36 (0.00 to 2.68) | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 5.52) |
| >65 years, Week 44 | 0.47 (0.06 to 1.67) | 0.00 (0.00 to 5.60) | 0.00 (0.00 to 4.99) |
| >65 years, Week 45 | 0.45 (0.00 to 2.99) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 6.06) |
| >65 years, Week 46 | 0.00 (0.00 to 3.18) | 2.70 (0.00 to 82.29) | 0.00 (0.00 to 10.89) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 11.57) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 4.55 (0.00 to 99.99) | 0.00 (0.00 to 30.85) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-38 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 0.37 (0.01 to 2.05) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.51 (0.06 to 1.83) | 0.00 (0.00 to 5.78) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.34 (0.04 to 1.23) | 0.00 (0.00 to 4.56) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.55 (0.15 to 1.40) | 0.00 (0.00 to 4.30) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.54 (0.17 to 1.25) | 0.00 (0.00 to 1.58) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.47 (0.15 to 1.10) | 0.00 (0.00 to 1.57) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.40 (0.13 to 0.92) | 0.00 (0.00 to 1.51) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.37 (0.12 to 0.87) | 0.00 (0.00 to 1.30) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.37 (0.12 to 0.87) | 0.00 (0.00 to 1.28) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 5.52) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 4.11) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 2.91) | 0.00 (0.00 to 3.81) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 1.63) | 0.00 (0.00 to 1.07) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 1.06) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.61) | 0.00 (0.00 to 1.03) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.60) | 0.00 (0.00 to 0.87) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 0.58) | 0.00 (0.00 to 0.87) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 70.76) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 9.74) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 7.11) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 2.20) | 0.00 (0.00 to 1.44) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.00 (0.00 to 2.05) | 0.00 (0.00 to 1.43) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 2.00) | 0.00 (0.00 to 1.40) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 1.98) | 0.00 (0.00 to 1.40) |
| 18 - 65 years, Week 35-36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 35-37 | 0.97 (0.30 to 2.34) | 0.00 (0.00 to 70.76) | 0.00 (0.0 to 2.25) |
| 18 - 65 years, Week 35-38 | 0.95 (0.34 to 2.08) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 1.13) |
| 18 - 65 years, Week 35-39 | 0.77 (0.38 to 1.38) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 0.78) |
| 18 - 65 years, Week 35-40 | 0.75 (0.39 to 1.29) | 0.00 (0.00 to 4.51) | 0.00 (0.00 to 0.55) |
| 18 - 65 years, Week 35-41 | 0.64 (0.35 to 1.07) | 0.00 (0.00 to 2.10) | 0.00 (0.00 to 0.47) |
| 18 - 65 years, Week 35-42 | 0.59 (0.33 to 0.98) | 0.00 (0.00 to 1.29) | 0.00 (0.00 to 0.43) |
| 18 - 65 years, Week 35-43 | 0.61 (0.36 to 0.96) | 0.00 (0.00 to 0.91) | 0.00 (0.00 to 0.39) |
| 18 - 65 years, Week 35-44 | 0.61 (0.37 to 0.95) | 0.00 (0.00 to 0.76) | 0.00 (0.00 to 0.36) |
| 18 - 65 years, Week 35-45 | 0.58 (0.35 to 0.91) | 0.00 (0.00 to 0.68) | 0.00 (0.00 to 0.33) |
| 18 - 65 years, Week 35-46 | 0.60 (0.36 to 0.92) | 0.00 (0.00 to 0.63) | 0.00 (0.00 to 0.32) |
| 18 - 65 years, Week 35-47 | 0.58 (0.35 to 0.90) | 0.16 (0.00 to 0.89) | 0.00 (0.00 to 0.30) |
| 18 - 65 years, Week 35-48 | 0.57 (0.35 to 0.89) | 0.15 (0.00 to 0.85) | 0.00 (0.00 to 0.30) |
| >65 years, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.85) |
| >65 years, Week 35-37 | 0.69 (0.36 to 1.20) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 0.99) |
| >65 years, Week 35-38 | 0.53 (0.32 to 0.82) | 0.00 (0.00 to 33.63) | 0.27 (0.03 to 1.03) |
| >65 years, Week 35-39 | 0.41 (0.27 to 0.61) | 0.00 (0.00 to 20.59) | 0.18 (0.02 to 0.73) |
| >65 years, Week 35-40 | 0.44 (0.30 to 0.61) | 0.00 (0.00 to 6.16) | 0.21 (0.04 to 0.60) |
| >65 years, Week 35-41 | 0.41 (0.28 to 0.57) | 0.73 (0.02 to 4.00) | 0.19 (0.04 to 0.55) |
| >65 years, Week 35-42 | 0.39 (0.28 to 0.54) | 0.50 (0.01 to 2.73) | 0.17 (0.04 to 0.51) |
| >65 years, Week 35-43 | 0.39 (0.28 to 0.54) | 0.35 (0.01 to 1.95) | 0.17 (0.03 to 0.49) |
| >65 years, Week 35-44 | 0.40 (0.28 to 0.54) | 0.29 (0.01 to 1.59) | 0.16 (0.03 to 0.47) |
| >65 years, Week 35-45 | 0.40 (0.28 to 0.54) | 0.26 (0.01 to 1.44) | 0.16 (0.03 to 0.46) |
| >65 years, Week 35-46 | 0.39 (0.28 to 0.53) | 0.47 (0.06 to 1.70) | 0.15 (0.03 to 0.45) |
| >65 years, Week 35-47 | 0.39 (0.28 to 0.53) | 0.45 (0.05 to 1.60) | 0.15 (0.03 to 0.44) |
| >65 years, Week 35-48 | 0.39 (0.28 to 0.53) | 0.64 (0.05 to 2.56) | 0.15 (0.03 to 0.44) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 1.77) | 0.00 (0.00 to 23.16) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 7.71) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.90) | 0.00 (0.00 to 19.51) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.00 (0.00 to 1.79) | 0.00 (0.00 to 2.48) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 1.80) | 0.00 (0.00 to 30.85) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 9.03) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.57) | 0.00 (0.00 to 6.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 12.34) | 0.00 (0.00 to 14.82) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 40.96) |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.66) | 0.00 (0.00 to 1.47) |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.55) | 0.00 (0.00 to 97.50) |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.34) | 0.00 (0.00 to 24.71) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 5.78) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 41 | 10.00 (0.00 to 71.81) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 10.89) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 23.16) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 0.49 (0.01 to 2.69) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 37 | 5.29 (3.30 to 7.98) | 0.00 (0.00 to 70.76) | 0.66 (0.02 to 3.61) |
| 18 - 65 years, Week 38 | 3.72 (2.55 to 5.22) | 0.00 (0.00 to 60.24) | 0.61 (0.01 to 3.60) |
| 18 - 65 years, Week 39 | 3.96 (3.00 to 5.11) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 2.48) |
| 18 - 65 years, Week 40 | 3.37 (2.11 to 5.10) | 4.76 (0.10 to 24.55) | 0.51 (0.01 to 2.82) |
| 18 - 65 years, Week 41 | 2.36 (0.99 to 4.70) | 0.00 (0.00 to 3.85) | 0.00 (0.00 to 3.30) |
| 18 - 65 years, Week 42 | 2.25 (0.62 to 5.66) | 0.91 (0.02 to 4.96) | 0.00 (0.00 to 4.45) |
| 18 - 65 years, Week 43 | 4.52 (1.78 to 9.28) | 0.00 (0.00 to 3.05) | 1.16 (0.03 to 6.31) |
| 18 - 65 years, Week 44 | 1.28 (0.25 to 3.78) | 5.06 (0.82 to 15.56) | 0.00 (0.00 to 4.56) |
| 18 - 65 years, Week 45 | 2.23 (0.47 to 6.33) | 1.82 (0.00 to 93.05) | 0.00 (0.00 to 4.35) |
| 18 - 65 years, Week 46 | 2.24 (0.73 to 5.15) | 1.96 (0.02 to 12.89) | 0.00 (0.00 to 8.81) |
| 18 - 65 years, Week 47 | 2.05 (0.43 to 5.89) | 0.00 (0.00 to 9.03) | 0.00 (0.00 to 5.69) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 3.45 (0.00 to 94.80) | 0.00 (0.00 to 12.34) |
| >65 years, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.98) |
| >65 years, Week 37 | 3.86 (2.98 to 4.91) | 0.00 (0.00 to 84.19) | 0.32 (0.01 to 1.76) |
| >65 years, Week 38 | 3.26 (2.29 to 4.49) | 0.00 (0.00 to 45.93) | 0.27 (0.01 to 1.51) |
| >65 years, Week 39 | 3.03 (2.26 to 3.97) | 0.00 (0.00 to 40.96) | 1.19 (0.32 to 3.01) |
| >65 years, Week 40 | 2.23 (1.04 to 4.13) | 2.38 (0.06 to 12.57) | 0.55 (0.07 to 1.97) |
| >65 years, Week 41 | 2.55 (1.49 to 4.08) | 0.00 (0.00 to 4.56) | 0.00 (0.00 to 2.35) |
| >65 years, Week 42 | 1.83 (0.75 to 3.69) | 1.54 (0.04 to 8.28) | 0.00 (0.00 to 3.03) |
| >65 years, Week 43 | 2.19 (0.81 to 4.71) | 1.22 (0.00 to 92.27) | 1.54 (0.01 to 11.02) |
| >65 years, Week 44 | 2.33 (0.54 to 6.33) | 3.13 (0.00 to 88.31) | 0.00 (0.00 to 4.99) |
| >65 years, Week 45 | 3.15 (0.79 to 8.23) | 2.70 (0.00 to 99.67) | 0.00 (0.00 to 6.06) |
| >65 years, Week 46 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 9.49) | 6.25 (0.77 to 20.81) |
| >65 years, Week 47 | 1.89 (0.14 to 7.77) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 11.57) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 4.55 (0.00 to 99.99) | 0.00 (0.00 to 30.85) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-38 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.93) | 0.00 (0.00 to 5.78) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 0.63) | 0.00 (0.00 to 4.56) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.51) | 0.00 (0.00 to 4.30) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 1.58) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.35) | 0.00 (0.00 to 1.57) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.29) | 0.00 (0.00 to 1.51) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.28) | 0.00 (0.00 to 1.30) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.27) | 0.00 (0.00 to 1.28) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 5.52) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 4.11) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 2.91) | 0.00 (0.00 to 3.81) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 1.63) | 0.00 (0.00 to 1.07) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 1.06) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.61) | 0.00 (0.00 to 1.03) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.60) | 0.00 (0.00 to 0.87) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 0.87) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 70.76) |
| 13 - 17 years, Week 35-41 | 1.82 (0.01 to 12.25) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-42 | 1.69 (0.02 to 10.77) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-43 | 1.64 (0.02 to 10.46) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 9.74) |
| 13 - 17 years, Week 35-44 | 1.61 (0.02 to 10.31) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 7.11) |
| 13 - 17 years, Week 35-45 | 1.43 (0.02 to 9.07) | 0.00 (0.00 to 2.20) | 0.39 (0.01 to 2.17) |
| 13 - 17 years, Week 35-46 | 1.32 (0.01 to 8.53) | 0.00 (0.00 to 2.05) | 0.39 (0.01 to 2.15) |
| 13 - 17 years, Week 35-47 | 1.22 (0.01 to 8.11) | 0.00 (0.00 to 2.00) | 0.38 (0.01 to 2.11) |
| 13 - 17 years, Week 35-48 | 1.16 (0.01 to 7.70) | 0.00 (0.00 to 1.98) | 0.38 (0.01 to 2.11) |
| 18 - 65 years, Week 35-36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 35-37 | 5.29 (3.30 to 7.98) | 0.00 (0.00 to 70.76) | 0.62 (0.02 to 3.39) |
| 18 - 65 years, Week 35-38 | 4.43 (3.14 to 6.06) | 0.00 (0.00 to 40.96) | 0.61 (0.02 to 3.25) |
| 18 - 65 years, Week 35-39 | 4.21 (3.48 to 5.04) | 0.00 (0.00 to 19.51) | 0.42 (0.01 to 2.46) |
| 18 - 65 years, Week 35-40 | 4.04 (3.42 to 4.74) | 3.75 (0.78 to 10.57) | 0.45 (0.05 to 1.61) |
| 18 - 65 years, Week 35-41 | 3.80 (3.16 to 4.53) | 1.72 (0.36 to 4.96) | 0.39 (0.04 to 1.44) |
| 18 - 65 years, Week 35-42 | 3.68 (2.98 to 4.50) | 1.41 (0.39 to 3.57) | 0.35 (0.03 to 1.35) |
| 18 - 65 years, Week 35-43 | 3.72 (2.96 to 4.61) | 0.99 (0.99 to 2.52) | 0.42 (0.06 to 1.46) |
| 18 - 65 years, Week 35-44 | 3.57 (2.77 to 4.54) | 1.66 (0.72 to 3.24) | 0.39 (0.05 to 1.37) |
| 18 - 65 years, Week 35-45 | 3.52 (2.78 to 4.40) | 1.68 (0.77 to 3.16) | 0.36 (0.04 to 1.30) |
| 18 - 65 years, Week 35-46 | 3.47 (2.74 to 4.33) | 1.70 (0.82 to 3.11) | 0.35 (0.04 to 1.27) |
| 18 - 65 years, Week 35-47 | 3.43 (2.70 to 4.30) | 1.59 (0.77 to 2.91) | 0.33 (0.04 to 1.21) |
| 18 - 65 years, Week 35-48 | 3.38 (2.66 to 4.24) | 1.68 (0.84 to 2.98) | 0.32 (0.04 to 1.20) |
| >65 years, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.85) |
| >65 years, Week 35-37 | 3.86 (2.98 to 4.91) | 0.00 (0.00 to 70.76) | 0.27 (0.01 to 1.50) |
| >65 years, Week 35-38 | 3.55 (2.79 to 4.44) | 0.00 (0.00 to 33.63) | 0.27 (0.01 to 1.45) |
| >65 years, Week 35-39 | 3.33 (2.59 to 4.20) | 0.00 (0.00 to 20.59) | 0.55 (0.13 to 1.51) |
| >65 years, Week 35-40 | 3.14 (2.47 to 3.93) | 1.72 (0.04 to 9.24) | 0.55 (0.16 to 1.39) |
| >65 years, Week 35-41 | 3.07 (2.43 to 3.82) | 0.73 (0.02 to 4.00) | 0.50 (0.14 to 1.26) |
| >65 years, Week 35-42 | 2.99 (2.36 to 3.74) | 0.99 (0.12 to 3.53) | 0.46 (0.13 to 1.18) |
| >65 years, Week 35-43 | 2.97 (2.33 to 3.73) | 1.06 (0.22 to 3.06) | 0.50 (0.18 to 1.10) |
| >65 years, Week 35-44 | 2.94 (2.33 to 3.66) | 1.44 (0.47 to 3.32) | 0.48 (0.17 to 1.06) |
| >65 years, Week 35-45 | 2.95 (2.35 to 3.65) | 1.56 (0.57 to 3.36) | 0.47 (0.17 to 1.03) |
| >65 years, Week 35-46 | 2.91 (2.31 to 3.62) | 1.42 (0.52 to 3.07) | 0.56 (0.24 to 1.12) |
| >65 years, Week 35-47 | 2.90 (2.30 to 3.61) | 1.34 (0.49 to 2.89) | 0.56 (0.24 to 1.10) |
| >65 years, Week 35-48 | 2.89 (2.29 to 3.60) | 1.49 (0.60 to 3.04) | 0.55 (0.24 to 1.10) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48 of 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 1.77) | 0.00 (0.00 to 23.16) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 7.71) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.90) | 0.00 (0.00 to 19.51) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.00 (0.00 to 1.79) | 0.00 (0.00 to 2.48) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 1.80) | 0.00 (0.00 to 30.85) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 9.03) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.57) | 0.00 (0.00 to 6.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 12.34) | 0.00 (0.00 to 14.82) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 40.96) |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.66) | 0.00 (0.00 to 1.47) |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.55) | 0.00 (0.00 to 97.50) |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.34) | 0.00 (0.00 to 24.71) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 5.78) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 10.89) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 23.16) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 0.00 (0.00 to 1.78) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 37 | 0.28 (0.03 to 1.00) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 2.40) |
| 18 - 65 years, Week 38 | 0.35 (0.04 to 1.25) | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 2.22) |
| 18 - 65 years, Week 39 | 0.28 (0.02 to 1.17) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 2.48) |
| 18 - 65 years, Week 40 | 0.00 (0.00 to 0.50) | 1.59 (0.04 to 8.63) | 0.00 (0.00 to 1.87) |
| 18 - 65 years, Week 41 | 0.16 (0.00 to 0.93) | 1.06 (0.03 to 5.79) | 0.00 (0.00 to 3.30) |
| 18 - 65 years, Week 42 | 0.00 (0.00 to 1.03) | 0.00 (0.00 to 3.30) | 0.00 (0.00 to 4.45) |
| 18 - 65 years, Week 43 | 0.00 (0.00 to 1.66) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 4.20) |
| 18 - 65 years, Week 44 | 0.00 (0.00 to 1.17) | 0.00 (0.00 to 4.56) | 0.00 (0.00 to 4.56) |
| 18 - 65 years, Week 45 | 0.00 (0.00 to 1.63) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 4.35) |
| 18 - 65 years, Week 46 | 0.00 (0.00 to 1.64) | 0.00 (0.00 to 6.98) | 0.00 (0.00 to 8.81) |
| 18 - 65 years, Week 47 | 0.00 (0.00 to 2.49) | 2.56 (0.00 to 25.31) | 0.00 (0.00 to 5.69) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 12.34) |
| >65 years, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.98) |
| >65 years, Week 37 | 0.29 (0.09 to 0.67) | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 1.16) |
| >65 years, Week 38 | 0.27 (0.07 to 0.72) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.97) |
| >65 years, Week 39 | 0.19 (0.06 to 0.44) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 1.09) |
| >65 years, Week 40 | 0.00 (0.00 to 0.28) | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.01) |
| >65 years, Week 41 | 0.20 (0.00 to 1.20) | 0.00 (0.00 to 4.56) | 0.65 (0.00 to 4.69) |
| >65 years, Week 42 | 0.00 (0.00 to 0.67) | 0.00 (0.00 to 5.52) | 0.00 (0.00 to 3.03) |
| >65 years, Week 43 | 0.00 (0.00 to 1.34) | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 5.52) |
| >65 years, Week 44 | 0.23 (0.00 to 1.90) | 0.00 (0.00 to 5.60) | 0.00 (0.00 to 4.99) |
| >65 years, Week 45 | 0.00 (0.00 to 1.65) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 6.06) |
| >65 years, Week 46 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 9.49) | 0.00 (0.00 to 10.89) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 11.57) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 30.85) |
AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48 of 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-38 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.93) | 0.00 (0.00 to 5.78) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 0.63) | 0.00 (0.00 to 4.56) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.51) | 0.00 (0.00 to 4.30) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 1.58) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.35) | 0.00 (0.00 to 1.57) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.29) | 0.00 (0.00 to 1.51) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.28) | 0.00 (0.00 to 1.30) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.27) | 0.00 (0.00 to 1.28) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 5.52) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 4.11) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 2.91) | 0.00 (0.00 to 3.81) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 1.63) | 0.00 (0.00 to 1.07) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 1.06) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.61) | 0.00 (0.00 to 1.03) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.60) | 0.00 (0.00 to 0.87) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 0.58) | 0.00 (0.00 to 0.87) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 70.76) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 9.74) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 7.11) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 2.20) | 0.00 (0.00 to 1.44) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.00 (0.00 to 2.05) | 0.00 (0.00 to 1.43) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 2.00) | 0.00 (0.00 to 1.40) |
| 13 - 17 years, Week 35-48 | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 1.98) | 0.00 (0.00 to 1.40) |
| 18 - 65 years, Week 35-36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 35-37 | 0.28 (0.03 to 1.00) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 2.25) |
| 18 - 65 years, Week 35-38 | 0.32 (0.07 to 0.88) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 1.13) |
| 18 - 65 years, Week 35-39 | 0.30 (0.11 to 0.67) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 0.78) |
| 18 - 65 years, Week 35-40 | 0.24 (0.07 to 0.60) | 1.25 (0.03 to 6.77) | 0.00 (0.00 to 0.55) |
| 18 - 65 years, Week 35-41 | 0.23 (0.07 to 0.55) | 1.15 (0.14 to 4.09) | 0.00 (0.00 to 0.47) |
| 18 - 65 years, Week 35-42 | 0.21 (0.06 to 0.52) | 0.70 (0.09 to 2.52) | 0.00 (0.00 to 0.43) |
| 18 - 65 years, Week 35-43 | 0.20 (0.06 to 0.50) | 0.50 (0.06 to 1.78) | 0.00 (0.00 to 0.39) |
| 18 - 65 years, Week 35-44 | 0.19 (0.05 to 0.48) | 0.41 (0.05 to 1.49) | 0.00 (0.00 to 0.36) |
| 18 - 65 years, Week 35-45 | 0.18 (0.05 to 0.46) | 0.37 (0.05 to 1.34) | 0.00 (0.00 to 0.33) |
| 18 - 65 years, Week 35-46 | 0.18 (0.05 to 0.44) | 0.34 (0.04 to 1.22) | 0.00 (0.00 to 0.32) |
| 18 - 65 years, Week 35-47 | 0.17 (0.05 to 0.43) | 0.48 (0.10 to 1.39) | 0.00 (0.00 to 0.30) |
| 18 - 65 years, Week 35-48 | 0.17 (0.05 to 0.43) | 0.46 (0.09 to 1.33) | 0.00 (0.00 to 0.30) |
| >65 years, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.85) |
| >65 years, Week 35-37 | 0.29 (0.09 to 0.67) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 0.99) |
| >65 years, Week 35-38 | 0.28 (0.13 to 0.51) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 0.49) |
| >65 years, Week 35-39 | 0.24 (0.13 to 0.40) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 0.34) |
| >65 years, Week 35-40 | 0.20 (0.11 to 0.33) | 0.00 (0.00 to 6.16) | 0.00 (0.00 to 0.25) |
| >65 years, Week 35-41 | 0.20 (0.11 to 0.33) | 0.00 (0.00 to 2.66) | 0.06 (0.00 to 0.51) |
| >65 years, Week 35-42 | 0.19 (0.10 to 0.32) | 0.00 (0.00 to 1.81) | 0.06 (0.00 to 0.47) |
| >65 years, Week 35-43 | 0.18 (0.10 to 0.31) | 0.00 (0.00 to 1.29) | 0.06 (0.00 to 0.46) |
| >65 years, Week 35-44 | 0.18 (0.10 to 0.31) | 0.00 (0.00 to 1.05) | 0.05 (0.00 to 0.43) |
| >65 years, Week 35-45 | 0.18 (0.09 to 0.31) | 0.00 (0.00 to 0.95) | 0.05 (0.00 to 0.42) |
| >65 years, Week 35-46 | 0.18 (0.09 to 0.30) | 0.00 (0.00 to 0.87) | 0.05 (0.00 to 0.41) |
| >65 years, Week 35-47 | 0.17 (0.09 to 0.30) | 0.00 (0.00 to 0.82) | 0.05 (0.00 to 0.40) |
| >65 years, Week 35-48 | 0.17 (0.09 to 0.30) | 0.00 (0.00 to 0.78) | 0.05 (0.00 to 0.40) |
"SAEs reported here are derived from 2 sources of data - ADR cards and SAEs routinely collected from GPs. SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017"
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 1.77) | 0.00 (0.00 to 23.16) |
| 6 months to 5 years, Week 41 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.95) | 0.00 (0.00 to 7.71) |
| 6 months to 5 years, Week 42 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 1.90) | 0.00 (0.00 to 19.51) |
| 6 months to 5 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 2.55) | 0.00 (0.00 to 52.18) |
| 6 months to 5 years, Week 44 | — | 0.00 (0.00 to 1.79) | 0.00 (0.00 to 2.48) |
| 6 months to 5 years, Week 45 | — | 0.00 (0.00 to 2.82) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 46 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 1.80) | 0.00 (0.00 to 30.85) |
| 6 months to 5 years, Week 47 | — | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 9.03) |
| 6 months to 5 years, Week 48 | — | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 60.24) |
| 6 - 12 years, Week 37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 38 | 0.00 (0.00 to 40.96) | — | — |
| 6 - 12 years, Week 39 | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 40 | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 41 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 11.57) | 0.00 (0.00 to 6.49) |
| 6 - 12 years, Week 42 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 12.34) | 0.00 (0.00 to 14.82) |
| 6 - 12 years, Week 43 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 40.96) |
| 6 - 12 years, Week 44 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 3.66) | 0.00 (0.00 to 1.47) |
| 6 - 12 years, Week 45 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 3.55) | 0.00 (0.00 to 97.50) |
| 6 - 12 years, Week 46 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.34) | 0.00 (0.00 to 24.71) |
| 6 - 12 years, Week 47 | — | 0.00 (0.00 to 21.80) | 0.00 (0.00 to 5.78) |
| 6 - 12 years, Week 48 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 17.65) | — |
| 13 - 17 years, Week 37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 38 | 0.00 (0.00 to 20.59) | — | — |
| 13 - 17 years, Week 39 | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 40 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 41 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 19.51) | 0.00 (0.00 to 10.89) |
| 13 - 17 years, Week 42 | 0.00 (0.00 to 60.24) | 0.00 (0.00 to 19.51) | — |
| 13 - 17 years, Week 43 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 44 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 13.72) | 0.00 (0.00 to 23.16) |
| 13 - 17 years, Week 45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 4.51) | 0.00 (0.00 to 1.78) |
| 13 - 17 years, Week 46 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 84.19) |
| 13 - 17 years, Week 47 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 52.18) |
| 13 - 17 years, Week 48 | 25.00 (0.63 to 80.59) | 0.00 (0.00 to 97.50) | — |
| 18 - 65 years, Week 36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 37 | 0.14 (0.00 to 0.95) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 2.40) |
| 18 - 65 years, Week 38 | 0.00 (0.00 to 0.43) | 0.00 (0.00 to 60.24) | 0.61 (0.01 to 3.47) |
| 18 - 65 years, Week 39 | 0.00 (0.00 to 0.26) | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 2.48) |
| 18 - 65 years, Week 40 | 0.27 (0.03 to 0.98) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 1.87) |
| 18 - 65 years, Week 41 | 0.00 (0.00 to 0.58) | 0.00 (0.00 to 3.85) | 1.82 (0.22 to 6.41) |
| 18 - 65 years, Week 42 | 0.00 (0.00 to 1.03) | 0.00 (0.00 to 3.30) | 0.00 (0.00 to 4.45) |
| 18 - 65 years, Week 43 | 0.00 (0.00 to 1.66) | 0.00 (0.00 to 3.05) | 0.00 (0.00 to 4.20) |
| 18 - 65 years, Week 44 | 0.00 (0.00 to 1.17) | 1.27 (0.00 to 19.00) | 0.00 (0.00 to 4.56) |
| 18 - 65 years, Week 45 | 0.00 (0.00 to 1.63) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 4.35) |
| 18 - 65 years, Week 46 | 0.45 (0.01 to 2.58) | 0.00 (0.00 to 6.98) | 0.00 (0.00 to 8.81) |
| 18 - 65 years, Week 47 | 0.00 (0.00 to 2.49) | 0.00 (0.00 to 9.03) | 0.00 (0.00 to 5.69) |
| 18 - 65 years, Week 48 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 12.34) |
| >65 years, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.98) |
| >65 years, Week 37 | 0.12 (0.01 to 0.42) | 0.00 (0.00 to 84.19) | 0.32 (0.00 to 2.60) |
| >65 years, Week 38 | 0.27 (0.06 to 0.75) | 0.00 (0.00 to 45.93) | 0.27 (0.00 to 1.83) |
| >65 years, Week 39 | 0.11 (0.02 to 0.35) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 1.09) |
| >65 years, Week 40 | 0.15 (0.01 to 0.62) | 0.00 (0.00 to 8.41) | 0.27 (0.00 to 2.12) |
| >65 years, Week 41 | 0.20 (0.01 to 0.94) | 0.00 (0.00 to 4.56) | 0.00 (0.00 to 2.35) |
| >65 years, Week 42 | 0.00 (0.00 to 0.67) | 1.54 (0.04 to 8.28) | 0.00 (0.00 to 3.03) |
| >65 years, Week 43 | 0.73 (0.01 to 4.84) | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 5.52) |
| >65 years, Week 44 | 0.47 (0.00 to 3.34) | 0.00 (0.00 to 5.60) | 2.78 (0.31 to 9.95) |
| >65 years, Week 45 | 0.45 (0.00 to 3.24) | 2.70 (0.00 to 93.12) | 0.00 (0.00 to 6.06) |
| >65 years, Week 46 | 0.88 (0.01 to 5.78) | 0.00 (0.00 to 9.49) | 3.13 (0.08 to 16.22) |
| >65 years, Week 47 | 0.00 (0.00 to 3.42) | 0.00 (0.00 to 12.77) | 3.33 (0.04 to 19.38) |
| >65 years, Week 48 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 15.44) | 0.00 (0.00 to 30.85) |
SAEs reported here are derived from 2 sources of data - ADR cards and SAEs routinely collected from GPs. SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| 6 months to 5 years, Week 35-37 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-38 | — | — | 0.00 (0.00 to 97.50) |
| 6 months to 5 years, Week 35-39 | 0.00 (0.00 to 84.19) | 0.00 (0.00 to 5.69) | 0.00 (0.00 to 84.19) |
| 6 months to 5 years, Week 35-40 | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 20.59) |
| 6 months to 5 years, Week 35-41 | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.93) | 0.00 (0.00 to 5.78) |
| 6 months to 5 years, Week 35-42 | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 0.63) | 0.00 (0.00 to 4.56) |
| 6 months to 5 years, Week 35-43 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.51) | 0.00 (0.00 to 4.30) |
| 6 months to 5 years, Week 35-44 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.40) | 0.00 (0.00 to 1.58) |
| 6 months to 5 years, Week 35-45 | 0.00 (0.00 to 36.94) | 0.00 (0.00 to 0.35) | 0.00 (0.00 to 1.57) |
| 6 months to 5 years, Week 35-46 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.29) | 0.00 (0.00 to 1.51) |
| 6 months to 5 years, Week 35-47 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.28) | 0.00 (0.00 to 1.30) |
| 6 months to 5 years, Week 35-48 | 0.00 (0.00 to 30.85) | 0.00 (0.00 to 0.27) | 0.00 (0.00 to 1.28) |
| 6 - 12 years, Week 35-37 | 0.00 (0.00 to 52.18) | — | — |
| 6 - 12 years, Week 35-38 | 0.00 (0.00 to 26.46) | — | — |
| 6 - 12 years, Week 35-39 | 0.00 (0.00 to 14.25) | 0.00 (0.00 to 16.11) | — |
| 6 - 12 years, Week 35-40 | 0.00 (0.00 to 12.77) | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 30.85) |
| 6 - 12 years, Week 35-41 | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 4.99) | 0.00 (0.00 to 5.52) |
| 6 - 12 years, Week 35-42 | 0.00 (0.00 to 10.28) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 4.11) |
| 6 - 12 years, Week 35-43 | 0.00 (0.00 to 10.00) | 0.00 (0.00 to 2.91) | 0.00 (0.00 to 3.81) |
| 6 - 12 years, Week 35-44 | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 1.63) | 0.00 (0.00 to 1.07) |
| 6 - 12 years, Week 35-45 | 0.00 (0.00 to 8.41) | 0.00 (0.00 to 1.13) | 0.00 (0.00 to 1.06) |
| 6 - 12 years, Week 35-46 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.61) | 0.00 (0.00 to 1.03) |
| 6 - 12 years, Week 35-47 | 0.00 (0.00 to 7.55) | 0.00 (0.00 to 0.60) | 0.00 (0.00 to 0.87) |
| 6 - 12 years, Week 35-48 | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 0.58) | 0.00 (0.00 to 0.87) |
| 13 - 17 years, Week 35-37 | 0.00 (0.00 to 36.94) | — | — |
| 13 - 17 years, Week 35-38 | 0.00 (0.00 to 14.25) | — | — |
| 13 - 17 years, Week 35-39 | 0.00 (0.00 to 9.25) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 97.50) |
| 13 - 17 years, Week 35-40 | 0.00 (0.00 to 7.87) | 0.00 (0.00 to 23.16) | 0.00 (0.00 to 70.76) |
| 13 - 17 years, Week 35-41 | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-42 | 0.00 (0.00 to 6.06) | 0.00 (0.00 to 7.40) | 0.00 (0.00 to 10.00) |
| 13 - 17 years, Week 35-43 | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 5.87) | 0.00 (0.00 to 9.74) |
| 13 - 17 years, Week 35-44 | 0.00 (0.00 to 5.78) | 0.00 (0.00 to 4.20) | 0.00 (0.00 to 7.11) |
| 13 - 17 years, Week 35-45 | 0.00 (0.00 to 5.13) | 0.00 (0.00 to 2.20) | 0.00 (0.00 to 1.44) |
| 13 - 17 years, Week 35-46 | 0.00 (0.00 to 4.74) | 0.00 (0.00 to 2.05) | 0.00 (0.00 to 1.43) |
| 13 - 17 years, Week 35-47 | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 2.00) | 0.00 (0.00 to 1.40) |
| 13 - 17 years, Week 35-48 | 1.16 (0.03 to 6.31) | 0.00 (0.00 to 1.98) | 0.00 (0.00 to 1.40) |
| 18 - 65 years, Week 35-36 | — | — | 0.00 (0.00 to 30.85) |
| 18 - 65 years, Week 35-37 | 0.14 (0.00 to 0.95) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 2.25) |
| 18 - 65 years, Week 35-38 | 0.06 (0.00 to 0.45) | 0.00 (0.00 to 40.96) | 0.31 (0.00 to 1.91) |
| 18 - 65 years, Week 35-39 | 0.03 (0.00 to 0.03) | 0.00 (0.00 to 19.51) | 0.21 (0.00 to 1.31) |
| 18 - 65 years, Week 35-40 | 0.08 (0.02 to 0.24) | 0.00 (0.00 to 4.51) | 0.15 (0.00 to 0.97) |
| 18 - 65 years, Week 35-41 | 0.07 (0.01 to 0.21) | 0.00 (0.00 to 2.10) | 0.39 (0.04 to 1.50) |
| 18 - 65 years, Week 35-42 | 0.06 (0.01 to 0.19) | 0.00 (0.00 to 1.29) | 0.35 (0.04 to 1.33) |
| 18 - 65 years, Week 35-43 | 0.06 (0.01 to 0.18) | 0.00 (0.00 to 0.91) | 0.32 (0.03 to 1.22) |
| 18 - 65 years, Week 35-44 | 0.06 (0.01 to 0.17) | 0.21 (0.00 to 2.26) | 0.29 (0.03 to 1.13) |
| 18 - 65 years, Week 35-45 | 0.05 (0.01 to 0.16) | 0.19 (0.00 to 1.89) | 0.27 (0.03 to 1.05) |
| 18 - 65 years, Week 35-46 | 0.07 (0.01 to 0.22) | 0.17 (0.00 to 1.64) | 0.26 (0.03 to 1.01) |
| 18 - 65 years, Week 35-47 | 0.07 (0.01 to 0.21) | 0.16 (0.00 to 1.51) | 0.25 (0.02 to 0.95) |
| 18 - 65 years, Week 35-48 | 0.07 (0.01 to 0.21) | 0.15 (0.00 to 1.42) | 0.24 (0.02 to 0.93) |
| >65 years, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| >65 years, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.85) |
| >65 years, Week 35-37 | 0.12 (0.01 to 0.42) | 0.00 (0.00 to 70.76) | 0.27 (0.00 to 2.23) |
| >65 years, Week 35-38 | 0.19 (0.06 to 0.45) | 0.00 (0.00 to 33.63) | 0.27 (0.02 to 1.22) |
| >65 years, Week 35-39 | 0.16 (0.07 to 0.29) | 0.00 (0.00 to 20.59) | 0.18 (0.01 to 0.85) |
| >65 years, Week 35-40 | 0.16 (0.08 to 0.28) | 0.00 (0.00 to 6.16) | 0.21 (0.04 to 0.64) |
| >65 years, Week 35-41 | 0.16 (0.07 to 0.31) | 0.00 (0.00 to 2.66) | 0.19 (0.03 to 0.58) |
| >65 years, Week 35-42 | 0.14 (0.07 to 0.29) | 0.50 (0.01 to 2.73) | 0.17 (0.03 to 0.53) |
| >65 years, Week 35-43 | 0.17 (0.07 to 0.35) | 0.35 (0.01 to 1.95) | 0.17 (0.03 to 0.51) |
| >65 years, Week 35-44 | 0.18 (0.06 to 0.41) | 0.29 (0.01 to 1.59) | 0.27 (0.07 to 0.68) |
| >65 years, Week 35-45 | 0.19 (0.07 to 0.40) | 0.52 (0.06 to 1.86) | 0.26 (0.07 to 0.66) |
| >65 years, Week 35-46 | 0.20 (0.07 to 0.42) | 0.47 (0.06 to 1.70) | 0.31 (0.11 to 0.68) |
| >65 years, Week 35-47 | 0.19 (0.07 to 0.41) | 0.45 (0.05 to 1.60) | 0.35 (0.12 to 0.81) |
| >65 years, Week 35-48 | 0.19 (0.07 to 0.41) | 0.43 (0.05 to 1.53) | 0.35 (0.12 to 0.81) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 1.69 (0.00 to 16.08) |
| At risk, Week 37 | 11.44 (9.28 to 13.90) | 0.00 (0.00 to 52.18) | 0.68 (0.01 to 4.04) |
| At risk, Week 38 | 9.76 (7.27 to 12.76) | 14.29 (0.00 to 90.97) | 1.61 (0.70 to 3.14) |
| At risk, Week 39 | 9.72 (8.38 to 11.18) | 2.06 (0.25 to 7.25) | 2.46 (0.94 to 5.16) |
| At risk, Week 40 | 9.78 (5.87 to 15.06) | 7.35 (4.71 to 10.82) | 1.72 (0.50 to 4.22) |
| At risk, Week 41 | 8.79 (6.62 to 11.38) | 5.96 (2.86 to 10.77) | 0.30 (0.00 to 2.16) |
| At risk, Week 42 | 5.58 (3.15 to 9.07) | 2.53 (1.14 to 4.80) | 1.89 (0.23 to 6.66) |
| At risk, Week 43 | 6.26 (2.99 to 11.35) | 4.28 (1.91 to 8.16) | 1.52 (0.11 to 6.34) |
| At risk, Week 44 | 6.17 (2.44 to 12.51) | 4.80 (1.53 to 11.02) | 0.19 (0.00 to 1.08) |
| At risk, Week 45 | 6.04 (2.99 to 10.69) | 2.97 (0.05 to 16.62) | 2.61 (0.35 to 8.77) |
| At risk, Week 46 | 5.95 (2.73 to 11.05) | 1.07 (0.06 to 4.86) | 3.85 (0.36 to 14.33) |
| At risk, Week 47 | 3.77 (1.30 to 8.36) | 2.19 (0.45 to 6.27) | 1.14 (0.06 to 5.29) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 4.76 (0.38 to 18.41) | 0.00 (0.00 to 9.74) |
| Not at risk, Week 36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 37 | 15.04 (9.43 to 22.26) | — | 9.68 (2.04 to 25.75) |
| Not at risk, Week 38 | 13.94 (9.05 to 20.18) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 8.22) |
| Not at risk, Week 39 | 13.53 (9.92 to 17.85) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 9.25) |
| Not at risk, Week 40 | 12.00 (6.25 to 20.24) | 6.90 (0.85 to 22.77) | 0.00 (0.00 to 5.69) |
| Not at risk, Week 41 | 6.71 (1.53 to 17.74) | 2.44 (0.06 to 12.86) | 1.56 (0.01 to 10.47) |
| Not at risk, Week 42 | 2.27 (0.26 to 8.11) | 0.00 (0.00 to 6.38) | 0.00 (0.00 to 11.94) |
| Not at risk, Week 43 | 3.85 (0.33 to 14.73) | 5.45 (0.66 to 18.46) | 3.13 (0.08 to 16.22) |
| Not at risk, Week 44 | 4.35 (0.91 to 12.18) | 14.81 (3.75 to 35.25) | 2.17 (0.06 to 11.53) |
| Not at risk, Week 45 | 9.46 (3.89 to 18.52) | 4.00 (1.10 to 9.93) | 4.68 (2.36 to 8.22) |
| Not at risk, Week 46 | 12.35 (2.91 to 30.79) | 3.70 (0.24 to 15.41) | 0.00 (0.00 to 17.65) |
| Not at risk, Week 47 | 6.52 (1.37 to 17.90) | 9.52 (1.17 to 30.38) | 4.17 (0.02 to 27.48) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 6.25 (0.00 to 64.40) | 0.00 (0.00 to 45.93) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 1.67 (0.00 to 14.74) |
| At risk, Week 35-37 | 11.43 (9.27 to 13.90) | 0.00 (0.00 to 45.93) | 0.80 (0.08 to 3.04) |
| At risk, Week 35-38 | 10.56 (8.59 to 12.79) | 7.69 (0.08 to 41.17) | 1.20 (0.59 to 2.19) |
| At risk, Week 35-39 | 10.19 (8.58 to 11.99) | 2.73 (0.34 to 9.45) | 1.59 (0.75 to 2.95) |
| At risk, Week 35-40 | 10.12 (8.28 to 12.21) | 6.15 (4.03 to 8.91) | 1.63 (0.71 to 3.15) |
| At risk, Week 35-41 | 9.95 (8.12 to 12.04) | 6.07 (3.78 to 9.16) | 1.43 (0.61 to 2.85) |
| At risk, Week 35-42 | 9.67 (7.83 to 11.79) | 4.90 (2.99 to 7.53) | 1.47 (0.64 to 2.88) |
| At risk, Week 35-43 | 9.56 (7.73 to 11.66) | 4.76 (2.94 to 7.23) | 1.47 (0.66 to 2.82) |
| At risk, Week 35-44 | 9.40 (7.56 to 11.50) | 4.77 (2.70 to 7.73) | 1.27 (0.60 to 2.34) |
| At risk, Week 35-45 | 9.31 (7.50 to 11.38) | 4.51 (2.26 to 7.96) | 1.31 (0.67 to 2.32) |
| At risk, Week 35-46 | 9.25 (7.44 to 11.32) | 3.89 (1.61 to 7.74) | 1.37 (0.73 to 2.33) |
| At risk, Week 35-47 | 9.17 (7.35 to 11.26) | 3.80 (1.60 to 7.52) | 1.36 (0.73 to 2.31) |
| At risk, Week 35-48 | 9.10 (7.28 to 11.20) | 3.83 (1.61 to 7.58) | 1.35 (0.72 to 2.29) |
| Not at risk, Week 35-36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 35-37 | 15.04 (9.43 to 22.26) | — | 9.09 (1.92 to 24.33) |
| Not at risk, Week 35-38 | 14.43 (10.64 to 18.94) | 0.00 (0.00 to 70.76) | 3.95 (0.82 to 11.11) |
| Not at risk, Week 35-39 | 13.95 (10.83 to 17.57) | 0.00 (0.00 to 26.46) | 2.63 (0.55 to 7.50) |
| Not at risk, Week 35-40 | 13.53 (10.44 to 17.13) | 4.88 (0.60 to 16.53) | 1.69 (0.30 to 5.19) |
| Not at risk, Week 35-41 | 12.38 (9.23 to 16.15) | 3.66 (0.76 to 10.32) | 1.66 (0.45 to 4.19) |
| Not at risk, Week 35-42 | 11.55 (8.60 to 15.08) | 2.17 (0.45 to 6.22) | 1.48 (0.41 to 3.75) |
| Not at risk, Week 35-43 | 11.19 (8.25 to 14.73) | 3.11 (1.13 to 6.70) | 1.66 (0.54 to 3.82) |
| Not at risk, Week 35-44 | 10.79 (7.93 to 14.25) | 5.67 (2.91 to 9.80) | 1.72 (0.64 to 3.71) |
| Not at risk, Week 35-45 | 10.71 (8.05 to 13.89) | 5.19 (3.10 to 8.07) | 2.92 (1.21 to 5.82) |
| Not at risk, Week 35-46 | 10.81 (8.35 to 13.71) | 4.84 (2.37 to 8.64) | 2.82 (1.13 to 5.77) |
| Not at risk, Week 35-47 | 10.67 (8.29 to 13.46) | 5.04 (2.58 to 8.76) | 2.88 (1.27 to 5.53) |
| Not at risk, Week 35-48 | 10.44 (8.07 to 13.22) | 5.08 (2.50 to 9.05) | 2.85 (1.25 to 5.51) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.06) |
| At risk, Week 37 | 0.39 (0.16 to 0.76) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.84) |
| At risk, Week 38 | 0.46 (0.18 to 0.99) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 0.74) |
| At risk, Week 39 | 0.50 (0.21 to 1.02) | 0.00 (0.00 to 3.73) | 0.22 (0.00 to 1.63) |
| At risk, Week 40 | 0.37 (0.13 to 0.84) | 1.28 (0.12 to 4.96) | 0.00 (0.00 to 0.70) |
| At risk, Week 41 | 0.40 (0.15 to 0.87) | 0.66 (0.08 to 2.37) | 0.00 (0.00 to 1.10) |
| At risk, Week 42 | 0.00 (0.00 to 0.45) | 0.00 (0.00 to 1.03) | 0.00 (0.00 to 1.72) |
| At risk, Week 43 | 0.45 (0.05 to 1.62) | 0.00 (0.00 to 1.12) | 0.00 (0.00 to 2.76) |
| At risk, Week 44 | 0.29 (0.02 to 1.34) | 0.48 (0.06 to 1.72) | 0.00 (0.00 to 0.71) |
| At risk, Week 45 | 0.26 (0.00 to 1.93) | 0.00 (0.00 to 1.21) | 0.00 (0.00 to 3.16) |
| At risk, Week 46 | 0.37 (0.00 to 2.71) | 0.21 (0.00 to 2.05) | 0.00 (0.00 to 4.62) |
| At risk, Week 47 | 0.47 (0.00 to 3.37) | 0.73 (0.01 to 4.77) | 0.00 (0.00 to 2.09) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 9.74) |
| Not at risk, Week 36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 37 | 1.50 (0.18 to 5.33) | — | 0.00 (0.00 to 11.22) |
| Not at risk, Week 38 | 1.82 (0.30 to 5.77) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 8.22) |
| Not at risk, Week 39 | 0.59 (0.07 to 2.11) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 9.25) |
| Not at risk, Week 40 | 1.14 (0.02 to 6.55) | 3.45 (0.09 to 17.76) | 0.00 (0.00 to 5.69) |
| Not at risk, Week 41 | 0.00 (0.00 to 2.22) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 5.60) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 6.38) | 0.00 (0.00 to 11.94) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 10.89) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 0.00 (0.00 to 6.60) | 0.00 (0.00 to 7.71) |
| Not at risk, Week 45 | 0.00 (0.00 to 4.86) | 0.00 (0.00 to 3.62) | 0.43 (0.01 to 2.35) |
| Not at risk, Week 46 | 1.23 (0.00 to 9.48) | 0.00 (0.00 to 3.36) | 0.00 (0.00 to 17.65) |
| Not at risk, Week 47 | 0.00 (0.00 to 7.71) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 14.25) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 45.93) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.96) |
| At risk, Week 35-37 | 0.39 (0.16 to 0.76) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.74) |
| At risk, Week 35-38 | 0.43 (0.26 to 0.65) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 0.37) |
| At risk, Week 35-39 | 0.46 (0.25 to 0.77) | 0.00 (0.00 to 3.30) | 0.07 (0.00 to 0.50) |
| At risk, Week 35-40 | 0.44 (0.27 to 0.68) | 0.95 (0.03 to 4.78) | 0.05 (0.00 to 0.38) |
| At risk, Week 35-41 | 0.44 (0.29 to 0.64) | 0.83 (0.18 to 2.32) | 0.04 (0.00 to 0.32) |
| At risk, Week 35-42 | 0.41 (0.26 to 0.61) | 0.56 (0.09 to 1.77) | 0.04 (0.00 to 0.29) |
| At risk, Week 35-43 | 0.41 (0.26 to 0.61) | 0.43 (0.06 to 1.48) | 0.04 (0.00 to 0.28) |
| At risk, Week 35-44 | 0.41 (0.26 to 0.60) | 0.44 (0.11 to 1.19) | 0.03 (0.00 to 0.23) |
| At risk, Week 35-45 | 0.40 (0.26 to 0.60) | 0.38 (0.08 to 1.07) | 0.03 (0.00 to 0.23) |
| At risk, Week 35-46 | 0.40 (0.26 to 0.60) | 0.35 (0.08 to 0.95) | 0.03 (0.00 to 0.22) |
| At risk, Week 35-47 | 0.40 (0.26 to 0.59) | 0.37 (0.11 to 0.88) | 0.03 (0.00 to 0.21) |
| At risk, Week 35-48 | 0.40 (0.26 to 0.59) | 0.35 (0.11 to 0.85) | 0.03 (0.00 to 0.21) |
| Not at risk, Week 35-36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 35-37 | 1.50 (0.18 to 5.33) | — | 0.00 (0.00 to 10.58) |
| Not at risk, Week 35-38 | 1.68 (0.36 to 4.74) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 4.74) |
| Not at risk, Week 35-39 | 1.10 (0.32 to 2.70) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 3.18) |
| Not at risk, Week 35-40 | 1.11 (0.34 to 2.63) | 2.44 (0.06 to 12.86) | 0.00 (0.00 to 2.06) |
| Not at risk, Week 35-41 | 0.92 (0.27 to 2.25) | 1.22 (0.03 to 6.61) | 0.00 (0.00 to 1.52) |
| Not at risk, Week 35-42 | 0.85 (0.24 to 2.11) | 0.72 (0.02 to 3.97) | 0.00 (0.00 to 1.36) |
| Not at risk, Week 35-43 | 0.81 (0.22 to 2.05) | 0.52 (0.01 to 2.85) | 0.00 (0.00 to 1.21) |
| Not at risk, Week 35-44 | 0.76 (0.20 to 1.98) | 0.40 (0.01 to 2.23) | 0.00 (0.00 to 1.05) |
| Not at risk, Week 35-45 | 0.71 (0.18 to 1.87) | 0.29 (0.01 to 1.60) | 0.17 (0.00 to 0.95) |
| Not at risk, Week 35-46 | 0.75 (0.16 to 2.11) | 0.22 (0.01 to 1.22) | 0.17 (0.00 to 0.92) |
| Not at risk, Week 35-47 | 0.72 (0.16 to 2.03) | 0.21 (0.01 to 1.16) | 0.16 (0.00 to 0.89) |
| Not at risk, Week 35-48 | 0.71 (0.15 to 1.99) | 0.20 (0.01 to 1.13) | 0.16 (0.00 to 0.88) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.06) |
| At risk, Week 37 | 1.71 (0.61 to 3.77) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.84) |
| At risk, Week 38 | 1.35 (0.69 to 2.37) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 0.74) |
| At risk, Week 39 | 1.80 (1.28 to 2.45) | 0.00 (0.00 to 3.73) | 0.00 (0.00 to 0.82) |
| At risk, Week 40 | 1.70 (0.71 to 3.39) | 0.32 (0.00 to 2.10) | 0.00 (0.00 to 0.70) |
| At risk, Week 41 | 1.53 (0.97 to 2.29) | 0.99 (0.14 to 3.38) | 0.00 (0.00 to 1.10) |
| At risk, Week 42 | 0.61 (0.10 to 1.96) | 0.56 (0.06 to 2.06) | 0.00 (0.00 to 1.72) |
| At risk, Week 43 | 0.45 (0.05 to 1.66) | 0.61 (0.04 to 2.64) | 0.00 (0.00 to 2.76) |
| At risk, Week 44 | 0.88 (0.13 to 2.95) | 0.48 (0.06 to 1.72) | 0.00 (0.00 to 0.71) |
| At risk, Week 45 | 1.05 (0.20 to 3.17) | 0.66 (0.00 to 4.55) | 0.00 (0.00 to 3.16) |
| At risk, Week 46 | 0.74 (0.09 to 2.70) | 0.21 (0.00 to 2.00) | 0.00 (0.00 to 4.62) |
| At risk, Week 47 | 0.94 (0.05 to 4.24) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 2.09) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 9.74) |
| Not at risk, Week 36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 37 | 5.26 (1.54 to 12.59) | — | 3.23 (0.08 to 16.70) |
| Not at risk, Week 38 | 6.06 (2.82 to 11.16) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 8.22) |
| Not at risk, Week 39 | 3.53 (1.49 to 6.97) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 9.25) |
| Not at risk, Week 40 | 4.57 (1.62 to 9.92) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 5.69) |
| Not at risk, Week 41 | 0.61 (0.00 to 4.32) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 5.60) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 6.38) | 0.00 (0.00 to 11.94) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.85) | 1.82 (0.05 to 9.72) | 0.00 (0.00 to 10.89) |
| Not at risk, Week 44 | 4.35 (0.91 to 12.18) | 1.85 (0.05 to 9.89) | 0.00 (0.00 to 7.71) |
| Not at risk, Week 45 | 0.00 (0.00 to 4.86) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 1.56) |
| Not at risk, Week 46 | 3.70 (0.08 to 19.40) | 1.85 (0.01 to 13.63) | 0.00 (0.00 to 17.65) |
| Not at risk, Week 47 | 2.17 (0.01 to 16.04) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 14.25) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 45.93) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.96) |
| At risk, Week 35-37 | 1.71 (0.61 to 3.77) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.74) |
| At risk, Week 35-38 | 1.52 (0.82 to 2.57) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 0.37) |
| At risk, Week 35-39 | 1.64 (1.07 to 2.42) | 0.00 (0.00 to 3.30) | 0.00 (0.00 to 0.25) |
| At risk, Week 35-40 | 1.65 (1.09 to 2.41) | 0.24 (0.01 to 1.31) | 0.00 (0.00 to 0.19) |
| At risk, Week 35-41 | 1.64 (1.13 to 2.29) | 0.55 (0.04 to 2.31) | 0.00 (0.00 to 0.16) |
| At risk, Week 35-42 | 1.57 (1.13 to 2.07) | 0.56 (0.05 to 2.20) | 0.00 (0.00 to 0.15) |
| At risk, Week 35-43 | 1.53 (1.11 to 2.03) | 0.57 (0.05 to 2.27) | 0.00 (0.00 to 0.14) |
| At risk, Week 35-44 | 1.50 (1.09 to 2.02) | 0.55 (0.07 to 1.95) | 0.00 (0.00 to 0.12) |
| At risk, Week 35-45 | 1.49 (1.09 to 1.99) | 0.56 (0.11 to 1.70) | 0.00 (0.00 to 0.11) |
| At risk, Week 35-46 | 1.48 (1.08 to 1.96) | 0.50 (0.07 to 1.74) | 0.00 (0.00 to 0.11) |
| At risk, Week 35-47 | 1.47 (1.08 to 1.95) | 0.48 (0.06 to 1.65) | 0.00 (0.00 to 0.10) |
| At risk, Week 35-48 | 1.46 (1.07 to 1.94) | 0.46 (0.06 to 1.60) | 0.00 (0.00 to 0.10) |
| Not at risk, Week 35-36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 35-37 | 5.26 (1.54 to 12.59) | — | 3.03 (0.08 to 15.76) |
| Not at risk, Week 35-38 | 5.70 (2.72 to 10.36) | 0.00 (0.00 to 70.76) | 1.32 (0.03 to 7.11) |
| Not at risk, Week 35-39 | 4.55 (2.27 to 8.04) | 0.00 (0.00 to 26.46) | 0.88 (0.01 to 5.49) |
| Not at risk, Week 35-40 | 4.55 (2.58 to 7.37) | 0.00 (0.00 to 8.60) | 0.56 (0.00 to 3.91) |
| Not at risk, Week 35-41 | 3.89 (2.24 to 6.23) | 0.00 (0.00 to 4.40) | 0.41 (0.00 to 2.93) |
| Not at risk, Week 35-42 | 3.57 (2.12 to 5.59) | 0.00 (0.00 to 2.64) | 0.37 (0.00 to 2.63) |
| Not at risk, Week 35-43 | 3.40 (2.06 to 5.26) | 0.52 (0.01 to 2.85) | 0.33 (0.00 to 2.35) |
| Not at risk, Week 35-44 | 3.46 (2.21 to 5.14) | 0.81 (0.10 to 2.89) | 0.29 (0.00 to 2.09) |
| Not at risk, Week 35-45 | 3.25 (2.08 to 4.82) | 0.58 (0.07 to 2.07) | 0.17 (0.00 to 1.48) |
| Not at risk, Week 35-46 | 3.28 (2.27 to 4.57) | 0.88 (0.24 to 2.24) | 0.17 (0.00 to 1.42) |
| Not at risk, Week 35-47 | 3.24 (2.26 to 4.50) | 0.84 (0.23 to 2.14) | 0.16 (0.00 to 1.37) |
| Not at risk, Week 35-48 | 3.17 (2.20 to 4.41) | 0.81 (0.22 to 2.07) | 0.16 (0.00 to 1.35) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.06) |
| At risk, Week 37 | 3.98 (3.21 to 4.89) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.84) |
| At risk, Week 38 | 3.20 (2.36 to 4.25) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 0.74) |
| At risk, Week 39 | 3.12 (2.30 to 4.14) | 1.03 (0.03 to 5.61) | 0.45 (0.05 to 1.60) |
| At risk, Week 40 | 2.55 (1.89 to 3.37) | 2.56 (0.56 to 7.10) | 0.00 (0.00 to 0.70) |
| At risk, Week 41 | 2.00 (1.23 to 3.06) | 1.32 (0.18 to 4.50) | 0.00 (0.00 to 1.10) |
| At risk, Week 42 | 1.70 (0.59 to 3.80) | 0.56 (0.06 to 2.06) | 0.00 (0.00 to 1.72) |
| At risk, Week 43 | 2.24 (0.84 to 4.75) | 0.92 (0.06 to 3.95) | 0.00 (0.00 to 2.76) |
| At risk, Week 44 | 2.06 (0.81 to 4.27) | 1.44 (0.23 to 4.65) | 0.00 (0.00 to 0.71) |
| At risk, Week 45 | 1.57 (0.42 to 4.04) | 1.32 (0.06 to 6.37) | 0.00 (0.00 to 3.16) |
| At risk, Week 46 | 0.74 (0.09 to 2.70) | 0.21 (0.00 to 2.00) | 0.00 (0.00 to 4.62) |
| At risk, Week 47 | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 2.09) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 9.74) |
| Not at risk, Week 36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 37 | 4.51 (1.67 to 9.56) | — | 3.23 (0.02 to 21.72) |
| Not at risk, Week 38 | 3.03 (0.99 to 6.93) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 8.22) |
| Not at risk, Week 39 | 5.29 (2.04 to 10.94) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 9.25) |
| Not at risk, Week 40 | 4.57 (1.90 to 9.06) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 5.69) |
| Not at risk, Week 41 | 1.83 (0.23 to 6.42) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 5.60) |
| Not at risk, Week 42 | 1.14 (0.01 to 7.02) | 0.00 (0.00 to 6.38) | 0.00 (0.00 to 11.94) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.85) | 1.82 (0.05 to 9.72) | 0.00 (0.00 to 10.89) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 3.70 (0.16 to 16.98) | 0.00 (0.00 to 7.71) |
| Not at risk, Week 45 | 1.35 (0.01 to 9.52) | 2.00 (0.10 to 9.21) | 2.13 (0.69 to 4.90) |
| Not at risk, Week 46 | 2.47 (0.12 to 11.36) | 0.93 (0.00 to 9.43) | 0.00 (0.00 to 17.65) |
| Not at risk, Week 47 | 2.17 (0.06 to 11.53) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 14.25) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 45.93) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.96) |
| At risk, Week 35-37 | 3.98 (3.21 to 4.89) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.74) |
| At risk, Week 35-38 | 3.57 (2.77 to 4.53) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 0.37) |
| At risk, Week 35-39 | 3.38 (2.56 to 4.36) | 0.91 (0.02 to 4.96) | 0.14 (0.02 to 0.50) |
| At risk, Week 35-40 | 3.23 (2.49 to 4.12) | 2.13 (0.63 to 5.14) | 0.10 (0.01 to 0.37) |
| At risk, Week 35-41 | 3.08 (2.37 to 3.93) | 1.79 (0.53 to 4.37) | 0.09 (0.01 to 0.31) |
| At risk, Week 35-42 | 2.99 (2.26 to 3.87) | 1.39 (0.39 to 3.47) | 0.08 (0.01 to 0.29) |
| At risk, Week 35-43 | 2.96 (2.23 to 3.86) | 1.28 (0.30 to 3.51) | 0.08 (0.01 to 0.27) |
| At risk, Week 35-44 | 2.92 (2.18 to 3.82) | 1.32 (0.29 to 3.68) | 0.06 (0.01 to 0.23) |
| At risk, Week 35-45 | 2.88 (2.15 to 3.78) | 1.32 (0.33 to 3.49) | 0.06 (0.01 to 0.22) |
| At risk, Week 35-46 | 2.85 (2.12 to 3.74) | 1.12 (0.20 to 3.43) | 0.06 (0.01 to 0.22) |
| At risk, Week 35-47 | 2.81 (2.08 to 3.70) | 1.06 (0.19 to 3.26) | 0.06 (0.01 to 0.20) |
| At risk, Week 35-48 | 2.78 (2.06 to 3.68) | 1.03 (0.19 to 3.15) | 0.06 (0.01 to 0.20) |
| Not at risk, Week 35-36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 35-37 | 4.51 (1.67 to 9.56) | — | 3.03 (0.01 to 20.77) |
| Not at risk, Week 35-38 | 3.69 (1.86 to 6.51) | 0.00 (0.00 to 70.76) | 1.32 (0.01 to 9.66) |
| Not at risk, Week 35-39 | 4.55 (2.51 to 7.51) | 0.00 (0.00 to 26.46) | 0.88 (0.01 to 6.17) |
| Not at risk, Week 35-40 | 4.55 (2.93 to 6.70) | 0.00 (0.00 to 8.60) | 0.56 (0.00 to 4.02) |
| Not at risk, Week 35-41 | 4.09 (2.49 to 6.31) | 0.00 (0.00 to 4.40) | 0.41 (0.00 to 2.67) |
| Not at risk, Week 35-42 | 3.85 (2.32 to 5.97) | 0.00 (0.00 to 2.64) | 0.37 (0.00 to 2.46) |
| Not at risk, Week 35-43 | 3.67 (2.21 to 5.70) | 0.52 (0.01 to 2.85) | 0.33 (0.00 to 2.19) |
| Not at risk, Week 35-44 | 3.46 (2.05 to 5.43) | 1.21 (0.25 to 3.51) | 0.29 (0.00 to 1.77) |
| Not at risk, Week 35-45 | 3.33 (2.06 to 5.08) | 1.44 (0.47 to 3.33) | 1.03 (0.14 to 3.49) |
| Not at risk, Week 35-46 | 3.28 (2.05 to 4.95) | 1.32 (0.43 to 3.06) | 1.00 (0.13 to 3.44) |
| Not at risk, Week 35-47 | 3.24 (2.09 to 4.79) | 1.26 (0.40 to 2.97) | 0.96 (0.12 to 3.36) |
| Not at risk, Week 35-48 | 3.17 (2.04 to 4.69) | 1.22 (0.38 to 2.91) | 0.95 (0.12 to 3.35) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 1.69 (0.00 to 16.08) |
| At risk, Week 37 | 6.34 (5.19 to 7.65) | 0.00 (0.00 to 52.18) | 0.46 (0.01 to 2.71) |
| At risk, Week 38 | 4.86 (3.62 to 6.37) | 14.29 (0.00 to 90.97) | 0.60 (0.03 to 2.75) |
| At risk, Week 39 | 4.71 (3.97 to 5.55) | 1.03 (0.03 to 5.61) | 1.34 (0.35 to 3.48) |
| At risk, Week 40 | 5.47 (3.22 to 8.62) | 4.15 (2.16 to 7.15) | 1.15 (0.41 to 2.55) |
| At risk, Week 41 | 4.79 (3.67 to 6.14) | 3.97 (2.07 to 6.84) | 0.00 (0.00 to 1.10) |
| At risk, Week 42 | 2.79 (1.54 to 4.63) | 0.84 (0.17 to 2.44) | 1.89 (0.23 to 6.66) |
| At risk, Week 43 | 3.13 (1.02 to 7.19) | 2.75 (0.81 to 6.65) | 0.00 (0.00 to 2.76) |
| At risk, Week 44 | 3.23 (1.03 to 7.47) | 3.12 (1.08 to 6.91) | 0.19 (0.00 to 1.08) |
| At risk, Week 45 | 1.57 (0.30 to 4.67) | 1.32 (0.01 to 8.97) | 1.74 (0.21 to 6.14) |
| At risk, Week 46 | 1.86 (0.41 to 5.21) | 0.21 (0.00 to 2.00) | 0.00 (0.00 to 4.62) |
| At risk, Week 47 | 2.36 (0.33 to 7.88) | 1.46 (0.18 to 5.17) | 1.14 (0.06 to 5.29) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 1.19 (0.01 to 7.80) | 0.00 (0.00 to 9.74) |
| Not at risk, Week 36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 37 | 8.27 (4.20 to 14.32) | — | 3.23 (0.02 to 21.72) |
| Not at risk, Week 38 | 4.85 (2.12 to 9.33) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 8.22) |
| Not at risk, Week 39 | 7.94 (4.20 to 13.40) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 9.25) |
| Not at risk, Week 40 | 3.43 (1.27 to 7.31) | 3.45 (0.09 to 17.76) | 0.00 (0.00 to 5.69) |
| Not at risk, Week 41 | 3.66 (1.33 to 7.88) | 2.44 (0.06 to 12.86) | 1.56 (0.01 to 10.47) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 6.38) | 0.00 (0.00 to 11.94) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.85) | 3.64 (0.44 to 12.53) | 0.00 (0.00 to 10.89) |
| Not at risk, Week 44 | 1.45 (0.01 to 10.55) | 7.41 (2.06 to 17.89) | 2.17 (0.06 to 11.53) |
| Not at risk, Week 45 | 5.41 (5.41 to 14.52) | 1.00 (0.03 to 5.45) | 2.55 (0.94 to 5.47) |
| Not at risk, Week 46 | 6.17 (1.50 to 15.96) | 2.78 (0.15 to 12.35) | 0.00 (0.00 to 17.65) |
| Not at risk, Week 47 | 4.35 (0.33 to 17.06) | 0.00 (0.00 to 16.11) | 4.17 (0.02 to 27.48) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 6.25 (0.00 to 64.40) | 0.00 (0.00 to 45.93) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 1.67 (0.00 to 14.74) |
| At risk, Week 35-37 | 6.34 (5.19 to 7.65) | 0.00 (0.00 to 45.93) | 0.60 (0.08 to 2.12) |
| At risk, Week 35-38 | 5.56 (4.76 to 6.45) | 7.69 (0.08 to 41.17) | 0.60 (0.13 to 1.73) |
| At risk, Week 35-39 | 5.19 (4.45 to 6.02) | 1.82 (0.22 to 6.41) | 0.83 (0.21 to 2.21) |
| At risk, Week 35-40 | 5.24 (4.33 to 6.29) | 3.55 (1.86 to 6.08) | 0.92 (0.25 to 2.34) |
| At risk, Week 35-41 | 5.19 (4.30 to 6.19) | 3.72 (2.42 to 5.45) | 0.78 (0.20 to 2.05) |
| At risk, Week 35-42 | 5.03 (4.13 to 6.06) | 2.78 (1.75 to 4.16) | 0.88 (0.26 to 2.15) |
| At risk, Week 35-43 | 4.97 (4.06 to 6.01) | 2.77 (1.75 to 4.16) | 0.83 (0.25 to 2.02) |
| At risk, Week 35-44 | 4.89 (3.98 to 5.92) | 2.85 (1.74 to 4.38) | 0.73 (0.24 to 1.67) |
| At risk, Week 35-45 | 4.80 (3.90 to 5.83) | 2.63 (1.37 to 4.54) | 0.76 (0.29 to 1.61) |
| At risk, Week 35-46 | 4.75 (3.83 to 5.81) | 2.19 (0.96 to 4.25) | 0.75 (0.29 to 1.57) |
| At risk, Week 35-47 | 4.71 (3.80 to 5.77) | 2.16 (0.98 to 4.10) | 0.77 (0.32 to 1.55) |
| At risk, Week 35-48 | 4.68 (3.76 to 5.74) | 2.13 (0.96 to 4.06) | 0.76 (0.31 to 1.53) |
| Not at risk, Week 35-36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 35-37 | 8.27 (4.20 to 14.32) | — | 3.03 (0.01 to 20.77) |
| Not at risk, Week 35-38 | 6.38 (3.88 to 9.78) | 0.00 (0.00 to 70.76) | 1.32 (0.01 to 8.76) |
| Not at risk, Week 35-39 | 7.21 (5.08 to 9.87) | 0.00 (0.00 to 26.46) | 0.88 (0.01 to 5.83) |
| Not at risk, Week 35-40 | 6.40 (4.46 to 8.83) | 2.44 (0.06 to 12.86) | 0.56 (0.00 to 3.88) |
| Not at risk, Week 35-41 | 5.94 (4.35 to 7.88) | 2.44 (0.30 to 8.53) | 0.83 (0.08 to 3.19) |
| Not at risk, Week 35-42 | 5.45 (3.94 to 7.31) | 1.45 (0.18 to 5.14) | 0.74 (0.08 to 2.76) |
| Not at risk, Week 35-43 | 5.19 (3.75 to 6.98) | 2.07 (0.57 to 5.22) | 0.66 (0.07 to 2.52) |
| Not at risk, Week 35-44 | 4.97 (3.59 to 6.70) | 3.24 (1.41 to 6.28) | 0.86 (0.18 to 2.50) |
| Not at risk, Week 35-45 | 5.00 (3.77 to 6.49) | 2.59 (1.19 to 4.87) | 1.54 (0.57 to 3.34) |
| Not at risk, Week 35-46 | 5.07 (3.96 to 6.38) | 2.64 (1.37 to 4.56) | 1.50 (0.53 to 3.30) |
| Not at risk, Week 35-47 | 5.05 (3.96 to 6.33) | 2.52 (1.31 to 4.36) | 1.60 (0.64 to 3.28) |
| Not at risk, Week 35-48 | 4.94 (3.87 to 6.20) | 2.64 (1.31 to 4.72) | 1.58 (0.63 to 3.25) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.06) |
| At risk, Week 37 | 2.10 (1.36 to 3.09) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.84) |
| At risk, Week 38 | 1.74 (0.95 to 2.90) | 14.29 (0.00 to 90.97) | 0.00 (0.00 to 0.74) |
| At risk, Week 39 | 1.46 (0.97 to 2.10) | 0.00 (0.00 to 3.73) | 0.00 (0.00 to 0.82) |
| At risk, Week 40 | 1.54 (0.97 to 2.32) | 1.28 (0.35 to 3.24) | 0.00 (0.00 to 0.70) |
| At risk, Week 41 | 1.26 (0.62 to 2.28) | 0.66 (0.08 to 2.37) | 0.00 (0.00 to 1.10) |
| At risk, Week 42 | 1.09 (0.50 to 2.06) | 0.00 (0.00 to 1.03) | 0.00 (0.00 to 1.72) |
| At risk, Week 43 | 0.89 (0.24 to 2.28) | 0.00 (0.00 to 1.12) | 0.76 (0.00 to 5.65) |
| At risk, Week 44 | 0.73 (0.24 to 1.71) | 0.24 (0.00 to 1.48) | 0.00 (0.00 to 0.71) |
| At risk, Week 45 | 2.10 (0.56 to 5.34) | 0.66 (0.00 to 4.55) | 0.87 (0.02 to 4.75) |
| At risk, Week 46 | 1.86 (0.20 to 6.79) | 0.21 (0.00 to 1.71) | 1.28 (0.01 to 8.31) |
| At risk, Week 47 | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 2.09) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 9.74) |
| Not at risk, Week 36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 37 | 2.26 (0.23 to 8.42) | — | 3.23 (0.02 to 21.72) |
| Not at risk, Week 38 | 3.03 (0.99 to 6.93) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 8.22) |
| Not at risk, Week 39 | 2.06 (0.68 to 4.71) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 9.25) |
| Not at risk, Week 40 | 0.57 (0.01 to 3.31) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 5.69) |
| Not at risk, Week 41 | 1.22 (0.03 to 6.81) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 5.60) |
| Not at risk, Week 42 | 1.14 (0.01 to 7.91) | 0.00 (0.00 to 6.38) | 0.00 (0.00 to 11.94) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 10.89) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 1.85 (0.05 to 9.89) | 0.00 (0.00 to 7.71) |
| Not at risk, Week 45 | 1.35 (0.03 to 7.30) | 2.00 (0.10 to 9.21) | 0.85 (0.10 to 3.04) |
| Not at risk, Week 46 | 0.00 (0.00 to 4.45) | 0.00 (0.00 to 3.36) | 0.00 (0.00 to 17.65) |
| Not at risk, Week 47 | 0.00 (0.00 to 7.71) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 14.25) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 45.93) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.96) |
| At risk, Week 35-37 | 2.10 (1.36 to 3.09) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.74) |
| At risk, Week 35-38 | 1.91 (1.42 to 2.50) | 7.69 (0.08 to 41.17) | 0.00 (0.00 to 0.37) |
| At risk, Week 35-39 | 1.71 (1.24 to 2.31) | 0.91 (0.02 to 4.96) | 0.00 (0.00 to 0.25) |
| At risk, Week 35-40 | 1.68 (1.29 to 2.16) | 1.18 (0.38 to 2.74) | 0.00 (0.00 to 0.19) |
| At risk, Week 35-41 | 1.63 (1.24 to 2.11) | 0.97 (0.35 to 2.10) | 0.00 (0.00 to 0.16) |
| At risk, Week 35-42 | 1.60 (1.22 to 2.05) | 0.65 (0.23 to 1.42) | 0.00 (0.00 to 0.15) |
| At risk, Week 35-43 | 1.57 (1.20 to 2.02) | 0.50 (0.16 to 1.17) | 0.04 (0.00 to 0.30) |
| At risk, Week 35-44 | 1.53 (1.18 to 1.96) | 0.44 (0.10 to 1.23) | 0.03 (0.00 to 0.20) |
| At risk, Week 35-45 | 1.55 (1.22 to 1.94) | 0.47 (0.16 to 1.05) | 0.06 (0.00 to 0.39) |
| At risk, Week 35-46 | 1.55 (1.23 to 1.94) | 0.42 (0.15 to 0.93) | 0.09 (0.01 to 0.37) |
| At risk, Week 35-47 | 1.53 (1.20 to 1.92) | 0.40 (0.15 to 0.88) | 0.09 (0.01 to 0.36) |
| At risk, Week 35-48 | 1.52 (1.19 to 1.90) | 0.39 (0.14 to 0.85) | 0.08 (0.01 to 0.35) |
| Not at risk, Week 35-36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 35-37 | 2.26 (0.23 to 8.42) | — | 3.03 (0.01 to 20.77) |
| Not at risk, Week 35-38 | 2.68 (0.87 to 6.18) | 0.00 (0.00 to 70.76) | 1.32 (0.01 to 9.66) |
| Not at risk, Week 35-39 | 2.35 (0.93 to 4.85) | 0.00 (0.00 to 26.46) | 0.88 (0.01 to 6.17) |
| Not at risk, Week 35-40 | 1.97 (0.76 to 4.12) | 0.00 (0.00 to 8.60) | 0.56 (0.00 to 4.02) |
| Not at risk, Week 35-41 | 1.84 (0.79 to 3.62) | 0.00 (0.00 to 4.40) | 0.41 (0.00 to 2.67) |
| Not at risk, Week 35-42 | 1.78 (0.81 to 3.37) | 0.00 (0.00 to 2.64) | 0.37 (0.00 to 2.46) |
| Not at risk, Week 35-43 | 1.70 (0.77 to 3.23) | 0.00 (0.00 to 1.89) | 0.33 (0.00 to 2.19) |
| Not at risk, Week 35-44 | 1.60 (0.69 to 3.14) | 0.40 (0.01 to 2.23) | 0.29 (0.00 to 1.77) |
| Not at risk, Week 35-45 | 1.59 (0.73 to 2.99) | 0.86 (0.18 to 2.51) | 0.51 (0.07 to 1.75) |
| Not at risk, Week 35-46 | 1.49 (0.67 to 2.84) | 0.66 (0.14 to 1.91) | 0.50 (0.07 to 1.73) |
| Not at risk, Week 35-47 | 1.44 (0.66 to 2.74) | 0.63 (0.13 to 1.83) | 0.48 (0.06 to 1.69) |
| Not at risk, Week 35-48 | 1.41 (0.64 to 2.67) | 0.61 (0.13 to 1.77) | 0.47 (0.06 to 1.68) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.06) |
| At risk, Week 37 | 0.69 (0.01 to 4.05) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.84) |
| At risk, Week 38 | 0.54 (0.05 to 2.13) | 0.00 (0.00 to 40.96) | 0.20 (0.00 to 1.15) |
| At risk, Week 39 | 0.34 (0.03 to 1.39) | 0.00 (0.00 to 3.73) | 0.00 (0.00 to 0.82) |
| At risk, Week 40 | 0.48 (0.06 to 1.75) | 0.64 (0.01 to 4.17) | 0.00 (0.00 to 0.70) |
| At risk, Week 41 | 0.20 (0.04 to 0.60) | 0.99 (0.14 to 3.38) | 0.00 (0.00 to 1.10) |
| At risk, Week 42 | 0.00 (0.00 to 0.45) | 0.28 (0.00 to 2.18) | 0.00 (0.00 to 1.72) |
| At risk, Week 43 | 0.22 (0.00 to 1.51) | 0.00 (0.00 to 1.12) | 0.00 (0.00 to 2.76) |
| At risk, Week 44 | 0.29 (0.02 to 1.34) | 0.24 (0.00 to 1.48) | 0.00 (0.00 to 0.71) |
| At risk, Week 45 | 0.26 (0.00 to 1.87) | 0.00 (0.00 to 1.21) | 0.00 (0.00 to 3.16) |
| At risk, Week 46 | 0.37 (0.00 to 2.68) | 0.00 (0.00 to 0.78) | 0.00 (0.00 to 4.62) |
| At risk, Week 47 | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 2.09) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 9.74) |
| Not at risk, Week 36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 37 | 0.75 (0.01 to 5.16) | — | 0.00 (0.00 to 11.22) |
| Not at risk, Week 38 | 1.21 (0.15 to 4.31) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 8.22) |
| Not at risk, Week 39 | 1.18 (0.17 to 3.93) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 9.25) |
| Not at risk, Week 40 | 0.00 (0.00 to 2.09) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 5.69) |
| Not at risk, Week 41 | 0.61 (0.01 to 3.69) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 5.60) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 6.38) | 0.00 (0.00 to 11.94) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 10.89) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 3.70 (0.16 to 16.98) | 0.00 (0.00 to 7.71) |
| Not at risk, Week 45 | 0.00 (0.00 to 4.86) | 0.00 (0.00 to 3.62) | 0.43 (0.01 to 2.35) |
| Not at risk, Week 46 | 0.00 (0.00 to 4.45) | 0.00 (0.00 to 3.36) | 0.00 (0.00 to 17.65) |
| Not at risk, Week 47 | 0.00 (0.00 to 7.71) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 14.25) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 45.93) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.96) |
| At risk, Week 35-37 | 0.69 (0.01 to 4.05) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.74) |
| At risk, Week 35-38 | 0.61 (0.03 to 2.87) | 0.00 (0.00 to 24.71) | 0.10 (0.00 to 0.57) |
| At risk, Week 35-39 | 0.49 (0.03 to 2.21) | 0.00 (0.00 to 3.30) | 0.07 (0.00 to 0.40) |
| At risk, Week 35-40 | 0.49 (0.03 to 2.11) | 0.47 (0.01 to 2.52) | 0.05 (0.00 to 0.31) |
| At risk, Week 35-41 | 0.46 (0.04 to 1.88) | 0.69 (0.05 to 2.89) | 0.04 (0.00 to 0.26) |
| At risk, Week 35-42 | 0.43 (0.03 to 1.79) | 0.56 (0.11 to 1.63) | 0.04 (0.00 to 0.24) |
| At risk, Week 35-43 | 0.42 (0.03 to 1.73) | 0.43 (0.09 to 1.23) | 0.04 (0.00 to 0.23) |
| At risk, Week 35-44 | 0.41 (0.04 to 1.64) | 0.38 (0.06 to 1.26) | 0.03 (0.00 to 0.20) |
| At risk, Week 35-45 | 0.41 (0.04 to 1.59) | 0.33 (0.04 to 1.17) | 0.03 (0.00 to 0.19) |
| At risk, Week 35-46 | 0.41 (0.04 to 1.61) | 0.27 (0.02 to 1.07) | 0.03 (0.00 to 0.19) |
| At risk, Week 35-47 | 0.40 (0.04 to 1.59) | 0.26 (0.02 to 1.02) | 0.03 (0.00 to 0.18) |
| At risk, Week 35-48 | 0.40 (0.04 to 1.57) | 0.25 (0.02 to 0.99) | 0.03 (0.00 to 0.18) |
| Not at risk, Week 35-36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 35-37 | 0.75 (0.01 to 5.16) | — | 0.00 (0.00 to 10.58) |
| Not at risk, Week 35-38 | 1.01 (0.18 to 3.13) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 4.74) |
| Not at risk, Week 35-39 | 1.10 (0.21 to 3.29) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 3.18) |
| Not at risk, Week 35-40 | 0.86 (0.12 to 2.89) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 2.06) |
| Not at risk, Week 35-41 | 0.82 (0.15 to 2.52) | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 1.52) |
| Not at risk, Week 35-42 | 0.75 (0.12 to 2.39) | 0.00 (0.00 to 2.64) | 0.00 (0.00 to 1.36) |
| Not at risk, Week 35-43 | 0.72 (0.11 to 2.31) | 0.00 (0.00 to 1.89) | 0.00 (0.00 to 1.21) |
| Not at risk, Week 35-44 | 0.67 (0.10 to 2.22) | 0.81 (0.10 to 2.89) | 0.00 (0.00 to 1.05) |
| Not at risk, Week 35-45 | 0.63 (0.09 to 2.11) | 0.58 (0.07 to 2.07) | 0.17 (0.00 to 0.95) |
| Not at risk, Week 35-46 | 0.60 (0.09 to 2.01) | 0.44 (0.05 to 1.58) | 0.17 (0.00 to 0.92) |
| Not at risk, Week 35-47 | 0.58 (0.08 to 1.93) | 0.42 (0.05 to 1.51) | 0.16 (0.00 to 0.89) |
| Not at risk, Week 35-48 | 0.56 (0.08 to 1.89) | 0.41 (0.05 to 1.46) | 0.16 (0.00 to 0.88) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.06) |
| At risk, Week 37 | 0.69 (0.39 to 1.11) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.84) |
| At risk, Week 38 | 0.39 (0.19 to 0.71) | 0.00 (0.00 to 40.96) | 0.40 (0.04 to 1.53) |
| At risk, Week 39 | 0.32 (0.16 to 0.55) | 0.00 (0.00 to 3.73) | 0.00 (0.00 to 0.82) |
| At risk, Week 40 | 0.58 (0.29 to 1.04) | 0.32 (0.01 to 1.77) | 0.19 (0.00 to 1.06) |
| At risk, Week 41 | 0.13 (0.02 to 0.48) | 0.66 (0.08 to 2.37) | 0.00 (0.00 to 1.10) |
| At risk, Week 42 | 0.12 (0.00 to 0.89) | 0.00 (0.00 to 1.03) | 0.00 (0.00 to 1.72) |
| At risk, Week 43 | 0.67 (0.12 to 2.07) | 0.61 (0.07 to 2.19) | 0.00 (0.00 to 2.76) |
| At risk, Week 44 | 0.59 (0.12 to 1.70) | 0.24 (0.00 to 1.45) | 0.00 (0.00 to 0.71) |
| At risk, Week 45 | 0.26 (0.00 to 1.82) | 0.00 (0.00 to 1.21) | 0.00 (0.00 to 3.16) |
| At risk, Week 46 | 0.37 (0.00 to 2.54) | 0.21 (0.00 to 1.90) | 0.00 (0.00 to 4.62) |
| At risk, Week 47 | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 2.09) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 1.19 (0.01 to 7.80) | 0.00 (0.00 to 9.74) |
| Not at risk, Week 36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 37 | 2.26 (0.47 to 6.45) | — | 0.00 (0.00 to 11.22) |
| Not at risk, Week 38 | 3.03 (0.44 to 9.92) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 8.22) |
| Not at risk, Week 39 | 0.88 (0.13 to 2.92) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 9.25) |
| Not at risk, Week 40 | 0.57 (0.00 to 3.97) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 5.69) |
| Not at risk, Week 41 | 0.00 (0.00 to 2.22) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 5.60) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 6.38) | 0.00 (0.00 to 11.94) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 10.89) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 0.00 (0.00 to 6.60) | 0.00 (0.00 to 7.71) |
| Not at risk, Week 45 | 0.00 (0.00 to 4.86) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 1.56) |
| Not at risk, Week 46 | 1.23 (0.01 to 8.69) | 0.00 (0.00 to 3.36) | 0.00 (0.00 to 17.65) |
| Not at risk, Week 47 | 0.00 (0.00 to 7.71) | 4.76 (0.12 to 23.82) | 0.00 (0.00 to 14.25) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 45.93) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.96) |
| At risk, Week 35-37 | 0.69 (0.39 to 1.11) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.74) |
| At risk, Week 35-38 | 0.53 (0.35 to 0.77) | 0.00 (0.00 to 24.71) | 0.20 (0.02 to 0.74) |
| At risk, Week 35-39 | 0.44 (0.31 to 0.60) | 0.00 (0.00 to 3.30) | 0.14 (0.01 to 0.53) |
| At risk, Week 35-40 | 0.46 (0.34 to 0.61) | 0.24 (0.01 to 1.31) | 0.15 (0.03 to 0.45) |
| At risk, Week 35-41 | 0.42 (0.31 to 0.55) | 0.41 (0.09 to 1.20) | 0.13 (0.03 to 0.38) |
| At risk, Week 35-42 | 0.40 (0.30 to 0.53) | 0.28 (0.06 to 0.81) | 0.12 (0.02 to 0.35) |
| At risk, Week 35-43 | 0.41 (0.31 to 0.54) | 0.36 (0.12 to 0.83) | 0.11 (0.02 to 0.33) |
| At risk, Week 35-44 | 0.42 (0.32 to 0.54) | 0.33 (0.12 to 0.71) | 0.09 (0.02 to 0.29) |
| At risk, Week 35-45 | 0.42 (0.32 to 0.54) | 0.28 (0.10 to 0.61) | 0.09 (0.02 to 0.28) |
| At risk, Week 35-46 | 0.42 (0.32 to 0.54) | 0.27 (0.11 to 0.55) | 0.09 (0.02 to 0.27) |
| At risk, Week 35-47 | 0.41 (0.31 to 0.53) | 0.26 (0.10 to 0.53) | 0.09 (0.02 to 0.26) |
| At risk, Week 35-48 | 0.41 (0.31 to 0.53) | 0.28 (0.12 to 0.56) | 0.08 (0.02 to 0.26) |
| Not at risk, Week 35-36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 35-37 | 2.26 (0.47 to 6.45) | — | 0.00 (0.00 to 10.58) |
| Not at risk, Week 35-38 | 2.68 (0.73 to 6.77) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 4.74) |
| Not at risk, Week 35-39 | 1.72 (0.47 to 4.35) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 3.18) |
| Not at risk, Week 35-40 | 1.48 (0.48 to 3.42) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 2.06) |
| Not at risk, Week 35-41 | 1.23 (0.41 to 2.79) | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 1.52) |
| Not at risk, Week 35-42 | 1.13 (0.39 to 2.52) | 0.00 (0.00 to 2.64) | 0.00 (0.00 to 1.36) |
| Not at risk, Week 35-43 | 1.07 (0.38 to 2.39) | 0.00 (0.00 to 1.89) | 0.00 (0.00 to 1.21) |
| Not at risk, Week 35-44 | 1.01 (0.35 to 2.27) | 0.00 (0.00 to 1.48) | 0.00 (0.00 to 1.05) |
| Not at risk, Week 35-45 | 0.95 (0.33 to 2.13) | 0.00 (0.00 to 1.06) | 0.00 (0.00 to 0.63) |
| Not at risk, Week 35-46 | 0.97 (0.39 to 1.98) | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.61) |
| Not at risk, Week 35-47 | 0.94 (0.37 to 1.93) | 0.21 (0.01 to 1.16) | 0.00 (0.00 to 0.59) |
| Not at risk, Week 35-48 | 0.92 (0.36 to 1.90) | 0.20 (0.01 to 1.13) | 0.00 (0.00 to 0.58) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.06) |
| At risk, Week 37 | 4.11 (2.99 to 5.51) | 0.00 (0.00 to 52.18) | 0.23 (0.00 to 1.36) |
| At risk, Week 38 | 3.36 (2.39 to 4.57) | 0.00 (0.00 to 40.96) | 0.40 (0.05 to 1.44) |
| At risk, Week 39 | 3.20 (2.58 to 3.93) | 0.00 (0.00 to 3.73) | 0.89 (0.24 to 2.27) |
| At risk, Week 40 | 2.39 (1.62 to 3.40) | 1.28 (0.01 to 8.23) | 0.57 (0.07 to 2.08) |
| At risk, Week 41 | 2.53 (1.80 to 3.46) | 0.00 (0.00 to 1.21) | 0.00 (0.00 to 1.10) |
| At risk, Week 42 | 2.18 (0.95 to 4.26) | 0.56 (0.06 to 2.06) | 0.00 (0.00 to 1.72) |
| At risk, Week 43 | 3.13 (1.44 to 5.87) | 0.31 (0.00 to 1.95) | 0.76 (0.01 to 5.02) |
| At risk, Week 44 | 2.06 (0.73 to 4.52) | 0.96 (0.01 to 5.84) | 0.00 (0.00 to 0.71) |
| At risk, Week 45 | 2.36 (0.70 to 5.70) | 0.66 (0.05 to 2.81) | 0.00 (0.00 to 3.16) |
| At risk, Week 46 | 1.12 (0.23 to 3.22) | 0.00 (0.00 to 0.78) | 2.56 (0.31 to 8.96) |
| At risk, Week 47 | 1.89 (0.28 to 6.18) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 2.09) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 2.38 (0.29 to 8.34) | 0.00 (0.00 to 9.74) |
| Not at risk, Week 36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 37 | 6.77 (2.22 to 15.15) | — | 3.23 (0.08 to 16.70) |
| Not at risk, Week 38 | 3.64 (1.16 to 8.42) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 8.22) |
| Not at risk, Week 39 | 4.71 (2.21 to 8.64) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 9.25) |
| Not at risk, Week 40 | 5.14 (1.78 to 11.28) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 5.69) |
| Not at risk, Week 41 | 2.44 (0.64 to 6.27) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 5.60) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 6.38) | 0.00 (0.00 to 11.94) |
| Not at risk, Week 43 | 3.85 (0.33 to 14.73) | 0.00 (0.00 to 6.49) | 3.13 (0.08 to 16.22) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 3.70 (0.16 to 16.98) | 0.00 (0.00 to 7.71) |
| Not at risk, Week 45 | 4.05 (0.52 to 13.69) | 0.00 (0.00 to 3.62) | 0.43 (0.01 to 2.35) |
| Not at risk, Week 46 | 2.47 (0.07 to 12.65) | 0.93 (0.00 to 9.43) | 0.00 (0.00 to 17.65) |
| Not at risk, Week 47 | 2.17 (0.06 to 11.53) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 14.25) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 45.93) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.96) |
| At risk, Week 35-37 | 4.11 (2.99 to 5.51) | 0.00 (0.00 to 45.93) | 0.20 (0.00 to 1.12) |
| At risk, Week 35-38 | 3.71 (2.74 to 4.92) | 0.00 (0.00 to 24.71) | 0.30 (0.06 to 0.88) |
| At risk, Week 35-39 | 3.49 (2.70 to 4.43) | 0.00 (0.00 to 3.30) | 0.48 (0.18 to 1.03) |
| At risk, Week 35-40 | 3.30 (2.62 to 4.10) | 0.95 (0.03 to 5.00) | 0.51 (0.17 to 1.16) |
| At risk, Week 35-41 | 3.20 (2.54 to 3.97) | 0.55 (0.04 to 2.31) | 0.43 (0.13 to 1.04) |
| At risk, Week 35-42 | 3.14 (2.46 to 3.93) | 0.56 (0.05 to 2.20) | 0.40 (0.12 to 0.96) |
| At risk, Week 35-43 | 3.14 (2.46 to 3.94) | 0.50 (0.10 to 1.49) | 0.42 (0.16 to 0.88) |
| At risk, Week 35-44 | 3.08 (2.40 to 3.89) | 0.60 (0.07 to 2.19) | 0.35 (0.11 to 0.84) |
| At risk, Week 35-45 | 3.07 (2.41 to 3.84) | 0.61 (0.08 to 2.13) | 0.34 (0.10 to 0.81) |
| At risk, Week 35-46 | 3.03 (2.38 to 3.80) | 0.50 (0.05 to 1.95) | 0.39 (0.14 to 0.85) |
| At risk, Week 35-47 | 3.01 (2.36 to 3.79) | 0.48 (0.04 to 1.86) | 0.37 (0.13 to 0.82) |
| At risk, Week 35-48 | 2.99 (2.34 to 3.77) | 0.53 (0.06 to 1.93) | 0.36 (0.13 to 0.81) |
| Not at risk, Week 35-36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 35-37 | 6.77 (2.22 to 15.15) | — | 15.15 (0.08 to 15.76) |
| Not at risk, Week 35-38 | 5.03 (2.53 to 8.85) | 0.00 (0.00 to 70.76) | 1.32 (0.03 to 7.11) |
| Not at risk, Week 35-39 | 4.86 (2.85 to 7.68) | 0.00 (0.00 to 26.46) | 0.88 (0.01 to 5.49) |
| Not at risk, Week 35-40 | 4.92 (3.02 to 7.52) | 0.00 (0.00 to 8.60) | 0.56 (0.00 to 3.91) |
| Not at risk, Week 35-41 | 4.50 (2.87 to 6.69) | 0.00 (0.00 to 4.40) | 0.41 (0.00 to 2.93) |
| Not at risk, Week 35-42 | 4.13 (2.69 to 6.03) | 0.00 (0.00 to 2.64) | 0.37 (0.00 to 2.63) |
| Not at risk, Week 35-43 | 4.12 (2.71 to 5.98) | 0.00 (0.00 to 1.89) | 0.66 (0.08 to 2.37) |
| Not at risk, Week 35-44 | 3.88 (2.57 to 5.60) | 0.81 (0.10 to 2.89) | 0.57 (0.06 to 2.16) |
| Not at risk, Week 35-45 | 3.89 (2.72 to 5.37) | 0.58 (0.07 to 2.07) | 0.51 (0.11 to 1.50) |
| Not at risk, Week 35-46 | 3.80 (2.78 to 5.07) | 0.66 (0.13 to 1.98) | 0.50 (0.10 to 1.45) |
| Not at risk, Week 35-47 | 3.75 (2.75 to 4.98) | 0.63 (0.12 to 1.92) | 0.48 (0.10 to 1.39) |
| Not at risk, Week 35-48 | 3.67 (2.68 to 4.89) | 0.61 (0.11 to 1.88) | 0.47 (0.10 to 1.38) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.06) |
| At risk, Week 37 | 0.21 (0.07 to 0.50) | 0.00 (0.00 to 52.18) | 0.00 (0.00 to 0.84) |
| At risk, Week 38 | 0.27 (0.11 to 0.56) | 0.00 (0.00 to 40.96) | 0.00 (0.00 to 0.74) |
| At risk, Week 39 | 0.21 (0.04 to 0.63) | 0.00 (0.00 to 3.73) | 0.00 (0.00 to 0.82) |
| At risk, Week 40 | 0.00 (0.00 to 0.20) | 0.32 (0.00 to 2.10) | 0.00 (0.00 to 0.70) |
| At risk, Week 41 | 0.20 (0.03 to 0.66) | 0.33 (0.01 to 1.83) | 0.30 (0.00 to 2.16) |
| At risk, Week 42 | 0.00 (0.00 to 0.45) | 0.00 (0.00 to 1.03) | 0.00 (0.00 to 1.72) |
| At risk, Week 43 | 0.00 (0.00 to 0.82) | 0.00 (0.00 to 1.12) | 0.00 (0.00 to 2.76) |
| At risk, Week 44 | 0.15 (0.00 to 1.16) | 0.00 (0.00 to 0.88) | 0.00 (0.00 to 0.71) |
| At risk, Week 45 | 0.00 (0.00 to 0.96) | 0.00 (0.00 to 1.21) | 0.00 (0.00 to 3.16) |
| At risk, Week 46 | 0.00 (0.00 to 1.36) | 0.00 (0.00 to 0.78) | 0.00 (0.00 to 4.62) |
| At risk, Week 47 | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 2.66) | 0.00 (0.00 to 2.09) |
| At risk, Week 48 | 0.00 (0.00 to 3.18) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 9.74) |
| Not at risk, Week 36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 37 | 1.50 (0.18 to 5.33) | — | 0.00 (0.00 to 11.22) |
| Not at risk, Week 38 | 0.61 (0.01 to 4.01) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 8.22) |
| Not at risk, Week 39 | 0.29 (0.00 to 2.20) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 9.25) |
| Not at risk, Week 40 | 0.00 (0.00 to 2.09) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 5.69) |
| Not at risk, Week 41 | 0.00 (0.00 to 2.22) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 5.60) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 6.38) | 0.00 (0.00 to 11.94) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 10.89) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 0.00 (0.00 to 6.60) | 0.00 (0.00 to 7.71) |
| Not at risk, Week 45 | 0.00 (0.00 to 4.86) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 1.56) |
| Not at risk, Week 46 | 0.00 (0.00 to 4.45) | 0.00 (0.00 to 3.36) | 0.00 (0.00 to 17.65) |
| Not at risk, Week 47 | 0.00 (0.00 to 7.71) | 4.76 (0.12 to 23.82) | 0.00 (0.00 to 14.25) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 45.93) |
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.96) |
| At risk, Week 35-37 | 0.21 (0.07 to 0.50) | 0.00 (0.00 to 45.93) | 0.00 (0.00 to 0.74) |
| At risk, Week 35-38 | 0.24 (0.13 to 0.43) | 0.00 (0.00 to 24.71) | 0.00 (0.00 to 0.25) |
| At risk, Week 35-39 | 0.23 (0.10 to 0.44) | 0.00 (0.00 to 3.30) | 0.00 (0.00 to 0.19) |
| At risk, Week 35-40 | 0.19 (0.08 to 0.38) | 0.24 (0.01 to 1.31) | 0.00 (0.00 to 0.19) |
| At risk, Week 35-41 | 0.19 (0.09 to 0.35) | 0.28 (0.02 to 1.16) | 0.04 (0.00 to 0.35) |
| At risk, Week 35-42 | 0.18 (0.08 to 0.33) | 0.19 (0.02 to 0.74) | 0.04 (0.00 to 0.32) |
| At risk, Week 35-43 | 0.17 (0.08 to 0.33) | 0.14 (0.01 to 0.57) | 0.04 (0.00 to 0.30) |
| At risk, Week 35-44 | 0.17 (0.08 to 0.32) | 0.11 (0.01 to 0.48) | 0.03 (0.00 to 0.20) |
| At risk, Week 35-45 | 0.17 (0.08 to 0.31) | 0.09 (0.00 to 0.44) | 0.03 (0.00 to 0.20) |
| At risk, Week 35-46 | 0.16 (0.08 to 0.31) | 0.08 (0.00 to 0.40) | 0.03 (0.00 to 0.19) |
| At risk, Week 35-47 | 0.16 (0.07 to 0.31) | 0.07 (0.00 to 0.38) | 0.03 (0.00 to 0.18) |
| At risk, Week 35-48 | 0.16 (0.07 to 0.30) | 0.07 (0.00 to 0.37) | 0.03 (0.00 to 0.18) |
| Not at risk, Week 35-36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 35-37 | 1.50 (0.18 to 5.33) | — | 0.00 (0.00 to 10.58) |
| Not at risk, Week 35-38 | 1.01 (0.13 to 3.49) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 4.74) |
| Not at risk, Week 35-39 | 0.63 (0.08 to 2.26) | 0.00 (0.00 to 2.26) | 0.00 (0.00 to 3.18) |
| Not at risk, Week 35-40 | 0.49 (0.05 to 1.84) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 2.06) |
| Not at risk, Week 35-41 | 0.41 (0.04 to 1.57) | 0.00 (0.00 to 4.40) | 0.00 (0.00 to 1.52) |
| Not at risk, Week 35-42 | 0.38 (0.04 to 1.43) | 0.00 (0.00 to 2.64) | 0.00 (0.00 to 1.36) |
| Not at risk, Week 35-43 | 0.36 (0.04 to 1.35) | 0.00 (0.00 to 1.89) | 0.00 (0.00 to 1.21) |
| Not at risk, Week 35-44 | 0.34 (0.03 to 1.28) | 0.00 (0.00 to 1.48) | 0.00 (0.00 to 1.05) |
| Not at risk, Week 35-45 | 0.32 (0.03 to 1.21) | 0.00 (0.00 to 1.06) | 0.00 (0.00 to 0.63) |
| Not at risk, Week 35-46 | 0.30 (0.03 to 1.12) | 0.00 (0.00 to 0.81) | 0.00 (0.00 to 0.61) |
| Not at risk, Week 35-47 | 0.29 (0.03 to 1.09) | 0.21 (0.00 to 1.78) | 0.00 (0.00 to 0.59) |
| Not at risk, Week 35-48 | 0.28 (0.03 to 1.07) | 0.20 (0.00 to 1.69) | 0.00 (0.00 to 0.58) |
SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system)within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 6.06) |
| At risk, Week 37 | 0.13 (0.02 to 0.39) | 0.00 (0.00 to 52.18) | 0.23 (0.00 to 1.85) |
| At risk, Week 38 | 0.19 (0.04 to 0.55) | 0.00 (0.00 to 40.96) | 0.40 (0.05 to 1.44) |
| At risk, Week 39 | 0.08 (0.01 to 0.24) | 0.00 (0.00 to 3.73) | 0.00 (0.00 to 0.82) |
| At risk, Week 40 | 0.16 (0.02 to 0.62) | 0.00 (0.00 to 2.10) | 0.19 (0.00 to 1.43) |
| At risk, Week 41 | 0.13 (0.01 to 0.62) | 0.00 (0.00 to 1.83) | 0.30 (0.00 to 2.28) |
| At risk, Week 42 | 0.00 (0.00 to 0.45) | 0.28 (0.01 to 1.56) | 0.00 (0.00 to 1.72) |
| At risk, Week 43 | 0.45 (0.01 to 2.83) | 0.00 (0.00 to 1.12) | 0.00 (0.00 to 2.76) |
| At risk, Week 44 | 0.29 (0.00 to 2.07) | 0.24 (0.00 to 1.63) | 0.39 (0.00 to 3.12) |
| At risk, Week 45 | 0.26 (0.00 to 1.93) | 0.33 (0.00 to 2.29) | 0.00 (0.00 to 3.16) |
| At risk, Week 46 | 0.74 (0.09 to 2.66) | 0.00 (0.00 to 0.78) | 1.28 (0.01 to 8.31) |
| At risk, Week 47 | 0.00 (0.00 to 1.72) | 0.00 (0.00 to 2.66) | 0.57 (0.00 to 4.84) |
| At risk, Week 48 | 0.88 (0.01 to 5.39) | 0.00 (0.00 to 4.30) | 0.00 (0.00 to 9.74) |
| Not at risk, Week 36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 37 | 0.00 (0.00 to 2.74) | — | 0.00 (0.00 to 11.22) |
| Not at risk, Week 38 | 0.00 (0.00 to 2.21) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 8.22) |
| Not at risk, Week 39 | 0.00 (0.00 to 1.08) | 0.00 (0.00 to 33.63) | 0.00 (0.00 to 9.25) |
| Not at risk, Week 40 | 0.57 (0.00 to 4.23) | 0.00 (0.00 to 11.94) | 0.00 (0.00 to 5.69) |
| Not at risk, Week 41 | 0.00 (0.00 to 2.22) | 0.00 (0.00 to 8.60) | 1.56 (0.01 to 10.47) |
| Not at risk, Week 42 | 0.00 (0.00 to 4.11) | 0.00 (0.00 to 6.38) | 0.00 (0.00 to 11.94) |
| Not at risk, Week 43 | 0.00 (0.00 to 6.85) | 0.00 (0.00 to 6.49) | 0.00 (0.00 to 10.89) |
| Not at risk, Week 44 | 0.00 (0.00 to 5.21) | 0.00 (0.00 to 6.60) | 0.00 (0.00 to 7.71) |
| Not at risk, Week 45 | 0.00 (0.00 to 4.86) | 0.00 (0.00 to 3.62) | 0.00 (0.00 to 1.56) |
| Not at risk, Week 46 | 0.00 (0.00 to 4.45) | 0.00 (0.00 to 3.36) | 0.00 (0.00 to 17.65) |
| Not at risk, Week 47 | 0.00 (0.00 to 7.71) | 0.00 (0.00 to 16.11) | 0.00 (0.00 to 14.25) |
| Not at risk, Week 48 | 0.00 (0.00 to 11.22) | 0.00 (0.00 to 20.59) | 0.00 (0.00 to 45.93) |
SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system) Vaccination of the subjects happened between week 35 and week 48 of the year 2017
| Percentage of subjects | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| At risk, Week 35-35 | — | — | 0.00 (0.00 to 97.50) |
| At risk, Week 35-36 | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 97.50) | 0.00 (0.00 to 5.96) |
| At risk, Week 35-37 | 0.13 (0.02 to 0.39) | 0.00 (0.00 to 45.93) | 0.22 (0.00 to 1.61) |
| At risk, Week 35-38 | 0.16 (0.06 to 0.35) | 0.00 (0.00 to 24.71) | 0.30 (0.06 to 0.88) |
| At risk, Week 35-39 | 0.13 (0.06 to 0.23) | 0.00 (0.00 to 3.30) | 0.21 (0.04 to 0.61) |
| At risk, Week 35-40 | 0.13 (0.07 to 0.22) | 0.00 (0.00 to 0.87) | 0.20 (0.04 to 0.62) |
| At risk, Week 35-41 | 0.13 (0.07 to 0.23) | 0.00 (0.00 to 0.51) | 0.22 (0.04 to 0.67) |
| At risk, Week 35-42 | 0.12 (0.07 to 0.21) | 0.09 (0.00 to 0.51) | 0.20 (0.04 to 0.59) |
| At risk, Week 35-43 | 0.13 (0.06 to 0.25) | 0.07 (0.00 to 0.40) | 0.19 (0.04 to 0.56) |
| At risk, Week 35-44 | 0.14 (0.06 to 0.29) | 0.08 (0.01 to 0.40) | 0.22 (0.05 to 0.62) |
| At risk, Week 35-45 | 0.15 (0.07 to 0.28) | 0.14 (0.02 to 0.52) | 0.21 (0.05 to 0.60) |
| At risk, Week 35-46 | 0.16 (0.07 to 0.31) | 0.12 (0.01 to 0.44) | 0.24 (0.07 to 0.59) |
| At risk, Week 35-47 | 0.15 (0.07 to 0.31) | 0.11 (0.01 to 0.42) | 0.26 (0.08 to 0.63) |
| At risk, Week 35-48 | 0.16 (0.06 to 0.33) | 0.07 (0.01 to 0.40) | 0.25 (0.07 to 0.62) |
| Not at risk, Week 35-36 | — | — | 0.00 (0.00 to 84.19) |
| Not at risk, Week 35-37 | 0.00 (0.00 to 2.74) | — | 0.00 (0.00 to 10.58) |
| Not at risk, Week 35-38 | 0.00 (0.00 to 1.23) | 0.00 (0.00 to 70.76) | 0.00 (0.00 to 4.74) |
| Not at risk, Week 35-39 | 0.00 (0.00 to 0.58) | 0.00 (0.00 to 26.46) | 0.00 (0.00 to 3.18) |
| Not at risk, Week 35-40 | 0.12 (0.00 to 0.81) | 0.00 (0.00 to 8.60) | 0.00 (0.00 to 2.06) |
| Not at risk, Week 35-41 | 0.10 (0.00 to 0.68) | 0.00 (0.00 to 4.40) | 0.41 (0.00 to 2.77) |
| Not at risk, Week 35-42 | 0.09 (0.00 to 0.62) | 0.00 (0.00 to 2.64) | 0.37 (0.00 to 2.41) |
| Not at risk, Week 35-43 | 0.09 (0.00 to 0.58) | 0.00 (0.00 to 1.89) | 0.33 (0.00 to 2.22) |
| Not at risk, Week 35-44 | 0.08 (0.00 to 0.55) | 0.00 (0.00 to 1.48) | 0.29 (0.00 to 1.97) |
| Not at risk, Week 35-45 | 0.08 (0.00 to 0.52) | 0.00 (0.00 to 1.06) | 0.17 (0.00 to 1.43) |
| Not at risk, Week 35-46 | 0.07 (0.00 to 0.49) | 0.00 (0.00 to 0.81) | 0.17 (0.00 to 1.38) |
| Not at risk, Week 35-47 | 0.07 (0.00 to 0.47) | 0.00 (0.00 to 1.78) | 0.16 (0.00 to 1.32) |
| Not at risk, Week 35-48 | 0.07 (0.00 to 0.46) | 0.00 (0.00 to 1.69) | 0.16 (0.00 to 1.30) |
Collected over AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vaccinated_Fluarix Tetra Group | 3/16,433 (0%) | 25/16,433 (0.2%) | 1,514/16,433 (9.2%) |
| Vaccinated_Non GSK Group | 0/3,310 (0%) | 3/3,310 (0.1%) | 133/3,310 (4%) |
| Vaccinated_Unknown Brand Group | 0/4,196 (0%) | 10/4,196 (0.2%) | 66/4,196 (1.6%) |
| Event | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Accidental fallInjury, poisoning and procedural complications | 5/16433 | 0/3310 | 1/4196 |
| Unknown, non-causalGeneral disorders | 5/16433 | 0/3310 | 1/4196 |
| Atrial FibrillationCardiac disorders | 0/16433 | 1/3310 | 0/4196 |
| CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/16433 | 1/3310 | 0/4196 |
| Chest PainGeneral disorders | 3/16433 | 1/3310 | 0/4196 |
| Abdominal PainGastrointestinal disorders | 1/16433 | 0/3310 | 1/4196 |
| Chronic Ear InfectionInfections and infestations | 0/16433 | 0/3310 | 1/4196 |
| HyperkalemiaMetabolism and nutrition disorders | 0/16433 | 0/3310 | 1/4196 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/16433 | 0/3310 | 1/4196 |
| Infection of Chronic WoundInfections and infestations | 1/16433 | 0/3310 | 1/4196 |
| Event | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group |
|---|---|---|---|
| Muscle aches / myalgiaMusculoskeletal and connective tissue disorders | 454/16433 | 18/3310 | 15/4196 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 366/16433 | 28/3310 | 3/4196 |
| CoughRespiratory, thoracic and mediastinal disorders | 318/16433 | 43/3310 | 22/4196 |
| HeadacheGeneral disorders | 271/16433 | 23/3310 | 6/4196 |
| Local symptoms (i.e. local erythema)General disorders | 264/16433 | 17/3310 | 1/4196 |
| FatigueGeneral disorders | 249/16433 | 10/3310 | 3/4196 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 219/16433 | 12/3310 | 7/4196 |
| CoryzaRespiratory, thoracic and mediastinal disorders | 172/16433 | 12/3310 | 2/4196 |
| ArthropathyMusculoskeletal and connective tissue disorders | 143/16433 | 7/3310 | 1/4196 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 139/16433 | 10/3310 | 3/4196 |
Participant flow data were only collected for the overall group.
| Age, Continuous(Years) | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group | Total |
|---|---|---|---|---|
| Mean | 65.9 ± 16.3 | 23.6 ± 27.4 | 52.2 ± 28.0 | 57.67 ± 25.21 |
| Sex: Female, Male(Participants) | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group | Total |
|---|---|---|---|---|
| Female | 9177 | 1696 | 2330 | 13203 |
| Male | 7256 | 1614 | 1866 | 10736 |
| Race/Ethnicity, Customized(Participants) | Vaccinated_Fluarix Tetra Group | Vaccinated_Non GSK Group | Vaccinated_Unknown Brand Group | Total |
|---|---|---|---|---|
| Asian | 393 | 63 | 98 | 554 |
| Black | 84 | 26 | 17 | 127 |
| White | 11697 | 2121 | 2880 | 16698 |
| Mixed | 57 | 21 | 23 | 101 |
| Other | 25 | 3 | 15 | 43 |
| Missing | 4177 | 1076 | 1163 | 6416 |
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