跳至主要内容
临床试验/NCT03278067
NCT03278067已完成不适用

Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England 2017/18

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 23,939 人开始时间: 2017年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23,939
试验地点
1
主要终点
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All individuals who receive influenza vaccination among the 10 participating GP practices between 1 September and 30 November 2017 are eligible for inclusion in the analysis.

排除标准

  • Registered patients who have explicitly opted out of data sharing will be excluded from the analysis.

结局指标

主要结局

Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group

时间窗: Within 7 days post vaccination

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.

Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

时间窗: Within 7 days post vaccination

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

次要结局

  • Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group(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(Within 7 days post vaccination)
  • Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status(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(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(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status(Within 7 days post vaccination)
  • Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status(Within 7 days post vaccination)
  • Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group(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(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(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(Within 7 days post vaccination)
  • Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status(Within 7 days post vaccination)
  • Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status(Within 7 days post vaccination)
  • Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status(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(Within 7 days post vaccination)
  • Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status(Within 7 days post vaccination)
  • Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status(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(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(Within 7 days post vaccination)
  • Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status(Within 7 days post vaccination)
  • Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status(Within 7 days post vaccination)
  • Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status(Within 7 days post vaccination)

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