COVID-19 Vaccines Induced Malaise: A Retrospective Study and Analysis of the WHO Pharmacovigilance Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,534,706
- 试验地点
- 1
- 主要终点
- disproportionality analysis in VigiBase® : search for an over-reporting of malaise with COVID-19 vaccines compared to influenza vaccines
研究概览
简要总结
COVID-19 vaccines induced malaise have recently been reported in the literature. Our study aims to identify risk factors associated with the onset of COVID-19 vaccines induced malaise and to assess if certain COVID-19 vaccines could be more prone to cause malaise compared to influenza vaccines.
To do so we performed a disproportionality analysis adjusted on age class, sex, region and type of reporter in VigiBase®, the WHO pharmacovigilance database, restricted to data from 01/01/2021 to 26/01/2022 to assess the association between all COVID-19 vaccines on the market and malaise. Demographic data were also analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all adverse events reported in the WHO pharmacovigilance database
排除标准
- 未提供
研究组 & 干预措施
Patients presenting a malaise after the vaccination by any vaccine
干预措施: SARS-CoV-2 vaccine (Drug)
Patients presenting any other adverse event after the vaccination by any vaccine
干预措施: SARS-CoV-2 vaccine (Drug)
结局指标
主要结局
disproportionality analysis in VigiBase® : search for an over-reporting of malaise with COVID-19 vaccines compared to influenza vaccines
时间窗: from the 01/01/2021 to the 26/01/2022
case/no case study
次要结局
未报告次要终点