COVID-19 Vaccines Associated Malaise
- Registration Number
- NCT05234333
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1534706
Inclusion Criteria
- all adverse events reported in the WHO pharmacovigilance database
Exclusion Criteria
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients presenting a malaise after the vaccination by any vaccine SARS-CoV-2 vaccine - Patients presenting any other adverse event after the vaccination by any vaccine SARS-CoV-2 vaccine -
- Primary Outcome Measures
Name Time Method disproportionality analysis in VigiBase® : search for an over-reporting of malaise with COVID-19 vaccines compared to influenza vaccines from the 01/01/2021 to the 26/01/2022 case/no case study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Caen University Hospital, Department of Pharmacology
🇫🇷Caen, Normandie, France