COVID-19 Vaccines Associated Malaise

University Hospital, Caen1,534,706 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,534,706

Conditions

Vaccine Adverse Reaction

Interventions

SARS-CoV-2 vaccineDRUG

SARS-CoV-2 vaccination

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * all adverse events reported in the WHO pharmacovigilance database Exclusion Criteria: * none

Locations (1)

Caen University Hospital, Department of Pharmacology

Caen, Normandy, France

Outcomes

Primary Outcomes

disproportionality analysis in VigiBase® : search for an over-reporting of malaise with COVID-19 vaccines compared to influenza vaccines

case/no case study

Time frame: from the 01/01/2021 to the 26/01/2022

Data from ClinicalTrials.gov

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