NCT05234333

COVID-19 Vaccines Associated Malaise

COVID-19 Vaccines Induced Malaise: A Retrospective Study and Analysis of the WHO Pharmacovigilance Database

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,534,706 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Vaccine Adverse Reaction

Interventions

Type	Name	Description
DRUG	SARS-CoV-2 vaccine	SARS-CoV-2 vaccination

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-01-26
• Completion: 2022-01-26
• First posted: 2022-02-10
• Last updated: 2022-05-05

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study