COVID-19 Vaccines Associated Malaise

Caen University Hospital

Status: Completed

Conditions: Vaccine Adverse Reaction

Treatments: Drug: SARS-CoV-2 vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT05234333

Pharmaco 20220203

Details and patient eligibility

About

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.

Enrollment: 1,534,706 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• all adverse events reported in the WHO pharmacovigilance database

Exclusion criteria

• none

Trial design

1,534,706 participants in 2 patient groups

Patients presenting a malaise after the vaccination by any vaccine

Treatment:

Drug: SARS-CoV-2 vaccine

Patients presenting any other adverse event after the vaccination by any vaccine

Treatment:

Drug: SARS-CoV-2 vaccine