COVID-19 Vaccines Associated Malaise

April 29, 2022 updated by: University Hospital, Caen

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1534706

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Normandie
      • Caen, Normandie, France, 14033
        • Caen University Hospital, Department of Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients

Description

Inclusion Criteria:

  • all adverse events reported in the WHO pharmacovigilance database

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients presenting a malaise after the vaccination by any vaccine
Drug: SARS-CoV-2 vaccine
SARS-CoV-2 vaccination
Patients presenting any other adverse event after the vaccination by any vaccine
Drug: SARS-CoV-2 vaccine
SARS-CoV-2 vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disproportionality analysis in VigiBase® : search for an over-reporting of malaise with COVID-19 vaccines compared to influenza vaccines
Time Frame: from the 01/01/2021 to the 26/01/2022
case/no case study
from the 01/01/2021 to the 26/01/2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ACTUAL)

January 26, 2022

Study Completion (ACTUAL)

January 26, 2022

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (ACTUAL)

February 10, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Pharmaco 20220203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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