Disproportionality analysis of European safety reports on autoimmune and rheumatic diseases following COVID-19 vaccination.

ABSTRACT: The safety profile of COVID-19 vaccines is well-established, yet the widespread immunization campaign has led to an increase in reported cases of Immune-Mediated and Rheumatic Diseases (IMDRs). This study aimed to assess the reporting of Adverse Events Following Immunization (AEFIs) related to IMDRs after COVID-19 vaccination. We analyzed all individual case safety reports (ICSRs) related to COVID-19 vaccines authorized in the European Union (i.e., tozinameran, elasomeran, ChAdOx1-S NCoV-19, and Ad26.Cov2.S) registered in the EudraVigilance (EV) database from January 1, 2021, to October 23, 2023. Our analysis identified ICSRs with events indicative of IMDRs and conducted disproportionality analysis (i.e., Reporting Odds Ratio (ROR) with 95% CI) to examine the frequency of different IMDR ty

SUBMITTER: Fraenza F 

PROVIDER: S-EPMC12034749 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature