COVID-19 vaccination and systemic autoimmune rheumatic diseases: No evidence of disproportionately increased reporting in Vaccine Adverse Event Reporting System (VAERS)
Authors' conclusion
In a large national pharmacovigilance dataset, COVID-19 vaccines were not associated with a disproportionate increase in reports of any SARD.
Study context
- Population
- VAERS reports, December 2020 to December 2024; Systemic autoimmune rheumatic diseases (SARDs) identified by MedDRA terms (PMR, GCA, SLE, SSc, Sjögren's syndrome, myositis, other vasculitides)approximately
- Participants
- 680,000 participants
- Exposure
- COVID-19 vaccines vs all other vaccines in VAERS
- Outcome
- Disproportionate reporting of SARDs as adverse events after COVID-19 vaccination:
- PRR
- ROR
- IC
Methodological detailsVAERS, proportional reporting ratio (PRR), reporting odds ratio (ROR) and Bayesian information component (IC), stratified by sex
- VAERS
- PRR, ROR and Bayesian IC
- Stratified by sex
Main finding
As reported in the abstract
Disproportionality signal for SARDs
- No significant disproportionality signal for any SARD
- PMR, GCA, SLE, SSc, Sjögren's syndrome and myositis: no evidence of disproportionate reporting after COVID-19 vaccination
- Other vasculitides: lower reporting frequency after COVID-19 vaccination vs other vaccines
Observational data: associations, not effects.
Further findings
Sex-stratified analyses
- Consistent findings across sex subgroups
Original publication
COVID-19 vaccination and systemic autoimmune rheumatic diseases: No evidence of disproportionately increased reporting in VAERS. Semin Arthritis Rheum. Published 2 January 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →