Objectives: To investigate whether systemic autoimmune rheumatic diseases (SARDs) were disproportionately reported as adverse events following COVID-19 vaccination compared with other vaccines, using data from the Vaccine Adverse Event Reporting System (VAERS). Methods: We conducted a retrospective disproportionality analysis of VAERS reports collected between December 2020 and December 2024. Reports were identified using a structured query based on MedDRA terms for specific SARDs, including polymyalgia rheumatica, giant cell arteritis, systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, myositis, and other vasculitides. For each disease, the proportional reporting ratio (PRR), reporting odds ratio (ROR), and Bayesian information component (IC) were calculated, comparing COVID-19 vaccines (BNT162b2, mRNA-1273, Ad26.COV2.S) with all other vaccines in VAERS. Analyses were further stratified by sex to explore consistency. Results: Among approximately 680,000 valid adverse event reports, encompassing both COVID-19 and non-COVID-19 vaccines, no significant disproportionality signal was identified for any SARD. Polymyalgia rheumatica, giant cell arteritis, systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, and myositis showed no evidence of disproportionate reporting following COVID-19 vaccination. The category "other vasculitides" displayed a lower reporting frequency following COVID-19 vaccination compared with other vaccines. Stratified analyses yielded consistent findings across sex subgroups. Conclusion: In a large national pharmacovigilance dataset, COVID-19 vaccines were not associated with a disproportionate increase in reports of any SARD. These results support the favorable safety profile of COVID-19 vaccines with respect to autoimmune rheumatic events, while highlighting the value of ongoing post-marketing surveillance for rare immune-mediated reactions.
Ciaffi, J., Torrigiani, G., Ruscitti, P., Zambon, A., Ursini, F. (2026). COVID-19 vaccination and systemic autoimmune rheumatic diseases: No evidence of disproportionately increased reporting in VAERS. SEMINARS IN ARTHRITIS AND RHEUMATISM, 77, 1-9 [10.1016/j.semarthrit.2025.152911].
COVID-19 vaccination and systemic autoimmune rheumatic diseases: No evidence of disproportionately increased reporting in VAERS
Ciaffi J.Primo
;Ursini F.Ultimo
2026
Abstract
Objectives: To investigate whether systemic autoimmune rheumatic diseases (SARDs) were disproportionately reported as adverse events following COVID-19 vaccination compared with other vaccines, using data from the Vaccine Adverse Event Reporting System (VAERS). Methods: We conducted a retrospective disproportionality analysis of VAERS reports collected between December 2020 and December 2024. Reports were identified using a structured query based on MedDRA terms for specific SARDs, including polymyalgia rheumatica, giant cell arteritis, systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, myositis, and other vasculitides. For each disease, the proportional reporting ratio (PRR), reporting odds ratio (ROR), and Bayesian information component (IC) were calculated, comparing COVID-19 vaccines (BNT162b2, mRNA-1273, Ad26.COV2.S) with all other vaccines in VAERS. Analyses were further stratified by sex to explore consistency. Results: Among approximately 680,000 valid adverse event reports, encompassing both COVID-19 and non-COVID-19 vaccines, no significant disproportionality signal was identified for any SARD. Polymyalgia rheumatica, giant cell arteritis, systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, and myositis showed no evidence of disproportionate reporting following COVID-19 vaccination. The category "other vasculitides" displayed a lower reporting frequency following COVID-19 vaccination compared with other vaccines. Stratified analyses yielded consistent findings across sex subgroups. Conclusion: In a large national pharmacovigilance dataset, COVID-19 vaccines were not associated with a disproportionate increase in reports of any SARD. These results support the favorable safety profile of COVID-19 vaccines with respect to autoimmune rheumatic events, while highlighting the value of ongoing post-marketing surveillance for rare immune-mediated reactions.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
