| アブストラクト | 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. |
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| ジャーナル名 | Seminars in arthritis and rheumatism |
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| Pubmed追加日 | 2026/1/8 |
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| 投稿者 | Ciaffi, Jacopo; Torrigiani, Ginevra; Ruscitti, Piero; Zambon, Antonella; Ursini, Francesco |
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| 組織名 | Medicine & Rheumatology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy;;Department of Biomedical and Neuromotor Sciences (DIBINEM), Alma Mater Studiorum;University of Bologna, Bologna, Italy. Electronic address:;jacopo.ciaffi@unibo.it.;Laboratory of Quantitative methods for Life, Health and Society (QmLHS-Lab),;Department of Statistics and Quantitative Methods, University of Milano-Bicocca,;Milan, Italy.;Department of Biotechnological and Applied Clinical Sciences, University of;L'Aquila, L'Aquila, Italy.;Milan, Italy; Biostatistics Unit, IRCCS Istituto Auxologico Italiano, Milan,;Italy.;University of Bologna, Bologna, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41500053/ |
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