Analysis of vaccine adverse events associated with rheumatoid arthritis: A pharmacovigilance study based on the VAERS database.
RA-related vaccine adverse events are rare and mainly musculoskeletal, with certain vaccines showing stronger signals in specific populations.
Where it sits
this study against the rest of the pt-141 (bremelanotide) corpusSummary and findings
This study analyzed vaccine-associated rheumatoid arthritis (RA) adverse events using the VAERS database from 1990 to 2026. Among 11,532,185 reports, 34,498 RA-related adverse events were identified, with females comprising 77.9% of cases. The COVID-19 vaccine had the highest number of reports but a weak signal, while the Lyme disease, rubella, and anthrax vaccines showed stronger signals.
Abstract
Vaccination is a principal method of infectious disease prevention, but its association with rheumatoid arthritis (RA) remains controversial. This study assessed vaccine‑associated RA using the Vaccine Adverse Event Reporting System (VAERS). Data from 1990 to 2026 were extracted. Descriptive statistics, Weibull fitting, and disproportionality analysis using four methods, including the reporting odds ratio (ROR), along with subgroup analyses by age, sex, and pre‑/post‑COVID, were performed. Among 11,532,185 reports, 34,498 RA‑related adverse events (AEs) (0.03%) involved 5006 subjects. Females comprised 77.9% and 18-65 predominated. Serious outcomes occurred in 13.48%. Most AEs (47.49%) were musculoskeletal. 47.0% occurred within 7d (median 5.4), indicating early failure. The COVID‑19 vaccine had the most reports (n = 24,266) but a weak signal (ROR = 1.25); the Lyme disease vaccine (ROR = 27.81), the rubella vaccine (ROR = 5.69), and the anthrax vaccine (ROR = 3.90) exhibited the strongest signals. Subgroup signals: Lyme disease vaccine except 2021-2026; rubella vaccine only in females/≤17; anthrax vaccine in 18-64. RA‑related vaccine AEs are extremely rare, mainly musculoskeletal and within 1 week. High COVID‑19 volume did not align with its weak signal, while strong signals for the Lyme disease, rubella, and anthrax vaccines reflected specific populations. No strong disproportionality signal was found. However, VAERS is passive, cannot establish causality or confirm safety.
Background
The study addresses the controversial association between vaccination and rheumatoid arthritis (RA), a topic of interest due to the widespread use of vaccines for infectious disease prevention. Previous literature has debated the potential link between vaccines and autoimmune conditions like RA. This study is significant as it utilizes a large dataset from the VAERS database to explore this association over an extended period.
Methods
The study used data from the Vaccine Adverse Event Reporting System (VAERS) spanning from 1990 to 2026. Descriptive statistics, Weibull fitting, and disproportionality analysis, including the reporting odds ratio (ROR), were employed. Subgroup analyses were conducted based on age, sex, and pre-/post-COVID periods. The primary focus was on RA-related adverse events reported in association with various vaccines.
Results
Among 11,532,185 reports, 34,498 RA-related adverse events were identified, representing 0.03% of the total. Females accounted for 77.9% of these events, with a predominance in the 18-65 age group. Serious outcomes occurred in 13.48% of cases. The COVID-19 vaccine had the most reports (n=24,266) but a weak signal (ROR=1.25). In contrast, the Lyme disease vaccine showed a strong signal (ROR=27.81), followed by the rubella vaccine (ROR=5.69) and the anthrax vaccine (ROR=3.90).
Interpretation
The study's findings suggest that while RA-related vaccine adverse events are rare, certain vaccines like the Lyme disease, rubella, and anthrax vaccines exhibit stronger signals in specific populations. The weak signal associated with the COVID-19 vaccine, despite its high report volume, highlights the complexity of interpreting VAERS data. The study's reliance on passive reporting limits its ability to establish causality, and the findings should be interpreted with caution.
Key findings
- 11,532,185 total reports analyzed.
- 34,498 RA-related adverse events identified (0.03%).
- 77.9% of RA-related AEs occurred in females.
- 47.0% of AEs occurred within 7 days (median 5.4 days).
- COVID-19 vaccine had 24,266 reports with ROR=1.25.
- Lyme disease vaccine had ROR=27.81.
Limitations
- Passive VAERS data cannot establish causality.
- High COVID-19 report volume with weak signal.
- Potential reporting bias in VAERS.
- Subgroup analyses may not capture all confounding factors.