Lupus & antiphospholipid syndrome
Vaccine-associated lupus and related organ involvements: A pharmacovigilance analysis of Vaccine Adverse Event Reporting System (VAERS) database 1990–2025
Authors' conclusion
Vaccine-associated lupus is uncommon and manifestations are generally mild. HPV and HBV vaccines show strong associations with lupus AEs with distinct organ involvements.
Study context
- Population
- Vaccine-associated systemic lupus erythematosus (SLE) reports in VAERS, 1990–2025of 11,301,263 adverse events (AEs) reported
- Participants
- 1,976 participants
- Outcome
- Incidence of vaccine-associated SLE over time
Methodological detailsdisproportionality analysis, case-control analysis, VAERS database
- Disproportionality analysis
- Case-control analysis
- VAERS database
Main finding
As reported in the abstract
Vaccine-associated lupus cases among VAERS AE reports
Cases of vaccine-associated lupus among 11,301,263 AEs
1976
0.017%
Median time from vaccination to symptom onset (range), days
8
0–8,070
Observational data: associations, not effects.
Further findings
Manifestations
- Musculoskeletal and connective tissue disorders
- 82.94%
- Skin and subcutaneous tissue lesions
- 10.83%
- Kidney and nervous system involvements rare
Vaccine associations with lupus AEs
- Human papilloma virus (HPV) vaccine associated with lupus AEs, especially musculoskeletal/connective tissue disorders, kidney and nervous system involvements
- Hepatitis B virus (HBV) vaccine correlated with lupus AEs, particularly musculoskeletal/connective tissue disorders
- COVID-19, influenza and zoster vaccines: no relationship with lupus AEs or specific organ involvements
- Recombinant protein vaccines: significant links with lupus AEs
Serious outcomes and deaths
- Serious outcomes
- 702 (40.48%)
- Died
- 22 (3.13%)
Original publication
Vaccine-associated lupus and related organ involvements: A pharmacovigilance analysis of VAERS database 1990–2025. Semin Arthritis Rheum. Published 23 January 2026. doi:10.
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