ArticleInternational journal of environmental research and public health2026
Autoimmune Reporting Signals in FAERS Reports Listing COVID-19 Vaccines as Suspect Products: An Active-Comparator Disproportionality Analysis.
Article in International journal of environmental research and public health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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6 authors.
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Abstract
BACKGROUND/
objectivesAutoimmune and immune-mediated adverse events coded in reports listing COVID-19 vaccines as suspect products are rare, heterogeneous, and difficult to evaluate in spontaneous reporting systems. We characterized autoimmune reporting signals using strict case definitions and an active-comparator disproportionality design.
methodsFAERS reports from 2021Q1 to 2023Q4 were deduplicated and harmonized by vaccine product, platform, sex, age group, and MedDRA Preferred Term (PT). COVID-19 vaccine reports recorded as primary or secondary suspect products were compared with traditional non-COVID vaccine reports. Strict autoimmune events were grouped into neurological, endocrine, rheumatological, hematological, dermatological, and cardiac categories. Reporting odds ratios (RORs), proportional reporting ratios (PRRs), PT-level rankings, masking audits, and sensitivity analyses were evaluated.
resultsThe primary analysis included 4191 COVID-19 vaccine reports, 2817 comparator reports, and 311 strict-autoimmune reports contributing 316 report-category observations. Positive category-level signals were identified for dermatological (ROR 10.49; 95% CI: 2.51-43.86), endocrine (ROR 5.39; 95% CI: 1.24-23.48), hematological (ROR 4.68; 95% CI: 2.32-9.44), and neurological events (ROR 1.63; 95% CI: 1.16-2.29). Rheumatological reporting was lower, strict cardiac events were absent, and hematological signals were most consistent across sensitivity analyses. Among five adjusted-positive finite PT signals, immune thrombocytopenia was more stable, multiple sclerosis intermediate, and acquired hemophilia, myasthenia gravis, and optic neuritis sparse/imprecise. A post hoc audit identified four potential clusters among 20 acquired-hemophilia reports; cluster collapse reduced the ROR to 2.70 (95% CI 0.30-24.18;
conclusionsThese findings are hypothesis-generating and do not establish incidence, absolute risk, or causality.
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