{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T12:24:24Z","timestamp":1787315064543,"version":"build-2736575974"},"reference-count":20,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T00:00:00Z","timestamp":1787270400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Int. J. Environ. Res. Public Health","IJERPH"],"abstract":"<jats:p>Background\/Objectives: Autoimmune 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. Methods: FAERS 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. Results: The 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\u201343.86), endocrine (ROR 5.39; 95% CI: 1.24\u201323.48), hematological (ROR 4.68; 95% CI: 2.32\u20139.44), and neurological events (ROR 1.63; 95% CI: 1.16\u20132.29). 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\u201324.18; p = 0.654). Conclusions: These findings are hypothesis-generating and do not establish incidence, absolute risk, or causality.<\/jats:p>","DOI":"10.3390\/ijerph23081088","type":"journal-article","created":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T11:37:34Z","timestamp":1787312254000},"page":"1088","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Autoimmune Reporting Signals in FAERS Reports Listing COVID-19 Vaccines as Suspect Products: An Active-Comparator Disproportionality Analysis"],"prefix":"10.3390","volume":"23","author":[{"given":"Assylzhan M.","family":"Messova","sequence":"first","affiliation":[{"name":"Pediatric Diseases Department, Astana Medical University, Astana 010000, Kazakhstan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-8242-4082","authenticated-orcid":false,"given":"Makhmutbay","family":"Sanbayev","sequence":"additional","affiliation":[{"name":"Department of Traumatology and Pediatric Surgery, Semey Medical University, Semey 071400, Kazakhstan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sagira T.","family":"Abdrahmanova","sequence":"additional","affiliation":[{"name":"Pediatric Diseases Department, Astana Medical University, Astana 010000, Kazakhstan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raikhan","family":"Temirkhanova","sequence":"additional","affiliation":[{"name":"Department of General Practice, Semey Medical University, Semey 071400, Kazakhstan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3600-8840","authenticated-orcid":false,"given":"Nadiar M.","family":"Mussin","sequence":"additional","affiliation":[{"name":"Department of General Surgery, West Kazakhstan Marat Ospanov Medical University, Aktobe 030019, Kazakhstan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0222-3035","authenticated-orcid":false,"given":"Amin","family":"Tamadon","sequence":"additional","affiliation":[{"name":"Department of Natural Sciences, West Kazakhstan Marat Ospanov Medical University, Aktobe 030019, Kazakhstan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,8,21]]},"reference":[{"key":"ref_1","unstructured":"World Health Organization (2021). 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Neurol."}],"container-title":["International Journal of Environmental Research and Public Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1660-4601\/23\/8\/1088\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T11:41:44Z","timestamp":1787312504000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1660-4601\/23\/8\/1088"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,21]]},"references-count":20,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2026,8]]}},"alternative-id":["ijerph23081088"],"URL":"https:\/\/doi.org\/10.3390\/ijerph23081088","relation":{},"ISSN":["1660-4601"],"issn-type":[{"value":"1660-4601","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,21]]}}}