Autoimmune Reporting Signals in FAERS Reports Listing COVID-19 Vaccines as Suspect Products: An Active-Comparator Disproportionality Analysis.

3区综合性期刊

International Journal of Environmental Research and Public Health Pub Date : 2026-08-21 DOI:10.3390/ijerph23081088

Assylzhan M Messova, Makhmutbay Sanbayev, Sagira T Abdrahmanova, Raikhan Temirkhanova, Nadiar M Mussin, Amin Tamadon

{"title":"Autoimmune Reporting Signals in FAERS Reports Listing COVID-19 Vaccines as Suspect Products: An Active-Comparator Disproportionality Analysis.","authors":"Assylzhan M Messova, Makhmutbay Sanbayev, Sagira T Abdrahmanova, Raikhan Temirkhanova, Nadiar M Mussin, Amin Tamadon","doi":"10.3390/ijerph23081088","DOIUrl":null,"url":null,"abstract":"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: 2.51-43.86), 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; p = 0.654).Conclusions: These findings are hypothesis-generating and do not establish incidence, absolute risk, or causality.","PeriodicalId":49056,"journal":{"name":"International Journal of Environmental Research and Public Health","volume":"23 8","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13513629/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Environmental Research and Public Health","FirstCategoryId":"103","ListUrlMain":"https://doi.org/10.3390/ijerph23081088","RegionNum":3,"RegionCategory":"综合性期刊","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}

引用次数: 0

Abstract

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: 2.51-43.86), 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; p = 0.654).

Conclusions: These findings are hypothesis-generating and do not establish incidence, absolute risk, or causality.

查看原文本刊更多论文

FAERS报告中将COVID-19疫苗列为可疑产品的自身免疫报告信号：活性比较物歧化分析

背景/目的：在自发报告系统中，将COVID-19疫苗列为可疑产品的报告中编码的自身免疫和免疫介导的不良事件罕见、异质性且难以评估。我们使用严格的病例定义和主动比较器歧化设计来表征自身免疫报告信号。方法：根据疫苗产品、平台、性别、年龄组和MedDRA首选术语（PT）对2021Q1 - 2023Q4的FAERS报告进行重复和统一。将记录为主要或次要可疑产品的COVID-19疫苗报告与传统的非COVID-19疫苗报告进行比较。严格的自身免疫事件分为神经学、内分泌学、风湿病学、血液学、皮肤病和心脏类。评估报告优势比（RORs）、比例报告比（PRRs）、pt水平排名、掩蔽审计和敏感性分析。结果：初步分析包括4191份COVID-19疫苗报告，2817份比较报告和311份严格自身免疫报告，共316份报告类别观察结果。在皮肤病学（ROR 10.49; 95% CI: 2.51-43.86）、内分泌学（ROR 5.39; 95% CI: 1.24-23.48）、血液学（ROR 4.68; 95% CI: 2.32-9.44）和神经学事件（ROR 1.63; 95% CI: 1.16-2.29）中发现了阳性的类别水平信号。风湿病报告较低，没有严重的心脏事件，血液学信号在敏感性分析中最一致。在5个调整阳性有限PT信号中，免疫性血小板减少较稳定，多发性硬化症居中，获得性血友病、重症肌无力和视神经炎稀疏/不精确。事后审计在20份获得性血友病报告中确定了4个潜在的群集；聚类崩溃使ROR降至2.70 （95% CI 0.30-24.18; p = 0.654）。结论：这些发现是假设产生的，不能确定发病率、绝对风险或因果关系。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

International Journal of Environmental Research and Public Health ENVIRONMENTAL SCIENCES-

自引率

0.00%

发文量

14422

期刊介绍： International Journal of Environmental Research and Public Health (IJERPH) (ISSN 1660-4601) is a peer-reviewed scientific journal that publishes original articles, critical reviews, research notes, and short communications in the interdisciplinary area of environmental health sciences and public health. It links several scientific disciplines including biology, biochemistry, biotechnology, cellular and molecular biology, chemistry, computer science, ecology, engineering, epidemiology, genetics, immunology, microbiology, oncology, pathology, pharmacology, and toxicology, in an integrated fashion, to address critical issues related to environmental quality and public health. Therefore, IJERPH focuses on the publication of scientific and technical information on the impacts of natural phenomena and anthropogenic factors on the quality of our environment, the interrelationships between environmental health and the quality of life, as well as the socio-cultural, political, economic, and legal considerations related to environmental stewardship and public health. The 2018 IJERPH Outstanding Reviewer Award has been launched! This award acknowledge those who have generously dedicated their time to review manuscripts submitted to IJERPH. See full details at http://www.mdpi.com/journal/ijerph/awards.