Full metadata record
DC Field | Value | Language |
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dc.contributor.author | 최남경 | - |
dc.date.accessioned | 2024-05-16T16:31:00Z | - |
dc.date.available | 2024-05-16T16:31:00Z | - |
dc.date.issued | 2024 | - |
dc.identifier.issn | 0031-6970 | - |
dc.identifier.other | OAK-35163 | - |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/268199 | - |
dc.description.abstract | Purpose: Owing to adverse event following immunization (AEFI) related to autoimmune disorders and coronavirus disease 2019 (COVID-19) vaccines sharing common biological mechanisms, identifying the risk of AEFIs associated with COVID-19 vaccines remains a critical unmet need. We aimed to assess the potential safety signals for 16 AEFIs and explore co-reported adverse events (AEs) and drugs using the global database of the World Health Organization, VigiBase. Methods: We assessed the occurrence of 16 AEFIs following COVID-19 vaccination through the Standardized MedDRA Queries group “Immune-mediated/Autoimmune Disorders” from MedDRA and performed a disproportionality analysis using reporting odds ratio (ROR) and information component (IC) with 95% confidence intervals (CIs). Results: We identified 25,219 events associated with COVID-19 vaccines in VigiBase. Although rare, we detected four potential safety signals related to autoimmune disorders following COVID-19 vaccination, including ankylosing spondylitis or psoriatic arthritis (ROR 1.86; 95% CI 1.53–2.27), inflammatory bowel disease (ROR 1.77; 95% CI 1.60–1.96), polymyalgia rheumatica (ROR 1.42; 95% CI 1.30–1.55), and thyroiditis (ROR 1.40; 95% CI 1.30–1.50), with positive IC025 values. The top co-reported AEs were musculoskeletal disorders, and immunosuppressants were the most representative co-reported drugs. Conclusion: In addressing the imperative to comprehend AEFI related to autoimmune disorders following COVID-19 vaccination, our study identified four potential safety signals. Thus, our research underscores the importance of proactive safety monitoring for the identification of the four AEFIs following COVID-19 vaccination, considering the associated advantages. © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2024. | - |
dc.language | English | - |
dc.publisher | Springer Science and Business Media Deutschland GmbH | - |
dc.subject | Adverse events | - |
dc.subject | Autoimmune disorders | - |
dc.subject | Coronavirus disease (COVID-19) vaccines | - |
dc.subject | Pharmacovigilance | - |
dc.subject | Reporting odds ratio | - |
dc.title | Autoimmune disorders reported following COVID-19 vaccination: A disproportionality analysis using the WHO database | - |
dc.type | Article | - |
dc.relation.issue | 3 | - |
dc.relation.volume | 80 | - |
dc.relation.index | SCIE | - |
dc.relation.index | SCOPUS | - |
dc.relation.startpage | 445 | - |
dc.relation.lastpage | 453 | - |
dc.relation.journaltitle | European Journal of Clinical Pharmacology | - |
dc.identifier.doi | 10.1007/s00228-023-03618-w | - |
dc.identifier.scopusid | 2-s2.0-85182170261 | - |
dc.author.google | Kim | - |
dc.author.google | Seohyun | - |
dc.author.google | Bea | - |
dc.author.google | Sungho | - |
dc.author.google | Choe | - |
dc.author.google | Seung-Ah | - |
dc.author.google | Choi | - |
dc.author.google | Nam-Kyong | - |
dc.author.google | Shin | - |
dc.author.google | Ju-Young | - |
dc.contributor.scopusid | 최남경(35486895900) | - |
dc.date.modifydate | 20240516114845 | - |