Evidence map›Paper›PMID 38212538›Full record

ArticleEuropean journal of clinical pharmacology2024

Autoimmune disorders reported following COVID-19 vaccination: A disproportionality analysis using the WHO database.

Seohyun Kim, Sungho Bea, Seung-Ah Choe, Nam-Kyong Choi, Ju-Young Shin

Abstract read
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In one paragraph

Article in European journal of clinical pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.7field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Seohyun KimDepartment of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, South Korea.
Sungho BeaSchool of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon-si, Gyeonggi-do 16419, South Korea.
Seung-Ah ChoeDepartment of Preventive Medicine, Korea University College of Medicine, Seoul, South Korea.
Nam-Kyong ChoiDepartment of Health Convergence, College of Science & Industry Convergence, Ewha Womans University, Seoul, Korea.
Ju-Young ShinDepartment of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, South Korea. shin.jy@skku.edu.ORCID http://orcid.org/0000-0003-1010-7525
Sungkyunkwan University · KREwha Womans University · KRKorea University · KR

Funding

the Ministry of Food and Drug Safety of South Korea 21153MFDS607, 22183MFDS433
6 · The paper itself

Abstract

purposeOwing 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.

methodsWe 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).

resultsWe 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 IC

conclusionIn 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.

Indexed as

Autoimmune DiseasesCOVID-19Adverse Drug Reaction Reporting SystemsCOVID-19 VaccinesHumansPharmacovigilanceVaccinationCOVID-19 VaccinesAdverse eventsAutoimmune disordersCoronavirus disease (COVID-19) vaccinesPharmacovigilanceReporting odds ratio

Identifiers

PMID38212538
OpenAlexW4390791830

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.