PMID- 38212538
OWN - NLM
STAT- MEDLINE
DCOM- 20240219
LR  - 20240219
IS  - 1432-1041 (Electronic)
IS  - 0031-6970 (Linking)
VI  - 80
IP  - 3
DP  - 2024 Mar
TI  - Autoimmune disorders reported following COVID-19 vaccination: A 
      disproportionality analysis using the WHO database.
PG  - 445-453
LID - 10.1007/s00228-023-03618-w [doi]
AB  - 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 IC(025) 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.
CI  - (c) 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, 
      part of Springer Nature.
FAU - Kim, Seohyun
AU  - Kim S
AD  - Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, South 
      Korea.
FAU - Bea, Sungho
AU  - Bea S
AD  - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon-si, 
      Gyeonggi-do 16419, South Korea.
FAU - Choe, Seung-Ah
AU  - Choe SA
AD  - Department of Preventive Medicine, Korea University College of Medicine, Seoul, 
      South Korea.
FAU - Choi, Nam-Kyong
AU  - Choi NK
AD  - Department of Health Convergence, College of Science & Industry Convergence, Ewha 
      Womans University, Seoul, Korea.
FAU - Shin, Ju-Young
AU  - Shin JY
AUID- ORCID: 0000-0003-1010-7525
AD  - Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, South 
      Korea. shin.jy@skku.edu.
AD  - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon-si, 
      Gyeonggi-do 16419, South Korea. shin.jy@skku.edu.
AD  - Department of Clinical Research Design & Evaluation, Samsung Advanced Institute 
      for Health Sciences & Technology, Sungkyunkwan University, Seoul, South Korea. 
      shin.jy@skku.edu.
LA  - eng
GR  - 21153MFDS607, 22183MFDS433/the Ministry of Food and Drug Safety of South Korea/
PT  - Journal Article
DEP - 20240112
PL  - Germany
TA  - Eur J Clin Pharmacol
JT  - European journal of clinical pharmacology
JID - 1256165
RN  - 0 (COVID-19 Vaccines)
SB  - IM
MH  - Humans
MH  - COVID-19 Vaccines/adverse effects
MH  - Pharmacovigilance
MH  - *COVID-19/epidemiology/prevention & control
MH  - Vaccination/adverse effects
MH  - *Autoimmune Diseases/chemically induced/epidemiology
MH  - Adverse Drug Reaction Reporting Systems
OTO - NOTNLM
OT  - Adverse events
OT  - Autoimmune disorders
OT  - Coronavirus disease (COVID-19) vaccines
OT  - Pharmacovigilance
OT  - Reporting odds ratio
EDAT- 2024/01/12 00:42
MHDA- 2024/02/19 06:44
CRDT- 2024/01/11 23:25
PHST- 2023/08/30 00:00 [received]
PHST- 2023/12/30 00:00 [accepted]
PHST- 2024/02/19 06:44 [medline]
PHST- 2024/01/12 00:42 [pubmed]
PHST- 2024/01/11 23:25 [entrez]
AID - 10.1007/s00228-023-03618-w [pii]
AID - 10.1007/s00228-023-03618-w [doi]
PST - ppublish
SO  - Eur J Clin Pharmacol. 2024 Mar;80(3):445-453. doi: 10.1007/s00228-023-03618-w. 
      Epub 2024 Jan 12.