PMID- 36520333
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230214
IS  - 2193-8229 (Print)
IS  - 2193-6382 (Electronic)
IS  - 2193-6382 (Linking)
VI  - 12
IP  - 2
DP  - 2023 Feb
TI  - Safety Profiles of mRNA COVID-19 Vaccines Using World Health Organization Global 
      Scale Database (VigiBase): A Latent Class Analysis.
PG  - 443-458
LID - 10.1007/s40121-022-00742-5 [doi]
AB  - INTRODUCTION: Although messenger RNA (mRNA) vaccines have been developed and 
      widely utilized to mitigate the coronavirus disease (COVID-19) pandemic, it is 
      essential to describe the adverse events (AEs) following immunization. This study 
      aimed to identify the patterns associated with serious AE reports after mRNA 
      COVID-19 vaccination in the World Health Organization (WHO)'s global scale 
      database (VigiBase). METHODS: This study performed a latent class analysis (LCA) 
      of reports of serious AEs following mRNA COVID-19 vaccination from VigiBase 
      between December 28, 2020 , and February 28, 2022 (N = 312878). The Medical 
      Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) terms were 
      selected for LCA. The reporting characteristics in accordance with the cluster 
      were described. We used a multinomial logistic regression model to estimate the 
      association between potential factors and each cluster. RESULTS: Five clusters of 
      AE reports were distinguished through LCA: infection AEs (cluster 1), cardiac AEs 
      (cluster 2), respiratory/thrombotic AEs (cluster 3), systemic AEs (cluster 4), 
      and nervous system AEs (cluster 5). Compared to cluster 4, cluster 2 had a higher 
      proportion of males (OR 2.98; 95% confidence interval (CI) 2.87-3.09), and 
      cluster 1 had a longer time to onset than other AEs (>/= 14 days) (OR 16.2; 95% CI 
      15.5-16.9). CONCLUSION: Using LCA, we found five clusters of serious AEs 
      following mRNA COVID-19 vaccination. Each cluster was distinguished by potential 
      factors such as age, gender, region, and time to onset. We suggest that 
      monitoring should carefully consider the patterns of young males with cardiac AEs 
      and elderly individuals with thrombosis after respiratory AEs. Our findings could 
      contribute to enhancing understanding of safety profiles and establishing 
      management strategies for serious AEs of special interest following mRNA COVID-19 
      vaccination.
CI  - (c) 2022. The Author(s).
FAU - Lee, Min-Taek
AU  - Lee MT
AUID- ORCID: 0000-0002-3178-9660
AD  - College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.
AD  - Department of Global Innovative Drugs, The Graduate School of Chung-Ang 
      University, Seoul, Republic of Korea.
FAU - Choi, Wonbin
AU  - Choi W
AUID- ORCID: 0000-0003-4191-6392
AD  - College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.
AD  - Department of Global Innovative Drugs, The Graduate School of Chung-Ang 
      University, Seoul, Republic of Korea.
FAU - You, Seung-Hun
AU  - You SH
AUID- ORCID: 0000-0002-2430-6907
AD  - College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.
AD  - Department of Global Innovative Drugs, The Graduate School of Chung-Ang 
      University, Seoul, Republic of Korea.
FAU - Park, Sewon
AU  - Park S
AUID- ORCID: 0000-0003-0122-9408
AD  - College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.
AD  - Department of Global Innovative Drugs, The Graduate School of Chung-Ang 
      University, Seoul, Republic of Korea.
FAU - Kim, Jeong-Yeon
AU  - Kim JY
AUID- ORCID: 0000-0002-1187-0605
AD  - College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.
AD  - Department of Global Innovative Drugs, The Graduate School of Chung-Ang 
      University, Seoul, Republic of Korea.
FAU - Nam, Dal Ri
AU  - Nam DR
AUID- ORCID: 0000-0002-0448-0916
AD  - College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.
AD  - Department of Global Innovative Drugs, The Graduate School of Chung-Ang 
      University, Seoul, Republic of Korea.
FAU - Lee, Ju Won
AU  - Lee JW
AUID- ORCID: 0000-0003-2956-3344
AD  - College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.
AD  - Department of Global Innovative Drugs, The Graduate School of Chung-Ang 
      University, Seoul, Republic of Korea.
FAU - Jung, Sun-Young
AU  - Jung SY
AUID- ORCID: 0000-0003-2032-112X
AD  - College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea. 
      jsyoung@cau.ac.kr.
AD  - Department of Global Innovative Drugs, The Graduate School of Chung-Ang 
      University, Seoul, Republic of Korea. jsyoung@cau.ac.kr.
LA  - eng
GR  - HG18C0066/Government-wide R&D Fund project for infectious disease research 
      (GFID)/
PT  - Journal Article
DEP - 20221215
PL  - New Zealand
TA  - Infect Dis Ther
JT  - Infectious diseases and therapy
JID - 101634499
PMC - PMC9753856
OTO - NOTNLM
OT  - COVID-19
OT  - Cluster
OT  - Latent class analysis
OT  - Serious adverse event
OT  - VigiBase
OT  - mRNA vaccine
EDAT- 2022/12/16 06:00
MHDA- 2022/12/16 06:01
PMCR- 2022/12/15
CRDT- 2022/12/15 11:19
PHST- 2022/10/03 00:00 [received]
PHST- 2022/11/24 00:00 [accepted]
PHST- 2022/12/16 06:00 [pubmed]
PHST- 2022/12/16 06:01 [medline]
PHST- 2022/12/15 11:19 [entrez]
PHST- 2022/12/15 00:00 [pmc-release]
AID - 10.1007/s40121-022-00742-5 [pii]
AID - 742 [pii]
AID - 10.1007/s40121-022-00742-5 [doi]
PST - ppublish
SO  - Infect Dis Ther. 2023 Feb;12(2):443-458. doi: 10.1007/s40121-022-00742-5. Epub 
      2022 Dec 15.