PMID- 37019851
OWN - NLM
STAT- MEDLINE
DCOM- 20230808
LR  - 20230809
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 32
IP  - 9
DP  - 2023 Sep
TI  - Signal detection of COVID-19 vaccines adverse events using spontaneous reports 
      from South Korea.
PG  - 961-968
LID - 10.1002/pds.5629 [doi]
AB  - PURPOSE: Studies on the detection of COVID-19 vaccine signals in South Korea are 
      insufficient. Therefore, to investigate adverse events (AEs) that might be 
      associated with COVID-19 vaccines, signals were detected using spontaneous 
      reports from South Korea. We compared the signals with the vaccine insert lists 
      of the regulators in the four countries. METHODS: Spontaneous reports from 62 
      sites were collected by the National Medical Center between January 2013 and May 
      2022. A descriptive analysis of AEs associated with COVID-19 vaccines (Pfizer, 
      Moderna, AstraZeneca, and Janssen) was performed, and the proportional reporting 
      ratio, reporting odds ratio, and information component were calculated. We 
      performed five analyses, with five cases and one control group. RESULTS: During 
      the study period, 68 355 cases were reported, of which 12 485 were COVID-19 
      vaccine AEs. Injection site pain (2198 cases, 17.6%), myalgia (1552 cases, 
      12.4%), headache (1145 cases, 9.2%), pyrexia (1003 cases, 8.0%), and fatigue (735 
      cases, 5.9%) were frequently reported. When comparing all COVID-19 vaccines with 
      other viral vaccines, 20 signals were detected, of which cachexia, dyspepsia, 
      abdominal discomfort, and mood swings were not listed on the vaccine inserts in 
      all four countries. Overall, 20, 17, 29, and 9 signals were detected in vaccines 
      developed by Pfizer, Moderna, AstraZeneca, and Janssen, respectively. 
      CONCLUSIONS: Based on a disproportionate analysis of COVID-19 vaccine AEs using 
      spontaneous reports from South Korea, different signals were detected for each 
      vaccine manufacturer.
CI  - (c) 2023 John Wiley & Sons Ltd.
FAU - Jeong, Hye Su
AU  - Jeong HS
AUID- ORCID: 0000-0002-8197-3212
AD  - Drug Safety Monitoring Center, National Medical Center, Seoul, South Korea.
AD  - Department of Epidemiology and Health Informatics, Graduate School of Public 
      Health, Korea University, Seoul, South Korea.
FAU - Chun, Byung Chul
AU  - Chun BC
AUID- ORCID: 0000-0001-6576-8916
AD  - Department of Epidemiology and Health Informatics, Graduate School of Public 
      Health, Korea University, Seoul, South Korea.
AD  - Department of Preventive Medicine, Korea University College of Medicine, Seoul, 
      South Korea.
LA  - eng
PT  - Journal Article
DEP - 20230413
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (Vaccines)
SB  - IM
MH  - Humans
MH  - Adverse Drug Reaction Reporting Systems
MH  - *COVID-19/epidemiology/prevention & control
MH  - *COVID-19 Vaccines/adverse effects
MH  - Republic of Korea/epidemiology
MH  - *Vaccines
OTO - NOTNLM
OT  - COVID-19 vaccines
OT  - adverse drug reaction reporting systems
OT  - data mining
OT  - drug-related side effects and adverse reactions
OT  - pharmacovigilance
EDAT- 2023/04/06 06:00
MHDA- 2023/08/08 06:42
CRDT- 2023/04/05 22:53
PHST- 2023/02/14 00:00 [revised]
PHST- 2022/10/12 00:00 [received]
PHST- 2023/03/31 00:00 [accepted]
PHST- 2023/08/08 06:42 [medline]
PHST- 2023/04/06 06:00 [pubmed]
PHST- 2023/04/05 22:53 [entrez]
AID - 10.1002/pds.5629 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2023 Sep;32(9):961-968. doi: 10.1002/pds.5629. Epub 
      2023 Apr 13.