PMID- 37309116
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231010
IS  - 2713-4148 (Electronic)
IS  - 2713-4148 (Linking)
VI  - 66
IP  - 10
DP  - 2023 Oct
TI  - Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, 
      Republic of Korea.
PG  - 415-423
LID - 10.3345/cep.2022.00815 [doi]
AB  - As of June 2022, 5 coronavirus disease 2019 (COVID-19) vaccine brands have been 
      used in Korea's national immunization program. The Korea Disease Control and 
      Prevention Agency has enhanced vaccine safety monitoring through a passive 
      web-based reporting system and active text message-based monitoring. In this 
      study, an enhanced safety monitoring system for COVID-19 vaccines is described 
      and the frequencies and types of adverse events (AEs) associated with the 5 
      COVID-19 vaccine brands were analyzed. AE reports from the web-based COVID-19 
      Vaccination Management System and text message-based reports from recipients were 
      analyzed. AEs were classified as nonserious or serious (e.g., death or 
      anaphylaxis). The AE reporting rates were calculated based on the number of 
      COVID-19 vaccine doses administered. A total of 125,107,883 doses were 
      administered in Korea from February 26, 2021, to June 4, 2022. Among them, 
      471,068 AEs were reported, of which 96.1% were nonserious and 3.9% were serious. 
      Among the 72,609 participants in the text message-based AE monitoring process, a 
      higher AE rate of local and systemic reactions was reported for the 3rd versus 
      1st doses. A total of 874 cases of anaphylaxis (7.0 per 1,000,000 doses), 4 cases 
      of thrombocytopenia syndrome (TTS), 511 cases of myocarditis (4.1 per 1,000,000 
      doses), and 210 cases of pericarditis (1.7 per 1,000,000 doses) were confirmed. 
      Six fatalities were causally associated with COVID-19 vaccination (1 of TTS and 5 
      of myocarditis). Young adult age and female sex were related with a higher AE 
      rate for COVID-19 vaccines. Most reported AEs were nonserious and of mild 
      intensity.
FAU - Lee, Yeon-Kyeng
AU  - Lee YK
AD  - Adverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination 
      Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
FAU - Kwon, Yunhyung
AU  - Kwon Y
AD  - Adverse Event Information Analysis Team, Immunization Safety Group, COVID-19 
      Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, 
      Korea.
FAU - Heo, Yesul
AU  - Heo Y
AD  - Adverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination 
      Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
FAU - Kim, Eun Kyoung
AU  - Kim EK
AD  - Adverse Event Investigation Team, Immunization Safety Group, COVID-19 Vaccination 
      Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
FAU - Kim, Seung Yun
AU  - Kim SY
AD  - Adverse Event Investigation Team, Immunization Safety Group, COVID-19 Vaccination 
      Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
FAU - Cho, Hoon
AU  - Cho H
AD  - Adverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination 
      Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
FAU - Kim, Seontae
AU  - Kim S
AD  - Adverse Event Information Analysis Team, Immunization Safety Group, COVID-19 
      Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, 
      Korea.
FAU - Ko, Mijeong
AU  - Ko M
AD  - Adverse Event Information Analysis Team, Immunization Safety Group, COVID-19 
      Vaccination Task Force, Korea Disease Control and Prevention Agency, Cheongju, 
      Korea.
FAU - Lim, Dosang
AU  - Lim D
AD  - Adverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination 
      Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
FAU - Seo, Soon-Young
AU  - Seo SY
AD  - Adverse Event Management Team, Immunization Safety Group, COVID-19 Vaccination 
      Task Force, Korea Disease Control and Prevention Agency, Cheongju, Korea.
FAU - Cho, Enhi
AU  - Cho E
AD  - Immunization Safety Group, COVID-19 Vaccination Task Force, Korea Disease Control 
      and Prevention Agency, Cheongju, Korea.
LA  - eng
PT  - Journal Article
DEP - 20230613
PL  - Korea (South)
TA  - Clin Exp Pediatr
JT  - Clinical and experimental pediatrics
JID - 101761234
PMC - PMC10556797
OTO - NOTNLM
OT  - Adverse reactions
OT  - COVID-19
OT  - Pharmacovigilance
OT  - Safety
OT  - Vaccination
COIS- Conflicts of interest No potential conflict of interest relevant to this article 
      was reported.
EDAT- 2023/06/13 06:42
MHDA- 2023/06/13 06:43
PMCR- 2023/06/13
CRDT- 2023/06/13 03:36
PHST- 2022/06/08 00:00 [received]
PHST- 2023/05/31 00:00 [accepted]
PHST- 2023/06/13 06:43 [medline]
PHST- 2023/06/13 06:42 [pubmed]
PHST- 2023/06/13 03:36 [entrez]
PHST- 2023/06/13 00:00 [pmc-release]
AID - cep.2022.00815 [pii]
AID - cep-2022-00815 [pii]
AID - 10.3345/cep.2022.00815 [doi]
PST - ppublish
SO  - Clin Exp Pediatr. 2023 Oct;66(10):415-423. doi: 10.3345/cep.2022.00815. Epub 2023 
      Jun 13.