PMID- 32608206
OWN - NLM
STAT- MEDLINE
DCOM- 20200818
LR  - 20200818
IS  - 1976-2437 (Electronic)
IS  - 0513-5796 (Print)
IS  - 0513-5796 (Linking)
VI  - 61
IP  - 7
DP  - 2020 Jul
TI  - Updates on Vaccine Safety and Post-Licensure Surveillance for Adverse Events 
      Following Immunization in South Korea, 2005-2017.
PG  - 623-630
LID - 10.3349/ymj.2020.61.7.623 [doi]
AB  - PURPOSE: Vaccine hesitancy is among the top ten threats to global health, and 
      access to precise data on adverse events following immunization (AEFIs) is 
      imperative to alleviate public concerns surrounding vaccines. This study aimed to 
      present the overall trends of AEFIs reported in South Korea. MATERIALS AND 
      METHODS: We evaluated the trends of AEFIs using the Korea Institute of Drug 
      Safety & Risk Management-Korea Adverse Event Reporting System database between 
      January 2005 and December 2017. AEFIs were classified into five categories to 
      evaluate associations between vaccines and AEFIs through a case-non-case study: 
      neurologic reactions, general systemic reactions, local reactions, allergic 
      reactions, and others. RESULTS: Among 54378 reported adverse events (AEs) 
      associated with all vaccines approved in South Korea, more than half (56.7%) 
      occurred following influenza vaccination, followed by the pneumococcal (11.6%) 
      and Bacillus Calmette-Guerin (BCG) vaccines (5.0%). After immunization with most 
      vaccines, general systemic reactions were most common, followed by local and 
      neurologic reactions. Adjusted reporting odds ratios were calculated for all 
      neurologic, general, local, and allergic reactions: of all vaccines, rotavirus 
      [neurologic 2.43, 95% confidence interval (CI), 2.25-2.62], BCG (general; 2.20, 
      95% CI, 1.91-2.53), BCG (local; 3.15, 95% CI, 2.69-3.68), and Japanese 
      encephalitis (allergic 2.38, 95% CI, 1.98-2.87) vaccines showed the highest 
      values. CONCLUSION: The majority of reported AEFIs were non-serious and mostly 
      general systemic reactions. Sufficient knowledge on the AEFIs would secure public 
      confidence on the safety of vaccines, thereby reducing public health burden from 
      vaccine-preventable diseases.
CI  - (c) Copyright: Yonsei University College of Medicine 2020.
FAU - Yoon, Dongwon
AU  - Yoon D
AUID- ORCID: 0000-0002-9369-0789
AD  - School of Pharmacy, Sungkyunkwan University, Suwon, Korea.
FAU - Kim, Ju Hwan
AU  - Kim JH
AUID- ORCID: 0000-0001-7253-6515
AD  - School of Pharmacy, Sungkyunkwan University, Suwon, Korea.
FAU - Lee, Hyesung
AU  - Lee H
AUID- ORCID: 0000-0001-6556-9984
AD  - School of Pharmacy, Sungkyunkwan University, Suwon, Korea.
FAU - Shin, Ju Young
AU  - Shin JY
AUID- ORCID: 0000-0003-1010-7525
AD  - School of Pharmacy, Sungkyunkwan University, Suwon, Korea. shin.jy@skku.edu.
LA  - eng
GR  - HG18C0068/Health Fellowship Foundation and Government-wide R&D/Korea
PT  - Journal Article
PL  - Korea (South)
TA  - Yonsei Med J
JT  - Yonsei medical journal
JID - 0414003
RN  - 0 (BCG Vaccine)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Algorithms
MH  - BCG Vaccine
MH  - Databases, Factual
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Humans
MH  - Hypersensitivity/*epidemiology
MH  - Immunization/*adverse effects/psychology
MH  - Male
MH  - *Product Surveillance, Postmarketing
MH  - Republic of Korea
MH  - Vaccination/*adverse effects/psychology/statistics & numerical data
PMC - PMC7329746
OTO - NOTNLM
OT  - Vaccines
OT  - adverse drug reaction reporting systems
OT  - drug-related side effects and adverse reactions
OT  - postmarketing
OT  - product surveillance
OT  - signal detection
COIS- The authors have no potential conflicts of interest to disclose.
EDAT- 2020/07/02 06:00
MHDA- 2020/08/19 06:00
PMCR- 2020/07/01
CRDT- 2020/07/02 06:00
PHST- 2019/12/20 00:00 [received]
PHST- 2020/04/10 00:00 [revised]
PHST- 2020/05/21 00:00 [accepted]
PHST- 2020/07/02 06:00 [entrez]
PHST- 2020/07/02 06:00 [pubmed]
PHST- 2020/08/19 06:00 [medline]
PHST- 2020/07/01 00:00 [pmc-release]
AID - 61.623 [pii]
AID - 10.3349/ymj.2020.61.7.623 [doi]
PST - ppublish
SO  - Yonsei Med J. 2020 Jul;61(7):623-630. doi: 10.3349/ymj.2020.61.7.623.