PMID- 37272559
OWN - NLM
STAT- MEDLINE
DCOM- 20230606
LR  - 20230610
IS  - 1598-6357 (Electronic)
IS  - 1011-8934 (Print)
IS  - 1011-8934 (Linking)
VI  - 38
IP  - 22
DP  - 2023 Jun 5
TI  - A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and 
      Its Associated Factors.
PG  - e170
LID - 10.3346/jkms.2023.38.e170 [doi]
LID - e170
AB  - BACKGROUND: Although coronavirus disease 2019 (COVID-19) vaccines have been 
      distributed worldwide under emergency use authorization, the real-world safety 
      profiles of mRNA vaccines still need to be clearly defined. We aimed to identify 
      the overall incidence and factors associated with adverse events (AEs) following 
      mRNA COVID-19 vaccination. METHODS: We conducted web-based survey from December 2 
      to 10 in 2021 with a 2,849 nationwide sampled panel. Study participants were 
      individuals who had elapsed at least two-weeks after completing two dosing 
      schedules of COVID-19 vaccination aged between 18-49 years. We weighted the 
      participants to represent the Korean population. The outcome was the overall 
      incidence of AEs following mRNA COVID-19 vaccination and associated factors. We 
      estimated the weighted odds ratios (ORs) using multivariable logistic regression 
      models to identify the factors associated with AEs. RESULTS: Of the 2,849 
      participants (median [interquartile range] age, 35 [27-42] years; 51.6% male), 
      90.8% (n = 2,582) for the first dose and 88.7% (n = 2,849) for the second dose 
      reported AEs, and 3.3% and 4.3% reported severe AEs, respectively. Occurrence of 
      AEs was more prevalent in mRNA-1273 (OR, 2.06; 95% confidence interval [CI], 
      1.59-2.67 vs. BNT162b2), female sex (1.88; 1.52-2.32), and those with 
      dermatologic diseases (2.51; 1.32-4.77). History of serious allergic reactions 
      (1.96; 1.06-3.64) and anticoagulant medication use (4.72; 1.92-11.6) were 
      associated with severe AEs. CONCLUSION: Approximately 90% of participants 
      reported AEs following mRNA COVID-19 vaccination. Substantial factors, including 
      vaccine type (mRNA-1273), female sex, and dermatologic diseases were associated 
      with AEs. Our findings could aid policymakers in establishing vaccination 
      strategies tailored to those potentially susceptible to AEs.
CI  - (c) 2023 The Korean Academy of Medical Sciences.
FAU - Yoon, Dongwon
AU  - Yoon D
AUID- ORCID: 0000-0002-9369-0789
AD  - School of Pharmacy, Sungkyunkwan University, Suwon, Korea.
FAU - Jeon, Ha-Lim
AU  - Jeon HL
AUID- ORCID: 0000-0002-9429-8711
AD  - School of Pharmacy, Jeonbuk National University, Jeonju, Korea.
FAU - Noh, Yunha
AU  - Noh Y
AUID- ORCID: 0000-0002-3645-7358
AD  - School of Pharmacy, Sungkyunkwan University, Suwon, Korea.
FAU - Choe, Young June
AU  - Choe YJ
AUID- ORCID: 0000-0003-2733-0715
AD  - Department of Pediatrics, Korea University Anam Hospital, Seoul, Korea.
FAU - Choe, Seung-Ah
AU  - Choe SA
AUID- ORCID: 0000-0001-6270-5020
AD  - Department of Preventive Medicine, Korea University College of Medicine, Seoul, 
      Korea.
AD  - Division of Life Sciences, Korea University, Seoul, Korea.
FAU - Jung, Jaehun
AU  - Jung J
AUID- ORCID: 0000-0002-4856-3668
AD  - Department of Preventive Medicine, Gachon University College of Medicine, 
      Incheon, Korea.
FAU - Shin, Ju-Young
AU  - Shin JY
AUID- ORCID: 0000-0003-1010-7525
AD  - School of Pharmacy, Sungkyunkwan University, Suwon, Korea.
AD  - Department of Clinical Research Design & Evaluation, Samsung Advanced Institute 
      for Health Sciences & Technology (SAIHST), Sungkyunkwan University, Seoul, Korea.
AD  - Department of Biohealth Regulatory Science, School of Pharmacy, Sungkyunkwan 
      University, Suwon, Korea. shin.jy@skku.edu.
LA  - eng
GR  - HG18C0068/Government-wide R&D Fund/Korea
GR  - RS-2022-00166769/National Research Foundation of Korea/Korea
GR  - Ministry of Food and Drug Safety/Korea
PT  - Journal Article
DEP - 20230605
PL  - Korea (South)
TA  - J Korean Med Sci
JT  - Journal of Korean medical science
JID - 8703518
RN  - 0 (COVID-19 Vaccines)
RN  - EPK39PL4R4 (2019-nCoV Vaccine mRNA-1273)
RN  - 0 (BNT162 Vaccine)
RN  - 0 (RNA, Messenger)
SB  - IM
MH  - Humans
MH  - Female
MH  - Male
MH  - Adolescent
MH  - Young Adult
MH  - Adult
MH  - Middle Aged
MH  - *COVID-19/epidemiology/prevention & control
MH  - COVID-19 Vaccines/adverse effects
MH  - 2019-nCoV Vaccine mRNA-1273
MH  - BNT162 Vaccine
MH  - RNA, Messenger
MH  - Vaccination/adverse effects
PMC - PMC10244024
OTO - NOTNLM
OT  - COVID-19 Vaccines
OT  - Drug-Related Side Effects and Adverse Reactions
OT  - Risk Factors
OT  - Survey and Questionnaires
OT  - mRNA Vaccines
COIS- Ju-Young Shin received grants from the Ministry of Food and Drug Safety, the 
      Ministry of Health and Welfare, the National Research Foundation of Korea, and 
      pharmaceutical companies, including Daiichi Sankyo, GSK, and Pfizer, outside the 
      submitted work.
EDAT- 2023/06/05 13:04
MHDA- 2023/06/06 06:42
PMCR- 2023/06/05
CRDT- 2023/06/05 07:23
PHST- 2022/11/30 00:00 [received]
PHST- 2023/02/23 00:00 [accepted]
PHST- 2023/06/06 06:42 [medline]
PHST- 2023/06/05 13:04 [pubmed]
PHST- 2023/06/05 07:23 [entrez]
PHST- 2023/06/05 00:00 [pmc-release]
AID - 38.e170 [pii]
AID - 10.3346/jkms.2023.38.e170 [doi]
PST - epublish
SO  - J Korean Med Sci. 2023 Jun 5;38(22):e170. doi: 10.3346/jkms.2023.38.e170.