PMID- 35214779
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220301
IS  - 2076-393X (Print)
IS  - 2076-393X (Electronic)
IS  - 2076-393X (Linking)
VI  - 10
IP  - 2
DP  - 2022 Feb 17
TI  - The Safety of mRNA-1273, BNT162b2 and JNJ-78436735 COVID-19 Vaccines: Safety 
      Monitoring for Adverse Events Using Real-World Data.
LID - 10.3390/vaccines10020320 [doi]
LID - 320
AB  - Two mRNA COVID-19 vaccines (mRNA-1273, Moderna; and BNT162b2, Pfizer-BioNTech) 
      and one viral vector vaccine (JNJ-78436735, Janssen/Johnson and Johnson) are 
      authorized in the US to hinder COVID-19 infections. We analyzed severe and common 
      adverse events in response to COVID-19 vaccines using real-world, Vaccine Adverse 
      Effect Reporting System (VAERS) data. From 14 December 2020 to 30 September 2021, 
      481,172 (50.7 +/- 17.5 years, males 27.89%, 12.35 per 100,000 people) individuals 
      reported adverse events (AEs). The median time to severe AEs was 2 days after 
      injection. The risk of severe AEs following the one viral vector vaccine (OR = 
      1.044, 95% CI = 1.005-1.086) was significantly higher than that after the two 
      mRNA vaccines, and the risk among males (OR = 1.374, 95% CI = 1.342-1.406) was 
      higher than among females, except for anaphylaxis. For common AEs, however, the 
      risk to males (OR = 0.621, 95% CI = 0.612-0.63) was lower than to females. In 
      conclusion, we provided medical insight and clinical guidance about vaccine types 
      by characterizing AEs using real-world data. In particular, COVID-19 mRNA 
      vaccines are safer than viral vector vaccines with regard to coagulation 
      disorders, whereas inflammation-related AEs are lower in the viral vaccine. The 
      risk-benefit ratio of vaccines should be carefully considered, and close 
      monitoring and management of severe AEs is needed.
FAU - Sa, Soonok
AU  - Sa S
AD  - Department of Biomedical Informatics, CHA University School of Medicine, CHA 
      University, Seongnam 13488, Korea.
AD  - Institute of Basic Medical Sciences, School of Medicine, CHA University, Seongnam 
      13488, Korea.
AD  - Institute for Biomedical Informatics, School of Medicine, CHA University, 
      Seongnam 13488, Korea.
FAU - Lee, Chae Won
AU  - Lee CW
AUID- ORCID: 0000-0002-9380-8230
AD  - Department of Biomedical Informatics, CHA University School of Medicine, CHA 
      University, Seongnam 13488, Korea.
AD  - Institute of Basic Medical Sciences, School of Medicine, CHA University, Seongnam 
      13488, Korea.
AD  - Institute for Biomedical Informatics, School of Medicine, CHA University, 
      Seongnam 13488, Korea.
FAU - Shim, Sung Ryul
AU  - Shim SR
AD  - Department of Biomedical Informatics, CHA University School of Medicine, CHA 
      University, Seongnam 13488, Korea.
AD  - Institute of Basic Medical Sciences, School of Medicine, CHA University, Seongnam 
      13488, Korea.
AD  - Institute for Biomedical Informatics, School of Medicine, CHA University, 
      Seongnam 13488, Korea.
AD  - Healthcare Big-Data Center, Bundang CHA Hospital, Seongnam 13488, Korea.
AD  - Department of Health and Medical Informatics, Kyungnam University, College of 
      Health Sciences, Changwon 51767, Korea.
FAU - Yoo, Hyounggyoon
AU  - Yoo H
AUID- ORCID: 0000-0003-2785-4383
AD  - Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, 
      CHA University, Seongnam 13496, Korea.
FAU - Choi, Jinwha
AU  - Choi J
AD  - Department of Pediatrics, Korea University College of Medicine, Seoul 08308, 
      Korea.
FAU - Kim, Ju Hee
AU  - Kim JH
AD  - Department of Biomedical Informatics, CHA University School of Medicine, CHA 
      University, Seongnam 13488, Korea.
AD  - Institute of Basic Medical Sciences, School of Medicine, CHA University, Seongnam 
      13488, Korea.
AD  - Institute for Biomedical Informatics, School of Medicine, CHA University, 
      Seongnam 13488, Korea.
FAU - Lee, Kiwon
AU  - Lee K
AD  - Spidercore Inc., Daejeon 34134, Korea.
FAU - Hong, Myunghee
AU  - Hong M
AUID- ORCID: 0000-0002-4573-3625
AD  - Department of Biomedical Informatics, CHA University School of Medicine, CHA 
      University, Seongnam 13488, Korea.
AD  - Institute of Basic Medical Sciences, School of Medicine, CHA University, Seongnam 
      13488, Korea.
AD  - Institute for Biomedical Informatics, School of Medicine, CHA University, 
      Seongnam 13488, Korea.
FAU - Han, Hyun Wook
AU  - Han HW
AUID- ORCID: 0000-0002-6918-5694
AD  - Department of Biomedical Informatics, CHA University School of Medicine, CHA 
      University, Seongnam 13488, Korea.
AD  - Institute of Basic Medical Sciences, School of Medicine, CHA University, Seongnam 
      13488, Korea.
AD  - Institute for Biomedical Informatics, School of Medicine, CHA University, 
      Seongnam 13488, Korea.
AD  - Healthcare Big-Data Center, Bundang CHA Hospital, Seongnam 13488, Korea.
LA  - eng
GR  - 20015086/Ministry of Trade, Industry and Energy/
GR  - Ministry of Science and ICT/
GR  - 2020R1F1A1068423, NRF-2019M3C7A1032262/Ministry of Education/
GR  - 2019-0-00224/Ministry of Science and ICT/
PT  - Journal Article
DEP - 20220217
PL  - Switzerland
TA  - Vaccines (Basel)
JT  - Vaccines
JID - 101629355
PMC - PMC8879025
OTO - NOTNLM
OT  - COVID-19
OT  - safety
OT  - severe adverse events
OT  - vaccines
COIS- We declare no competing interest.
EDAT- 2022/02/27 06:00
MHDA- 2022/02/27 06:01
PMCR- 2022/02/17
CRDT- 2022/02/26 01:04
PHST- 2022/01/05 00:00 [received]
PHST- 2022/02/14 00:00 [revised]
PHST- 2022/02/14 00:00 [accepted]
PHST- 2022/02/26 01:04 [entrez]
PHST- 2022/02/27 06:00 [pubmed]
PHST- 2022/02/27 06:01 [medline]
PHST- 2022/02/17 00:00 [pmc-release]
AID - vaccines10020320 [pii]
AID - vaccines-10-00320 [pii]
AID - 10.3390/vaccines10020320 [doi]
PST - epublish
SO  - Vaccines (Basel). 2022 Feb 17;10(2):320. doi: 10.3390/vaccines10020320.