PMID- 35632500
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230308
IS  - 2076-393X (Print)
IS  - 2076-393X (Electronic)
IS  - 2076-393X (Linking)
VI  - 10
IP  - 5
DP  - 2022 May 9
TI  - Adverse Events and Safety Profile of the COVID-19 Vaccines in Adolescents: Safety 
      Monitoring for Adverse Events Using Real-World Data.
LID - 10.3390/vaccines10050744 [doi]
LID - 744
AB  - A COVID-19 vaccine BNT162b2 (Pfizer-BioNTech) has recently been authorized for 
      adolescents in the US. However, the impact of adverse events on adolescents after 
      vaccination has not been fully investigated. To assess the safety of the COVID-19 
      vaccine in adolescents, the incidence of adverse events (AEs) in adolescents and 
      adults was compared after vaccination. We included 6304 adolescents (68.14 per 
      100,000 people) who reported adverse events using vaccine adverse event reporting 
      system (VAERS) data from 10 May 2021 to 30 September 2021. The mean age was 13.6 
      +/- 1.1 years and women (52.7%) outnumbered men. We analyzed severe and common 
      adverse events in response to the COVID-19 vaccine among 6304 adolescents (68.14 
      per 100,000 people; 52% female; mean age, 13.6 +/- 1.1 years). The risk of 
      myocarditis or pericarditis among adolescents was significantly higher in men 
      than in women (OR = 6.61, 95% CI = 4.43 to 9.88; p < 0.001), with a higher 
      frequency after the second dose of the vaccine (OR = 8.52, 95% CI = 5.79 to 
      12.54; p < 0.001). In addition, severe adverse events such as multisystem 
      inflammatory syndromes, where the incidence rate per 100,000 people was 0.11 (n = 
      10), and the relative risk was 244.3 (95% CI = 31.27 to 1908.38; p < 0.001), were 
      significantly higher in adolescents than in adults. The risk of the inflammatory 
      response to the COVID-19 vaccine, including myocarditis, pericarditis, or 
      multisystem inflammatory syndromes, was significantly higher in men than in 
      women, with a higher frequency in adolescents than in adults. The 
      inflammation-related AEs may require close monitoring and management in 
      adolescents.
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 - 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 - 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 - Kim, Jihyun
AU  - Kim J
AD  - Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School 
      of Medicine, Seoul 06351, Korea.
FAU - Shim, Sung Ryul
AU  - Shim SR
AUID- ORCID: 0000-0003-4143-7383
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 - 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  - No. 20015086/Ministry of Trade, Industry and Energy/
GR  - National IT Industry Promotion Agency (NIPA)/Ministry of Science ICT and Future 
      Planning/
GR  - No.2020R1F1A1068423/Ministry of Education/
PT  - Journal Article
DEP - 20220509
PL  - Switzerland
TA  - Vaccines (Basel)
JT  - Vaccines
JID - 101629355
PMC - PMC9143867
OTO - NOTNLM
OT  - BNT162b2
OT  - COVID-19
OT  - adolescents
OT  - safety
OT  - severe adverse events
OT  - vaccines
COIS- The authors declare no conflict of interest.
EDAT- 2022/05/29 06:00
MHDA- 2022/05/29 06:01
PMCR- 2022/05/09
CRDT- 2022/05/28 01:44
PHST- 2022/04/12 00:00 [received]
PHST- 2022/05/06 00:00 [revised]
PHST- 2022/05/07 00:00 [accepted]
PHST- 2022/05/28 01:44 [entrez]
PHST- 2022/05/29 06:00 [pubmed]
PHST- 2022/05/29 06:01 [medline]
PHST- 2022/05/09 00:00 [pmc-release]
AID - vaccines10050744 [pii]
AID - vaccines-10-00744 [pii]
AID - 10.3390/vaccines10050744 [doi]
PST - epublish
SO  - Vaccines (Basel). 2022 May 9;10(5):744. doi: 10.3390/vaccines10050744.