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KMID : 1120220220130050382
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Osong Public Health and Research Perspectives
2022 Volume.13 No. 5 p.382 ~ p.390
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Adverse events of the Pfizer-BioNTech COVID-19 vaccine in Korean children and adolescents aged 5 to 17 years
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Kim Seon-Tae
Heo Ye-Seul
Seo Soon-Young
Lim Do-Sang
Cho En-Hi
Lee Yeon-Kyeng
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Abstract
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Objectives: This study aimed to identify potential safety signals and adverse events following the primary Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccination series among children and adolescents aged 5 to 17 years in the Republic of Korea.
Methods: Adverse events reported through the COVID-19 vaccination management system (CVMS, a web-based passive vaccine safety surveillance system) and adverse events and health conditions collected from a text message-based survey were analyzed.
Results: A total of 14,786 adverse events among 5- to 17-year-old children and adolescents were reported in the CVMS; 14,334 (96.9%) were non-serious and 452 (3.1%) were serious, including 125 suspected cases of acute cardiovascular injury and 101 suspected cases of anaphylaxis. The overall reporting rate was lower in 5- to 11-year-old children (64.5 per 100,000 doses) than in 12- to 17-year-old adolescents (300.5 per 100,000 doses). The text message survey identified that local and systemic adverse events after either dose were reported less frequently in 5- to 11-year-old children than in 12- to 17-year-old adolescents (p<0.001). The most commonly reported adverse events were pain at the injection site, myalgia, headache, and fatigue/tiredness.
Conclusion: The overall results are consistent with the results of controlled trials; serious adverse events were extremely rare among 5- to 17-year-old children and adolescents following Pfizer-BioNTech COVID-19 vaccination. Adverse events were less frequent in children aged 5 to 11 years than in adolescents aged 12 to 17 years.
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KEYWORD
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Adolescent, Child, COVID-19, Safety, Vaccination, Vaccines
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