Adverse events of the Pfizer-BioNTech COVID-19 vaccine in Korean children and adolescents aged 5 to 17 years

• Published in: Osong public health and research perspectives 2022-10, Vol.13 (5), p.382-390
• Main Authors: Kim, Seontae, Heo, Yeseul, Seo, Soon-Young, Lim, Do Sang, Cho, Enhi, Lee, Yeon-Kyeng
• Format: Article
• Language: English
• Subjects: adolescent; Brief Report; child; covid-19; safety; vaccination; vaccines
• ISSN: 2210-9099; 2233-6052; 2210-9110
• DOI: 10.24171/j.phrp.2022.0233

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