OBJECTIVES: : Evaluating the side effects of COVID-19 vaccines and educating the public about their occurrence may dispel concerns and promote higher vaccination rates. This study focuses on the safety of COVID-19 vaccines approved in the U.S. for children between 5 and 17 years of age by considering spontaneous reports of adverse events from the Vaccine Adverse Event Reporting System (VAERS) database.

METHODS: : An observational descriptive study was conducted by reviewing reports of adverse events related with the Pfizer/Biotech, Moderna, and Janssen vaccines reported in the VAERS database from the dates the vaccines were approved through December 1, 2021. A summary of the most frequently reported adverse events, including specific descriptions for thrombotic, anaphylactic and death events, was conducted.

RESULTS: : A total of 687,402 adverse events mentioning any of the COVID-19 vaccines were reported in the VAERS database, with 2.9% involving children 5 to 17 years of age. Of these reports, 52% were female, and 45.2% had received the Moderna vaccine, 42.7% the Pfizer/BioNTech vaccine and 12.1% the Janssen vaccine. The most common adverse events for all children were fatigue, chills, and headache. For children 5 to 11 years old, fatigue (18.7% of reports), chills (16.5%) and headache (16.1%) were most common; for children 12 to 15 years old, fatigue (17.8%), headache (17.7%), and chills (16.6%) were most common; and for children 16 to 17 years old, fatigue (23.1%), headache (19.7%) and chills (19.2%) were most common. Anaphylactic reactions were found in 0.3% of reports, myocarditis or pericarditis in 0.09%, and death in 0.14%.