This is a prospective, observational study. During the study, children and adolescents (ages ≥ 5 to \< 16) will be followed post administration of mRNA COVID-19 vaccines. Injection site (local), systemic reaction, and unsolicited adverse event data will be assessed on vaccination day and during the 7 days following each vaccination using either identical web-based or paper diaries, depending on study participant preference. At Duke University, Cincinnati's Children Hospital, and Kaiser Permanente Northern California, serum samples will be collected for optional assessment of antibody titers to COVID-19. Each participant who opts in will have baseline (within 3 days of vaccination) serologies obtained and immunogenicity assessment at 28 (+7) days after each dose. All participants will be followed for 180 days after dose 2 for serious adverse events and adverse events of special interest.
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Number of participants with defined local or systemic reactogenicity events after each dose of COVID-19 vaccine
Timeframe: Up to 7 days post-vaccination
Number of participants with at least one severe (Grade 3) solicited local or systemic reactogenicity event after each dose of COVID-19 vaccine
Timeframe: Up to 7 days post-vaccination
Number of participants with at least one moderate-to-severe (Grade 2-3) solicited local or systemic reactogenicity event after each dose of COVID-19 vaccine
Timeframe: Up to 7 days post-vaccination
Number of participants with an unsolicited adverse events after each dose of COVID-19 vaccine
Timeframe: Up to 7 days post-vaccination
Number of participants with an adverse event of special interest
Timeframe: Up to 29 days post-vaccination
The number and percent of participants with at least one serious adverse event after dose 2 of COVID-19 vaccine
Timeframe: Up to 29 days post-vaccination