The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12–15 Years

United States, May 2021

Megan Wallace, DrPH; Kate R. Woodworth, MD; Julia W. Gargano, PhD; Heather M. Scobie, PhD; Amy E. Blain, MPH; Danielle Moulia, MPH; Mary Chamberland, MD; Nicole Reisman, MPH; Stephen C. Hadler, MD; Jessica R. MacNeil, MPH; Doug Campos-Outcalt, MD; Rebecca L. Morgan, PhD; Matthew F. Daley, MD; José R. Romero, MD; H. Keipp Talbot, MD; Grace M. Lee, MD; Beth P. Bell, MD; Sara E. Oliver, MD

Disclosures

Morbidity and Mortality Weekly Report. 2021;70(20):749-752. 

In This Article

Reporting of Vaccine Adverse Events

FDA requires that vaccination providers report vaccination administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of COVID-19 vaccine under an EUA.[7] Adverse events that occur after receipt of any COVID-19 vaccine should be reported to the Vaccine Adverse Events Reporting System (VAERS). Information on how to submit a report to VAERS is available at https://vaers.hhs.gov/index.html or 1-800-822-7967. Any person who administers or receives a COVID-19 vaccine is encouraged to report any clinically significant adverse event, whether or not it is clear that a vaccine caused the adverse event. In addition, CDC has developed a new, voluntary smartphone-based online tool (v-safe) that uses text messaging and online surveys to provide near real-time health check-ins after receipt of a COVID-19 vaccine. Parents or guardians can register their adolescent children in v-safe and complete the health surveys on their behalf. CDC's v-safe call center follows up on reports to v-safe that include possible medically significant health events to collect additional information for completion of a VAERS report. Information on v-safe is available at https://www.cdc.gov/vsafe.

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