The number was revised down from 10, newly released documents show.
Food and Drug Administration experts concluded that COVID-19 vaccination probably or possibly resulted in the deaths of 10 children, before revising that number to seven, according to recently released documents.
FDA experts said the deaths of two boys, aged 13 and 7, from heart inflammation, were probably due to a COVID-19 vaccination, according to the files.
The 13-year-old was found dead three days after a COVID-19 vaccination. The death was reported after an autopsy in a study by medical examiners in 2022.
“There was temporal association of death following vaccination, and autopsy findings showed myocarditis of uncertain etiology as the cause of death,” FDA reviewers said in one of the files, a safety memorandum, made public by Sen. Ron Johnson (R-Wis.).
The 7-year-old, with no prior medical history, developed a fever and other problems 12 days after vaccination and died of cardiac arrest two days later.
“This case was assessed as probably associated with COVID-19 vaccination due to the 12-day symptom onset fitting into the known risk window,” the reviewers said.
The experts also concluded that the deaths of a 13-year-old male, two 13-year-old females, a 15-year-old male, and two 16-year-old males were possibly caused by COVID-19 vaccination, according to the memo.
All of the deaths deemed probable or possible came following vaccination with the Pfizer-BioNTech messenger ribonucleic acid (mRNA) vaccine.
Neither Pfizer nor BioNTech responded to The Epoch Times’ requests for comment by time of publication.
The assessment of deaths reported to the Vaccine Adverse Event Reporting System (VAERS) uncovered dangers “not currently described in the prescribing information for mRNA COVID-19 vaccines,” the FDA’s Center for Biologics Evaluation and Research said in the memo, dated Dec. 5, 2025. Prescribing information is given to doctors who administer vaccines.
