A newly released federal document reveals that an internal Department of Health and Human Services (HHS) analysis linked seven pediatric deaths to cardiac complications following COVID-19 vaccination.
The data was compiled in a December 5, 2025, internal memorandum titled “Structured Causality Assessment of VAERS Reports of Pediatric Deaths Following COVID-19 Vaccination.” It was handed over to the Senate Permanent Subcommittee on Investigations on May 4, 2026, and released publicly by Subcommittee Chairman Ron Johnson on May 11, 2026.
The investigation reviewed 96 unique U.S. pediatric death reports recorded between 2021 and 2024 involving patients under the age of 18. Using standard diagnostic criteria from the World Health Organization-Uppsala Monitoring Center (WHO-UMC), federal medical officers categorized seven of those deaths as “probably” or “possibly” related to the vaccine.
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All seven verified cases involved cardiac events and occurred after the patients received the Pfizer-BioNTech vaccine. Five of the children died from myocarditis or myopericarditis—an inflammation of the heart muscle or surrounding sac—which is an established risk for mRNA vaccines. The other two cases involved cardiomyopathy and cardiac arrhythmia.
According to the report, the patients included five males and two females ranging from 7 to 16 years old, with a median age of 13. The median time from vaccination to the onset of physical symptoms was three days, ranging from 1 to 15 days. Autopsy reports were available and reviewed for all seven cases. Six of the deaths followed the original monovalent vaccine formula, while one occurred after a bivalent booster dose.
Based on these findings, federal health officials concluded that the postmarketing spontaneous adverse event reports constitute “new safety information.” The memorandum noted that while myocarditis is a known serious risk, the reporting of fatal outcomes is not currently described in the prescribing information guidelines for mRNA vaccines. Reviewers stated that this new safety information regarding fatal outcomes is applicable to all mRNA COVID-19 vaccines.
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The remaining 89 pediatric deaths examined in the report were classified as either unlikely to be related to the vaccine (62 cases) or completely unassessable due to insufficient or contradictory information (27 cases).
Medical officers emphasized that the vast majority of these unrelated fatalities were caused by clear alternative etiological factors. These included advanced stage IV malignancies, accidental drowning, severe preexisting genetic conditions like Trisomy 18 and Leigh syndrome, acute bacterial meningitis, and suicide related to documented mental health history.
Federal reviewers noted that the Vaccine Adverse Event Reporting System (VAERS) is a passive surveillance database with inherent limitations. Because it relies on voluntary reporting and lacks a control group or true denominator data, officials cautioned that the findings cannot be used to calculate or estimate the exact incidence rate of these fatal cardiac events within the broader population.
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