Officials at the U.S. Food and Drug Administration reported that at least 10 children died after receiving the COVID-19 vaccine, according to an internal memo circulated last week. “These deaths are related to vaccination (likely/probable/possible attribution made by staff),” the memo, signed by Vinay Prasad, the director of the FDA’s Center for Biologics Evaluation and Research, read.
“This is a profound revelation. For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children,” it continued.
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These findings were based on an FDA analysis of data from the Vaccine Adverse Event Reporting Systems, or VAERS, a national surveillance platform that monitors potential safety issues following vaccination. Straight Arrow News analyzed publicly available VAERS data to better understand how many deaths were reported in the database, finding 83 reports of a child dying within two weeks of receiving a vaccine.
Researchers and public health experts have questioned and criticized the FDA’s finding.
“Currently, this is a completely unfounded claim unless they publish the report with data, methods and procedures to establish causality,” said Domenico Motola, an associate professor of pharmacology in Italy who has himself analyzed VAERS data.
What is the VAERS vaccine database?
VAERS itself is an imperfect source. The database is jointly run by the FDA and Centers for Disease Control and Prevention. Anyone — including health care providers, vaccine makers, parents or members of the public — can submit a report to VAERS if they experience or observe a health problem after vaccination.
VAERS only collects raw, unverified reports of side effects. CDC and FDA officials are supposed to review incoming reports for unusual patterns or trends that might signal a widespread safety concern. Each report to VAERS requires additional investigation to determine whether a side effect or death was in fact caused by a vaccine. While the publicly available VAERS data lists the raw reports, it does not include information about any further investigations.
A team at the FDA analyzed 96 deaths reported to VAERS between 2021 and 2024 and concluded that 10 were related to the COVID-19 vaccine, according to the memo.
“That number is certainly an underestimate due to underreporting, and inherent bias in attribution,” it read.
It could also be an overestimate: VAERS data are unverified and can be reported by anyone.
Prasad did not describe the researchers’ methods, nor did last week’s memo outline further information about the children or the types of COVID vaccines they received.
Many public health officials criticized the memo’s findings.
“It’s irresponsible science at best and it’s dangerous to the public at the very least,” Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, told Stat News.
“This memo conveys a very troubling mixture of misrepresentation and lies,” Peter Marks, the FDA’s former vaccine chief, told NBC News. “The climate within the agency is incredibly toxic right now.”
Prasad, a former hematologist-oncologist and epidemiology professor at the University of California San Francisco, has long criticized the FDA for rubber-stamping “too many useless products” and for its conflicts of interest with the industry it is meant to regulate.
He has also been vocal about the potential risk of myocarditis, an inflammation of the heart, following COVID-19 vaccination. Several studies found a slightly elevated risk of myocarditis following COVID-19 vaccination, especially among boys and young men. This June, the FDA required both Pfizer and Moderna to update warning labels to reflect this increased risk. Several months later, Pfizer formally acknowledged the risk in a press release. The company also noted that the risk of myocarditis after COVID-19 infection was about 42 times higher than from vaccination.
Inside the VAERS database
Straight Arrow News downloaded VAERS data files for each year between 2021 and 2025; each contains hundreds of thousands of entries. The FDA greenlit the first COVID-19 vaccine for emergency authorization use among people 16 years or older in December 2020, and formally approved the first vaccine in August 2021.
Each year included in the analysis required two data files. The first contains information about patient age, gender, symptoms, the date the patient received the vaccine, the day their symptoms began and the day the patient died, if applicable. All types of vaccines are included in the database, and not all entries in VAERS document patient deaths; some describe other potential side effects such as fever or rash. Others report instances when patients were given incorrect doses or expired vaccines.
The second file SAN reviewed contains information about the vaccine type and its manufacturer. Individual entries can be linked across these two data files by using the unique VAERS identification number.
SAN reviewed entries that reported a death among a person younger than 18 years of age. The analysis identified several likely instances of duplicated entries, which were removed prior to analysis and are not included in SAN’s final counts or graphs.
Several entries described an individual dying in a car crash or by suicide. SAN excluded entries that described a cause of death likely unrelated to vaccination. Entries with missing data were also excluded.
Between 2021 and 2025, VAERS recorded 83 deaths among children within two weeks of receiving any vaccine. Thirty-four of those cases involved kids who had been vaccinated against COVID-19, including 26 who had received a Pfizer shot, and eight who had received the Moderna vaccine, according to SAN’s analysis.
In that same time frame, VAERS records included 12 reports that a child died within two weeks of receiving a flu shot. Nine reports cited the Hepatitis A vaccine.
The majority of VAERS incidents recorded during this time frame involved the diphtheria, tetanus and pertussis, or DTaP, shot or one that combines DTaP with a vaccine for hepatitis B, poliovirus or Haemophilus influenzae type b.
This analysis relied on VAERS data only.
SAN presented its findings — that 34 children in the database had reportedly died within two weeks of receiving their COVID-19 shots — to both the FDA and CDC. Neither agency responded to requests for comment.
The FDA memo did not provide additional information about its investigation nor how it determined 10 deaths were linked to COVID-19 vaccines.
In September, Moderna published a statement reaffirming the safety of its COVID-19 vaccine.
“Multiple, overlapping safety monitoring systems are in place that work to detect and evaluate any new or evolving safety considerations. With more than one billion doses distributed globally, these systems —including in national health systems across Europe, the United Kingdom, Canada, Australia, and the U.S. — have not reported any new or undisclosed safety concerns in children or in pregnant women,” the company wrote.
Many previous studies, including large randomized trials — which are considered the gold standard for establishing a causal link between an intervention such as a vaccine and an outcome — concluded that COVID-19 vaccines were safe and that side effects, especially serious ones, were rare.
Several papers did note an increased risk of myocarditis, the inflammatory heart condition Prasad mentioned in his memo, after receiving a shot. A review of several studies estimated that anywhere between 12 and 118 kids out of a million experienced myopericarditis, a condition in which both the heart and its surrounding lining are inflamed.
One study that analyzed VAERS reports between December 2020 and January 2021 estimated that the mortality rate from COVID-19 vaccines among adults was 8.2 deaths per 1 million people. The benefits of vaccination outweighed the risks, researchers concluded.
The risk of dying from COVID-19 varied drastically based on an individual’s age and health status. Several COVID-19 variants, such as Omicron and Delta, circulated during the pandemic; some were more deadly than others. Two national seroprevalence studies — which look for antibodies in blood samples to estimate how many people were exposed to the virus rather than how many people sought medical attention — estimated that there were 770 and 970 deaths, respectively, per 1 million COVID infections among Americans younger than 60. That number was likely much lower among children. One study examined data from 29 countries and reported three deaths per 1 million COVID infections among people ages 0-19 years old.
It is important to consider how many lives vaccines saved when estimating how many they may have harmed, Motola told SAN.
“It’s always a balance of benefits versus possible risks. Zero risk doesn’t exist in nature,” he said.
Did the vaccine pose more harm to children than COVID-19?
Between 2019, when a mysterious virus first emerged in China, and 2023, over 1 million Americans died of COVID-19, according to CDC data, including more than 1,600 children.
Older age and certain medical conditions were major risk factors for COVID-19 death. In his memo, Prasad asserted that while an 80-year-old would benefit from the vaccine, younger people might not. However, he does not conclude that vaccines did more harm than good to children.
“Comparing the number of kids who died from COVID against these deaths would be a flawed comparison,” he wrote in his memo. “We do not know how many fewer kids would have died had they been vaccinated, and we do not know how many more kids died from taking vaccines than has been voluntarily reported. Instead, the truth is we do not know if we saved lives on balance.”
