FDA Didn’t Follow Up When Alerted to Postvaccination Death of Minor: Doctor

Dr. Patrick Whelan reported the death of an 8-year-old boy.

In this image from video, Dr. Patrick Whelan, left, testifies to the U.S. House Select Subcommittee on the Coronavirus Pandemic as Dr. David Gortler looks on, in Washington on March 21, 2024. The Epoch Times via U.S. House

A doctor who reported to U.S. drug regulators how a 7-year-old boy he was caring for died after receiving a COVID-19 vaccine said on Thursday that he’s still not sure whether regulators obtained information about the case.

Dr. Patrick Whelan, the California doctor, said he filed a report with the Vaccine Adverse Event Reporting System (VAERS) after the boy suffered cardiac arrest shortly after taking a shot. The boy died about a week later.

Dr. Whelan tried updating the VAERS report to reflect the death but learned the system could not be updated.

The public version of VAERS only includes initial reports, while a nonpublic version contains updated information, officials have acknowledged.

During a subsequent meeting with Dr. Peter Marks, a top U.S. Food and Drug Administration (FDA) official, Dr. Whelan brought up the death.

“I mentioned that I had had this patient who died,” Dr. Whelan told members of Congress. “The whole tenor of the discussion completely changed.”

Dr. Whelan said the FDA staffers met with him about the matter about a month later, but considers the issue unresolved.

“I’ve never received any follow-up. I’m not sure that they ever obtained the records on that particular case,” he said.

The FDA declined to comment.

Dr. Whelan was testifying during a March 21 hearing on vaccine safety systems held by the U.S. House of Representatives Select Subcommittee on the Coronavirus Pandemic.

The way the VAERS report filed by Dr. Whelan was not updated “serves to emphasize that death reports in VAERS are probably significantly underreported—for anyone who was reported as ill prior to their death,” Dr. Whelan told The Epoch Times in a previous email.

Rep. Debbie Lesko (R-Ariz.) said during the hearing that she knows of a man who was hospitalized after receiving a COVID-19 vaccine, prompting a VAERS report. But when he died, the family was unable to get the report updated. “The family has just been totally distressed, because it’s not reported accurately,” she said.

Dr. Whelan flagged the boy’s death in a meeting with Dr. Marks on a study he co-authored that reanalyzed results from clinical trials for the Pfizer and Moderna vaccines. The reanalysis found vaccinated people in the trials were at higher risk of serious adverse events. The FDA downplayed the findings, claiming they showed nothing new.

In a hearing earlier this year, health officials told the same congressional panel that it’s aware of criticism of the two-tiered VAERS system.

“One of the criticisms that we often receive is that we don’t make that additional information available. And I would say to you that it’s a challenge, because what we’ve learned is it’s very challenging to make available essentially protected health information,” Dr. Marks said. He added later, “So this is one of the challenges we face in making available information, but I think we'd like to work to make the most information available as possible.”

‘Under-Resourced’

The FDA and the U.S. Centers for Disease Control and Prevention (CDC) co-manage VAERS, to which patients or others can lodge reports of suspected vaccine injuries.

Dr. Daniel Jernigan, with the CDC, said that officials follow up on every report to VAERS that involves a serious adverse event.

Reports to the system have exploded since the introduction of the COVID-19 vaccines in late 2020.

One contractor tapped to process the reports became so overwhelmed that a backlog soared to nearly 94,000 reports, documents obtained by The Epoch Times show.

Amid the backlog, the CDC either missed or ignored a major safety signal, according to other documents.

Dr. Marks said that “the avalanche of reports was tremendous.”

Federal officials hired more people to process the VAERS reports and say they eventually caught up.

FDA officials have previously declined to disclose the autopsy records and results of analyses of the reports, citing exceptions to the Freedom of Information Act. Several lawsuits on the matter are ongoing.

Rep. Brad Wenstrup (R-Ohio), chairman of the panel, said Thursday that the hearings on vaccine safety systems were held to address problems with the systems.

“We can’t be fully prepared for a future pandemic until we properly address the shortcomings, shortcomings in our vaccine safety systems and any other shortcomings that we may recognize so that we can correct them,” he said.

Deaths Flagged for CDC

Dr. Whelan separately in May 2021 flagged reports of two children who suffered cardiac deaths after COVID-19 vaccination, among 82 children under 16 who were reported to have received a shot despite the vaccines not being authorized for the population at that time.

“Two out of 82 seems like a pretty high level of risk,” Dr. Whelan told Dr. Jernigan in an email obtained by The Epoch Times.

Internal CDC emails obtained by The Epoch Times showed that Dr. John Su, a CDC vaccine safety official, described one of the reports as probably false. The other, he said, involved a “high-risk patient” who “had been experiencing failure to thrive for some weeks prior to their demise.”

“Not a whole lot there,” another CDC official told Dr. Whelan. “Per usual, the public VAERS data aren’t that useful for evaluating death reports. I hope this helps allay any fears.”

The CDC did not respond to a request for comment, including whether the agency has since received any additional information on the deaths.

The agency maintains that only seven deaths in the entire country have been caused by COVID-19 vaccines, despite medical examiners and other experts attributing dozens to the shots.