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

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

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 he 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.

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