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The public can now see “real-time” drug adverse reaction reports filed with the U.S. Food and Drug Administration (FDA).
People who experience a reaction to a drug can report it here, to the FDA Adverse Event Reporting System (FAERS). The FDA will update the system daily.
“Adverse event reporting should be fast, seamless and transparent,” said FDA Commissioner Marty Makary in an Aug. 22 press release.
“People who navigate the government’s clunky adverse event reporting websites should not have to wait months for that information to become public. We’re closing that waiting period and will continue to streamline the process from start to finish,” Makary said.
FAERS is the agency’s main database for collecting and analyzing reports of adverse events linked to a marketed drug or medication. The database also tracks serious medication errors and product quality complaints for prescription drugs and therapeutic biologics, according to the FDA press release.
The agency’s real-time reporting is “one of many steps in the FDA’s broader data modernization strategy to streamline all of its adverse event reporting systems and increase reporting frequency across all systems to identify safety signals faster,” according to the press release.
FAERS is separate from the Vaccine Adverse Event Reporting System (VAERS), which is co-managed by the FDA and the Centers for Disease Control and Prevention (CDC) and tracks injuries and deaths reported following vaccinations.
Children’s Health Defense (CHD) Chief Scientific Officer Brian Hooker said the FDA’s decision regarding FAERS is a step in the right direction.
“Both FAERS and VAERS are ‘dinosaurs’ desperately in need of improvements to make them quicker and easier to use,” Hooker said.
Are changes coming to vaccine injury reporting, too?
U.S. Health Secretary Robert F. Kennedy Jr. has vowed to push for “radical transparency” at government health agencies, but what that means for VAERS is unclear.
The U.S. Department of Health and Human Services (HHS) is currently “building surveillance systems that will accurately measure vaccine risks as well as benefits,” an HHS spokesperson said.
The spokesperson said:
“Secretary Kennedy’s HHS has pledged radical transparency to the American public. This means being honest and straightforward about what we know — and what we don’t know — about medical products, including vaccines.
“The CDC’s own research has shown that the post-licensure surveillance system, VAERS, captures fewer than 1% of vaccine injuries. It’s a system that was designed to fail.”
The spokesperson added, “The Vaccine Safety Datalink (VSD) — intended as a backup to VAERS — is virtually unusable for serious research. Both systems have become templates of regulatory malpractice.”
Hooker agreed, noting that independent researchers don’t have access to VSD’s data.
“The lame excuse for prohibiting VSD access is always privacy issues, but it would be easy to de-identify patient records within the VSD to create a HIPAA-compliant dataset for public use,” he said.
According to Hooker, the “real reason” independent researchers have been denied access to VSD is that the “CDC historically has been completely committed to covering up any vaccine adverse events. This must change.”
More improvements in tracking adverse events are needed
FAERS and VAERS are both “passive” monitoring systems, meaning they rely on healthcare professionals, consumers or manufacturers to voluntarily submit a report.
Hooker said HHS should develop “active” monitoring systems that automatically track vaccine- or drug-related injuries using electronic medical records. He said:
“It could be as easy as automated tracking of health issues after vaccination using standard electronic health record systems. This was previously done successfully with the Harvard Pilgrim Health Group back in 2011.
“That would be much faster, easier and more reliable than expecting the doctor or patient to go online on their own time and submit a laborious report on a clunky government website.”
HHS did not provide specific details on the vaccine-related injury surveillance systems it is building.
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VAERS appears to withhold some reports from the public
Tom Yengst, a senior science associate with CHD, said the FDA’s recent move to make drug-related injury reports public daily is a “major step towards transparency” because it suggests that the agency isn’t keeping a set of reports for internal use while sharing only some of those reports with the public.
That’s been a concern with VAERS, Yengst said.
VAERS makes its reports public via the CDC’s Wonder website — and sometimes takes weeks or months to publish a report after receiving it, Yengst said.
Additionally, it appears VAERS has not publicly released all the reports it received, according to emails CHD obtained via a Freedom of Information Act request.
The emails revealed “Daily Priority Reports” sent from the VAERS contractor to the CDC that included VAERS ID numbers for each day’s reports of deaths, serious and non-serious adverse events reported after COVID-19 vaccination.
The emails were from Feb. 1, 2021, to May 8, 2023. CHD compared the data from the emails with VAERS reports made public during the same timeframe.
The emails included 5,037 adverse event reports that were not released publicly. Of those, 795 reports indicated death, 2,067 were serious reactions and 2,175 were non-serious reactions, according to an April 4 letter from CHD.
In that letter, CHD CEO Mary Holland and Hooker alerted then-CDC Acting Director Susan Monarez to VAERS’ lack of transparency. They wrote:
“VAERS is a system with two, contrasting faces: internal and external. The internal face — not accessible to the public — appears to be fully populated in close to real-time with original, updated, and follow-up adverse event reports received by VAERS.
“In contrast, the external face — accessible to the public through the CDC’s Wonder website — is populated at varying degrees of time-lag; with some but not all adverse event reports; some of which have been modified; with no updates or follow-up reports; and with periodic deletions of reports without warning or explanation.”
Hooker and Holland urged Monarez to bring “genuine transparency to the public-facing VAERS.”
CHD did not receive a response from Monarez, who last week was fired following clashes between her and Kennedy over vaccine policy.
Related articles in The Defender- Nearly 100 Children a Day Go to ER for Drug-Related Reactions, Australian Report Finds
- Number of Children Who Died After COVID Shots Much Higher Than VAERS Reports Indicate, Analyst Says
- CDC Runs Two VAERS Systems — The Public Can Access Only One of Them
- Breaking: Emails Obtained by CHD Reveal Government’s Failure to Monitor COVID Vaccine Injury Reports
