by Brenda Baletti, Ph.D., Childrens Health Defense:
After a group of people injured by the COVID-19 vaccine asked the FDA for an external audit of VAERS, they never heard from the agency again. Now they’re developing a system to audit vaccine injury reports in a continuing struggle to hold public health officials accountable.
A team of researchers is developing a tool to track reports in the Vaccine Adverse Event Reporting System (VAERS), so vaccine-injured people can follow what happens to the reports they submit.
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As part of a broader effort to hold public health agencies accountable, the tool will also make it possible to audit the VAERS system by identifying what types of reports are deleted, insufficiently updated or contain errors.
The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), which jointly oversee VAERS, have refused to do this work despite multiple appeals by advocates for the vaccine-injured, according to React19, the group leading the initiative.
React19, founded by a small group of medical professionals injured by COVID-19 vaccines, works with institutions and providers to increase understanding and awareness of patients experiencing lasting effects following COVID-19 and/or COVID-19 vaccines.
The group is teaming up with computer programmer Liz Wilner, founder of OpenVAERS — a website that provides tools for more easily accessing and searching VAERS data — and Children’s Health Defense (CHD) to develop the tool.
The idea for developing the automatic VAERS report tracking tool came out of a VAERS audit the group conducted in 2022 to assess how the FDA and CDC were following up on COVID-19 vaccine injury reports.
React19 worked with outside experts to review a sample of 126 VAERS reports filed by some of its members who wanted to know what happened to their reports.
After tracking down each person’s reports and following them through the VAERS system, they “were kind of shocked at how bad it is,” members of React19 told The Defender.
They found that only 61% of the reports filed were correctly logged and published in VAERS. Twenty-two percent of the reports were never issued a permanent ID and are therefore not publicly visible, 12% were deleted and in 5% of the cases, a report couldn’t be filed or their report number remains unknown due to system errors.
That means more than 1 in 3 reports searched couldn’t be found in a database that is meant to be publicly accessible and transparent. It also suggests that problems of “omission of data and underreporting may be even greater than estimated,” according to the audit report.
The group also found that the medical status of the deleted reports, “by and large, had a worse outcome than the ones that were still in the system,” they said. For example, they said, in the public-facing VAERS system, 23% of reports were for permanent disabilities — but in the deleted reports, 53% were for permanent disability.
“One of the more alarming things we found out was that not all death reports are investigated,” Brianne Dressen, React19 founder, told The Defender.
The group brought this to the attention of public health officials in their meetings, sharing examples of reports that had been updated by people’s families when they died, but didn’t show up on the public system.
They also found that many follow-up reports containing updates on worsening symptoms were gone from the system.
At the time, the group was meeting regularly with top officials, including Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, to discuss vaccine injuries and why the agencies were doing nothing to address them.
In those meetings, according to Dressen and React19 member Dr. Joel Wallskog, when they raised the issue that the agencies weren’t following up on VAERS reports, the FDA told them VAERS wasn’t a reliable indicator for vaccine injuries, because anyone could file an injury complaint, including “Mickey Mouse or Michael Jackson.”
“We told them we know thousands of people that have not had any follow-up on their VAERS reports that are not Mickey Mouse, and they’re suffering it every single day waiting for you guys to get back to them to investigate what happened to them,” Dressen said.
“And of course then they never did anything. So we were like, OK, fine. If they’re not going to generate the evidence, then we will ourselves.”
The group submitted their findings to Marks during a meeting with him and his team. Based on their findings they also requested an external audit of the entire VAERS system and posed a series of questions listed on their audit report webpage.
They never heard from the agencies again.
“We were like, really?” Dressen said. “We were having these regular meetings with them every one month or every two months, and then after that, they wouldn’t meet with us anymore.”
Dressen, who was injured in the AstraZeneca clinical trials and whose diagnosis of post-vaccine neuropathy and other vaccine-related disorders was confirmed by the National Institutes of Health, said her own VAERS report is not visible to the public. The agencies haven’t told her why.
More recently, still hoping for accountability from the public health agencies, React19 submitted its audit and complaint to the Office of Inspector General at the U.S. Department of Health and Human Services.
The only response they received was an autoresponse confirming receipt of the complaint.
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