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When Dr. Robert Sullivan collapsed on his treadmill three weeks after his second COVID-19 vaccine in early 2021, he fell into a “nightmare” ordeal that he said exposed glaring deficiencies in the nation’s vaccine safety monitoring system.
Diagnosed with sudden onset pulmonary hypertension, the healthy and fit 49-year-old anesthesiologist from Maryland attempted to file a report through the government-run Vaccine Adverse Event Reporting System (VAERS).
But like others interviewed in a recent investigation by The BMJ, Sullivan hit barrier after barrier when trying to submit and update his report.
Almost three years later, still grappling with debilitating symptoms, Sullivan’s experience highlights the systemic problems with the U.S. adverse events monitoring system run jointly by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).
From doctors unable to file reports to disappearing data, limits on transparency and lack of resources to follow up on concerning vaccine reactions, experts warn VAERS is failing to detect critical safety signals.
According to one of those experts — VAERS researcher Albert Benavides, whose experience includes HMO claims auditing, data analytics and revenue cycle management — VAERS’ failure isn’t accidental.
‘They even delete legitimate reports’
Like others interviewed by The BMJ, Sullivan experienced limited follow-up after submitting his VAERS report. He received only a temporary report number months after his initial submission.
A physician named “Helen” (pseudonym) told The BMJ that fewer than 20% of concerning reports get follow-up, including many deaths she reported.
In consultation with Benavides, an audit by React19 found that 1 in 3 COVID-19 vaccine adverse events reports in VAERS were either not posted publicly or were deleted. React19 is a nonprofit that collects stories of people injured by the mRNA vaccines.
According to The BMJ, of those queried by React19, “22% had never been given a permanent VAERS ID number and 12% had disappeared from the system entirely.”
Benavides, who publishes the VAERSAware dashboards documenting many of the problems with VAERS, said there is even deeper dysfunction in the VAERS system — from inventing symptoms to deleting reports.
“VAERS does not publish all legitimate reports received,” Benavides told The Defender. “They throttle publication of reports. They even delete legitimate reports.”
For a system dependent on voluntary engagement, these restrictive policies keep critical data hidden, according to Benavides.
In 2007, the U.S. Department of Health and Human Services (HHS) contracted with Harvard Pilgrim Health Care (HPHC) to review the VAERS system. In 2010, HPHC filed its r report, which determined that 1 in 39 people experienced vaccine injuries and that only around 1% of vaccine-related injuries or deaths are ever reported to VAERS.
‘Blind spots are self-created’
VAERS “collects reports of symptoms, diagnoses, hospital admissions, and deaths after vaccination for the purpose of capturing post-market safety signals,” according to The BMJ.
But the limited transparency of VAERS data presents barriers to proper analysis, according to The BMJ’s investigation and researchers like Benavides.
The public — including doctors and other report submitters — can access only incomplete initial reports, not updates with vital details.
This means outcomes like death are often excluded if the initial report was for an injury and a subsequent death report was filed.
“I made the false assumption that my conversation [with VAERS] would result in an adjustment to the publicly reported case,” Patrick Whelan, M.D., Ph.D., told The BMJ.
Whelan, a rheumatologist and researcher at the University of California Los Angeles, in 2022 filed a report of a cardiac arrest in a 7-year-old male patient after COVID-19 vaccination.
“I assumed that, since it was a catastrophic event, the safety committee would want to hear about it right away,” Whelan said. But nobody called him or requested an update after his submission.
“There was no mechanism for [updating] it,” Whelan told The BMJ. “The only option I had was to make a new VAERS report.” Without updates, the VAERS data showed that the boy was still hospitalized.
Whelan is one the authors of a recent critique of the Cochrane Review that concluded the COVID-19 mRNA vaccines were not dangerous.
The problem with VAERS is not limited to a lack of adequate follow-up but to the incomplete and often inaccurate information found there.
“VAERS in effect allows typos, truncated lot #’s, UNK [unknown] ages, UNK vax dates, UNK death dates, etc. to pass through into publication,” Benavides said.
Benavides said specific data — including ethnicity, hospital names, attending physicians, submitter’s relationship to the patient, patient and submitter addresses, telephone numbers and emails — collected by VAERS are not published,
“Any blind spots are self-created, in my opinion,” he said.
Agencies maintain two separate VAERS databases — public gets to see only one
“There’s two parts to VAERS, the front end and back end,” stated Narayan Nair, division director for the FDA’s Division of Pharmacovigilance at a December 2022 meeting with advocates, according to The BMJ. “Anything from medical records by law can’t be posted on the public-facing system,” he said.
The BMJ investigation discovered that the FDA and CDC maintain two separate VAERS databases, one available to the public that contains only initial reports, and a private back-end system containing all of the updates and corrections.
“Anything derived from medical records by law” cannot be posted on the public-facing system, Nair told the advocates, according to The BMJ.
In an apparent contradiction to this claim, The BMJ noted the FDA’s Adverse Event Reporting System (FAERS), which collects post-marketing information on drug reactions, posts its updates publicly.
Sullivan, who met Nair years before COVID-19 and considers him a friend, told The Defender that if this “very bright, kind and caring person” could not fix VAERS, “I don’t think it’s fixable.”
CDC says it reviewed 20,000 reports of deaths — none were related to COVID shots
Withholding outcome data like deaths obscures critical safety signals, experts contend.
James Gill, a medical examiner, reported the death of a 15-year-old patient after vaccination, but the case was dismissed by the CDC despite autopsy evidence, according to the BMJ investigation.
Physician “Helen” told The BMJ that after filing reports on her medical patients, including six who had died, she received only a single request for medical records on the death and two for hospital-admitted patients.
The standard operating procedure for COVID-19 vaccine reports in VAERS, according to The BMJ, is for reports to be processed quickly and for “serious reports” to receive special review by CDC staff.
However, while some other countries have acknowledged the probable connection between the mRNA vaccines and death, the CDC, while claiming to have reviewed nearly 20,000 death reports, has yet to acknowledge a single death linked to the COVID-19 vaccines, The BMJ said.
Benavides provided The Defender examples of VAERS “deleting legitimate reports,” not just duplicates or false claims.
“VAERS even deleted dead Pfizer Trial patients,” he said, claiming that this report, for example, was not a “duplicate” and did not appear to be fake.
“There are currently about 50 deaths that are not counted as deaths because the correct box is not checked off.
“There are thousands of reports and about 100 deaths in ‘UNKNOWN VAX TYPE’ in VAERS. Read the narrative to see these are clearly C19 jab-related deaths.
“There are over a thousand cardiac arrests where they are not marked as dead, and I question if they actually survived because there is no mention of ROSC [return of spontaneous circulation].”
“Why couldn’t VAERS populate the ages of these dead kids before publication?” Benavides said, pointing to this report on his website.
Physicians report only FDA-recognized adverse events
Ralph Edwards, former director of the Uppsala Monitoring Centre and until recently editor-in-chief of the International Journal of Risk & Safety in Medicine, told The BMJ the regulators may be relying too heavily on past epidemiological data, especially for new types of adverse events. “If something hasn’t been heard of before, it tends to be ignored,” he said.
Without guidance to report potential risks, doctors also face barriers. “Physicians are only willing to talk about FDA-recognized vaccine adverse events,” stated physician “Helen” in a 2021 meeting between the FDA and physicians and advocates, according to The BMJ.
Svetlana Blitshteyn, a neurologist and researcher at the University at Buffalo, New York, told The BMJ if physicians are not educated to look for a specific condition, they’re unlikely to test for it or know how to treat it.
Sullivan told The Defender he believes his experience of developing pulmonary hypertension after taking the mRNA vaccine is one such safety signal the CDC and FDA are overlooking — a condition he believes many athletes have unknowingly developed.
Sullivan co-authored a paper of his and one other similar case of post-vaccine pulmonary hypertension. According to the paper:
“Pulmonary hypertension is a serious disease characterized by damage to lung vasculature and restricted blood flow through narrowed arteries from the right to left heart. The onset of symptoms is typically insidious, progressive and incurable, leading to right heart failure and premature death.”
“Athletes are canaries in the coal mine,” Sullivan told The Defender, speaking of the unusual numbers of athlete deaths since the rollout of the vaccine. Sullivan thinks that those with superior physical conditioning, like him, stand a better chance of survival with early detection.
However, he said, “Athletes will get echocardiography, and it will be essentially normal. The only way to tell for sure is to do a right-heart catheterization” that can identify the anomaly.
Sullivan believes the lives of many athletes could still be saved if the reporting system recognized and investigated the signal — and said he would be happy to join a project dedicated to this goal.
He also told The Defender he believes many of the sudden deaths reported in the 25- to 44-year-old age group are a result of this hidden condition.
‘The buck stops with the CDC for reforms’
Critics point to choices by the CDC as compounding VAERS’ passive design and understaffing issues.
Despite over 1.7 million reports since the COVID-19 vaccine rollout, staffing was not boosted accordingly, according to statements the CDC made to The BMJ.
A Freedom of Information Act request by The BMJ revealed Pfizer has nearly 1,000 more full-time employees working on vaccine surveillance than the CDC. Records showed in 2021, Pfizer on-boarded 600 additional full-time employees to handle the volume of adverse reports and planned to hire 200 more.
Physician “Helen” in The BMJ article called for an end to the “negative feedback loop” whereby the FDA fails to list adverse reactions because passive surveillance systems like the FDA’s don’t display them, while at the same time, because of that lack of disclosure, “physicians are blinded to the adverse reactions in their patients, and thus aren’t reporting them.”
“The buck stops with the CDC for reforms needed to open up data,” Benavides told The Defender, adding several suggestions that could immediately improve VAERS:
“Revert back to pre-January 2011 when VAERS did append initial reports with follow-up data, including death. Take off the arbitrary 30-minute time limit to file a report before getting kicked off. Make the process easier to submit follow-up data.”
When asked why the incompetence of VAERS had been allowed to continue for so long, Sullivan told The Defender, “Because of the lack of product liability” for the vaccines “and the surge to defend economic interests.”
Sullivan said he’d like to see the following changes to the system:
Yale cardiologist takes on study of COVID vaccine injuries
Benavides said he spoke with Sen. Ron Johnson (R-Wis.) Monday and is also in discussion with Rep. Marjorie Taylor Greene (R-Ga.) of the House Select Subcommittee on the Coronavirus Pandemic to address the concerns with VAERS, including the under-publishing of reports.
“That’s a long overdue prospect and it would be incredible to actually get some analysis by that committee,” he said.
Another bright spot comes from news reported in The BMJ’s investigation that Dr. Harlan Krumholz, a cardiologist and researcher at Yale University, has been recruiting members of React19 to study their vaccine injuries.
“We are working hard to understand the experience, clinical course, and potential mechanisms of the ailments reported by those who have had severe symptoms arise soon after the vaccination,” Krumholz told The BMJ.
Sullivan told The Defender that medical science is “just beginning to catalog the damage to the heart” from the vaccines but that “in order to treat something, you have to diagnose it” — and that, because of the shortcomings with VAERS, “we have yet to scratch the surface of that.”
Sullivan, now almost three years into his ordeal, is outliving his initial prognosis.
“I have a grim diagnosis hanging over me, but I’m optimistic because I’m still here,” he said. “I had something bad happen to me, but I’ve met so many amazing, wonderful people along the way who are just interested in truth.”
“I’m going to live the best and most productive life I can with the time I have left,” Sullivan said, helping others who “have this cloud hanging over their future.”
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