An investigation by the British Medical Journal (BMJ) has raised serious concerns that the US Vaccine Adverse Event Reporting System (VAERS) is not operating as intended and that signals are being lost. In short, it’s a broken system that indicates it’s not fit for purpose and has been overwhelmed by the significant increase in reporting.
Parentingpatch.com
As reported by Jennifer Block for the BMJ;
Three weeks after receiving a second dose of a covid vaccine, Robert Sullivan collapsed at home on his treadmill. An anaesthesiologist in Maryland, USA, he was a particularly fit 49 year old: the week before falling ill, he’d been happily skiing at altitude in Colorado. Sullivan was given a diagnosis of sudden onset pulmonary hypertension, which is generally progressive, can be fatal, and in most cases can’t be cured. The condition is rare, especially in middle aged men. Sullivan decided to file a report in the Vaccine Adverse Event Reporting System (VAERS), which collects reports of symptoms, diagnoses, hospital admissions, and deaths after vaccination for the purpose of capturing post-market safety signals. But the submission process was a glitchy race against the clock. “The format is cumbersome and it times you out,” he tells The BMJ. For his troubles, Sullivan received a confirmation by email and a temporary “e-report” number. He learnt from his doctor’s office that a VAERS representative had requested medical records. Then he didn’t hear back for a year.
It became quite apparent in this investigation that VAERS is not meeting it’s own standards and with staffing levels failing to keep pace with the unprecedented number of reports rolling in since the roll out of the vaccine. Almost as if they expected it to be safe and effective with no adverse events. Prior to the pandemic VAERS was receiving nearly 60,000 adverse events per year. Since the roll out of the Covid-19 jab that has risen to 1.7 million and nearly one in five meet the criteria for serious.
Due to such a large roll out surely it would be expected that there would be a sharp increase in adverse events.
Indeed the system has come in for criticism for not being user friendly, timing people out and generally off-putting to busy healthcare professionals. Described as patchy” and “frustrating”. It is therefore reasonable to draw the assumption that many adverse events are not making themselves onto the list at all, seriously undermining the process itself, which is to draw attention to any problems or issues.
Furthermore, there has been a complete lack of follow up. VAERS has not acknowledged a single death due to the shot. While many other countries have acknowledged deaths that were “likely” or “probably” related to the mRNA jabs.
Meanwhile, under Freedom of Information of Act documents seen by the BMJ, Pfizer have employed more that 100 people over and above what the CDC have to work on vaccine surveillance. Indeed in February 2021 they had on-boarded an extra 600 staff with plans to recruit another 1800.
The BMJ article includes some specific cases amongst those they interviewed for this damning report. Such as Patrick Whelan, a rheumatologist and researcher at the University of California Los Angeles, who in 2022 reported how one of his patients, a 7 year old boy, had a cardiac arrest after covid vaccination. The patient was incubated when Whelan filed a VAERS report, and he expected a prompt follow-up call from a CDC investigator.
"I'd assumed that, since it was a catastrophic event, the safety committee would want to hear about it right away", he says. But, to his knowledge, nobody called or requested medical records. In an email sent to Whelan months later the FDA said that it had followed up “soon after” receiving his report and had made “several requests” for medical records. The agency added, “Generally speaking, staff might not reach out to providers unless they have specific questions about a case or a VAERS report.”
Then there is James Gill who has been a medical examiner and forensic pathologist for 25 years and is currently chief medical examiner for the state of Connecticut. In June 2021 he made the first VAERS report of his career. It was for a 15 year old boy who died suddenly days after getting a second jab—what Gill concluded on autopsy was;
stress cardiomyopathy following second dose of the Pfizer-BioNTech Covid-19 vaccine.
The BMJ article tells us that;
Gill, who has appointments at Yale University and the University of Connecticut, can’t recall getting any calls from VAERS after he filled out the online form, and he still has only a temporary “e-report” number. After he published the case reports in the Archives of Pathology & Laboratory Medicine in February 2022, however, the CDC did respond—in the form of a letter to the editor contesting Gill’s finding.
It appears that even those who did file reports on the VAERS system were not guaranteed to have actually been registered. In November 2022, React19, an advocacy group of some 30 000 people who have experienced prolonged illness after covid vaccination, reviewed 126 VAERS reports among its ranks. In its audit, which was conducted by volunteers inside and outside the organisation, 22% had never been given a permanent VAERS ID number and 12% had disappeared from the system entirely—in other words, one in three of the reports they looked for didn’t show up in the publicly searchable database.
As one intensive care and emergency physician put it to Marks (director of the Center for Biologics Evaluation and Research) and Nair (FDA division director who oversees VAERS) “There’s a breakdown in your system”. In March 2022, in response to the physician, Nair responded that if a report meets the definition of serious, “there really should be a request for records.” In the case of a reported death, “we prioritise getting the records for those extremely quickly.” He added, “You know, we’ve received a large volume [of serious reports]. And I don’t know what the back-up is.”
Another physician criticised the VAERS system for the inability to update the record, for example his young patient who subsequently died.
The BMJ has found that the FDA and CDC essentially maintain two separate VAERS databases: a public facing database, containing only initial reports; and a private, back end system containing all updates and corrections—such as a formal diagnosis, recovery, or death. This is to supposedly protect patient confidentiality.
It’s not that the VAERS system fails when it does detect something is wrong. For example, it took just six VAERS reports of thrombosis with thrombocytopenia syndrome after administration of the Janssen Covid vaccine for regulators to issue a “pause” in April 2021.
Approved in the UK in May 2021!!
Ralph Edwards, former director of the Uppsala Monitoring Centre and until recently editor in chief of the International Journal of Risk & Safety in Medicine, explains that monitoring systems such as VAERS excel at detecting adverse reactions that occur very soon after vaccination or are known from other vaccines, such as anaphylaxis or Guillain-Barré syndrome. But detecting new and unusual reactions, especially those with latent effects, has been an ongoing challenge .
The trouble is Edwards told the BMJ is that;
You’ll never get the evidence unless you have the idea to look for it in the first place.
For example Svetlana Blitshteyn, a neurologist and researcher at the University at Buffalo, New York, who has been treating postural orthostatic tachycardia syndrome for around 20 years and has seen the condition present after vaccination, told The BMJ that if physicians aren’t educated to look for the condition they’re unlikely to test for it or know how to treat it.
Due to monitoring The European Union, for its part, has added hypoaesthesia and paraesthesia (reduced or abnormal sensation in the skin such as numbness, tingling, or burning) to the labelling on mRNA Covid vaccines—based on around 21 000 cases reported by August 2021—as well as including heavy menstrual bleeding. Japan has also added paraesthesia and hypoaesthesia.
Harlan Krumholz, a cardiologist and researcher at Yale, has been recruiting members of React19 to study their reactions;
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.
He told The BMJ.;
There are so many people whose lives have been changed dramatically, but what I don’t know is how many or why.
Javier Richardson
