A new British Medical Journal investigation alleges the US Vaccine Adverse Event Reporting System is falling short.The BMJ report by Jennifer Block interviewed more than a dozen physicians who filed VAERS reports and reported similar shortcomings and frustrations.One of them was Robert Sullivan, a 49-year-old Maryland anesthesiologist the Western Standard interviewed in the summer. He collapsed from heart problems three weeks after his second COVID vaccine, but told the BMJ it was a glitchy process to submit a VAERS report.“The format is cumbersome and it times you out,” Sullivan told the BMJ. A VAERS representative contacted Sullivan’s doctor to request medical records, but made no further inquiries for a year.The BMJ also found the publicly available VAERS database on vaccines includes only initial reports. Case updates and corrections are kept on a separate, back-end system, allegedly for privacy and legal reasons. However, VAERS reports on drugs and medical devices are updated publicly and neither the FDA nor CDC could explain the rationale to the BMJ.Before the pandemic VAERS was receiving nearly 60,000 adverse event reports each year, even though a 2015 CDC article suggested VAERS only had enough capacity to follow up on a few thousand serious reports annually. VAERS has received 1.7 million reports since the rollout of COVID vaccines, but hasn’t hired the staff required to meet the demand.The Immunization Safety Office which houses VAERS had 70 to 80 full-time equivalent workers as of November 2022. Meanwhile, a February 2021 Pfizer report showed the company had onboarded 600 additional full-time employees to handle the volume of adverse event reports and planned to employ a total of 1,800.The BMJ said interview subjects had “a patchy and frustrating experience” reporting to VAERS. “Some of those making reports were told conflicting information about updating their report or were discouraged from making a report altogether,” Block wrote.Rheumatologist Patrick Whelan was one of them. In 2022 he reported how his seven-year-old male patient had a cardiac arrest after COVID vaccination. The patient was intubated when Whelan filed a VAERS report.“I assumed that, since it was a catastrophic event, the safety committee would want to hear about it right away,” Whelan said.To Whelan's knowledge, nobody called or requested medical records. Yet the FDA emailed Whelan months later to say that it had made “several requests” for medical records “soon after” Whelan’s report. The agency added, “Generally speaking, staff might not reach out to providers unless they have specific questions about a case or a VAERS report.”The boy was taken off life support a week later, but Whelan couldn’t change the report. “There was no mechanism for [updating] it,” he told the BMJ. “The only option I had was to make a new VAERS report.”Weeks later, Whelan met with the FDA in his capacity as a researcher at UCLA and mentioned the case. A subsequent meeting with Narayan Nair, the FDA division director who oversees VAERS, and a press officer, could not change the publicly-available report.“Think of all the people who are using VAERS data as a means to assess what’s happening with the vaccines — except in this case you’d be left with the false impression that the child had had a serious adverse event,” but not know he died, Whelan told the BMJ.James Gill, chief medical examiner for Connecticut, made the first VAERS report of his 25-year forensic pathology career in mid-2021. A 15-year-old boy died days after getting a second jab. On the autopsy, Gill credited the cause of death as “stress cardiomyopathy following second dose of the Pfizer-BioNTech COVID-19 vaccine.”VAERS never called Gill and he still has only a temporary “e-report” number. But after he published the case reports in the Archives of Pathology & Laboratory Medicine in February 2022, the CDC wrote a letter to the editor to contest Gill’s findings.For serious cases, reporters to VAERS are supposed to receive emails prompting them to provide updates. Doctors the BMJ spoke to didn’t get these confirmation emails.React19, an advocacy group of some 30,000 people who have experienced prolonged illness after COVID vaccination, reviewed 126 VAERS reports among its ranks. An audit in November 2022 found 22% had never been given a permanent VAERS ID number and 12% had disappeared from the system entirely. This meant one in three reports didn’t show up in the publicly searchable database.A group of physicians and advocates met seven times with FDA representatives from 2021 to 2022 to express their concerns with the system. An intensive care and emergency physician whose name was withheld, filed reports on behalf of several patients, including six who died. She told the BMJ she received a request for medical records for just one of the deaths and for two of her hospitalized patients.“You’re not meeting your defined definition of follow-up,” she told FDA officials on March 22, 2022. “There’s a breakdown in your system.”Nair acknowledged, “[W]e’ve received a large volume [of serious reports]. And I don’t know what the back-up is.” In subsequent responses, the FDA said it was “actively engaged in safety surveillance” and that “physicians and epidemiologists from the FDA and CDC continuously screen and analyse data from VAERS for COVID-19 vaccines to identify potential signals that would indicate the need for further study.”The BMJ also alleged US officials are slow to expand the list of adverse conditions the vaccines might trigger. This meant it would not occur to doctors to consider their patient’s condition as a vaccine adverse effect. By contrast, numerous case reports prompted the European Union and Japan to hypoesthesia and paresthesia to mRNA COVID vaccine labels.“While other countries have acknowledged deaths that were ‘likely’ or ‘probably’ related to mRNA vaccination, the CDC — which says that it has reviewed nearly 20,000 preliminary reports of death using VAERS (far more than other countries) — has not acknowledged a single death linked to mRNA vaccines,” the BMJ stated.
