by Jennifer Block
November 11, 2023
A BMJ investigation has raised concerns that the VAERS system isn’t operating as intended and that signals are being missed. Jennifer Block reports
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.
VAERS is supposed to be user friendly, responsive, and transparent. However, investigations by The BMJ have uncovered that it’s not meeting its own standards. Not only have staffing levels failed to keep pace with the unprecedented number of reports since the rollout of covid vaccines but there are signs that the system is overwhelmed, reports aren’t being followed up, and signals are being missed.
The BMJ has spoken to more than a dozen people, including physicians and a state medical examiner, who have filed VAERS reports of a serious nature on behalf of themselves or patients and were never contacted by clinical reviewers or were contacted months later.
Our investigation has also found that, in stark contrast to the US government’s handling of adverse reaction reports on drugs and devices, the publicly accessible VAERS database on vaccines includes only initial reports, while case updates and corrections are kept on a separate, back end system. Officials told The BMJ that this was to protect patient confidentiality—but this means that patients, doctors, and other public users of the database have access only to an incomplete and uncorrected version.
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