Vaccine Adverse Event Reporting System broken?

A BMJ investigation has raised concerns that the VAERS system isn’t operating as intended and that signals are being missed. Jennifer Block reports.

Read the full BMJ investigation here.The following excerpts are quoted verbatim from the original BMJ investigation.

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’s standard operating procedure for covid-19 states that reports must be processed quickly within days of receipt. “Serious reports” trigger the requisition of medical records and at minimum a “manual review,” while deaths and other “adverse events of special interest” may undergo a more “in-depth” clinical review by CDC staff. 

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, 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. 

A group of physicians and advocates have met multiple times with FDA representatives…

from 2021 to 2022, including Peter Marks, director of the Center for Biologics Evaluation and Research, and Narayan Nair, the FDA division director who oversees VAERS, to express their concerns that the system isn’t operating as intended and that signals are being missed. 

One participant in the group—Helen, an intensive care and emergency physician who asked to use a pseudonym to protect her employment—had filed reports on behalf of several patients, including six who died, among them a 40 year old man. She tells The BMJ that she received a request for medical records for just one of the deaths and for two of her patients admitted to hospital. “You’re not meeting your defined definition of follow-up,” she told Nair and Marks during an online meeting on 22 March last year. “There’s a breakdown in your system.” 

The BMJ obtained audio of these meetings, totaling seven. 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.” 

At the following meeting in May 2022 an FDA spokesperson, Lorrie McNeill, said that “for all of the reports categorised as serious, the VAERS contractor either obtained records, or made several attempts to do so and closed out a report if they didn’t get a response.” 

For the rest of the investigation—including deeper dives into understaffing, the two-tier VAERS database, and challenges in detecting signals—read the full story on The BMJ .