Is the US’s Vaccine Adverse Event Reporting System broken?

[Red Phoenix]

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

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"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."

 

Source: https://www.bmj.com/content/383/bmj.p2582

 

[Eleftheros]

The VAERS  system is only valuable to people who are interested in protecting the public's health. When they are focused only on protecting their own status and careers, then VAERS is a positive danger to them.

 

At this point, I would be amazed if VAERS was being kept in good shape to be used in the service of medical science.

[TallGuyJohninBKK]

There's some reasons in particular why the VAERS system may be being overwhelmed with dubious reports, making it more difficult for the CDC and FDA to evaluate legitimate ones -- per Johns Hopkins:

 

The public database of reported post-vaccination health issues is often misused to sow misinformation

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"Since the emergence of COVID-19 vaccines, however, the database has garnered more dubious notoriety. Anti-vaccination fringe groups have attempted to spin false stories using VAERS data, adding to misinformation about the safety of COVID-19 vaccinations.

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That means events that happen even years later and have no obvious connection to a vaccine, such as feelings of anger, end up reported in the system, says Talaat.

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“The COVID vaccine especially is where VAERS has gotten so misused,” Talaat says. “Eighty percent of people in this country have gotten at least one dose. Well, a lot of things have happened to 80% of people in the last two years that are unrelated to the vaccine.”

 

(more)

 

https://publichealth.jhu.edu/2022/what-vaers-is-and-isnt

 

[TallGuyJohninBKK]

What VAERS Can and Can’t Do, and How Anti-Vaccination Groups Habitually Misuse Its Data

June 6, 2023

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"As early as 1997, Ellenberg explained in a journal article that the way VAERS is designed, “sensitivity takes precedence over specificity; reporting of all serious events following vaccination is encouraged, inevitably resulting in large numbers of reports that do not represent vaccine-induced problems.”

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How are regulators so confident that the increased reporting in VAERS isn’t a safety concern? Because all of the data — including from VAERS, but also from all the other systems — consistently show that the COVID-19 vaccines have a good safety record.

 

“It’s data from multiple systems in the United States and data from other systems in other countries in Europe and in Canada and Israel, and really all over the globe,” Shimabukuro said."

 

https://www.factcheck.org/2023/06/scicheck-what-vaers-can-and-cant-do-and-how-anti-vaccination-groups-habitually-misuse-its-data/