by Dr. Joseph Mercola, Mercola:
- The Vaccine Adverse Events Reporting System (VAERS) does not meet its own standards, and safety signals are not being addressed
- Before the COVID pandemic, VAERS received an average of 60,000 adverse event reports after vaccination each year. In the first year of the rollout of the experimental gene therapies against COVID (2021), reports skyrocketed to 1 million. By the end of October 2023, the number of reports associated with the COVID shots was 1,605,764, and nearly 1 in 5 of those reports involves a “serious” adverse event
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- The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, which share responsibility for VAERS, insist these data in no way reflect a potential problem with the COVID shots
- Filing a VAERS report is a time-consuming process. It can take several hours for a trained medical professional to fill out a single report, and this is time that cannot be billed to anyone. As a result, side effects, including deaths, are massively underreported
- VAERS has a public front end and a private back end that public users aren’t allowed to see. The public database only contains the initial reports. Corrections and updates on outcomes go into the private-facing end. As a result, we have no idea how many of the injuries have resulted in death after an initial report was filed. The death count we see when we look at VAERS is the number of reports filed where death was the reason for filing the report in the first place. This “dual system” can leave the public with the false impression that deaths are less common than they are. We also don’t know how many injuries end up progressing and resulting in permanent disability, or how many of them resolve
According to the U.S. Food and Drug Administration, the agency “is actively engaged in safety surveillance” of the COVID shots. They also claim that medical doctors and epidemiologists at the FDA and Centers for Disease Control and Prevention “continuously screen and analyze” reports filed with the Vaccine Adverse Events Reporting System (VAERS) “to identify potential signals that would indicate the need for further study.”1 Facts suggest otherwise.
Even officials at the FDA itself have stated that VAERS is not operating as intended, and that safety signals are not being addressed. Among them are Peter Marks, director of the Center for Biologics Evaluation and Research, and Narayan Nair, the FDA division director who oversees VAERS.
Both spoke to investigative reporter Jennifer Block, whose article on the failures of VAERS was published in The BMJ in November 2023.2
“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,” Block writes.
“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.
However, The BMJ has learnt that in the face of an unprecedented 1.7 million reports since the rollout of COVID vaccines, VAERS’s staffing was likely not commensurate with the demands of reviewing the serious reports submitted, including reports of death.
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.”
Unprecedented Influx of Reports Is a Clue in Itself
Before the COVID pandemic, VAERS received an average of 60,000 adverse event reports after vaccination each year. In the first year of the rollout of the experimental gene therapies against COVID (2021), reports skyrocketed to 1 million.
By the end of October 2023, the number of reports associated with the COVID shots was 1,605,7643 and, according to Block, nearly 1 in 5 of those reports involves a “serious” adverse event.
In 2021, few had ever heard of VAERS and medical staff were not instructed to file reports. In fact, there are many stories out there of medical staff being discouraged from doing so. Yet despite the lack of awareness and the intentional suppression of reporting, record setting numbers of adverse event reports were and continue to be filed.
That alone tells us something, and should have set off alarm bells at the FDA and CDC, which share responsibility for the VAERS database. Yet no bells have gone off, and both agencies nonchalantly insist that these data in no way reflect a potential problem.
Egregious Lies About VAERS
The video above features testimony from then-CDC director Dr. Rochelle Walensky and then-director of the National Institutes of Allergy and Infectious Diseases (NIAID) Dr. Anthony Fauci. Both claimed they had no idea how many deaths had been recorded in VAERS following the COVID shot — something which could have been done on the spot using a smartphone.
Even more egregious, Walensky claimed that “all” side effects are reported to VAERS. “So, if you get hit by a car shortly after being vaccinated, that gets reported in the VAER system,” she said. Fauci, apparently short on creativity, then repeated the same idiotic scenario to downplay the importance and value of VAERS as a pharmacovigilance system.
The fact of the matter is, there’s no artificial intelligence that automatically fills out post-vaccination stubbed toe and fender bender reports, and no one in their right mind would spend hours filing a report unless they suspected a link to a recently given vaccine. VAERS is a passive, voluntary reporting system, and the CDC was not encouraging, let alone requiring, anyone to file reports.
VAERS Is Shamefully Inadequate
Many who have tried to file a VAERS report have been struck by how difficult it is to use. Unless you have all your ducks in a row and every required piece of data at your fingertips, the system will time out, forcing you to start all over again.
Even as artificial intelligence is now being used to formulate drugs from scratch,4 one of the most important pharmacovigilance databases in existence hasn’t even been equipped with an intermittent save feature. Go figure.