VAERS System Broken: Few Reporting Adverse Reactions

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  • Source: UncoverDC
  • 09/19/2023

The VAERS reporting system has allegedly been significantly underutilized during the pandemic—it is well known few people use the platform. Many in medical practice do not know of their obligation or even how to report an adverse event with the COVID-19 vaccine.

The Vaccine Adverse Event Reporting System or VAERS is a national program managed by the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) to monitor the safety of all vaccines licensed in the United States. It is one part of a critical U.S. infrastructure that purportedly protects Americans from harmful and, even in some cases, deadly vaccines.

WMBF News reported that the VAERS system "functions as a kind of canary in a coal mine, to detect possible safety issues by gathering details about possible side effects or health problems. It accepts entries from anyone aware of some kind of health problem after a vaccination—medical providers, vaccine manufacturers and the general public."

The VAERS Fact Sheet from the CDC states:

"VAERS collects and reviews reports of adverse events that occur after vaccination. An 'adverse event' is any health problem or 'side effect' that happens after a vaccination. VAERS cannot determine if a vaccine caused an adverse event, but can determine if further investigation is needed."

"VAERS is an early-warning system that detects problems possibly related to vaccines. The system relies on reports from healthcare providers, vaccine manufacturers, and the general public. Reporting gives CDC and FDA important information to identify health concerns and ensure vaccines are safe in order to protect the public's health."

In Part One of the series COVID-19 Vaccine Exposed, Project Veritas allegedly exposes problems at the Phoenix Indian Medical Center (PIMC), a 127-bed facility focusing on the needs of American Indians in Arizona. The healthcare workers featured in the video also talk about the fact that no one in the hospital is really reporting adverse events from the COVID-19 jab. UncoverDC reported:

"Federal law requires healthcare professionals to file a Vaccine Adverse Event (VAERS) report for certain adverse events after administering a COVID-19 drug injection under Emergency Use Authorization. CDC and HHS further encourage it even if it isn't clear that the vaccine caused it. Human errors in the administration of the drug are also to be reported. Anyone is welcome to make a VAERS report, including a patient or observer such as a parent. Federal law prohibits filing a false VAERS report knowingly. O'Malley told O'Keefe that her federal facility has never sent out a directive for reporting."

Congressman Paul Gosar (R-AZ) wants to hold the Department of Health and Human Services accountable according to his Sept. 23 letter to Health Secretary Xavier Becerra. He lays out four requests for immediate implementation. If it is true, healthcare providers are not reporting adverse reactions; they are "breaking the law," says Gosar.

It seems that the PIMC incident is not an isolated one. A Sept. 18 Highwire exclusive interview with Del BigTree shows Deborah Conrad, a hospitalist physician's assistant talking in great detail and providing phone recordings of calls she had with her hospital's administration about the importance of VAERS reporting and their seeming lack of interest in ensuring that it would be adopted as a required procedure. The caption for the video accurately reads:

"In riveting detail, including emails & recorded phone conversations, Conrad exposes the internal push to turn a blind eye to injuries and "tow the company line" that this vaccine is safe."[/embed]

Conrad exposes the unwieldy nature of the VAERS reporting system. It is so difficult to complete the report that many do not want to take the time to do it. She actually volunteered to do it for the staff in her hospital—at home on her own time.

She also says she doubts that many patients are actually the ones reporting their injuries because most patients would not know some of the required information—like the lot number of the vaccine they received. Conrad says it takes hours to fill out a report, and while her experiences with the VAERS staff have been good, the online system is glitchy at best. A report cannot be saved for later additions or review—an impractical feature of the online reporting system, especially for doctors who are often interrupted or work in chunks of time.

Conrad also said that very few in the medical field even know they should be reporting adverse events to VAERS. It isn't even a part of their training, in most cases. Even pediatricians do not always report, according to Conrad.

A lengthy December 2020 letter in The Defender from Robert F. Kennedy, Jr., Chairman of Children's Health Defense, to Dr. David Kessler, newly-named co-chair of Biden's COVID-19 Advisory Committee at the time, highlighted the need for an improved VAERS reporting system.

Kennedy asked Kessler "to consider the long-overdue need for a comprehensive, high-integrity system to monitor adverse outcomes following vaccination." Kennedy continued:

"[As] former FDA Commissioner, a professor with triple expertise in pediatrics, epidemiology, and biostatistics—and as someone who has repeatedly called attention to the structural deficiencies of our nation's drug adverse event reporting systems—you are uniquely qualified to articulate the system's existing shortcomings and recommend badly needed improvements."

"COVID-19 vaccines are intended for more Americans than any prior vaccine. As a result, shortcomings in the existing vaccine injury surveillance system will be even more obvious."

"Regulatory officials can't count on post-marketing surveillance to reveal COVID-19 vaccine injuries because the Vaccine Adverse Event Reporting System (VAERS) is broken."

Concerning post-marketing surveillance, Kennedy warns:

"Since vaccine companies are immune from liability for injuries caused by their products and therefore have no incentive to make them safe, our public health regulators have an amplified responsibility to monitor adverse events. There is widespread agreement, even among physicians, that vaccine adverse events—especially those that are relatively rare—can be difficult to detect pre-licensure. COVID vaccine advocates argue that post-licensing surveillance will remedy the deficiencies in the pre-licensing clinical trial data collection system. As you know, this is not true. The Vaccine Adverse Event Reporting System (VAERS), a voluntary reporting system co-administered by FDA and CDC since 1990, is a well-documented public failure."

"You have said yourself that the vaccine injury reports received by FDA' represent only a fraction of the serious adverse events' that occur. For twenty years, thoughtful public health advocates—including the United States Congress—have reiterated your concerns. A 2010 federal study commissioned by HHS and performed by Harvard consultants on behalf of the Agency for Healthcare Research and Quality (AHRQ) found that 'fewer than 1% of vaccine adverse events' are ever reported to VAERS."

Many important points are made in the letter. Still, point number four stood out under the heading, "Because COVID-19 vaccines are intended for more Americans than any prior vaccine, COVID-19 vaccination promises to bring existing surveillance systems' shortcomings into even sharper relief."

His prediction is prescient and accurate, considering what is now being discussed in the media. He concludes:

"As you aptly noted almost three decades ago, lack of reporting delays problem detection. CDC researchers agree that surveillance systems that 'detect adverse events as soon as possible after the introduction of new vaccines' are essential to 'speed the recognition of increased rates of adverse events' and 'inform public policy.' VAERS's 30-year-old deficits and the non-transparency of systems like the Vaccine Safety Datalink and PRISM/Sentinel are likely to hinder HHS's ability to rapidly identify emerging safety issues with COVID-19 vaccines. These lacunae represent, therefore, a direct threat to patient life and public health. Your committee should not allow further rollout of COVID-19 vaccines until FDA's capacities for monitoring long-term vaccine safety are significantly improved."

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