(Vaccine Adverse Events Reporting System) For many years, the U.S. Department of Health and Human Services (HHS) has maintained a post-licensing surveillance system to track adverse effects and deaths from vaccines. Even government insiders like Surgeon General Dr. David Kessler acknowledged that VAERS is an abysmal failure. Nevertheless, it is only by clinging to this “designed to fail” system that regulators and industry have maintained their pretense that current vaccine risk profiles are acceptable. A 2010 study funded by HHS concluded that VAERS captured “fewer than 1% of injuries.” In other words, the actual injury rates from mandated vaccines are more than 100x what HHS has been telling the public!
The 2010 HHS study found that the true risk for serious adverse events was 26/1,000, or one in 37. Similarly, Merck’s clinical trials for Gardasil found that an astonishing half of all vaccine recipients suffered from adverse events, which Merck euphemistically called “new medical conditions,” and that 2.3% of vaccine recipients (1 in 43) suffered from autoimmune disease within six months of vaccination.
Similarly, a recent Italian study found that 46% of vaccine recipients (462 adverse events per 1,000 doses) suffered adverse events, with 11% of these rated “serious,” meaning 38 serious adverse events per 1,000 vaccinated individuals. These include grave gastrointestinal and “serious neurological disorders.” This amounts to a “serious” injury rate of 1/26.
Amazingly, a 2013 study found that nearly 30 percent of all health care professionals have never even heard of VAERS. This means that an even greater percentage of their patients have likely never heard of it, either. Among those who do know about VAERS and come across a potential adverse effect, a whopping 83 percent fail to ever report it.
A peer reviewed journal, Science, Public Health Policy, and The Law, published an article on vaccine adverse event reporting for human papilloma virus (HPV) vaccines in early May 2021. The article calls into question the integrity of VAERS.
From 1998-2020, the Centers for Disease Control and Prevention (CDC) failed to acknowledge “persistent or significant disability/incapacity” as a serious adverse event (SAE) in VAERS, even though the Code of Federal Regulations requires that it be categorized as “serious.” In a 2009 study on Merck’s HPV vaccine Gardasil, the U.S. Food and Drug Administration (FDA) and CDC determined the rate of SAEs to be 6.2%, which they concluded did not signal a safety problem.
The FDA and CDC officials excluded “a persistent or significant disability/incapacity” as “serious” despite federal regulations to the contrary. They appear to have left out thousands of disability and incapacity reports from teenagers and young adults after Gardasil vaccination. An independent assessment of SAEs based on the correct regulatory definition suggests that VAERS was off by almost 400%. The article explores the implications of this grossly inadequate reporting.
“The failure of the VAERS system is profound,” said Robert F. Kennedy, Jr., Chair of Children’s Health Defense. “This article pinpoints the FDA and CDC’s dereliction of duty regarding Gardasil vaccines; its implications are enormous.” Lead authors Lucija Tomljenovic and Emily Tarsell agree new surveillance methods are critically needed and long overdue.
Obstacles include health professionals’ (and vaccine recipients’) inability to recognize (or even suspect) a possible relationship between a given vaccine and the adverse outcomes; the powerful disincentives for physicians to acknowledge or report vaccine injuries; uncertainty surrounding which adverse events ought to be reported; a medical “culture” that has not made adverse event reporting an “ingrained practice”; and logistics barriers such as cumbersome forms or clinical time constraints. Some of the provider uncertainty about VAERS reporting is likely related to HHS’s spartan Vaccine Injury Table. Notwithstanding the CDC’s addition of a large number of vaccines to the childhood and adult vaccine schedules since 1986 (following passage of the National Childhood Vaccine Injury Act), HHS has made almost no revisions to the table, largely limiting table injuries to a small number of acute reactions occurring within the first 48 hours post-vaccination. In contrast, pre-licensing trials and post-marketing reports have produced documentation (in vaccine package inserts) of nearly 400 different types of adverse events following vaccination.
Another important VAERS limitation is that the system does not routinely follow up on the reports it receives by contacting the reporting health professional, six to 12 months later, to determine if the individual fully recovered from the reaction or further deteriorated. Without this longitudinal information, neither the CDC nor doctors can have accurate or meaningful safety data on vaccines. The Vaccine Injury Table again illustrates the fallout; despite numerous published reports linking vaccines to a wide range of autoimmune conditions—and despite latency periods for autoimmune reactions known to range from weeks to years—the only autoimmune-like conditions listed in the table are chronic arthritis (in association with rubella-containing vaccines), thrombocytopenic purpura (measles-containing vaccines), and Guillain-Barré syndrome (seasonal influenza vaccines).
HHS has Ignored Numerous Opportunities to Strengthen VAERS
The 2010 AHRQ study—which analyzed several years of data (2006-2009) on 1.4 million doses of 45 different vaccines administered to over 376,000 individuals—found at least one adverse event (AE) for every 39 vaccines given, representing a shocking injury rate of approximately 2.6%. Before seeing these data, HHS had purposed to develop an effective “AI” or “machine counting” system to replace the “designed to fail” VAERS system; AHRQ tested its pilot AI system, called ESP-VAERS (Electronic Support for Public Health-Vaccine Adverse Event Reporting System), on the Harvard Pilgrim health maintenance organization (HMO). However, when CDC saw the alarming levels of vaccine injury exposed by AHRQ’s system, CDC killed the pilot study and refused to take phone calls from the AHRQ consultants. As discreetly stated in the final report, “Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation.”
One of the AHRQ consultants, affiliated with both Harvard Pilgrim Health Care and Brigham and Women’s Hospital, went on to co-author a 2015 study that put ESP-VAERS to the test in a large health network in Ohio (a system with approximately one million patient encounters annually) between 2012 and 2013. The goal was “to facilitate automated AE detection and reporting” using electronic health records (EHRs), prospectively monitoring the records for “new diagnoses, changes in laboratory values and new allergies for up to 6 weeks following vaccinations” and sending messages to clinicians when the system flagged “suggestive events.” The system also automatically reported “high probability AEs following vaccination” to VAERS, even if the clinician chose to take no action. Over eight months and almost 92,000 vaccinations, the ESP-VAERS system generated from zero to eight alerts per clinician per month (mean=0.4) and captured adverse outcomes including seizures, rashes and other allergic reactions, Bell’s palsy, pleural effusion, lymphocytopenia, and hypothyroidism. At the study’s conclusion, the researchers reported that “The odds of a VAERS report submission during the pilot period were 30.2 . . . times greater than the odds during the comparable pre-pilot period.”
A similar “proof-of-concept” study focusing on use of EHR-based systems to automatically send electronic reports of adverse drug events to the FDA “in real time,” carried out at Brigham and Women’s Hospital in 2008-2009 and published in 2010, found that such systems are not only “efficient and acceptable to clinicians,” but can provide detailed clinical information and have “the potential to greatly increase the number and quality of spontaneous reports submitted to the FDA.” As an added bonus, the researchers found that it took clinicians, on average, 53 seconds to complete and submit the requisite form.
In 1990, an FDA-commissioned study in Rhode Island showed that even a simple intervention to educate physicians about reporting adverse drug reactions resulted in a 17-fold increase in submitted reports compared to the prior year, including significant increases in the number of severe reactions reported.
Referred to as a “passive” surveillance system, VAERS was never intended to track every instance of someone dying or becoming permanently injured from a vaccine. Instead, it relies entirely on voluntary reporting. The website CovidVaccineReactions.com does a better job of capturing injuries and deaths associated with Wuhan Flu shots, but even this resource is likely inadequate. However, the medical cabal made it difficult and put up resistance to reporting adverse events related to the Covid vaccine. Hospital physician’s assistant Deborah Conrad came forward with her testimony of the massive amount of COVID vaccine Adverse Events not being reported by hospitals. She recorded a call with her hospital’s president that reveals the shocking truth.
“Why on earth is the CDC still using a passive surveillance system proven completely worthless over a decade ago that anyone could see was bound to massively undercount potential side effects, as nothing has been done to ensure public awareness of such a reporting system in the first place?” asks Dr. Michael Thau, Ph.D., writing for Revolver.
“And, unfortunately, the only answer seems to be that, for whatever dark reason, that’s exactly what the CDC wants … And not just because they’ve made no effort to publicize VAERS and increase the dismal reporting rate among medical professionals nor replaced it with something better.”