The British Medical Journal Agrees – VAERS is Broken

For years, we have been told that the VAERS system is a great tool for monitoring adverse reactions to vaccines. It is a self-reporting system; doctors and patients can use it to report their experiences after taking a vaccine. The FDA and CDC have heralded the system, and physicians and “experts” have used it to calm their patient’s fears about the safety of vaccines. 

I looked at news reports and medical studies from 2015 to 2019. I want to show you some examples of what I found. Here, the American Academy of Ophthalmology used the VAERS reporting system to reassure their patients and doctors about the safety of the new Shingles vaccine. They stated: 

“According to the CDC, safety data for the eight months following FDA approval of Shingrix are consistent with comparable data from prelicensure clinical trials.2 “Systemic and local reactions were most commonly reported, but [they] tended to be nonserious and self-limited,” said lead author Elisabeth M. Hesse, MD, at the CDC in Atlanta. The post-licensure safety profile is based on reports to the Vaccine Adverse Event Reporting System (VAERS), a national passive surveil­lance system. VAERS received 4,381 reports of adverse events, including reports from healthcare providers and the public, between October and June 2018. During that time, some 3.2 mil­lion doses of Shingrix were distributed.” 

American Family Physician pointed to VAERS in 2019 as a tool that reaffirmed the safety of vaccines, stating:

“The FDA and the CDC maintain the Vaccine Adverse Event Reporting System (VAERS) as a post-marketing safety surveillance program for adverse events that occur after immunization. Vaccine manufacturers and healthcare professionals are required to submit potential adverse events.91 VAERS receives approximately 30,000 reports each year. The effectiveness of VAERS as an early warning system was demonstrated by reports of an increased incidence of intussusception after immunization with rotavirus vaccine.91 In 1990, the Vaccine Safety Datalink, a collaboration between the CDC and nine healthcare organizations, was developed to investigate rare and serious adverse effects reported in the medical literature and to VAERS. The program monitors vaccine safety when a new vaccine is approved or when there are new vaccine recommendations.”

In many of the CDC’s own Morbidity and Mortality Reports, they cite VAERS as the vehicle they use to assess the safety of vaccines. In this one about the “Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines,” they mention their reliance on VAERS 31 times. 

So, we have doctors making decisions about how to advise their patients using VAERS, and we have the CDC itself stating that it uses VAERS to determine the safety of vaccines. There are numerous examples of this. However, something changed with the introduction of the COVID-19 vaccine.

I’ll cite just one example. The Surgeon General of Florida, Joseph Ladapo, recommended against using the mRNA shots in February of 2023, citing VAERS as one of the reasons for it. He cited the safety signals observed—safety signals that far outweigh the signals for every single other vaccine ever tracked with the system—and the CDC wrote a 4-page scathing letter informing him of just how unreliable the VAERS system is.

Their excuses ranged from “it was caused by a pre-existing condition” to “you didn’t interpret the data properly” to “the FDA approved it and it’s safe!” So, which is it, CDC? For years, Del Bigtree has been talking about the inaccuracy of the VAERS system, but not for false reporting! It underreports actual issues!! Not only that, but they were so overwhelmed with reports after the mRNA rollout that you could say it stopped working at all. 

And now, the British Medical Journal agrees. In a scathing report, author Jennifer Block systematically dissects just some of the issues with VAERS. For example, VAERS standard operating procedure requires that reports be processed quickly, within a few 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,” reports Jennifer. However, there have been an unprecedented 1.2 million reports of adverse events since the rollout—and the CDC doesn’t have the staff to get to a massive percentage of them. 

By comparison, Jennifer says, “The BMJ suggests that Pfizer has around 1000 more full-time employees working on vaccine surveillance than the CDC, despite the latter’s responsibility for handling adverse event reports on all products. The CDC did not provide The BMJ with specific numbers, instead stating that its staffing “reflects the needs of the office” at any given time and can range from ‘several dozen to hundreds,’ including contractors and individuals reassigned ‘from across the agency.’ The latest confirmed number of staff, as of November 2022—at the Immunization Safety Office, which houses VAERS—is 70-80 full-time equivalent workers.” Ouch.

Additionally, the experience of reporting an incident is patchy, cumbersome, and riddled with problems that, most of the time, lead to no follow-up, even in the case of a very severe reaction or even death. There are also reports that contributions have been removed from the system completely after having existed in the past. 

Also noted in the report is a complete lack of follow-up from the CDC regarding the medical records of those who had a serious adverse event. How can they state that reports in VAERS are not caused by the shot but by a pre-existing condition if, the majority of the time, they are not even reviewing a patient’s medical records?

And in what may be the worst transgression, but one we have all suspected and known about from the beginning, CDC is managing not one but two VAERS databases. The one we are allowed to see and the one we aren’t. This is contrary to what the FDA does with their database. Jennifer rightly asks the question, “Why can’t the CDC operate this way, too?”

In conclusion, the BMJ report speaks of the importance of pharmacovigilance, citing a few examples of when the VAERS system was used to pause a drug after very few observable safety signals. Clearly, the CDC has advocated on its behalf in the past when making recommendations about which drugs are safe and for whom, citing the VAERS system in their reasoning. However, the backlog of processing and analysis, coupled with signals that the health establishment certainly does not want to see, has led the CDC to not only trash their own system when it is convenient, ala Ladapo, but also to use it as a positive when they need to—to cite the safety of vaccines. All in all, the VAERS system is unreliable and broken. To keep our citizenry’s well-being in mind, it must rapidly become reliable and functional.