VAERS – The Last Bastion of Vaccine Free Speech?

Originally posted on America Out Loud.

Why do the CDC and FDA dismiss Vaccine Adverse Event Reporting System (VAERS) as a credible safety surveillance system for adverse events following COVID-19 vaccination? After all, VAERS is intended to be the “front line” of vaccine safety and is “especially valuable in assessing the safety of newly marketed vaccines” – to quote a report from the House Committee on Government Reform on Oct. 12, 2000.¹

The short answer? To maintain control of the false narrative that the COVID-19 vaccines are safe. Like the flip side of a coin, denigrating the integrity of VAERS allows the CDC, FDA, and others to bestow favor on their preferred vaccine safety surveillance systems – Vaccine Safety Datalink (VSD) and Biologics Effectiveness and Safety (BEST). Yet, because of government capture and control, as well as the use of limiting and illogical protocols, the VSD and BEST safety surveillance systems may actually be far less reliable than VAERS.

Consider the story of Ms. Danielle Baker. After taking the COVID-19 vaccines to keep her job in 2021, Ms. Baker suffered a host of life-altering adverse reactions, as previously reported in The Defender, causing her to lose her 17-year career as a certified hospice and palliative care registered nurse.² Her adverse reactions included cognitive and physical impairments, which left her unable to engage in activities of everyday living – including loss of bladder and bowel function, about which she testified at the Jan. 26, 2023 Vaccine and Related Biological Products Advisory Committee (VRBPAC) meeting.³ Ms. Baker developed transverse myelitis and eventually received a diagnosis that her injuries were caused by the vaccine. When Ms. Baker submitted her vaccine adverse event report to VAERS on August 4, 2021, her report disappeared from the system, and she heard nothing from the FDA. Was this purposeful?

Ms. Baker’s story may be shocking to those who still naively believe the overriding mission of the CDC, and FDA is to preserve public health, or who still believe the false HHS vaccine propaganda that the COVID-19 vaccines are safe and effective (although this group seems to be shrinking). We may never know for certain whether Ms. Baker’s report was purposefully removed from VAERS. However, one thing is clear: although there is growing evidence that the COVID-19 vaccines can be dangerous and, at times, even deadly,⁶ the CDC and FDA have largely failed to publicly acknowledge these risks.

Sadly, public VRBPAC meetings, testimonies of vaccine-injured individuals, federal vaccine “safety” systems allegedly monitoring for danger signals – at the end of the day, it all seems part of a charade orchestrated by CDC and FDA to make it seem as if they care about those harmed by the COVID-19 vaccines. In the January 2023 VRBPAC meeting – where Ms. Baker testified about her vaccine injuries and missing VAERS report – we get a window into how this charade operates. Answering questions about vaccine safety, Director of the CDC’s Immunization Office, Dr. Tom Shimabukuro, heartlessly doubles down: “I’ll just reiterate that CDC continues to recommend that everyone eligible for a COVID-19 mRNA bivalent booster or a flu vaccination get vaccinated.”⁷

Yet the VAERS system continues to scream danger. In addition to VAERS, the CDC, and FDA manage multiple vaccine safety surveillance systems, which together are supposed to alert federal authorities (and ostensibly the public) if the COVID-19 vaccines are causing harm. Two concurrently operating systems, which are claimed to be complementary to VAERS, include the Vaccine Safety Datalink (VSD) and Biologics Effectiveness and Safety (BEST).

However, don’t hold your breath waiting for these federal safety systems to alert you of danger with the COVID-19 vaccines. Forced to play with no “stopping rules,”⁸ the VSD and BEST safety surveillance systems are – unlike VAERS – under complete government capture and corrupted by financial bias. In addition, VSD and BEST appear to be manipulated by flawed methodology and illogical protocols, which seem intentionally designed to limit (and even prevent) the emergence of vaccine danger signals.

Vaccine Adverse Event Reporting System (VAERS) – An Ignored System Screams Danger

Perhaps the most widely recognized vaccine safety surveillance system in the US is VAERS. Established in 1990 and co-managed by CDC and FDA, VAERS is the nation’s first-alert warning system for detecting safety issues with vaccines. Yet, the CDC and FDA have failed to adequately monitor safety signals associated with COVID-19 vaccination which are contained in VAERS – even ignoring what has been termed the death signal by its very own operating procedures.⁹ One VAERS expert claims that vaccine adverse events are being suppressed and removed at alarming rates.¹⁰ Even so, the VAERS data continue to show that the COVID-19 shots are the most dangerous “vaccines” ever rolled out.¹¹

But how does VAERS operate? VAERS operates as a passive (meaning voluntary) reporting system for adverse events following vaccination and is open to all members of the public. Unlike other vaccine safety surveillance systems utilized by the CDC and FDA – which operate as closed systems unavailable to access by the general public – VAERS relies on individuals from all walks of life to report adverse events following vaccination and allows the person making the report to provide a narrative description.¹² Many of these reports come from those, like Ms. Baker, who have suffered first-hand an injury following vaccination. Some reports might also come from those who have cared for a loved one suffering an adverse event (for example, a parent) or others, such as a treating physician. While anyone can report an adverse event following vaccination to VAERS, healthcare professionals and vaccine manufacturers are required to report certain adverse events,¹³ although some healthcare professionals reportedly are hesitant to submit a VAERS report,¹⁴ likely for fear of backlash.

Institutions Denigrate the Credibility of or Ignore VAERS

The CDC and FDA, as well as other influential organizations, have downplayed the credibility of VAERS regarding the safety of the COVID-19 vaccines or simply ignored VAERS.¹⁵ As a striking example, the Johns Hopkins Bloomberg School of Public Health claims on a webpage that VAERS has gained “dubious notoriety” during the pandemic and has sowed “misinformation about the safety of the COVID-19 vaccines.”¹⁶ What this John Hopkins webpage doesn’t tell you, however, is that Johns Hopkins University is one of only seven (7) medical research centers in the US which have been chosen to partner with the CDC in its Clinical Immunization Safety Assessment (CISA) project,¹⁷ or that John Hopkins has received $1.3 billion dollars in federal contract awards since 2008.¹⁸

It may come as no surprise that none of the medical entities who are COVID-19 vaccine safety “partners” with the CDC – whether as part of CISA, or part of VDS and BEST – has publicly challenged the CDC’s narrative that the COVID-19 vaccines are safe. Nor have they publicly acknowledged the danger signals in VAERS, at least from our research. In addition to Johns Hopkins, the other CISA partners include Cincinnati Children’s Hospital,¹⁹ Boston Medical Center,²⁰ Columbia University,²¹ Duke University,²² Vanderbilt University Medical Center,²³ and Kaiser Permanente,²⁴ Northern California. All of these institutions, at a minimum, strongly recommend vaccination, and one institution, Columbia University, still mandates it.

With the Rollout of the mRNA Vaccines, CDC and FDA Rewrite the Rules?

The CDC and FDA continue to maintain that the mRNA vaccines are safe, claiming there is no evidence of increased death following the COVID-19 mRNA vaccines.²⁵ They downplay VAERS safety signals, claiming any challenge to the “safety” of the mRNA vaccines – even claims appearing to be truthful – are harmful to the public.²⁶ The CDC and FDA are also quick to point out that reports of adverse events in VAERS do not prove causation²⁷. However, this is a false flag argument – and it rewrites history involving CDC decisions to pause vaccines. With respect to vaccines introduced before the introduction of the COVID-19 vaccines, proving causation was not required to pause the rollout of vaccines that were potentially dangerous. This bears repeating: until the COVID-19 vaccines were rolled out to the public, association – not causation – has been more than enough to warrant a pause in rollout when danger signals emerged.

For example, in 1976, a small increased risk of Guillain-Barre Syndrome (GBS) was noted after the rollout of the swine flu vaccine, estimated at approximately one additional case of GBS for every 100,000 persons who received the vaccine.²⁸ Federal officials determined, in the CDC’s own words, that “the possibility of an association of GBS with the vaccine, however small,” required that the vaccine be stopped until further research could take place.²⁹

Another more recent example is federal officials pulling the rotovirus vaccine in the late nineties, due to a rare condition called intussusception (bowel obstruction where the bowel telescopes or folds in on itself) following vaccination in infants. Although causation was not shown, and it was “not clear if the vaccine or some other factor was causing the bowel obstructions,” CDC quickly recommended that the vaccine be suspended and began emergency investigations.³⁰

With the introduction of COVID-19 vaccinations, however, CDC and FDA have departed from past vaccine history, rewriting the rules of the game. Instead of “association,” the CDC and FDA now argue that “causation” must be shown prior to acknowledging that COVID-19 vaccines are dangerous.³¹ Yet, this is all part of a game as well – direct causation is a laborious and lengthy process that often takes years (if not decades) to definitively prove.

Incredulously, the CDC and FDA have also claimed that most of the reports in VAERS “do not represent adverse events caused by the vaccine and instead represent a pre-existing condition that preceded vaccination or an underlying medical condition that precipitated the event.”³² This fails to recognize that the mRNA vaccines can exacerbate underlying medical conditions and is a shameful attempt to blame the victim for the adverse event. At the same time, CDC and FDA also shockingly admit that the number of adverse events following COVID-19 vaccination is expected to increase.³³

On the issue of safety, the VAERS data is clear – COVID-19 vaccines carry far greater health risks compared to all other vaccines, many of which have been used for decades.³⁴ Moreover, the number of adverse events reported to VAERS following vaccination has historically been underreported³⁵ – not overreported, as many suggest. It has been estimated that “only a fraction” of serious events are actually reported to VAERS.³⁶

Dismissal of the VAERS data raises questions about whether federal authorities and their partners have been forthright and truthful with the public about the known risks associated with the COVID-19 vaccines – even though this is a prerequisite for lawful informed consent. One groundbreaking lawsuit has recently been filed involving a young adult male who developed myocarditis and died following the Pfizer vaccines, and the suit alleges fraud involving willful misconduct against the Department of Defense.³⁷

VAERS – The Last Bastion of Vaccine “Free Speech”?

Because of the corrupt government takeover of corporate media during the pandemic and the silencing of the vaccine injured that subsequently occurred, VAERS may be the last bastion of free speech for the vaccine injured. This may be precisely why CDC, FDA, and others denigrate it. As a system that is open to the public for reporting adverse events – even allowing the report to contain a narrative description of what occurred – VAERS is more resilient to government capture compared with closed CDC and FDA safety surveillance systems, such as VSD and BEST. As such, VAERS must terrify CDC and FDA in their potential to expose the dangers of the COVID-19 vaccines and expose the “safe” narrative as false. While VAERS has flaws, it gives needed balance to captured CDC and FDA vaccine surveillance systems, providing a voice for the vaccine injured and a repository for adverse events that the CDC and FDA cannot fully shape or control.

Read Part Two:  The Rules Are Stacked Against Protecting the Public – Welcome to the Hunger Games

Listen to the audio version on America Out Loud here.

James A. Thorp, MD
Board Certified ObGyn
Board Certified Maternal Fetal Medicine

References

¹ The Vaccine Injury Compensation Program: Addressing Needs and Improving Practices, 6^th Report. October 12, 2000. House Committee on Government Reform, 106^th Congress, 2d Session, House Report 106-977, p. 4. Accessed June 1, 2023. https://www.congress.gov/congressional-report/106th-congress/house-report/977/1 .

² Nevradakis, Michael. 2023. The Defender: Children’s Health Defense News & Views, “Exclusive: Woman Diagnosed with Vaccine-Induced Transverse Myelitis After Pfizer Shots.” Jan. 31, 2023. Accessed May 31, 2023. https://childrenshealthdefense.org/defender/danielle-baker-pfizer-shots-transverse-myelitis/ .

³ U.S. Food and Drug Administration (FDA). FDA Docket Number FDA-2022-N-2810. “178^th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC)” (recorded live broadcast). Posted on YouTube, January 26, 2023. Accessed May 31, 2023 (cited material located at 5:36:38 – 5:40:51). https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement .

⁴ Id.

⁵ Id.

⁶ Baletti, Brenda. 2023. The Defender: Children’s Health Defense News & Views, “Breaking: Family of 24-Year-Old Who Died from COVID Vaccine Sues DOD in ‘Groundbreaking Case.’” May 31, 2023. Accessed June 1, 2023. https://childrenshealthdefense.org/defender/george-watts-jr-pfizer-covid-vaccine-injury/ .

⁷ U.S. Food and Drug Administration (FDA). FDA Docket Number FDA-2022-N-2810. “178^th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC)” (recorded live broadcast). Posted on YouTube, January 26, 2023. Accessed May 31, 2023 (cited material located at ~6:53). https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-january-26-2023-meeting-announcement .

⁸ Vaccine Safety Database (VSD). 2021. “Rapid Cycle Analysis (RCA) to Monitor the Safety of COVID-19 Vaccines in Near Real-Time with the Vaccine Safety Data Link,” Project #1342, Version 1.1, March 3, 2021, p. 13 (noting, “Signaling criteria will not be considered ‘stopping rules’”). Accessed May 31, 2023. https://www.cdc.gov/vaccinesafety/pdf/VSD-1342-COVID19-RCA-Protocol_FinalV1.1_508.pdf .

⁹ Kirsch, Steve. Substack. 2022. “Exclusive: Proof that the CDC is Deliberately Ignoring the Safety Signals from the COVID Vax.” Steve Kirsch’s Newsletter, October 3, 2022. Accessed May 31, 2023.

¹⁰ Welcome the Eagle88. Substack. 2023. “Don’t Mind Jansen & VAERS, They are Just Scrubbing the System!” WelcomeTheEagle88’s Substack, May 27, 2023. Accessed May 31, 2023. See also, Welcome the Eagle88. Substack. 2023. “New VAERS Bombshell: 750 Reports Just Deleted 5/26/2023.” WelcomeTheEagle88’s Substack, May 26, 2023. Accessed June 1, 2023.

¹¹ Thorp JA, Rogers C; Deskevich, MP, Tankersley S, Benavides A, Redshaw, M.D.; McCullough, P.A. COVID-19 Vaccines: The Impact on Pregnancy Outcomes and Menstrual Function. Journal of the American Physicians & Surgeons Spring 2023; 28(1) https://www.jpands.org/vol28no1/thorp.pdf.

¹² The Vaccine Injury Compensation Program: Addressing Needs and Improving Practices, 6^th Report. October 12, 2000. House Committee on Government Reform, 106^th Congress, 2d Session, House Report 106-977, p. 4. Accessed June 1, 2023. https://www.congress.gov/congressional-report/106th-congress/house-report/977/1 .

¹³ VAERS: Vaccine Adverse Event Reporting System. 2023. “About VAERS.” Accessed May 31, 2023. https://vaers.hhs.gov/about.html#:~:text=Established%20in%201990%2C%20the%20Vaccine,and%20Drug%20Administration%20(FDA) .

¹⁴ Berenson, Alex. Substack. 2023. “From a Reader Whose Wife Suffered Severe Post-mRNA Vaginal Bleeding.” Unreported Truths, May 22, 2023. Accessed June 1, 2023.

¹⁵ CDC: Centers for Disease Control and Prevention. 2023. “FDA and CDC Response to the Florida Surgeon General.” CDC Newsroom. March 10, 2023. Accessed May 31, 2023. https://www.cdc.gov/media/releases/2023/p0313-letter.html .

¹⁶ Johns Hopkins: Bloomberg School of Public Health. 2022. “What VAERS Is (And Isn’t”): The Public Database of Reported Post-vaccination Health Issues is Often Misused to Sow Misinformation.” May 3, 2022. Accessed May 31, 2023. https://publichealth.jhu.edu/2022/what-vaers-is-and-isnt .

¹⁷ CDC: Centers for Disease Control and Prevention. 2023. “Clinical Immunization Safety Assessment (CISA) Project.” Accessed May 31, 2023. https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html#anchor_1580313832826 .

¹⁸ USASPENDING.gov. 2023. “John Hopkins University, The.” Accessed May 31, 2023. https://www.usaspending.gov/recipient/e895f676-c226-223f-b5ed-dda80c2ec73a-C/latest .

¹⁹ Cincinnati Children’s Hospital. 2023. Link to PDF: “The COVID-19 Vaccine and Your Teenager: Important Information and Frequently Asked Questions for Parents and Teenagers.” Accessed June 1, 2023 (recommending teens get COVID-19 vaccinated). https://www.cincinnatichildrens.org/search?q=covid%20vaccine .

²⁰ Boston Medical Center. 2023. “COVID-19 Frequently Asked Questions.” Accessed June 1, 2023 (recommending vaccination as “the COVID-19 vaccines are very effective in preventing COVID-19”). https://www.bmc.org/covid-19-vaccine/frequently-asked-questions .

²¹ Columbia University in the City of New York. 2023. “COVID-19 Resource Guide for the Columbia Community.” Accessed June 1, 2023 (COVID-19 vaccination and all boosters are mandatory for students, faculty and staff). https://covid19.columbia.edu/vaccine-info#:~:text=Being%20up%20to%20date%20on,students%2C%20faculty%2C%20and%20staff .

²² Duke. 2023. “Changes to COVID Vaccination Requirements. April 13, 2023. Accessed June 1 2023 (while no longer mandating vaccines, Duke strongly recommending getting “up-to-date vaccinations against COVID-19”). https://coronavirus.duke.edu/2023/04/changes-to-covid-vaccination-requirements/#:~:text=Dear%20Students%2C%20Faculty%2C%20and%20Staff%2C&text=As%20a%20result%2C%20we%20no,place%20them%20at%20higher%20risk .

²³ Vanderbilt University. 2023. “Everything You Need to Know about COVID-19 Health and Safety for the Start of the 2022-23 Academic Year. August 11, 2022. Accessed June 1, 2023 (COVID-19 vaccines and boosters, although not mandated, are “strongly encouraged”). https://news.vanderbilt.edu/2022/08/11/everything-you-need-to-know-about-covid-19-health-and-safety-for-the-start-of-the-2022-23-academic-year/#:~:text=COVID%2D19%20vaccines%20and%20boosters,the%20vaccine%20tracker%2Fsubmission%20form.

²⁴ Kaiser Permanente. 2023. “How We Know the COVID-19 Vaccine is Safe and Effective.” February 11, 2022. Accessed June 1, 2023 (webpage states that “[t]he COVID-19 Vaccine is among the safest, most effective vaccines ever”). https://healthy.kaiserpermanente.org/northern-california/health-wellness/coronavirus-information/vaccine-learn/safe-and-effective.

²⁵ CDC: Centers for Disease Control and Prevention. 2023. “FDA and CDC Response to the Florida Surgeon General.” CDC Newsroom. March 10, 2023. Accessed May 31, 2023. https://www.cdc.gov/media/releases/2023/p0313-letter.html .

²⁶ Id.

²⁷ Id.

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³⁰ Id.

³¹ CDC: Centers for Disease Control and Prevention. 2023. “FDA and CDC Response to the Florida Surgeon General.” CDC Newsroom. March 10, 2023. Accessed May 31, 2023. https://www.cdc.gov/media/releases/2023/p0313-letter.html .

³² CDC: Centers for Disease Control and Prevention. 2023. “FDA and CDC Response to the Florida Surgeon General.” CDC Newsroom. March 10, 2023. Accessed May 31, 2023. https://www.cdc.gov/media/releases/2023/p0313-letter.html .

³³ Id.

³⁴ Thorp JA, Rogers C; Deskevich, MP, Tankersley S, Benavides A, Redshaw, M.D.; McCullough, P.A. COVID-19 Vaccines: The Impact on Pregnancy Outcomes and Menstrual Function. Journal of the American Physicians & Surgeons Spring 2023; 28(1) https://www.jpands.org/vol28no1/thorp.pdf .

³⁵ Davis R. L. (2013). Vaccine Safety Surveillance Systems: Critical Elements and Lessons Learned in the Development of the US Vaccine Safety Datalink’s Rapid Cycle Analysis Capabilities. Pharmaceutics, 5(1), 168–178. https://doi.org/10.3390/pharmaceutics5010168.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3834936/ .

³⁶ The Vaccine Injury Compensation Program: Addressing Needs and Improving Practices, 6^th Report. October 12, 2000. House Committee on Government Reform, 106^th Congress, 2d Session, House Report 106-977, p. 19. Accessed June 1, 2023. https://www.congress.gov/congressional-report/106th-congress/house-report/977/1 .

³⁷ Baletti, Brenda. 2023. The Defender: Children’s Health Defense News & Views, “Breaking: Family of 24-Year-Old Who Died from COVID Vaccine Sues DOD in ‘Groundbreaking Case.’” May 31, 2023. Accessed June 1, 2023. https://childrenshealthdefense.org/defender/george-watts-jr-pfizer-covid-vaccine-injury/ .