BOMBSHELL: VAERS Algorithm Allegedly Suppressed Reports

Senator Ron Johnson, chairman of the Senate Permanent Subcommittee on Investigations, released a bombshell interim majority staff report on April 29, 2026, titled “Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals.” The report, accompanied by approximately 600 pages of internal government emails and documents obtained through a subpoena of the Department of Health and Human Services, alleges that senior Biden-era health officials were made aware that their own data analysis system was actively concealing serious adverse events associated with COVID-19 vaccines and chose to do nothing about it.

Johnson released the report in conjunction with a formal Senate hearing of the same name. He summarized the core finding in plain language: Biden health officials knew that safety signals for COVID-19 injection injuries were being hidden by their VAERS analytic algorithm. They were shown an updated algorithm that signaled serious adverse events and refused to use it. Johnson stated that their cover-up jeopardized the health of millions of Americans.

The Vaccine Adverse Event Reporting System, known as VAERS, is the federal government’s primary post-market surveillance tool for detecting potential safety problems associated with vaccines after authorization. It is jointly managed by the FDA and the Centers for Disease Control and Prevention. The reports documented in Johnson’s investigation concern the statistical methodology used to analyze VAERS data and detect significant safety signals, which are patterns in adverse event reports that suggest a potential connection between a vaccine and a serious health outcome.

At the center of the report is Dr. Ana Szarfman, who at the time was a senior medical officer and safety data-mining developer at the FDA’s Center for Drug Evaluation and Research. Szarfman is one of the principal architects of the FDA’s own existing data-mining system and helped develop it. Beginning in early 2021, shortly after the COVID-19 vaccines began rolling out under Emergency Use Authorization, Szarfman began applying an improved, updated data analysis technique to VAERS data. Her new method addressed a known statistical problem called masking.

Masking is a technical flaw in which safety signals for one vaccine in a large reporting database are obscured or artificially suppressed by the sheer volume of adverse event reports from other vaccines in the same system. In the context of COVID-19 vaccine data, masking meant that signals potentially associated with specific vaccines such as Moderna or Pfizer could be statistically drowned out by the combined data from other vaccines, making serious adverse events invisible using the standard methodology. Szarfman and Dr. William DuMouchel, the statistician credited with inventing the FDA’s own gold-standard data-mining algorithm, developed an improved method called the Regression-Adjusted Gamma Poisson Shrinker, designed specifically to eliminate the masking problem.

The results of applying the improved method to COVID-19 VAERS data were alarming. The analyses identified dozens of statistically significant safety signals that the FDA’s standard methodology had completely missed. One review cited in the report found 49 examples of extreme masking, including approximately 25 previously undetected safety signals. Those newly surfaced signals included sudden cardiac death, Bell’s palsy, pulmonary infarction, non-site specific embolism and thrombosis, acute myocardial infarction, dementia associated with the Pfizer vaccine, and reports of death and sudden death associated with both the Moderna and Pfizer vaccines.

Szarfman shared her findings with senior FDA officials, including those specifically tasked with monitoring COVID-19 vaccine safety. According to the emails contained in the 600-page document release, the FDA’s response was not to investigate the signals further, alert the public, or pause distribution for review. The response was to tell Szarfman to stop.

By May 2021, senior officials at the FDA’s Center for Biologics Evaluation and Research, the unit specifically responsible for COVID-19 vaccine safety surveillance, directed Szarfman to cease and desist her data analysis. The instruction came from Dr. Peter Marks, who led the Center. In an internal email to Dr. Patrizia Cavazzoni, then-Director of the FDA’s Center for Drug Evaluation and Research, Marks warned that Szarfman’s data mining could “create erroneous conflicts that feed in to anti-vaccination rhetoric.” The fear documented in writing was not that the safety signals might be real. The fear was that detecting them publicly might undermine confidence in the vaccines.

Dr. Peter Stein, director of the CDER Office of New Drugs, responded to Marks with thanks for flagging the issue and confirmed that FDA leadership had made clear to Szarfman she should not be discussing or providing internal analyses externally. He closed his message with the phrase “Hopefully, you won’t have further surprises.” That phrase, in context, refers to a senior FDA researcher surfacing statistically significant safety signals for serious cardiac events and sudden death. The institutional priority structure it reflects is deeply troubling.

Szarfman did not stop. She and DuMouchel continued their analyses and continued to document what the improved methodology was detecting. Between March and July 2021, those analyses identified stronger statistical signals for acute myocardial infarction associated with Moderna and Pfizer vaccines, embolism and thrombosis linked to Pfizer and Janssen vaccines, dementia associated with Pfizer, and reports of death and sudden death associated with Moderna and Pfizer. By May 24, 2021, VAERS using the improved methodology was already signaling for myocarditis specifically in the age groups of 16 to 17 year olds and 18 to 24 year olds.

Johnson addressed the myocarditis finding directly during the hearing. He stated that when his committee searched the HHS documents for myocarditis, staff found that FDA officials absolutely had and admitted they had a safety signal on myocarditis by approximately May 2021. He said they hid it, did not immediately issue a warning on the Health Alert Network, and downplayed it in any subsequent communication. He called it a bombshell and a huge scandal.

A prior Johnson report from May 2025 had already documented the myocarditis suppression in detail, revealing that while Biden health officials were drafting a notification to healthcare providers about the cardiac signal, then-FDA Acting Commissioner Janet Woodcock pushed back on the CDC’s plan to formally notify providers through the Health Alert Network. The formal notification was rejected and replaced with a quieter posting on the CDC’s website. The American public and their doctors did not receive the urgent, prominent warning that the safety signal warranted under the government’s own internal protocols.

Rather than adopt the superior detection methodology, Biden health officials continued to use the older standard method with known limitations that prevented the FDA from detecting the adverse events that the improved tool was capturing. The report states that records indicate FDA did not make any adjustments to its data-mining methodology as recommended by Szarfman. The deliberate choice to continue using an inferior detection system, after being shown a better one that was actively surfacing serious safety signals, forms the core of Johnson’s allegation that this was a purposeful cover-up rather than an oversight failure.

The FOIA evasion dimension of the report adds a layer of documented intentionality. Emails included in the 600-page document release show that FDA officials attempted to avoid Freedom of Information Act requests related to COVID-19 vaccine safety signals. An April 15, 2021, email from FDA official Dr. David Menschik told colleagues they should meet internally before discussing the updated data-mining method with Szarfman, specifically because there were “many considerations not suited to email.” The awareness that sensitive communications about vaccine safety signals should not be committed to writing echoes the same institutional instinct toward concealment documented in the Morens indictment announced just one day earlier.

In a further escalation, internal FDA and CDC communications obtained by the subcommittee show that in the following year, officials discussed limiting the distribution of the FDA’s weekly COVID-19 vaccine data-mining reports entirely. A CDC official wrote that because of FOIA requests, officials may have asked FDA to stop sending the weekly data mining outputs. The weekly reports that would have captured Szarfman’s safety signal findings were suppressed specifically in response to transparency requests from the American public seeking to understand what the government knew about vaccine safety.

Szarfman and DuMouchel continued their work despite the institutional resistance and in 2022 co-authored a peer-reviewed paper in the journal Drug Safety demonstrating the effectiveness of the improved methodology and its superior capacity to unmask hidden signals in COVID-19 vaccine VAERS data. When Szarfman emailed the published paper to then-FDA Commissioner Robert Califf, he replied: “Thanks. These are good.” No changes were made to the FDA’s data-mining methodology. Szarfman retired from the FDA in 2025. Johnson has attempted to contact her regarding congressional testimony, but it remains unclear whether she will testify.

Dr. Karl Jablonowski, a senior research scientist who testified at the April 29 hearing, delivered a stark assessment of the institutional failure described in the report. He stated that the knowledge of COVID-19 vaccine safety prior to Emergency Use Authorization was poor. He told the committee that pharmacovigilance conducted behind closed doors should give everyone pause because it is too important not to do correctly and timely, and that lapses can be and were catastrophic.

The scale of adverse event data in VAERS during the COVID-19 vaccine rollout provides essential context. As of April 25, 2025, VAERS recorded 38,607 deaths and 1,663,348 total adverse events worldwide associated with COVID-19 injections. Of those deaths, 9,228, representing 25 percent of the total, occurred on Day 0, Day 1, or Day 2 following injection. By comparison, VAERS recorded 2,663 deaths associated with the flu vaccine over a period of 35 years. No other drug or vaccine in VAERS history comes close to the volume of adverse event reports generated by the COVID-19 vaccines. Yet the officials responsible for monitoring that data were using a method they had been shown was inferior to the available alternative.

Johnson subpoenaed HHS for COVID-19 vaccine safety records and pandemic-related communications in January 2025. The 600 pages released alongside the April 29 report represent a portion of the documents produced. Johnson has stated publicly that for years, Biden officials at HHS and its subcomponent agencies withheld crucial health information from the subcommittee and the public.

The report also connects to Johnson’s earlier investigation into ischemic stroke safety signals. CDC communications cited in a prior letter to Health and Human Services Secretary Robert F. Kennedy Jr. showed that between August 2022 and February 2023, there were 226 stroke cases flagged in connection with COVID-19 boosters. More stroke cases continued to surface through 2023 and 2024. Despite identifying a statistically significant ischemic stroke safety signal among adults aged 65 and older who received the Pfizer bivalent booster, the booster recommendations for that age group remained wholly unchanged throughout the period of investigation.

Kennedy has committed to what he has publicly described as radical transparency in his dealings with Congress, a posture that stands in direct contrast to the behavior of the Biden-era officials described in Johnson’s report. He has indicated his intention to produce all remaining records requested by the subcommittee related to the stroke signal investigation and the broader COVID vaccine safety surveillance failures documented in the report.

The timing of the report, released one day after the indictment of David Morens, Fauci’s former top adviser at NIAID, is not a coincidence in the broader COVID accountability narrative. Both stories involve senior federal health officials allegedly concealing pandemic-related information from the public and from Congress. Both involve FOIA evasion as a deliberate institutional strategy. Both involve communications moved or hidden specifically to prevent public scrutiny. Taken together, they describe what Johnson and his allies characterize as a systemic culture of concealment within the federal health bureaucracy during the pandemic years.

Johnson was direct during the hearing about his expectations for media coverage. He said he thinks this is a bombshell and a huge scandal, and openly questioned whether the legacy media will cover it or whether the corporate media will engage with the findings at all. He stated flatly that the media is part of the cover-up. That charge is not unfamiliar from Johnson, who has been one of the most persistent voices in Congress demanding COVID accountability since 2021, and who has repeatedly seen his investigations receive minimal mainstream media coverage relative to their scope and implications.

The report does not contend that the COVID-19 vaccines provide no benefit or that every VAERS adverse event report establishes a causal link with vaccination. VAERS is a passive surveillance system and a report in VAERS is not proof of causation. What the report does establish, based on documents produced under congressional subpoena, is that a superior method for detecting potential safety signals was available, was demonstrated to work, produced alarming results when applied, and was then deliberately suppressed by senior officials who prioritized protecting vaccine confidence over protecting vaccine recipients.

For the millions of Americans who received COVID-19 vaccines and subsequently experienced adverse health events, and for the families of those who died in the days and weeks following injection, the report represents something they have sought for five years. It is not a final verdict. The investigation is ongoing. But it is the most detailed, document-supported account yet of what federal health officials allegedly knew, when they knew it, and what they chose to do about it.