Report: U.S. Health Authorities Ignored Data on Serious Complications from COVID-19 Vaccines
According to a report by U.S. Senator Ron Johnson’s investigative committee, U.S. health officials decided to ignore early warnings about the side effects of COVID-19 vaccines.
A new report released by U.S. Senator Ron Johnson’s investigative committee analysed documents from the U.S. Department of Health and Human Services’ Vaccine Adverse Event Reporting System (VAERS) from early 2021, when the COVID-19 crisis was at its peak. The report focuses on the work of Dr. Ana Szarfman, then-chief medical officer at the Food and Drug Administration (FDA), who, starting in early 2021, used a new data mining analysis of vaccine adverse event reports that reduced the masking of the data and identified dozens of statistically significant adverse event signals associated with COVID-19 vaccines. However, senior officials at the health agencies at the time decided to ignore all these signals of side effects from COVID-19 vaccines. Instead, they focused on silencing the person reporting them.
More specifically, Dr. Ana Szarfman identified many new side effects associated with COVID-19 vaccines after analysing reports registered in the Vaccine Adverse Event Reporting System (VAERS), using a new data mining method. Most of the side effects she found had not been detected by the FDA’s previous method, as that method is limited by the fact that a single very common report in the data makes it harder to identify other signals. Dr. Szarfman was able to overcome this limitation, identifying approximately 49 examples of extreme masking and approximately 25 statistically significant safety signals, including sudden cardiac death, Bell’s palsy, and pulmonary infarction.
Dr. Szarfman first reported these findings to FDA vaccine safety officials as early as April 2021, and after discovering even more safety signals, she repeatedly reported those as well. Among these statistically significant safety signals with higher values for adverse events were, for example, acute myocardial infarction, death, and sudden death associated with the Moderna and Pfizer COVID-19 vaccines; non-site-specific embolism and thrombosis associated with the Janssen and Pfizer vaccines; and dementia associated with the Pfizer vaccine.
However, senior vaccine safety officials at the FDA’s Center for Biologics Evaluation and Research (CDER) ignored Dr. Szarfman’s information and were instead concerned about the doctor’s own actions. CDER officials asked Dr. Szarfman to halt the data mining and wait before submitting her analysis reports. Ultimately, Dr. Peter Marks, who was then the head of CDER and an enthusiastic supporter of COVID-19 vaccines, wrote that Dr. Szarfman’s data mining could “create erroneous conflicts that feed in to anti-vaccination rhetoric.” Dr. Marks found that Ana Szarfman’s work had “become a major distraction.” Dr. Peter Stein, then director of the CDER’s New Drugs Division, informed Dr. Marks that he had “made it clear” to Dr. Szarfman “that she should not be discussing or providing internal analyses externally, and needs to focus on her assigned work.”
Despite the prohibitions and warnings, Dr. Szarfman continued her work and defended her method that revealed far greater risks compared to the ongoing method and took a closer view of the pandemic situation. In 2022, Dr. Szarfman co-authored an article in the journal Drug Safety, which found that COVID-19 vaccines have approximately eight times the likelihood of disproportionality signals being masked, compared to other vaccines. In other words, the researchers found that masking occurs when signals from the vaccine in question are overshadowed by those of other vaccines. This, in turn, limits or delays the ability to detect risks associated with new vaccines. While the article did spark interest among CDER officials, it was viewed in a negative and problematic light.
Medical scientist David Wiseman reached a similar conclusion regarding masking, in an article published in a September 2025 preprint. In his assessment, conventional data mining carries a risk of masking, which led to an underestimation of the side effects of COVID-19 vaccines. Wiseman noted that “FDA’s analysis neglected to correct for masking, where signals for one vaccine are concealed by signals from other vaccines.” Senator Johnson has described how, if reports of a certain side effect are so widespread, the safety signal may still exceed the statistical threshold of the FDA’s data mining. For example, statistically significant safety signals for ischemic stroke emerged in individuals aged 65 and older following the Pfizer-BioNTech bivalent booster vaccine. Similarly, signs of myopericarditis were identified in May 2021 in the 16–17 and 18–24 age groups.
In any case, a committee of inquiry led by U.S. Senator Ron Johnson concluded that FDA officials decided to block Dr. Ana Szarfman’s data mining of COVID-19 vaccines and the dissemination of her analyses. Instead of taking the doctor’s reports seriously and further investigating the warning signs, all of her efforts were swept under the carpet. The FDA did not implement any changes or inform the public about the safety signals of the COVID-19 vaccines. Simply put, Senator Johnson’s report finds that the priority of U.S. health agencies was not the actual consequences and side-effects of the vaccines. For the agencies and high-ranking officials, it seemed far more important to avoid fuelling “anti-vaccine” sentiments and to suppress facts that did not align with the narrative approved by the authorities at the time.
The FDA has been infiltrated and corrupted long ago by those it was meant to watch over. And with no accountability for betraying their duties and abuse of office, an entire society pays the price. Their stamp of approval has become hollow and worthless.
Accessory to murder.