Shortly after receiving a COVID-19 vaccine in November 2020, Brianne Dressen, a preschool teacher in Utah, began experiencing tingling sensations in her arms and legs. Her health rapidly declined afterward, leading to double vision, persistent nausea, mental confusion, and severe fatigue. Once an enthusiastic rock climber, Dressen found herself relegated to the sofa.

Dressen’s health issues, while rare amidst the hundreds of millions of COVID-19 vaccinations administered that season, were significant enough to capture the interest of Avindra Nath, a neuroscientist at the National Institutes of Health. In 2021, Nath assessed Dressen and over thirty others with similar symptoms, advising treatments with steroids and antibodies, which Dressen credits with saving her life.

However, as revealed through emails reviewed by KFF Health News, Nath eventually disclosed that he could no longer offer assistance as his clinical study was wrapping up. He suggested that the patients seek local medical advice, a recommendation Dressen found futile in her situation.

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Nath refrained from discussing the situation with KFF Health News. Meanwhile, the FDA, after scouring international vaccine safety databases for small-fiber neuropathy—a symptom Nath noted—found it less commonly reported among vaccinated individuals than unvaccinated ones, according to Peter Marks, formerly the head of the FDA’s vaccine division until his dismissal by Health and Human Services Secretary Robert F. Kennedy Jr. in May.

Marks acknowledged the possibility of vaccine-related injuries among Nath’s patients but noted the difficulty in defining a syndrome due to the variability of the symptoms.

For Dressen and others who believe they were harmed by the vaccines, these experiences highlight the shortcomings of the U.S. system for tracking vaccine side effects. Critics argue that the system is underfunded and its inefficiencies contribute to vaccine hesitancy.

The limitations of this system became particularly evident during the pandemic’s mass vaccination efforts, where even rare serious side effects could impact thousands.

Prominent vaccine scientists are now calling for increased resources to study vaccine safety and better support for those alleging vaccine injuries, urging Kennedy to take action given his prior anti-vaccine stance.

“Investing in vaccine safety research is not an admission that vaccines are unsafe; rather, it demonstrates a commitment to enhancing safety,” stated Y. Tony Yang, a health policy professor at George Washington University’s Milken Institute School of Public Health.

However, these calls have largely gone unheeded. While Kennedy publicly criticizes vaccines, he has not proposed solutions to enhance their safety, exacerbating the issue by cutting programs and dismissing knowledgeable scientists, numerous experts contend.

“The focus has shifted from impartially determining vaccine safety signals to emphasizing disproven concerns, such as a vaccine-autism link, which is actually harmful,” remarked Marks.

Under the Trump administration, a substantial COVID-19 vaccine study was abruptly terminated as researchers began exploring genetic factors that might predispose individuals to vaccine-induced myocarditis, a condition that affected approximately 1 in 13,000 young males vaccinated with Pfizer or Moderna’s mRNA vaccines during 2020 and 2021.

On June 9, Kennedy dismissed all 17 members of the Advisory Committee on Immunization Practices (ACIP), which had reviewed safety data from nearly 700 million COVID-19 vaccinations during the pandemic. The newly appointed ACIP members have expressed skepticism about the safety and testing of most vaccines. Sen. Bill Cassidy (R-La.), chair of the Senate committee overseeing HHS, suggested on social media on June 23 that the ACIP meeting set for June 25-26 be postponed until the committee could be staffed with less biased, more informed members.

HHS officials indicate that Kennedy plans to overhaul the entire vaccine safety framework. In a statement to KFF Health News, spokesperson Emily Hilliard criticized the Centers for Disease Control and Prevention for “hiding information on vaccine injuries” and described the existing Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink as “designed to fail” and examples of “regulatory negligence.”

Hilliard mentioned that HHS is developing new systems to more accurately assess the risks and benefits of vaccines. However, when asked for details, she did not reply. The HHS budget proposal for fiscal year 2026 does not mention any vaccine safety initiatives.

The current U.S. vaccine safety infrastructure originated with the 1986 National Childhood Vaccine Injury Act, which aimed to stabilize the vaccine market by preventing lawsuits against pharmaceutical companies. At that time, companies were moving away from vaccine production, finding it less profitable and more litigious compared to manufacturing drugs for chronic conditions. The law established the National Vaccine Injury Compensation Program and VAERS.

Robert Chen, a CDC vaccine safety officer, expanded on VAERS by creating the Vaccine Safety Datalink to search for signs of vaccine harm in electronic health records. In 2001, the CDC launched the Clinical Immunization Safety Assessment project, which coordinates a network of eight U.S. centers to study rare vaccine reactions.

Despite these efforts, the budget for vaccine safety has largely remained static at around $20 million annually, insufficient for thorough investigations into uncommon but recurring vaccine injuries.

“$20 million to monitor all the licensed vaccines in the U.S. is clearly inadequate,” stated Dan Salmon, director of the Institute for Vaccine Safety at Johns Hopkins University, during a recent conference. Without greater commitment, he argued, “our vaccines won’t be as safe as they could be.”

As an HHS vaccine safety official across the Clinton, Bush, and Obama administrations, Salmon helped draft two plans that called for expanded safety research, including studies on whether the vaccine schedule could be contributing to a rise in allergic diseases.

A little-known 2022 CDC-led study suggested that the aluminum salts used in some pediatric vaccines might be linked to a higher incidence of asthma—an association that Salmon believes warrants further investigation. “This should have been researched decades ago,” he remarked.

An Inadequate Compensation System

Both vaccine advocates and critics agree that the government’s program to compensate individuals harmed by vaccines or other public health measures during emergencies—the Countermeasures Injury Compensation Program—has failed miserably in addressing COVID-19 vaccine-related injuries. As of June 1, the program has compensated only 39 of nearly 14,000 claimants. Only five of these have received awards exceeding $10,000.

This program is far less generous and user-friendly than the National Vaccine Injury Compensation Program, which has been funded since 1988 by an excise tax on vaccines and has paid out approximately $4.8 billion in about 12,000 awards, primarily for the care of vaccine-injured children.

Individuals suffering from COVID-19 vaccine injuries, however, find themselves in a state of limbo, often without clear medical options. “This situation is extremely detrimental to public confidence in vaccines,” stated Amy Pisani, CEO of Vaccinate Your Family, during a panel discussion with Salmon in April.

While Kennedy has criticized the injury compensation system for protecting drug companies from lawsuits, Gentry, who directs a law clinic for vaccine injuries at George Washington University Law School, argued that if Kennedy truly wishes to assist patients, he should incorporate COVID-19 vaccines into the program. “By leaving these individuals without support, you’re creating a perfect storm that will deter people from getting vaccinated,” she remarked.

A Halted Investigation into Vaccine Injuries

In December 2021, Nath informed Dressen and other individuals experiencing post-vaccine issues via email that he could no longer assist them. He later told Science magazine that investigating vaccine side effects was a sensitive issue, especially as public health officials were encouraging widespread vaccination.

“You must be extremely cautious. Drawing the wrong conclusion can have significant consequences,” he explained. Nath called for more research into vaccine-related neurological conditions in a 2023 article, and his lab released preliminary findings from its study involving Dressen and others, indicating potentially beneficial treatments. However, these findings have not yet been published in a peer-reviewed journal.

None of the federal agencies acknowledged that Dressen’s condition might be related to the vaccine, she noted, having received her dose during an AstraZeneca clinical trial. (FDA officials were concerned about the side effects associated with this vaccine, which was never approved for distribution in the United States.)

Dressen expressed her distress over Nath’s withdrawal. “They assure everyone there’s a safety net, but each of these measures has failed completely,” she stated. “I didn’t speak out because of my injury. I spoke out because of what happened afterward.”

“People are suffering, and we still don’t understand why or how to help them,” stated Harlan Krumholz, a cardiologist involved in a Yale University research project led by immunobiologist Akiko Iwasaki, which includes hundreds of patients with post-vaccine issues. “What’s worse, many feel ignored or dismissed by the very institutions meant to support them.”

Despite the prevalence of post-vaccine syndrome symptoms, which resemble those of long COVID, the NIH has not funded research into this condition. Genetic studies could help identify those more susceptible to these issues, Iwasaki suggested in an email.

Such investigations would be well-suited for the Clinical Immunization Safety Assessment, established to study rare vaccine reactions. However, this network has neither published findings on COVID-19 vaccines nor listed any relevant trials on government websites.

In contrast, German researchers have delved deeper into post-vaccine syndrome. In December, Germany’s Paul-Ehrlich-Institut, a regulatory body similar to the FDA for vaccines, reviewed 919 cases of post-vaccine syndrome resembling long COVID, occurring at a rate of about 1 in 100,000 vaccinations. It noted the difficulty in establishing causality due to the diverse symptoms reported.

Could Vaccine Safety Be Managed Outside of HHS?

In 1999, Chen, the CDC scientist, proposed in an article that transferring vaccine safety oversight to an independent agency, potentially modeled after the National Transportation Safety Board—which has the authority to subpoena records from industry or other government agencies—could expedite studies and enhance public trust.

Although HHS did not respond to inquiries about this suggestion, vaccine litigant Aaron Siri, who has served as a personal attorney for Kennedy, told KFF Health News that Kennedy supports the idea.

In the meantime, some vaccinologists hope to convince Kennedy to allocate more funds for credible vaccine safety research.

While witnessing Kennedy’s impact on HHS vaccine policy is “extremely distressing,” finding common ground is essential, Salmon stated at the conference. This does not mean “financing poor-quality studies to confirm preconceived notions,” he clarified.

Yet, many perceive Kennedy’s early actions as secretary in this light. One of his initial decisions was to appoint David Geier, whose previous work is widely regarded as lacking scientific validity, to review potential links between vaccines and autism—a connection that has been conclusively refuted by global research.

Expanding an Established System

When HHS’ Vaccine Safety Datalink was established in the early 1990s, it set a global standard for vaccine safety monitoring. Today, countries like Denmark, England, Israel, and Australia also have robust systems, but the U.S. framework has generally functioned effectively, according to Steve Black, who co-directed the Kaiser Permanente Vaccine Study Center until 2007.

The Vaccine Safety Datalink played a key role in the 1999 withdrawal of a rotavirus vaccine that caused rare intestinal disorders in infants. It also identified a rare but fatal side effect that prevented the AstraZeneca COVID-19 vaccine from entering the U.S. market and led to the discontinuation of the Johnson & Johnson vaccine. Additionally, it quickly detected myocarditis cases following the administration of mRNA vaccines to young men in 2021.

Since 2019, Black has co-led the Global Vaccine Data Network, an ambitious consortium spanning 30 countries, which facilitates vaccine safety analyses across vast, diverse populations worldwide.

The consortium had just begun its study on genetic predispositions to myocarditis when the Trump administration canceled a $2 million CDC funding agreement, effectively halting the research.

An email from the Department of Government Efficiency (DOGE) posed irrelevant questions, such as whether the researchers had received funding from China or collaborated with European counterparts, and abruptly ordered the network to cease operations without any due process or appeal options, Black explained.

Research funded by the grant had progressed to identifying seven genetic variants associated with cardiac inflammation in individuals who developed myocarditis following vaccination, according to Bruce Carleton, the study’s lead investigator at the University of British Columbia. While further work is needed, the data suggests that a $6 test could help identify patients at risk before they receive a vaccine, Carleton noted.

“Millions have received mRNA vaccines, but very few have developed myocarditis,” Black stated. “The public wants to know if they are at risk, and genetics could provide that answer.”

Black added that while the CDC has been a reliable source of vaccine safety information, if moving the issue out of HHS would boost public confidence, he supports the idea.

Vaccines must become safer, Dressen emphasized, but the notion of banning them altogether is not a viable solution. “There’s a faction that wants mRNA vaccines removed from the market, but that won’t solve the problem. Vaccines are here to stay,” she stated.

As of June 5, a patient group led by Dressen had allocated $1.2 million to 162 individuals requiring medical care for injuries they attributed to vaccination.

Meanwhile, the federal countermeasures program, responsible for distributing COVID-19 vaccine injury compensation through a trust, has committed $2.6 million for one patient and $370,376 for another. As of June 1, it had awarded an additional 37 claimants a total of $198,809.92.

KFF Health News, formerly known as Kaiser Health News (KHN), is a national newsroom dedicated to producing comprehensive journalism on health issues. It is one of the principal operating programs at KFF — an independent source for health policy research, polling, and journalism.