Federal Vaccine Safety Database Draws Misinformation Concerns

In 2004, Dr. James Laidler submitted an unusual report to the federal Vaccine Adverse Event Reporting System (VAERS): the flu vaccine had transformed him into the Incredible Hulk, complete with green skin and enormous muscles. His fictitious submission wasn’t meant to deceive but to demonstrate a critical flaw in the system — anyone can report anything, regardless of veracity.

VAERS, jointly operated by the FDA and CDC, receives more than 38,000 reports annually from Americans claiming vaccine side effects. While most submissions are genuine, the system’s open nature creates vulnerability. As Laidler later explained, VAERS officials contacted him about the unusual report and removed it with his permission, but countless other questionable reports remain in the database.

“VAERS can serve as an early warning system,” explains Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and former member of the CDC’s Advisory Committee on Immunization Practices (ACIP). “It can’t prove there’s a problem, but it can show that there might be. It’s also misused horribly by anti-vaccine activists who say, ‘Look at all these reports.'”

This tension between public health utility and potential misuse has grown more pronounced amid rising vaccine skepticism. Dorit Reiss, a University of California law professor who studies vaccine policy, notes: “VAERS is a passive reporting system, and that’s both its strength and weakness. It’s fast and turns up signals of a problem quickly and easily. But it can also create scare memes and spread unfounded fears.”

Established under the 1986 National Vaccine Childhood Injury Act during the Reagan administration, VAERS operates alongside the Office of Special Masters — commonly but misleadingly called “vaccine court.” This no-fault system allows people to litigate claims of vaccine injury without dragging manufacturers into endless lawsuits that might hamper vaccine production. A 75-cent surcharge on every vaccine dose funds compensation awards.

Despite the government’s efforts to explain the rationale behind this system, Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic, has argued that the “liability shield” should be removed to ensure “safe and effective vaccines.”

Since its 1990 implementation, VAERS has collected over two million reports and produced notable public health successes. In 1998, it helped identify a serious issue with the Rotashield vaccine when reports indicated some infants developed intussusception — a dangerous intestinal condition — shortly after vaccination. The manufacturer withdrew the product in 1999.

More recently, VAERS captured early accounts of myocarditis in young males following Pfizer-BioNTech and Moderna COVID vaccinations. Subsequent studies confirmed a link, though the risk was rare — approximately two additional cases per 100,000 vaccinated individuals. This was deemed acceptable considering COVID-19 infection itself increased myocarditis risk more than 16-fold.

Public health experts now worry about VAERS’s future credibility under current federal leadership. On June 9, Kennedy dismissed all members of the Advisory Committee on Immunization Practices, replacing them with hand-selected individuals more aligned with his views. HHS characterized this overhaul as “a bold step to restore public trust in vaccines.”

Kennedy stated: “A clean sweep is necessary to reestablish public confidence in vaccine science. ACIP’s new members will prioritize public health and evidence-based medicine. The Committee will no longer function as a rubber stamp for industry profit-taking agendas.”

Critics, including Republican Senator Bill Cassidy, who ironically supported Kennedy’s nomination, expressed concern that “ACIP will be filled up with people who know nothing about vaccines except suspicion.”

These fears appeared justified when on December 5, the reconfigured ACIP voted to reverse longstanding policy recommending hepatitis B vaccination for all newborns, instead limiting it to children of mothers who test positive or have unknown status.

Further controversy erupted on November 28 when Dr. Vinay Prasad, head of the FDA’s vaccine division, circulated an internal memo citing VAERS reports to link 10 children’s deaths to COVID vaccines. The memo recommended significant restrictions on vaccine approvals but lacked crucial details about the cases, including ages, pre-existing conditions, or methodology establishing causation.

“[Prasad] said he saw the data in VAERS, which proves nothing,” Offit criticizes. “He didn’t in any way back it up.”

While the FDA did not respond to comment requests, the CDC provided a statement claiming “VAERS captures fewer than 1% of vaccine injuries” and stating that HHS is “building surveillance systems that will accurately measure vaccine risks as well as benefits.”

The future of U.S. vaccine policy remains uncertain under the current administration. “You have an anti-vaccine President of the United States and an anti-vaccine Secretary of Health and Human Services. The world is upside down,” Offit observes. “I think that if there was a case or two of polio in this country, that may change the dynamic.”

Professor Reiss shares this concern: “I think we’re in trouble. Things are going to get worse before they get better.”