It is impossible to know whether anyone believed Dr. James Laidler in 2004. when he reported that the flu vaccine turned him into the Incredible Hulk. Symptoms he described definitely fits – green skin and huge muscles. And the news about his transformation appeared in a seemingly authoritative place – on the federal government website. Vaccine Adverse Event Reporting System (VAERS)jointly administered by the Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC).
Laidler wasn't the only one who reported his symptoms to VAERS. Every year more than 38,000 Americans report to the site about possible side effects of vaccines. Anyone can publish anything—true or not, plausible or not. And so Laidler, an Oregon anesthesiologist concerned about the unfiltered, unedited misinformation spreading about life-saving vaccines, published his fictional Hulk story to prove his point.
“Because the reported adverse event was so…unusual, I was contacted by a VAERS representative.” Laidler wrote on his blog at that time. “After discussing the VAERS database and its limitations, I was asked for permission to delete the record, and I gave my consent. If I had not agreed, the record would still be there.”
There are countless other false messages persisting on the site, and this is a potential problem. With vaccine hostility on the rise, experts say there is a risk that VAERS will increasingly be used for political or ideological purposes, turning what was intended as a way for epidemiologists to look for problems with vaccines into a tool for misinformation.
“VAERS can serve as an early warning system,” says Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia and a former longtime member of the Centers for Disease Control and Prevention (CDC). Advisory Committee on Immunization Practices (ACIP). “It can't prove there's a problem, but it can show that there might be one. It's also being terribly abused by anti-vaccine activists who say, 'Look at all these reports.'”
“VAERS is a passive reporting system, and that’s its strength and weakness,” says Dorit Reiss, a law professor at the University of California, San Francisco, who studies legal and policy issues related to vaccines, including vaccine mandates and the anti-vaccine movement. “It works quickly and quickly and easily identifies signals of trouble. But it can also create scary memes and spread unfounded fears.”
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VAERS was founded with the best of intentions and was authorized in 1986 under National Childhood Vaccine Injury Act. a new law was created what is widely (and erroneously) called the “vaccine harm trial” and is correctly called Office of Special Masters. Mindful of the need to vaccinate millions of children each year against preventable diseases and to keep the cost of vaccines low, Congress and then-President Ronald Reagan agreed to establish a no-fault court in which claims of adverse effects from vaccination could be litigated—or, more often, resolved—with awards awarded. funded by a 75 cent surcharge for every dose of vaccine produced in the United States. The court would spare pharmaceutical companies the endless lawsuits (many of which are either frivolous, fraudulent, or related to a genuine medical problem that was not actually caused by the vaccine) that could stop the necessary flow of vaccinations.
Over the years, the government has made serious efforts to explain the lack of guilt in court, which has nothing to do with Washington cutting lucrative deals with Big Pharma. But that didn't stop Health and Human Services (HHS) Secretary and longtime vaccine skeptic Robert F. Kennedy Jr. claiming“If we want safe and effective vaccines, we must end the liability shield.”
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VAERS was created as another rule of law. Since 1990, when the VAERS program became widespread, more than two million reports have been reported, most of which describe mild potential side effects. During this time, VAERS achieved several major public health successes. In 1998, the Rotashield vaccine, designed to protect against rotavirus, was introduced, and isolated cases of infection were reported shortly thereafter. intussusception— in which the intestines clot, causing a blockage and cutting off blood flow — began to appear in infants who received the vaccine. VAERS reports showed that the condition occurred within the first week after the first injection, and in 1999 the manufacturer pulled out the vaccine.
“Reports have shown that intussusception has been observed in infants as young as two months old,” Offit says. “This was unusual because it usually occurs in babies between five and nine months of age. And it made us look more closely at whether there was [the vaccine] there was a problem.”
More recently, VAERS was one of the sources of the first reports of boys and young adults. developing myocarditis— or heart inflammation — after receiving the Pfizer-BioNTech and Moderna COVID vaccines. Once those first reports were filed, Offit said, “you could do studies where, by looking at the link, you could answer the question, 'Would you be more likely to get myocarditis if you got the vaccine?'”
Communication was indeed established, but it was rare…approximately two additional cases for every 100,000 people who got shot. This was considered an acceptable risk, especially since the COVID virus itself has been linked to growth more than 16 times the risk of myocarditis jumped from a baseline of nine cases per 100,000 people to 150 cases per 100,000 people.
But trust in the VAERS system may be in jeopardy, some public health experts worry—not so much because of hoaxes like Laidler's, or honest vaccine recipients posting reports of purported side effects that turn out to be unrelated to the shot, but because of current federal public health guidance. The ACIP panel, on which Offit once served, consisted of 17 physicians, public health specialists and other relevant experts who advised HHS and the government as a whole. on vaccine distribution to civilians. June 9 Kennedy fired all committee membersreplacing them with a manually selected group more consistent with his long-standing anti-vaccine views. An press release of the XXX called the move “a bold move to restore public confidence in vaccines by re-establishing ACIP.”
“A complete cleanup is needed to restore public confidence in vaccine science,” Kennedy said in a statement. “The new ACIP members will prioritize public health and evidence-based medicine. The committee will no longer act as a rubber stamp for industry profit-making agendas.”
Others were not so optimistic. “Of course, there is now a fear that the ACIP will be filled with people who know nothing about vaccines other than suspicion,” wrote Republican Senator Bill Cassidy– doctor who voted for Kennedy's candidacy – X June 9.
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December 5 the newly configured ACIP panel has taken its first step toward repealing vaccination guidelines, voting to repeal existing policies that recommend hepatitis B vaccination for all newborns and instead call for its use only for children whose mothers have tested positive for the infection or whose status is unknown. HHS called the move “decision-making on a case-by-case basis.” Offit counters that Kennedy is “going to make vaccines less available, less accessible, and more dangerous.”
On November 28, HHS took action again. when Dr. Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER), the FDA's vaccine division, sent an email internal memo CBER staff, linking the deaths of 10 children to COVID vaccines and citing VAERS reports as part of the evidence. Prasad recommended a host of restrictions, including requiring vaccine makers to provide significantly more data supporting the safety of their products, revising recommendations for annual flu shots and asking whether people should get multiple vaccines at once. The memo contained few important details about the VAERS reports, including the children's ages, a full explanation of how CBER determined the vaccine was linked to their deaths, and information about whether they had any pre-existing conditions.
“[Prasad] said he saw data in VAERS that didn't prove anything, Offit says. “He didn’t confirm them in any way.”
While the FDA did not respond to a request for comment, the CDC provided a statement via email.
“The CDC's own research has shown that the post-licensing surveillance system, VAERS, records less than 1% of vaccinations. It was a system designed to fail,” the statement said. “HHS is now building surveillance systems that will accurately measure both the risks and benefits of vaccines, because real science requires both transparency and accountability.”
Where U.S. vaccine policy—and tools like VAERS and the Court of Special Masters—will go is unclear.
“You have an anti-vaccination President of the United States and an anti-vaccination Secretary of Health and Human Services. The world has been turned upside down,” Offit says. “I think if there were one or two cases of polio in this country, it could change the dynamic.”
Reiss, the law professor, doesn't think such a development is at all out of the realm of possibility. “I think we have a problem,” she says. “Things will get worse before they get better.”
