There’s no way to know if anyone believed Dr. James Laidler in 2004 when he reported that a flu shot had turned him into the Incredible Hulk. The symptoms he described certainly suit him: green skin and huge muscles. And news of its transformation emerged in a seemingly reputable place: the federal government’s Vaccine Adverse Event Reporting System (VAERS), run jointly by the Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC).
Laidler wasn’t the only one to submit his symptoms to VAERS. Each year, more than 38,000 Americans report possible vaccine side effects to the site. Anyone can post anything, true or not, plausible or not. That’s why Laidler, an Oregon-based anesthesiologist concerned about the unfiltered and unedited misinformation circulating about life-saving vaccines, published his made-up Hulk story to make his point.
“Because the reported adverse event was so… unusual, a VAERS representative contacted me,” Laidler wrote in a blog post at the time. “After a discussion about the VAERS database and its limitations, they asked me for permission to delete the record, which I granted. If I had not agreed, the record would still be there.”
Countless other false reports persist on the site, and this is a potential problem. With growing hostility toward vaccines, there is a risk that VAERS will increasingly be misused for political or ideological purposes, experts say, turning what was intended as a way for epidemiologists to research vaccine-related problems into a tool of misinformation.
“VAERS can serve as an early warning system,” says Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and former longtime member of the CDC’s Advisory Committee on Immunization Practices (ACIP). “It can’t prove that there’s a problem, but it can show that there might be one. It’s also horribly misused by anti-vaccine activists who say, ‘Look at all these reports.'”
“VAERS is a passive reporting system, and that is both its strength and its 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’s fast and detects signals of a problem quickly and easily. But it can also create scary memes and spread unfounded fears.”
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VAERS was created with the best of intentions and authorized in 1986 as part of the National Vaccine Childhood Injury Act. The new law created what is commonly – and incorrectly – called the “Vaccine Injury Court,” and correctly known as the Office of Special Masters. Recognizing the need to immunize millions of children each year against preventable diseases and to keep the cost of vaccines low, Congress and then-President Ronald Reagan agreed to create a no-fault court in which claims regarding adverse effects of vaccines could be litigated—or, more commonly, settled—with awards funded by a 75-cent surcharge on each dose of vaccine manufactured in the United States. not actually caused by the vaccine – it would stop the necessary flow of injections.
Over the years, the government has gone to great lengths to explain the reason for the court’s faultless nature – which has nothing to do with the fact that Washington has cut sweetheart deals with big pharmaceutical companies. But that didn’t stop Health and Human Services (HHS) Secretary and longtime vaccine skeptic Robert F. Kennedy Jr. from asserting, “If we want safe and effective vaccines, we must end the liability guarantee.” »
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VAERS was created as another provision of the law. Since 1990, when the VAERS program expanded, more than two million reports have been filed, most describing mild potential side effects. During this time, VAERS has achieved major public health victories. In 1998, the Rotashield vaccine, created to protect against rotavirus, was introduced and soon after, scattered cases of intussusception – in which the intestine folds in on itself, causing a blockage and cutting off blood flow – began to appear in babies who had received the vaccine. VAERS reports showed illness occurring within the first week after the first injection, and in 1999 the manufacturer withdrew the vaccine.
“Reports have shown that intussusception occurs in children as young as two months,” says Offit. “This was unusual because it usually occurs in children aged five to nine months. And it prompted us to take a closer look to see if [the vaccine] was a problem.
More recently, VAERS was one of the first sources of reports of boys and young men developing myocarditis – or heart inflammation – after receiving the Pfizer-BioNTech and Moderna COVID vaccines. Once those first accounts are filed, Offit says, “You could do the kind of studies that would look at the link, to answer the question: ‘Were you more likely to get myocarditis if you got the vaccine?’ »
A link was indeed established, but it was rare: around two additional cases per 100,000 people who received the vaccine. This was considered an acceptable risk, especially since the COVID virus itself was associated with a more than 16-fold increased risk of myocarditis, rising from a baseline of nine cases per 100,000 individuals to 150 cases per 100,000 individuals.
But the VAERS system’s credibility could be in jeopardy, some public health experts worry — not so much by pranks like Laidler’s or by honest vaccine recipients releasing reports of suspected side effects that turn out to be unrelated to a shot, but by current federal public health leadership. The ACIP panel on which Offit served was comprised of 17 physicians, public health specialists, and other relevant experts who advised HHS and the government as a whole on the rollout of vaccines to the civilian population. On June 9, Kennedy fired all committee members, replacing them with a hand-picked group more in line with his long-held anti-vaccine views. An HHS press release called the move “a bold step to restore public confidence in vaccines by reconstituting the ACIP.”
“A clean slate is needed to restore public confidence in vaccine science,” Kennedy said in a statement. “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 agendas.”
Others weren’t so optimistic. “Of course, there is now concern that ACIP is filled with people who know nothing about vaccines except suspicions,” Republican Senator Bill Cassidy – a doctor who voted in favor of Kennedy’s nomination – posted on X on June 9.
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On December 5, the newly formed ACIP panel took the first step toward overturning the vaccine guidelines, voting to overturn the existing policy that recommends the hepatitis B vaccine for all newborns and instead calling for it only for children of mothers who test positive for the infection or whose status is unknown. HHS called the move “individual decision making.” Offit counters that Kennedy “is going to make vaccines less available, less affordable and more feared.”
On November 28, HHS acted again when Dr. Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER), the FDA’s vaccine division, emailed an internal memo to CBER staff, linking the deaths of 10 children to COVID vaccines – and citing the VAERS reports as part of the body of evidence. Prasad recommended a series of restrictions, including requiring vaccine makers to provide significantly more data demonstrating the safety of their products, reviewing recommendations for annual flu shots and questioning whether people should receive multiple shots at once. The memo contained few important details about the VAERS reports, including the ages of the children, a full explanation of how CBER determined the vaccine was linked to their deaths, and information on whether they had any pre-existing health conditions.
“[Prasad] “He said he saw the data in VAERS, which doesn’t prove anything,” Offit says. “He didn’t save them in any way.”
Although the FDA did not respond to a request for comment, the CDC provided an emailed statement.
“The CDC’s own research has shown that the post-licensure surveillance system, VAERS, captures less than 1% of vaccine injuries. It is a system that was designed to fail,” the statement read in part. “HHS is currently establishing monitoring systems that will accurately measure the risks and benefits of vaccines, because real science requires both transparency and accountability.
The direction that US vaccine policy – and tools like VAERS and the Court of Special Masters – will take is unclear.
“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 says. “I think if there were one or two cases of polio in this country, that could change the dynamic. »
Reiss, the law professor, doesn’t think this type of development is at all outside the realm of possibility. “I think we’re in trouble,” she said. “Things are going to get worse before they get better.”
