In 2004, anesthesiologist James Laidler submitted an alarming report to the Vaccine Adverse Event Reporting System (VAERS). Laidler wrote that after he got his annual influenza vaccine, his muscles began to grow in size, his skin became green, and he turned into the Incredible Hulk.
Laidler’s intent was not to notify government officials of a dangerous side effect, but to show the need for caution when interpreting the data found in VAERS, the national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).
VAERS is a passive reporting surveillance system, and the people who submit to it can include doctors and healthcare providers, but also anyone who receives a vaccine, their family members, or even lawyers. (This is different from the CDC’s Vaccine Safety Datalink, which is limited to health care professionals, and requires more documentation for submissions.)
To the CDC’s credit, it followed up with Laidler and asked his permission to remove the report, which he agreed to. “If I had not agreed, the record would be there still, showing that any claim can become part of the database, no matter how outrageous or improbable,” he wrote at the time.
Since its inception in 1988, anti-vaccine groups have cherry-picked VAERS data and twisted it out of context to show the supposed dangers of vaccines. Now, with several COVID-19 vaccines being administered, and vaccine hesitancy and misinformation on the rise worldwide, VAERS is being used yet again by those same groups—as well as a crop of new bad actors—as a vehicle for claims that various vaccines cause serious side effects like Bell's palsy, hospitalizations, or death. (A CDC review of safety data to date found this week that Bell’s palsy is no more common in COVID-vaccinated populations than unvaccinated; nor is the rate of death, or other severe health complications.)
Take former New York Times journalist and current full-time COVID troll Alex Berenson, who has recently switched from downplaying the disease to fear-mongering about the vaccine. He’s used VAERS data to suggest that the COVID vaccine causes an increase in issues during pregnancy, including stillbirth, premature delivery, and abnormal fetal heart rates. (He also claims that a stillbirth at 28 weeks is “rare,” which an extremely cursory glance at the data shows is not true. Stillbirths have declined since the 1940s, according to the CDC, but 1 in 160 pregnancies still ends in stillbirth.) Because pregnant people are not included in clinical trials for vaccines, the decision about whether to get a COVID vaccine has been more complicated for these populations. Nonetheless, the CDC says pregnant people who qualify for the vaccine “may choose to be vaccinated.” The agency also says it is planning to study the vaccine in pregnant people, and that people who became pregnant during clinical trials are being monitored.
Berenson has also claimed the COVID vaccines have “roughly 50 times the rate of adverse events from the flu vaccine," again solely using VAERS data, a claim the Ron Paul Institute quickly began amplifying. Responding to Bereson’s claims, Daniel Freedman, an assistant professor of neurology at Dell Medical School, accused Berenson of “dumpster diving.” (Freedman’s tweets clearly reflect his own opinion and not that of Dell.)
“He claims two suicides are vaccine related," Freedman wrote. "There was also someone struck by lightning in the vaccine trial. Now lightning strikes must be vaccine related, right?”
Responding to a request for comment from VICE News, Berenson wrote, “Good luck with your story. I'm sure it will be enlightening, though perhaps not for the reasons you intend.” When one of the authors asked what he meant by that, Berenson responded, “If I have anything more to say I will say it on Twitter.” After we reached out for comment, Berenson added a further tweet, writing, “I suppose I could walk her through the stillbirth data (yes, stillbirths in healthy 20-35 week fetuses are indeed very rare), but, truly, what would be the point?”
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Meanwhile, Children’s Health Defense, the anti-vaccine group headed by famous activist Robert F. Kennedy Jr., is encouraging its followers to submit vaccine injuries to VAERS. (Separately, it's also encouraging them to submit reports to something called VaxxTracker, a clearly anti-vaccine site credited to an entity called the Repository for Vaccine Adverse Effects.) Kennedy and CHD regularly insist that VAERS is a broken and untrustworthy system, but also see a moment of opportunity during the pandemic. “With vaccines so much in the spotlight now, we have a tremendous opportunity to draw attention to the issues of vaccine safety and vaccine choice,” CHD president Lyn Redwood is quoted as saying in a post on their website.
Established anti-vaccine activists and groups are newly interested in mining VAERS data to suggest that matters are even worse than what it shows. Toby Rogers, a political economist associated with the anti-vaccine movement, claimed that VAERS data “represents an estimated 1% of actual vaccine injuries,” and has killed many thousands more than reported. This is a common talking point—that VAERS data only shows 1% of actual adverse events—and it’s as false as it is oft-repeated. It also doesn’t really make sense, as Paul Offit, an attending physician in the Division of Infectious Diseases at Children's Hospital of Philadelphia (CHOP) and the director of CHOP's Vaccine Education Center, pointed out to VICE News: “How would they know that? What gold standard are they applying it to? How do they know what the real number is?”
Vaccine-critical organizations like the National Vaccine Information Center (NVIC) have repeatedly referred to VAERS reports as a source of information without explaining that they're unverified. The fact that the data comes from the CDC can give VAERS an air of legitimacy, said Kolina Koltai, a Postdoctoral Fellow at the Center for an Informed Public (CIP) at the University of Washington.
Anti-vaccination campaigners outside the United States frequently use VAERS as well: Just a few weeks ago, Australian-Samoan anti-vax influencer Taylor Winterstein screenshotted a story about deaths following the COVID vaccine which refers to VAERS data and hashtagged it #ThinkForYourself2021.
Even a quick glance through the #VAERS hashtag on Instagram shows that people frequently refer to VAERS data as established fact—though only when it purports to show some particularly terrifying side effect or injury. The top posts on Instagram hashtagged #VAERS -- the ones with the most likes and comments—all come from anti-vaccine accounts. (Instagram does direct users looking at the hashtag to visit the CDC for “reliable, up-to-date” information about topics like vaccines.)
“The truth can’t be hidden anymore,” one poster, a chiropractor who frequently posts anti-vaccine memes and videos, crowed. “It’s too easy to get the information.”
In order to use VAERS data to show the supposed dangers of vaccines, anti-vaccine groups have to avoid mentioning two crucial things: Anyone can submit a report to the program, and all of those data—unverified, unresearched, often anecdotal—are immediately available to the public. (Two years after Laidler wrote that his flu shot had turned him into the Incredible Hulk, Kevin Leitch of the science blog Left Brain Right Brain demonstrated that what Laidler had done wasn’t any kind of fluke by submitting a VAERS report noting that his baby daughter had been turned into Wonder Woman following a vaccination.)
This doesn’t mean, necessarily, that the majority of reports in VAERS are outright false, but that any report in the VAERS system is, by its nature, unconfirmed. Ultimately, any concerning report needs to be verified and undergo further study.
Before one can even search through VAERS data, it’s necessary to click past a number of disclaimers, including one that reads: “Reports may include incomplete, inaccurate, coincidental and unverified information,” and another that says, plainly, “The number of reports alone cannot be interpreted or used to reach conclusions about the existence, severity, frequency, or rates of problems associated with vaccines.
But there is now a webpage called the OpenVAERS Project, which “allows browsing and searching of the reports without the need to compose an advanced search,” through the official VAERS website. The OpenVAERS Project has a dedicated page to the COVID-19 vaccines.
According to a Facebook post from February 2020, OpenVAERS appears to be the project of a website called The Arkivist, which describes itself as a source for "uncensored voices and medical freedom news." By creating a site that allows users to easily search through and highlight these reports, its designers bypass the explanations that this is a passive reporting system, as well as other details that OpenVAERS apparently considers unimportant.
"I turned my attention to asking what did most want out of VAERS and how would it be best delivered," a designer writing on the OpenVAERS Project explains on its "About the Data" page. “I decided what many want is to read the story that accompanies each record without getting super complicated in their queries. They wanted to answer relatively simple questions about how many died? How many had what my kid had? I set out to build a friendly interface for people to do that."
The OpenVAERS Project is “misinformation 101,” Koltai said. “It's decontextualization. I literally show examples like that in classes that I teach. You take a bit of information and you remove all the other context from it. That's common with almost any misinformation you can see.”
The types of “injuries" and adverse effects attributed to vaccines in the VAERS database are often a tip-off that not all the information is solid. There can also be a misunderstanding of what constitutes an “adverse event” in VAERS. Koltai said she’s seen statistics floating around that 80% of people are having an adverse reaction to a vaccine, "according to VAERS."
But those reactions could include anything from unconfirmed reports of minor side effects, like arm soreness, to events that likely are not caused by the vaccine. Adverse events in the database for the COVID vaccines currently include a traffic accident, a gunshot wound, illiteracy, a decreased “frustration tolerance,” and, counterintuitively, a negative chlamydia test.
For the people who know what they’re doing, VAERS serves an important function. Scientists, public health experts, and the government often use it to try to find out if a vaccine is having an unexpected or undesirable side effect. But even there, VAERS is the beginning, not the end.
“The best thing you can say about VAERS is that it’s a hypothesis-generating mechanism,” said Paul Offit, who besides being an attending physician at CHOP has also written several books about vaccine safety and is a co-inventor of a vaccine against the rotavirus. It was VAERS, in fact, that helped demonstrate that a previous rotavirus vaccine, Rotashield, which was approved for use in August 1998, was causing intestinal blockages.
“There were a number of VAERS reports that patients within a week developed an intestinal blockage,” after getting the shot, Offit said. “A study was done and it was shown to be a causal association. VAERS was the tipoff. There’s value in it.” (Rotashield was taken off the market in 1999 and is no longer available in the United States.)
VAERS reports alone didn’t prove that the vaccine caused intestinal blockages. This conclusion was drawn “in conjunction with state and local health departments, to implement a case-control study and case-series analysis and a retrospective cohort study,” Medscape wrote at the time.
“You can’t possibly say whether the vaccine caused the problem from VAERS on its own,” Offit said.
Even before COVID-19, VAERS misuse has been an issue. In fact, the misinformation began virtually the moment the program was created.
“It was immediate,” said Offit. “They said, 'Look, here are all these awful things happening after you get a vaccine,' not distinguishing between temporal and causal.”
Ironically, VAERS actually exists in part because of anti-vaccine campaigners. Barabara Loe Fisher of the anti-vaccine National Vaccine Information Center, was, Offit said, a driving force behind the creation of the 1986 National Childhood Vaccine Injury Act, which created both the VAERS database as well as a no-fault vaccine court system set up to compensate people who can convincingly show they or their children may have been injured by a vaccine. (In truth, the vaccine court system often awards plaintiffs even if the connection between the vaccine and their injury is not bulletproof.)
But once the system was created, it was quickly used to spread misinformation, and that’s never really slowed down, said Dorit Reiss; she’s a law professor at UC Hastings who frequently writes about vaccine policy issues. That includes the MMR vaccine, Gardasil (for HPV), and flu shots. “Any vaccine, any time,” Reiss said. “It’s just equal opportunity for them.”
There's been an uptick in VAERS submissions recently: There were 9645 reports in VAERS in December 2020 compared to 3454 in December 2019. January showed a more modest increase: There were 2162 reports from January 1 to January 22 this year, and 2058 over the same time span last year. In the past, an increase in VAERS reports has been associated with external factors. 75% of autism reports from 1990 to 2001 were submitted soon after the infamous—and repeatedly discredited and retracted—Wakefield study, one of the cornerstone events in creating the modern anti-vaccine movement. One study found that when a vaccine adverse event is being litigated, the number of reports for that adverse event increased in VAERS.
Even people who are sincerely trying to use VAERS to understand vaccine risks might run into trouble. For one thing, as Reiss points out, it’s largely confusing for lay people, not scientists and researchers. It might seem that the simplest answer is to prevent people who are not clinicians or researchers from submitting reports. But both she and Offit think it’s important that civilians should be able to continue using the system.
“Everybody should be able to submit a report,” Offit said. “There may be an unusual side effect that was unanticipated and it doesn’t matter to me who reports it.”
“We want to keep VAERS easy to use,” Reiss concurred. "So we don’t want to put too many requirements on it before people submit. But it might be worth it to have a primary verification system that can color code non-serious reports or not put out public reports that are clearly not credible.”
Ultimately, the way people use, and misuse, VAERS reveals a continued confusion between correlation and causation. For example, Koltai said she received the Gardasil vaccine when she was 18. Two years later, she got diagnosed with cervical cancer. She could, as a patient, file a report into VAERS that she got the very type of cancer Gardasil was supposed to protect against. Actually, Koltai found that the type of cancer she had wasn’t related to a viral infection.
“But an anti-vaccine community could say, 'Look here is proof from the CDC website that there are people who develop cervical cancer after getting supposedly a vaccine that prevents cervical cancer," Koltai said. "That's a perfect example of how I can be in good faith putting in something into VAERS, but in reality, there wasn't a relationship.”
One study that looked at a random sampling of VAERS reports to see how many of the adverse events could be causally linked to a vaccine found that just 3% percent of the cases were “definitely” caused by a vaccine, and that it was “probable” in less than 25% percent.
Even among public officials, there can be a misunderstanding of exactly what VAERS is and how it works. As Politifact reported in 2017, Bill Zedler, who was a Republican member of the Texas House of Representatives, had a disagreement with a physician about VAERS during a discussion of Texas laws affecting vaccinations.
Lindy McGee from Texas Children’s Hospital was responding to Zedler’s assertion that more people had died from the measles vaccination than from measles, explaining that death reports in VAERS didn’t mean that the vaccine caused those deaths. “People report to that system what they’ve seen,” she said. “So I can report if I get hit by a truck after I’ve gotten a vaccine and that would be reported as associated with a vaccine. It does not make any implication of causality. That’s just the way it is."
Zedler, who is a retired medical consultant, pushed back: “So they put on there and they say, oh, just any death, and we don’t have to prove causality?"
"Yes. It’s not a system to prove causality,” McGee replied. “It’s a system to track data and then the physicians or researchers at the CDC go and determine causality after that. It is not a system that could determine causality, it’s not."
Zedler responded, ”For you to get up and tell this committee that in essence they can put anything down there they want is quite dishonest." After more back and forth McGee said, "I welcome committee members to look up the system."
David Gorski, a surgical oncologist and researcher at Wayne State University and someone who writes frequently about medical misinformation, has called VAERS a “canary in the coalmine”—something that can provide an early warning. That was the case with the Rotashield vaccine and intestinal blockage: It served to set off the alarm bells needed for more serious study.
“For VAERS to work, we don't actually need to see every single little side effect,” said Risa Hoshino, a pediatrician in New York City. “We just really need people to submit the serious ones.” Hoshino said there’s nothing wrong with reporting minor symptoms, and she often does as a doctor—even when she’s unsure if a vaccine really caused those symptoms. “I submitted it because I wanted to do the right thing,” she said. But by doing so, it’s important not to over-interpret what the reports mean.
“I wouldn’t listen to anyone who says, ‘According to VAERS…’ or ‘VAERS shows the vaccine causes this specific side effect,’ because they don’t understand how VAERS works,” Hoshino said.
Koltai agreed that VAERS shouldn't be removed from public view or access, but thinks that more transparency could help people interpret what they’re seeing. Text within a report could indicate that an event is currently under investigation, and then results of those investigations could be posted explaining why an event is or isn’t related to a vaccine.
“VAERS was devised ultimately to be a reporting system, to flag as a potential signal that there might be an issue with the vaccine,” Koltai said. “Then the CDC can go investigate. What is happening now is that it's being used as evidence towards something else it's not." (VAERS administrators and the CDC didn’t respond to a request for comment by publication time about the ways the system is used and misused.)
Dorit Reiss, the UC Hastings law professor, thinks the best way to counter VAERS-based misinformation is to, as she puts it, “pre-bunk” the public. “We need to be more vocal about warning the public about these issues.” The level of misinformation around COVID vaccines was to be expected, she adds, “But I’m still concerned. Right now, people are vulnerable and looking for information. I’m worried this could be a gateway, and that people nervous about the COVID vaccine could be pulled into the anti-vax world for other vaccines as well.”