How Government Data Is Being Misused to Question COVID-19 Vaccine Safety
Unverified reports linking the vaccine to deaths have been circulating on social and mainstream media for months
In April, an Ohio woman in her 50s died after suffering “blunt force injuries from a motorcycle accident,” according to a report of the incident.
No other details about the crash or the woman were mentioned—save for one thing: About a week earlier, she had received her first dose of the Moderna coronavirus vaccine.
For that reason alone, details of the woman’s death were included in an obscure online government database known as VAERS (pronounced “vares”). It’s meant to be a place where anyone—healthcare providers, manufacturers, consumers—can report an adverse event after a vaccine is given. By design, reports are submitted without verification that the harm actually stemmed from the vaccine.
But vaccine opponents and others have been using the database to stoke concerns about the safety of COVID-19 vaccines. In mid-September, for example, when speaking about the number of people who allegedly died from the COVID-19 vaccine, the Fox News host Tucker Carlson said “reports collected by the Biden administration itself indicate that number is actually in the thousands,” an apparent reference to the VAERS database. (A spokesperson for Carlson didn’t respond to a request for comment.)
All vaccines, including those against COVID-19, undergo rigorous clinical trials, in some cases involving tens of thousands of people. But those trials might not involve enough people with a particular risk factor, meaning certain issues might not be noticed by researchers at the earlier stages. Moreover, any vaccine might cause rare side effects that emerge later on.
Launched in 1990, VAERS is used by the CDC and FDA to detect “concerning patterns or unusual and unexpected changes” that might indicate a safety problem once vaccines are on the market, according to a 2015 academic paper published by researchers at both agencies in the journal Vaccine.
“VAERS is important because it can capture events that were not routinely collected in active surveillance in clinical trials, more rare than would have been observed in trials because of limited sample sizes, or occur in populations not adequately studied in clinical trials,” says Steven J. Jacobsen, MD, interim executive director of the Marshfield Clinic Research Institute, a Wisconsin-based medical research institute, and former president of the American College of Epidemiology.
For example, government researchers investigated reports of myocarditis, or inflammation of the heart muscle, that were submitted to VAERS, and then alerted the public when they deemed that risk plausible. The CDC has said it’s continuing to monitor the development.
VAERS reports on their own communicate only that some sort of adverse event, minor or major, happened after someone received a vaccine. Additional work and information are needed to establish whether the vaccine was the cause.
Physicians, epidemiologists, and statisticians at the CDC and FDA assess the number of reports received, what sort of events are reported, and the number of doses distributed. Then they compare the rate an adverse event is reported in VAERS with the rate of the same adverse event with other vaccines.
So while the reports alone generally can’t tie a vaccine to an adverse event, it can play an important role.
“VAERS can often provide the earliest information on potential vaccine safety problems,” the 2015 vaccine paper by CDC and FDA researchers says.
If it does detect potential safety issues, researchers at the CDC and FDA can then investigate further using other systems, such as the CDC’s Vaccine Safety Datalink, which receives more specific data from nine major healthcare organizations and can help measure “attributable risk,” says Emory’s Orenstein.
Unverified and Misused
The website that hosts VAERS is plastered with disclaimers about the data’s limitations. “While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness,” one version of the warning reads.
For example, “It seems quite plausible that a child could have an anaphylactic reaction on the way home from receiving a vaccine as a result of a bee sting,” Jacobsen says. “Because of these and other limitations, it makes it difficult to draw conclusions from studies of VAERS data.”
It’s frustrating to have to deal with these misinterpretations, especially when they interfere in such major ways with critical public health issues like the rollout of COVID-19 vaccines.
And yet unsubstantiated claims are made anyway, and not just about the COVID-19 vaccine. The 2015 vaccine paper discusses articles circulated on the internet that attributed 100 deaths to the measles, mumps, and rubella (MMR) vaccine based on VAERS data.
But many of the deaths involved children with serious preexisting medical conditions or were otherwise unrelated to the vaccine, according to the paper.
The VAERS reports, additional health records, autopsy reports, and death certificates were reviewed by the CDC and FDA, the paper says, “and no concerning patterns emerged that would suggest a causal relationship with MMR vaccination and death.”
The System Can Work
Since its inception, VAERS has successfully identified a number of potential hazards that were found to be connected to a vaccine.
One such case in the late 1990s involved the first vaccine to combat rotavirus, which can cause severe vomiting and diarrhea in infants. According to Orenstein, VAERS reports raised suspicions at the CDC and FDA of a potential link between the vaccine RotaShield to intussusception, a kind of bowel obstruction, within months.
Upon further investigation, Orenstein says, “we decided to stop the use of that vaccine.”
VAERS was also the mechanism that identified a rare event linked to the Johnson & Johnson vaccine for COVID-19.
In April, the CDC and FDA announced they were reviewing six reports of a rare type of blood clotting out of the more than 6.8 million individuals who received the J&J shot in the U.S. The move led to a temporary pause in the distribution of the vaccine as regulators conducted a safety review.
That review ultimately led to the addition of a warning about blood clotting to the vaccine’s safety fact sheet.
The Value of Transparency
But if it’s impossible to draw conclusions from VAERS data without doing further inquiry, why publish it online at all?
Researchers and experts who spoke with CR acknowledged that the data can be and is misused, but argued that total transparency is necessary to earn the public’s trust.
“If [the data] are not publicly available, people will imagine that the government is hiding terrible stuff,” Ellenberg says. “They will not respond well to ‘just trust us, we are reviewing these data and will let you know if we find any problems.’”
Orenstein agrees. “The decision was that it would be better to get it out and then deal with misinterpretation than to hold on to it and then be accused of hiding information,” he says.
The CDC and FDA appreciate any reports received through VAERS, according to the 2015 vaccine paper, “even if the reporter is not sure if a vaccine caused the event.”
“VAERS accepts all reports without rendering judgment on clinical importance or whether vaccine(s) might have caused the adverse event,” the paper says.
But how well the government combats the misinterpretation of VAERS data is an unanswered question.
Ellenberg points out the CDC and FDA already publish “a lot of explanatory material” on VAERS for people to examine before accessing the data. But, she says, “nothing will distract those who believe they or their child were damaged by a vaccine, and it’s that small group that is vocal and gets public attention.”