Public health experts are concerned that unverified reports to a federal vaccine injury database are being misunderstood by the public and exploited by skeptics in a way that is undermining immunization efforts against COVID-19.
The raw data can be startling because the Vaccine Adverse Event Reporting System (VAERS) contains 299 reports of Minnesotans dying after COVID-19 vaccination, but most of the claims turn out to be coincidences or unrelated to the shots, said Dr. Gregory Poland, director of Mayo Clinic’s Vaccine Research Group.
“I will guarantee you there are not 299 Minnesotans who died as a result of COVID vaccine,” he said.
Health officials are pressing unvaccinated people to seek shots amid a worsening pandemic wave that is clogging hospital beds in Minnesota, but the remaining holdouts have been difficult to persuade and list safety fears as their top concerns. Some risk losing jobs in defiance of employer mandates while others face choices now that their children ages 5-11 are eligible for pediatric doses.
VAERS was designed as an early-warning system to amass enough reports from vaccine manufacturers, doctors and even patients to spot clusters of even the rarest side effects, but the reports themselves are not proof of cause and effect.
The COVID-19 vaccines are the most watched pharmaceuticals in medical history, with the database being part of the federal oversight that includes monitoring by the Defense and Veterans Affairs departments of their recipients. Locally, Mayo Clinic is tracking outcomes in thousands of its patients while Bloomington-based HealthPartners is part of a surveillance network of seven health systems that is monitoring 3% of the U.S. patient population.
The oversight has found rare side effects, including blood clots with the Johnson & Johnson vaccine, particularly in younger women, and a form of heart muscle inflammation called myocarditis with the other COVID-19 vaccines, particularly in younger men. Immediate anaphylactic allergic reactions have been found in two to five COVID-19 vaccine recipients per million, which is why people wait 15 minutes after receiving shots in pharmacies and clinics.
However, none of these confirmed incidents has tipped the scales against U.S. vaccine recommendations, with the risk of myocarditis being higher from contracting COVID-19 than from the shots.
HealthPartners and the Vaccine Safety Datalink group showed in October that non-COVID deaths were lower in vaccinated people than unvaccinated people, which is the opposite of what would be expected if the vaccines presented lethal threats.
“If … the risks of getting the disease far outweigh any risks that you might get from the vaccination, then get the vaccination,” said Dr. Sheldon Berkowitz, president of the Minnesota Chapter of American Academy of Pediatrics. “That’s what you want to do.”
Even if most injuries in the VAERS database weren’t caused by the vaccine, the total weighs on people such as Elizabeth Hedlund of Owatonna, whose family hasn’t been vaccinated against COVID-19. Hedlund is waiting for more safety data but has concerns about vaccines in general because her 11-year-old son suffered a prolonged illness years ago after a measles shot.
“It doesn’t absolutely mean there are that many adverse effects,” said Hedlund, 47, a physician assistant at an urgent care clinic. “The way I take it, though, is if there are that many reports — and that’s a lot — then somebody needs to look into that.”
Dr. Nadia Maccabee-Ryaboy had the opposite reaction. The Children’s Minnesota physician didn’t hesitate to get her two youngest children vaccinated last weekend at their school, which held a pajama day the following Monday in case students felt mild post-vaccine symptoms.
“It definitely changes my perception to see kids suffering from something that is potentially preventable,” said Maccabee-Ryaboy, who treats pediatric COVID-19 patients daily but has encountered two patients who may have had vaccine reactions.
“I appreciate that there is a database, a system, set up to monitor for side effects,” she added. “To me, it’s reassuring.”
CDC researchers review some reports, especially those indicating outcomes that are fatal, severe or associated with other vaccines such as Guillain-Barré syndrome — an immune disorder that can cause muscle weakness or paralysis.
Proving that any shot caused an injury is difficult, so researchers instead monitor broad injury trends and whether they exceed “background rates” in society, said Dr. Elyse Kharbanda, a researcher with HealthPartners and the Vaccine Safety Datalink group.
“The real goal is … to see if something is occurring beyond what would be expected by chance alone,” she said.
The VAERS database contains 12,861 claims of Minnesotans injured after COVID-19 vaccination, which equates to 0.3% of the state’s 3.7 million vaccine recipients.
Among the claims, 60% listed mild symptoms, such as arm soreness or fever, and no medical attention. Twelve percent involved hospitalizations, and nearly 2% cited permanent disabilities. Most cited symptoms within two days of shots.
The median age of Minnesotans in all reports was 59 but increased to 82 for claims about deaths. Some involved people who already had critical illnesses while others were reported by doctors who had no explainable causes for their patients’ deaths. Some reports were redundantly filed about the same injuries.
Kate Zerby, a St. Paul educator for deaf students, had health problems after COVID-19 vaccination that are detailed in five VAERS reports. Public versions don’t contain names, but she provided a copy of her claim and verified others filed by doctors who suspect the vaccine.
Zerby, 59, was excited Feb. 16 to get her first shot, but she awoke that night in a panic with joint pain. She later experienced severe ringing in her ears and was diagnosed with atrial fibrillation, an irregular heart rhythm, that hadn’t been identified before vaccination.
Her concern with VAERS is that researchers are searching it for common and suspected vaccine injuries, when people may be having a systemic reaction to the shot that is masked by their uncommon symptom combinations.
“There are a lot of people that have to make important decisions for themselves and their kids,” she said. “The question is, are we really chasing this data?”
Zerby received written permission from her doctor to skip her second COVID-19 vaccine dose to satisfy a workplace mandate. A federal review said “a causal relationship cannot be excluded” between the vaccine and her injury but that more information was needed.
Lynn Bahta, a vaccine expert with the Minnesota Department of Health, said she never disagrees with people who believe they were injured by vaccines because it’s difficult to know and more important to empathize and connect them with medical care. Federal benefits are available, as well, through the Countermeasures Injury Compensation Program even if people can’t prove COVID-19 vaccines injured them.
Serious side effects occur, but reviews disprove VAERS claims when people naturally but incorrectly associate injuries with recent events, said Bahta, who serves on the federal Advisory Committee on Immunization Practices. “If we get the stomach flu, we will never again eat whatever we had the night before because we’re sure that’s what caused it. When probably it’s something we ate before.”
Poland said he was among the first to report potential myocarditis risks with anthrax vaccine years ago, but over time, many reports in VAERS were disproved. A federal study of VAERS death claims from 1997 to 2013 similarly found no pattern of vaccination risks and that many of the deaths were from common causes and occurred at expected rates.
“In the U.S., roughly 10,000 people a day die,” Poland said. “By chance alone, thousands of those are going to die within X number of hours or days of getting a COVID vaccine. Does that mean it caused it? No more than the many thousands of people who get in a car accident today. Did the vaccine cause their accident?”
Jeremy Olson • 612-673-7744