List of vaccine injuries is not what it seems, public officials warn

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