The Register Citizen (Torrington, CT)
What reporting system shows about COVID vaccine reactions in CT
Of nearly 39,000 adverse reactions to COVID-19 vaccines reported in Connecticut, the most common is headache, according to the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System.
VAERS allows both doctors and patients to submit reactions, called “adverse events,” related to vaccines.
In Connecticut, there have been a total of 38,915 such reactions to COVID-19 vaccines submitted.
“When I went to sleep, it was like a ton of bricks,” one report says. Another reports vertigo, teeth chattering, headache, chills, tiredness and a “little wearied feeling.” One patient reported, “I feel weird, kind of spacey; metallic taste.”
Searching through the data reveals reports of “bumps in perimeter of my tongue,” multiple cases of sore arms, vision in the right eye becoming “blurry” with "bolts of color,” and thousands of other reactions.
There are 314 reports of “feeling abnormal,” 262 cases of diarrhea, 250 reports of malaise, 228 cases of tinnitus, 57 cases of “seizure” and many others.
VAERS reports consist of 8,565 individual types of events, though many are similar. For example, there are 1,216 reports of “pain,” 1,002 reports of “pain in extremity” and 514 reports of “injection site pain.”
“Somebody entered that they got vaccinated against COVID and it turned their patient into the Incredible Hulk,” said Rick Martinello, head of infectious disease at Yale New Haven Health. “My understanding is, that is in the data set now.”
The public nature of the reporting system means the data “needs to be interpreted with a grain of salt,” said Asha Shah, director of infectious disease at Stamford Health. “VAERS is an open forum.”
Another issue is causation. A patient may fall down after being vaccinated, but there may not be a relationship between the two events.
That’s probably the case with the 11 reports of spontaneous abortion, Martinello said.
“It's important to know that spontaneous abortions are incredibly common,” he said. “And, actually, this has been formally studied, and they've found no greater risk for spontaneous abortions among vaccine recipients versus nonrecipients. No significant difference.”
Shah also said the “denominator” is important. She said there have been over 5.5 million individual vaccine doses administered in Connecticut. According to the VAERS data, there have been 35 reports of myocarditis, and “35 over 5.5 million is a really small percentage,” she said.
“There are over 85,000 people we’ve vaccinated in our sites, there have been no immediate reactions,” she said. “Side effects happen, adverse events happen. That’s the case with any treatment. Nothing is risk free, but I think it’s clear that the benefits outweigh the risk.”
Colleen Teevan, as clinical pharmacy program manager, is responsible for entering all the adverse events reported to vaccine providers at Hartford HealthCare. She said the number of adverse events “waxes and wanes.”
“As new age groups get approved, or new boosters get approved, they tend to go up because we're just vaccinating more people,” she said. “In total, what we've had reported to us, since we started giving vaccines, has been 750 events total. And we've given over 500,000 vaccines.”
Teevan acts as a sort of clearinghouse for that data, using judgment about which events she reports.
“Anything that lands a patient in the hospital or in the emergency room, I tend to report those,” she said. “Whereas, things that are expected from the vaccines like, the next day people sometimes will have aches or fevers or chills, those I don't report because we have just a lot of those reports.”
There are those reactions that concern Teevan, such as reports of high blood pressure and faster heart rates, though she said, “a lot of times, those end up being associated with other underlying conditions the patient has.”
“Because the vaccines are all very new and we're still gathering data about them, anything that is significant like that, or seems strange and can't be attributed to something else, those ones I do report them just in case,” she said.
Despite the fact that VAERS data is not vetted, Martinello said it has some value.
“What Health and Human Services does is, they are constantly just looking at that data set to see if there's any concerning signals about issues,” he said. “Especially if there's something put in like a death, they will put more resources into investigating.”
The Johnson & Johnson vaccine pause earlier this year was the result of reports in the VAERS data, which showed six cases of a rare and severe type of blood clot.
“Using statistics, they can actually identify hypotheses from this, that then they can more formally look at,” Martienllo said. “So, it's a hypothesis-generating data set and not one that should be used to draw conclusions.”
Shah said it’s “useful data, but it needs to be interpreted carefully.”
While she said, “it’s nice to have a national monitoring system,” Shah does not use VAERS data to make medical decisions.
“I tend to use clinical trial data, stuff that is more peer reviewed, to guide any reaction or clinical guidance,” she said.