What’s inside Colorado’s vaccine safety data? Problem Solvers analyze reported side effects

Problem Solvers

DENVER (KDVR) – The country’s Vaccine Adverse Event Reporting System (VAERS), a side effect-monitoring database managed by the Centers for Disease Control and Prevention and the Food and Drug Administration, has received nearly 300 reports of adverse vaccine reactions from Colorado patients and healthcare providers since the COVID19 vaccine distribution began in Colorado.

“These are reports of individuals who get a vaccine and then at some time after the vaccine have an adverse health event,” said Tom Shimabukuro, the deputy director for the CDC’s immunization safety office. “Some of these reports might be true, adverse reactions that are caused by the vaccine,  and some of these reports are coincidental health events that are not related to the vaccine at all.”

Shimabukuro said VAERS allows anyone to submit reports of adverse reactions. Analysts review the data without making a judgment on whether the vaccine caused the side effect and without making judgments on the seriousness of the health event. “We accept them all, and they’ll all get analyzed,” he said.

In Colorado, where more than 539,590 people have received at least one COVID-19 vaccine dose, the Problem Solvers found common reports of body aches, dizziness, and fevers. Others reported tingling, diarrhea, and fatigue. There were a total of 281 Colorado reports filed with VAERS as of Monday morning.

Shimabukuro said many of the reports VAERS has received so far are common, adverse reactions that are expected.

“Some of these reactions – like sore arms and headache and fatigue and muscle aches and chills – are actually a sign that the vaccine is working, that the immune system is doing its job in responding to the vaccine, and although they may be unpleasant, I think people should take comfort in knowing that that’s the way vaccines work,” said Shimabukuro.

Shimabukuro said VAERS is one part of “the most intense vaccine safety monitoring program in the history of the United States.” He said there are multiple, complementary systems in place to rapidly detect any potential safety problems that may occur with the COVID-19 vaccines being distributed nationwide.

“We depend on healthcare providers and patients and parents and caregivers and others to send reports of adverse events following immunization to CDC to our VAERS system,” he said.

“If we detect any unusual or unexpected patterns, which might be indicative of a potential safety problem, we can go in, and we can further investigate those reports, and if necessary, we can go to other, more robust data systems to do further analysis and refined analysis of these potential safety concerns.”

Women are most often reporting vaccine side effects to tracking system, according to Colorado data analyzed by the FOX31 Problem Solvers. Of the 281 reports in the system as of Monday morning, 231 were from women.

“Healthcare workers were one of the first priority groups targeted for vaccination,” said Shimabukuro. “The healthcare workforce in the United States is overwhelmingly female, so there have been more doses of vaccine administered to females just in general.”

According to the state’s COVID-19 vaccine data dashboard, 61% of vaccine recipients in Colorado have been female. 

Shimabukuro said historically, more females tend to report to the VAERS, which also tracks many different vaccines.

Dr. Vandna Jerath, an obstetrician-gynecologist at Optima Women’s Health Care, said she eventually reported her side effects to the CDC through a separate tracking system, V-Safe.

However, her symptoms – including lip tingling, aches, and a flushed feeling – were typical, she said. 

“It means the vaccine is working. It means that my body is creating antibodies, so I was actually reassured by that,” she said. “I believe in the vaccine and want to advocate for it for others as well,” she said, explaining that she felt like she had a 72-hour flu after receiving her second COVID-19 dose.

Brian Stuart, a registered emergency nurse at Denver Health said his mild reactions to his second dose were minor compared to the devastating effects he sees COVID-19 having on some patients.

“About 12 hours into the vaccine, I had minor body aches, and I had a headache. And that lasted about 12 hours,” he said. “The effects of what I’ve seen COVID do to people is far, far worse than the side effects from the vaccine, if you get any at all.”

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