'I am told I'm not real.'

The COVID-19 vaccines are estimated to have prevented millions of hospitalizations and deaths. However, even the best vaccines can lead to rare but serious side effects, which doesn't negate the vaccines' benefit or suggest people should stop taking them, Mandavilli reports.

Nearly 667 million doses of COVID-19 vaccines have been doled out. Now, some Americans believe their serious conditions are a result of their vaccinations, but feel they aren't receiving much support or acknowledgement.

Michelle Zimmerman, 37, said that within minutes of receiving her COVID-19 vaccine from Johnson & Johnson (J&J), she felt pain racing up her left arm to her left ear and down her fingertips. Days later, she was extremely sensitive to light and had difficulty remembering simple facts.

Zimmerman has a Ph.D. in neuroscience and, until then, was able to ride her bicycle 20 miles, teach a dance class, and give a lecture on artificial intelligence all in one day. Now, over three years later, she lives with her parents and has been diagnosed with brain damage, unable to work, drive, or stand for long periods of time.

Shaun Barcavage is a 54-year-old nurse practitioner in New York City who worked on clinical trials for HIV and COVID-19. He said ever since his first COVID-19 shot, standing up caused his heart to race, a symptom that suggests postural orthostatic tachycardia syndrome — a neurological disorder linked to both COVID-19 and, less often, vaccination in some studies.

He's also experienced stinging pain in his eyes, mouth, and genitals, which has gone away, as well as tinnitus, which is still around.

"I can't get the government to help me," Barcavage said. "I am told I'm not real. I'm told I'm rare. I'm told I'm coincidence."

Renee France, a 49-year-old physical therapist in Seattle, developed a form of facial paralysis called Bell's palsy as well as a dramatic rash across her face. Bell's palsy is a known side effect of some vaccines and has been linked to COVID-19 vaccines in other studies, Mandavilli reports.

France said that doctors were dismissive of any potential connection between her conditions and COVID-19 vaccines. The rash, which ended up being a bout of shingles, debilitated France for three weeks, so she reported it to federal databases twice.

"I thought for sure someone would reach out, but no one ever did," she said.

Gregory Poland, the editor in chief of the journal Vaccine, said a loud whooshing sound in his ears accompanied every movement since he received his first shot, but his appeals to colleagues at CDC to explore his tinnitus haven't led anywhere.

He received polite email responses, but "I just don't get any sense of movement," he said, adding "If they have done studies, those studies should be published."

Similarly, Buddy Creech, who led multiple COVID-19 vaccine trials at Vanderbilt University, said he experienced tinnitus and a racing heart for around a week after each COVID-19 shot. "It's very similar to what I experienced during acute Covid, back in March of 2020," he said.

It's possible research may find most reported side effects are unrelated to the vaccine, Creech said. "Regardless, when our patients experience a side effect that may or may not be related to the vaccine, we owe it to them to investigate that as completely as we can," he said.

The known side effects of COVID-19 vaccines

Federal health officials say they don't believe COVID-19 vaccines caused the illnesses described by patients like Barcavage, Zimmerman, and France, Mandavilli reports. It's possible the vaccines could cause reactions like swelling, fatigue, and fever, according to CDC, but the agency has only documented four serious but rare side effects.

Two of those side effects are associated with the J&J vaccine, which isn't available in the United States anymore — Guillain-Barré syndrome, which is a known side effect of other vaccines, and a blood-clotting disorder.

CDC has linked mRNA vaccines made by Pfizer-BioNTech and Moderna to heart inflammation, or myocarditis, especially in boys and young men. CDC has also warned of anaphylaxis, which could occur after any vaccination.

Other country's health systems have linked other side effects to COVID-19 vaccines.

For example, the government in Hong Kong analyzed centralized medical records of patients after vaccination and paid people to come forward with any problems. This identified "a lot of mild cases that other countries would not otherwise pick up," said Ian Wong, a researcher at the University of Hong Kong.

That includes finding that in rare instances, the Pfizer-BioNTech vaccine led to a bout of shingles serious enough to require hospitalization.

Meanwhile, the European Medicines Agency (EMA) has linked both the Pfizer and Moderna vaccines to facial paralysis, tingling sensations, and numbness. EMA also considers tinnitus a side effect of the J&J vaccine, though American health agencies don't.

Why tracking COVID-19 vaccine side effects can be difficult

While many Americans have claimed they've experienced serious side effects of the COVID-19 vaccines, as of April, just 19% of over 13,000 vaccine-injury compensation claims have been reviewed. Of those, only 47 were deemed eligible for compensation, and just 12 paid out at an average of around $3,600.

Some experts worry that patients with real injuries aren't receiving the help they need and believe more needs to be done.

"At least long Covid has been somewhat recognized," said Akiko Iwasaki, an immunologist and vaccine expert at Yale University. However, people who say they have post-vaccination injuries are "just completely ignored and dismissed and gaslighted."

Federal officials have insisted that serious side effects of COVID-19 vaccines are extremely rare and that surveillance efforts are more than sufficient to detect any patterns of adverse events.

"Hundreds of millions of people in the United States have safely received Covid vaccines under the most intense safety monitoring in U.S. history," said Jeff Nesbit, a spokesperson for HHS.

However, former acting FDA Commissioner Janet Woodcock said she believes some recipients of the COVID-19 vaccines had uncommon but "serious" and "life-changing" reactions.

"I feel bad for those people," Woodcock said. "I believe their suffering should be acknowledged, that they have real problems, and they should be taken seriously."

Scientists at CDC are monitoring large databases with medical information on millions of Americans for any patterns that could suggest a currently unknown side effect of vaccination, according to Demetre Daskalakis, director of CDC's National Center for Immunization and Respiratory Diseases.

"We toe the line by reporting the signals that we think are real signals and reporting them as soon as we identify them as signals," he said. CDC's systems for monitoring vaccine safety are "pretty close" to ideal, he added.

Those databases include the Vaccine Adverse Event Reporting System, which is the largest database but also the least reliable, as reports of side effects can be submitted by anyone and aren't vetted, Mandavilli reports.

Researchers also look through databases that combine electronic health records with insurance claims on tens of millions of Americans and monitor the data for 23 conditions that could occur following COVID-19 vaccination.

However, there are some gaps, experts said. For example, the COVID-19 shots administered at mass vaccination sites weren't recorded in insurance claims databases, and medical records in the United States aren't centralized.

"It's harder to see signals when you have so many people and things are happening in different parts of the country, and they're not all collected in the same system," said Rebecca Chandler, a vaccine safety expert at the Coalition for Epidemic Preparedness Innovations.

The fragmented healthcare system in the United States also makes monitoring vaccine side effects difficult, as the process depends on large amounts of data, Mandavilli reports.

For example, there isn't a central repository of vaccine recipients or medical records and no easy way to collect the data.

"I mean, you're not going to find 'brain fog' in the medical record or claims data, and so then you're not going to find" a signal that it could be linked to vaccination, Woodcock said. If that kind of side effect isn't acknowledged by federal officials, "it's because it doesn't have a good research definition," she added. "It isn't, like, malevolence on their part."

The rise of the anti-vaccine movement has also made it difficult for scientists to address potential side effects, some experts said.

"The sheer nature of misinformation, the scale of misinformation, is staggering, and anything will be twisted to make it seem like it's not just a devastating side effect but proof of a massive cover-up," said Joshua Sharfstein, a vice dean at Johns Hopkins University.

Ultimately, the only way to determine what conditions are side effects of COVID-19 vaccines and what are simply coincidences is intense research, Mandavilli reports.

However, NIH is conducting almost no studies on COVID-19 vaccine safety, experts noted. William Murphy, a cancer researcher who worked at NIH for 12 years, has been pushing federal officials to begin these studies since 2021.

The officials responded with "that very tired mantra: 'But the virus is worse,'" Murphy said. "Yes, the virus is worse, but that doesn't obviate doing research to make sure that there may be other options." (Mandavilli, New York Times, 5/3 [1]; Mandavilli, New York Times, 5/3 [2])

Develop a strong COVID-19 vaccine communication strategy that shares information, addresses patient concerns, and encourages uptake.