Increasing numbers of people are claiming to have suffered lasting side effects from Covid-19 jabs, yet they – and various experts, including medical professionals – believe not enough is being done to scrutinise this or expand research into the problem.
Within minutes of getting the Johnson & Johnson Covid-19 vaccine, Michelle Zimmerman felt pain racing from her left arm up to her ear and down to her fingertips. Within days, she was unbearably sensitive to light and struggled to remember simple facts.
She was 37, with a PhD in neuroscience, and until then could ride her bicycle 30km, teach a dance class and give a lecture on artificial intelligence, all in the same day. Now, more than three years later, she lives with her parents. Eventually diagnosed with brain damage, she cannot work, drive or even stand for long periods. She believes her injury is due to a contaminated vaccine batch.
The Covid vaccines, a triumph of science and public health, are estimated to have prevented millions of hospitalisations and deaths, reports The New York Times.
Yet even the best vaccines produce rare but serious side effects. And the Covid vaccines have been given to more than 270m people in the United States alone, in nearly 677m doses.
As of April, just more than 13 000 vaccine-injury compensation claims have been filed with the US Government – but only 19% have been reviewed. Just 47 of those were eligible for compensation. Only 12 have been paid out (an average of about $3 600).
Some scientists fear patients with real injuries are being denied help and that more needs to be done to clarify the possible risks.
Federal health officials insist that serious side effects were extremely rare and that their surveillance efforts were more than sufficient to detect patterns of adverse events, but Dr Janet Woodcock, a long-time leader of the US Food and Drug Administration, who recently retired, said she believed some recipients had experienced uncommon but “serious” and “life-changing” reactions beyond those described by authorities.
Battle to ID side effects
Officials and independent scientists face numerous challenges in identifying potential vaccine side effects.
The nation’s fragmented healthcare system complicates detection of very rare side effects, a process that depends on an analysis of huge amounts of data. There is no central repository of vaccine recipients, nor of medical records, and no easy to way to pool these data. Reports to the largest federal database of so-called adverse events can be made by anyone, about anything.
The government’s understaffed compensation fund has paid so little because it officially recognises few side effects for Covid vaccines. And vaccine supporters, including officials, worry that even a whisper of possible side effects feeds into misinformation spread by a vitriolic anti-vaccine movement.
Shaun Barcavage (54), a nurse in New York City who has worked on clinical trials for HIV and Covid, said that ever since his first Covid shot, merely standing up sent his heart racing – a symptom suggestive of postural orthostatic tachycardia syndrome, a neurological disorder some studies have linked to both Covid and, less often, vaccination.
He also experienced stinging pain in his eyes, mouth and genitals, which has abated, and tinnitus, which has not.
“I can’t get the government to help me,” Barcavage said. “I am told I’m not real…that I’m rare… I’m coincidence.”
Renee France (49), a physical therapist in Seattle, developed Bell’s palsy and a dramatic rash that neatly bisected her face. Bell’s palsy is a known side effect of other vaccines, and has been linked to Covid vaccination in some studies.
But France said doctors were dismissive of any connection to the Covid vaccines. The rash, a bout of shingles, debilitated her for three weeks, so she reported it to federal databases twice.
“No one ever contacted me,” she said.
Similar sentiments were echoed in interviews with 30 people who said they had been harmed by Covid shots. They described various symptoms after vaccination, some neurological, some autoimmune, some cardiovascular.
All had been turned away by physicians, told their symptoms were psychosomatic, or labelled anti-vaccine – despite the fact that they supported vaccines.
Even leading experts in vaccine science have run up against disbelief and ambivalence.
Dr Gregory Poland (68) editor in chief of the journal Vaccine, said a loud whooshing sound in his ears had accompanied every moment since his first shot, but his appeals to colleagues at the US Centres for Disease Control and Prevention to explore the phenomenon, tinnitus, were unsuccessful.
Dr Buddy Creech (50) who led several Covid vaccine trials at Vanderbilt University, said his tinnitus and racing heart lasted about a week after each shot. “It’s similar to what I experienced during acute Covid, in March 2020,” he said.
Research may ultimately find that most reported side effects are unrelated to the vaccine, he acknowledged. Many can be caused by Covid itself.
“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,” Creech said.
Health officials say they do not believe the Covid vaccines caused the illnesses described by patients like Barcavage, Zimmerman and France. The jab may cause transient reactions, like swelling, fatigue and fever, said the CDC, but it has documented only four serious but rare side effects.
Two are associated with the J&J vaccine, which is no longer available in the US: Guillain-Barré syndrome, a known side effect of other vaccines, including the flu shot; and a blood-clotting disorder.
The CDC also links mRNA vaccines made by Pfizer-BioNTech and Moderna to heart inflammation, or myocarditis, especially in boys and young men. And the agency warns of anaphylaxis, or severe allergic reaction, which can occur after any vaccination.
Listening for signals
Agency scientists are monitoring large databases containing medical information on millions of Americans for patterns that might suggest a hitherto unknown side effect of vaccination, said Dr Demetre Daskalakis, director of the CDC’s National Centre for Immunisation and Respiratory Diseases.
“We report the signals we think are real … as soon as we identify them as signals,” he said. The agency’s systems for monitoring vaccine safety are “pretty close” to ideal.
National surveillance efforts include the Vaccine Adverse Event Reporting System (VAERS). It is the largest database, but also the least reliable: reports of side effects can be submitted by anyone and are not vetted, so may be subject to bias or manipulation.
The system contains roughly 1m reports regarding Covid vaccination, mostly for mild events, said the CDC.
Researchers also comb through databases combining electronic health records and insurance claims on tens of millions of Americans, monitoring the data for 23 conditions that may occur after Covid vaccination.
But there are gaps. The Covid shots administered at mass vaccination sites were not recorded in insurance claims databases, for example, and medical records in the US are not centralised.
An expert panel convened by the National Academies concluded in April that for most side effects, there were not enough data to accept or reject a link.
In Hong Kong, the government analysed centralised medical records of patients after vaccination and paid people to come forward with problems. The strategy identified “mild cases that other countries would not otherwise detect”, said Ian Wong, a researcher at the University of Hong Kong who led the nation’s vaccine safety efforts.
That included the finding that in rare instances – about seven per million doses – the Pfizer-BioNTech vaccine triggered a bout of shingles serious enough to require hospitalisation.
The European Medicines Agency has linked the Pfizer and Moderna vaccines to facial paralysis, tingling sensations and numbness. The EMA also counts tinnitus as a side effect of the J&J vaccine, although American health agencies do not. There are more than 17 000 reports of tinnitus after Covid vaccination in VAERS.
Are the two linked? It’s unclear. As many as one in four adults has some form of tinnitus. Stress, anxiety, grief and ageing can trigger the condition, as can infections like Covid itself, and flu.
There is no test or scan for tinnitus, and scientists cannot easily study it.
Still, an analysis of health records from nearly 2.6m Americans found that about 0.04%, or about 1 000, were diagnosed with tinnitus within three weeks of an mRNA shot.
But “…available evidence does not suggest a causal association with the Covid-19 vaccines”, the FDA said.
Despite surveillance efforts, US officials were not the first to identify a significant Covid vaccine side effect: myocarditis in young people receiving mRNA vaccines.
Israeli authorities first raised the alarm in April 2021. US officials said at the time they had not seen a link.
On 22 May 2021, news broke that the CDC was investigating “relatively few” cases of myocarditis. By 23 June, the number of reports had risen to more than 1 200.
Later analyses showed that the risk for myocarditis and pericarditis, a related condition, is highest after a second dose of an mRNA Covid vaccine in males aged 12 to 17.
In many people, vaccine-related myocarditis is transient. But some patients continue to experience pain, breathlessness and depression. Some show persistent changes on heart scans.
The CDC says there were no confirmed deaths related to myocarditis, but in fact there have been several accounts of deaths reported post-vaccination.
The rise of the anti-vaccine movement has made it difficult for scientists to candidly address potential side effects, some experts said. Much of the narrative on the purported dangers of Covid vaccines is patently false, or at least exaggerated, cooked up by savvy anti-vaccine campaigns.
“The sheer nature and scale of misinformation … is staggering, and anything will be twisted to make it seem as if it’s not just a devastating side effect but proof of a massive cover-up,” said Dr Joshua Sharfstein, a vice dean at Johns Hopkins University.
Among the hundreds of millions of Americans immunised for Covid, some number would have had heart attacks or strokes anyway. Some women would have miscarried.
How to distinguish those caused by the vaccine from those that are coincidences? The only way to resolve the question is intense research.
But the National Institutes of Health is conducting virtually no studies on Covid vaccine safety.
William Murphy, a cancer researcher who worked at the NIH for 12 years, has been prodding health officials to initiate these studies since 2021.
“They responded with that tired mantra that ‘the virus is worse’,” Murphy recalled. “Maybe so, but that doesn’t obviate doing research to eliminate other options.”
A deeper understanding of possible side effects, and who is at risk, could have implications for the design of future vaccines, or indicate that for some young and healthy people, the benefit of Covid shots may no longer outweigh the risks – as some European countries have determined.
See more from MedicalBrief archives:
Covid jabs saved 2.4m lives in first eight months – US study
Man claims R31m for Covid-19 jab ‘paralysis’
AstraZeneca sued over jab side effects
One year on, still no answers for man’s GBS death after J&J vaccine
Covid jab study of 99m people links shots to rare risk of disorders
Higher myocarditis risk in young males after mRNA jabs – Nordic cohort study of 23m