More than 10,000 Americans have reported tinnitus as a possible side effect of the COVID-19 vaccine, and some question why the FDA and CDC have not scrutinized their claims about hearing loss.
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“It’s a constant treble string,” Robert Edmonds told ABC15 during his July visit to Phoenix for tinnitus-related medical care. Tinnitus is a buzzing or buzzing sound in one or both ears that can be constant or come and go. Often associated with hearing loss.
Edmonds describes the noise as louder than his car stereo. He was a federal official in New Mexico and said he developed tinnitus with facial tingling and headaches shortly after receiving his first COVID-19 vaccination in January. He didn’t connect right away.
“Then I went to the clinic, and the doctor thought he couldn’t find anything wrong with my ears,” Edmonds said. “He tried antibiotics for ear infections.”
Since then, Edmonds said he saw several specials and took a diagnostic test.
“We have ruled out as much as we can, and we’ve probably left the vaccine playing some role in the development of tinnitus,” Edmonds said.
In Seattle, George Fu also had hearing problems after being vaccinated in February.
“The next morning, I noticed that my ears started to feel clogged,” Hu recalls. “It got worse by the second day and I literally didn’t hear anything on the third day.”
George said his hearing had returned after treatment with steroids, but tinnitus remained.
“Everyone is very skeptical in the medical world,” Hu said. “My own family didn’t think it could happen.”
Hu said his son experienced similar hearing loss after vaccination.
Hu, a former Microsoft employee, set up a support group on Facebook, but said he wasn’t vaccinated. In fact, he was one of the computer programmers who created CovidWA.com, a vaccine finder website across Washington.
Dr. Gregory Poland, director of the Mayo Clinic Vaccine Research Group, works daily to dispel the myths about the COVID-19 vaccine. However, he has experienced the relationship between vaccines and tinnitus himself, so he does not intend to downplay it.
“I can’t say with absolute confidence that it was the result of a vaccine,” said Dr. Poland. “It can only be said that it happened an hour and a half after the vaccination.”
CDC, FDA collect tinnitus reports, no change to US vaccine warning
Edmonds, Fu, and Poland are some of the 10,092 people who reported sudden onset or exacerbation of tinnitus in the CDC’s Vaccine Adverse Event Reporting System as of September 3. More than 200 reports are from Arizona.
Tinnitus reports are rare compared to nearly 211 million Americans who received at least one COVID19 vaccine. According to tinnitus reports, 1 in 21,000 vaccinated people.
According to the CDC website, the VAERS report is an important part of vaccine safety, but it cannot be used alone to determine if a vaccine has caused or contributed to an adverse event or illness. According to the CDC, reporting is voluntary and may be incomplete, inaccurate, accidental, or unverifiable.
“Tinnitus is a serious problem,” said Dr. Elizabeth Conick, director of the Infectious Diseases Division at the University of Arizona Medical Center in Tucson. “They haven’t made it up, and it’s very important not to make them feel alienated.”
Some people infected with the COVID-19 virus also reported hearing problems as follows: Recent research Conducted by the University of Manchester. Scientists published in the National Journal of Audiology estimated that 7.6% of people infected with COVID-19 experienced deafness and 14.8% suffered from tinnitus. The study also communicated the urgent need for additional studies.
“We really only have a hypothesis,” said Dr. Poland. “You are probably developing an immunological or inflammatory response targeting sensitive areas of the brain in this case.”
The European Medicines Agency, the FDA equivalent of the European Union, has examined data from both clinical trials and initial vaccine deployments.
In August, the EMA changed its recommendations and the Johnson & Johnson (Janssen) COVID-19 vaccine Add tinnitus to the list of possible side effects. Janssen is Johnson & Johnson’s pharmaceutical division.
Here in the United States, the CDC and FDA are also monitoring data.
While they identify some Rare post-vaccination health problems, The CDC and FDA do not consider tinnitus as a side effect, and authorities say there is no causal link between COVID-19 shots and the condition.
ABC15 investigators also contacted vaccine makers Johnson & Johnson (Janssen), Pfizer, and Moderna. All three pharmaceutical companies are urging people to report possible vaccine-related adverse events.
In addition, Pfizer said there was no evidence that tinnitus was associated with the vaccine.
A spokesperson for Johnson & Johnson also said, “We strongly support raising awareness of the signs and symptoms of rare events so that they can be identified and treated.”
Johnson and Johnson say they are working closely with the FDA to assess the potential for updating the COVID-19 vaccine fact sheet.
Tinnitus is common and sometimes unexplainable
Tinnitus is a common condition. The CDC estimates that nearly 15% of the general public (more than 50 million Americans) experience some form of tinnitus.
“We don’t have a clear understanding of why tinnitus occurs,” said Dr. Georgia Ray, an Arizona audiologist who specializes in tinnitus. “We know that most of the time it seems to result from damage to the cochlear’s auditory system.”
Head injuries, stuffy nose, stress, anxiety, autoimmune disorders, high blood pressure, and many other things can cause tinnitus.
Another audiologist, Dr. Susan Schmidt, who specializes in tinnitus in Arizona, said:
Dr. Schmidt said that in order to associate a patient’s tinnitus with a vaccine, everything else needs to be ruled out.
“It’s pretty unlikely, but as you know, I’m not downplaying it,” Dr. Ray added.
Postcovid Vaccine Victims of Tinnitus Demand Awareness
Patients with tinnitus after coronavirus vaccination told ABC15 that healthcare providers were reluctant to believe in them and were uncertain about the best treatment.
Hu said his online support group also ran into obstacles when Facebook deleted the page for a “review.”
“This is what some people think is false information, but it’s true,” Hu said. “Yes, when that happens to them, it’s important for people to know that others have experienced it.”
Some healthcare providers are asking the FDA, CDC, and researchers to be open-minded and thoroughly investigate the symptoms of these vaccinated people.
“If there are side effects, we need to educate the general public about them,” said Dr. Conick. We need to know about them so that we can give them the right advice. “
Dr. Poland said he believes that talking about tinnitus should not contribute to vaccine hesitation.
“I think it’s better to be informed, to know what’s going on, and to use that data to make rational and rational decisions,” Poland said. “COVID vaccines are undoubtedly overwhelmingly categorized in favor of vaccine availability.”
Edmonds said tinnitus was still present, more than six months after the last COVID-19 shot, but the sound was much quieter.
Edmonds said that knowing the potentially deadly and long-term effects of COVID-19 would not have changed his decision to be immunized.
“I would have gotten the vaccine,” Edmonds said. “I wish my doctor knew how to treat it, but I would like to see a doctor sooner.”
Read the full text of Pfizer:
Pfizer takes very seriously the possible adverse events associated with the Pfizer-BioNTech COVID-19 vaccine. Pfizer carefully monitors all such events, collects relevant information and shares it with regulators around the world. Based on ongoing safety reviews conducted by Pfizer, BioNTech, and health authorities, there is no evidence to conclude that tin is associated with the use of the Pfizer-BioNTech COVID-19 vaccine.
To date, hundreds of millions of people around the world have been vaccinated with the Pfizer-BioNTech COVID-19 vaccine. It is important to note that serious adverse events, including mortality unrelated to the vaccine, can unfortunately occur at the same rate as the general population.
Read the full text of Johnson & Johnson:
The safety and well-being of all individuals who receive Johnson & Johnson products is our number one priority. Johnson & Johnson’s single-shot COVID-19 vaccine report of adverse events and our own assessment of the report is from the European Medicines Agency, the US Food and Drug Administration (FDA), and the World Health Organization (WHO). And other appropriate health authorities for which our vaccine is licensed. We strongly support raising awareness of the signs and symptoms of rare events so that they can be quickly identified and dealt with effectively. We will continue to work closely with the FDA to assess the potential for COVID-19 vaccine fact sheet updates and to collect up-to-date information and post-approval experience from clinical trial programs. The modified version is available at the following URL: www.janssencovid19vaccine.com
Regarding tinnitus in our clinical trial program, as of February 26, 2021, there were 6 cases of tinnitus in the Phase 3 ENSEMBLE vaccine group and none in the placebo group. With a vaccine. All participants have an underlying medical history (tinnitus and migraine history, hypertension history, seasonal allergies, hypothyroidism, etc.) or drugs that provide a more plausible alternative to the event than a vaccine. Was used. None of these events reported further complications such as deafness, and this information is included in the current fact sheet for the COVID-19 vaccine.
You can find out about your last question Click here for more information on the safety of the COVID-19 vaccine.
As the CDC points out, the benefits / risks of the COVID-19 vaccine are positive, with millions of people in the United States vaccinated with the COVID-19 vaccine under strict safety surveillance and approved. The vaccine given was a serious illness, hospitalization, and death.
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