More than 10,000 Americans have reported tinnitus as a possible side effect of the COVID-19 vaccine, and some are now questioning why the FDA and CDC are not taking a deeper look into their claims about hearing problems.
Did you experience tinnitus or other hearing issues after getting coronavirus or the COVID-19 vaccine? Contact Investigator Melissa Blasius at Melissa.Blasius@abc15.com.
“It's a constant high pitch string,” Robert Edmonds told ABC15 during a July visit to Phoenix for tinnitus-related medical care. Tinnitus is a ringing or buzzing noise in one or both ears that may be constant or come and go. It is often associated with hearing loss.
Edmonds describes the noise as louder than his car stereo. He’s a federal government employee from New Mexico, and he said he developed tinnitus, along with tingling of the face and headaches, shortly after receiving his first COVID-19 vaccine shot in January. He did not make a connection right away.
“I then went to a clinic, and that doctor thought he couldn't find anything wrong with my ears,” Edmonds said. “He tried antibiotics for an ear infection.”
Since then, Edmonds said he saw multiple specials and underwent diagnostic testing.
“We've ruled out as many things as possible, and we're left with the vaccine played likely some role in the development of the tinnitus,” Edmonds said.
In Seattle, George Hu also had hearing issues after getting vaccinated in February
“The very next morning, I noticed I started having what felt like congestion in my ear,” Hu recalled. “It got worse by the second day, and the third day, I literally couldn't hear anything out of it.”
George said his hearing returned after treatment with steroids, but he was left with tinnitus.
“Everybody's very skeptical in the medical community,” Hu said. “My own family members didn't think that it could possibly be.”
Hu said his son experienced similar hearing problems post-vaccine.
Hu, a former Microsoft employee, started a support group on Facebook, and he said he’s not anti-vaccine. In fact, he was one of the computer programmers who created CovidWA.com, a vaccine finder website for the entire state of Washington.
Dr. Greg Poland, Director of Mayo Clinic's Vaccine Research Group, works every day to dispel myths about the COVID-19 vaccine. However, he is not willing to discount a connection between the vaccine and tinnitus because he experienced it himself.
“I can't tell with absolute confidence that it was a result of the vaccine,” Dr. Poland said. “I can only say that it happened an hour, hour-and-a-half after getting the vaccine.”
CDC, FDA COLLECT TINNITUS REPORTS, NO CHANGE TO U.S. VACCINE WARNINGS
Edmonds, Hu, and Poland are some of the 10,092 people who reported sudden onset or worsening tinnitus to CDC’s Vaccine Adverse Event Reporting System as of September 3. More than 200 people reporting are from Arizona.
The tinnitus reports are rare compared to the nearly 211 million Americans who received at least one dose of COVID 19 vaccine. The tinnitus reports account come from one out of every 21,000 people vaccinated.
According to the CDC’s website, VAERS reports are an important part of vaccine safety, but they cannot be used alone to determine if a vaccine caused or contributed to an adverse event or illness. The reports are voluntary and may be incomplete, inaccurate, coincidental, or unverifiable, according to the CDC.
“Tinnitus is a serious thing,” said Dr. Elizabeth Connick, Chief of the Division of Infectious Diseases at University of Arizona Medical Center in Tucson. “They're not making it up, and it's very important not to have them feel marginalized.”
Some people who got sick with the COVID-19 virus also reported auditory problems according to a recent study conducted by The University of Manchester. Published in the National Journal of Audiology, scientists estimated that 7.6% of people infected with COVID-19 experienced hearing loss and 14.8% suffered from tinnitus. This study also conveyed that there is an urgent need for additional studies.
“We really only have a hypothesis,” said Dr. Poland. “You're developing an immunologic or inflammatory response that is probably, in this case, targeting a susceptible area of the brain.”
The European Medicines Agency, which is the European Union’s equivalent to the FDA, looked at data from both clinical trials and the initial vaccine rollout.
In August, the EMA changed its recommendations to say the Johnson & Johnson (Janssen) COVID-19 vaccine should add tinnitus to its list of possible side effects. Janssen is the pharmaceutical division of Johnson & Johnson.
Here in the U.S., the CDC and FDA are also monitoring the data.
While they identified some rare post-vaccine health issues, the CDC and FDA do not consider tinnitus a side effect, and the agencies say there is no causal relationship between COVID-19 shots and the condition.
The ABC15 investigators also contacted the vaccine manufacturers, Johnson & Johnson (Janssen), Pfizer, and Moderna. All three drug makers urge people to report adverse events that could potentially be associated with the vaccine.
Additionally, Pfizer said there was no evidence that tinnitus was associated with its vaccine.
A Johnson & Johnson spokesperson also said, “We strongly support raising awareness of signs and symptoms of rare events so they can be identified and treated.”
Johnson and Johnson says it’s working closely with the FDA to assess potential updates to its COVID-19 vaccine fact sheet.
TINNITUS IS A COMMON, SOMETIMES UNEXPLAINABLE CONDITION
Ear ringing conditions are common. The CDC estimates that nearly 15% of the general public — over 50 million Americans —experience some form of tinnitus.
“We don't have a clear understanding of why tinnitus happens,” said Dr. Georgine Ray, an Arizona audiologist specializing in tinnitus. “We do know that it seems to emanate, for the most part, from damage to the auditory system, typically in the cochlea.”
Lots of other things can cause tinnitus including head injury, sinus congestion, stress, anxiety, autoimmune diseases, and high blood pressure.
“Some people spontaneously have hearing changes or have tinnitus, or increase their tinnitus, for a reason that we cannot explain,” said Dr. Susan Schmidt, another Arizona audiologist who specializes in tinnitus.
Dr. Schmidt said you would have to rule out everything else in order to link a patient’s tinnitus to the vaccine.
“The likelihood is fairly slim, but, you know, I don't make light of it,” Dr. Ray added.
POST-COVID-VACCINE TINNITUS SUFFERERS DEMAND RECOGNITION
Post-coronavirus vaccine tinnitus sufferers told ABC15 that medical providers were reluctant to believe them and were unsure about the best treatments.
Hu said his online support group also hit a roadblock when Facebook took down the page for “review.”
“This is something that some people think is misinformation, but it is the truth,” Hu said. “It's important for people to know that when it does happen to them that, yes, other people have experienced it.”
Some medical providers urge the FDA, CDC, and researchers to be open-minded and fully investigate these vaccine recipients’ symptoms.
“If there are side effects,” Dr. Connick said, “we need to educate the public about them. We need to know about them, so we can give people the right advice.”
Dr. Poland said he believes talking about tinnitus should not contribute to vaccine hesitancy.
“I think it's better to be informed and to know what's going on, and to use those data to make reasoned, rational judgments,” Poland said. “A COVID vaccine definitely falls into the category overwhelmingly in favor of getting a vaccine.”
More than six months after his last COVID-19 shot, Edmonds said his tinnitus still exists, but the sound is much quieter.
Edmonds said knowing the potentially deadly and long-term effects of COVID-19, he would not have changed his decision to get immunized.
"I would have gotten the vaccine," Edmonds said. “I just wish my doctors knew how to treat it, and I wish I knew to go and see a doctor sooner.”
Read Pfizer’s full statement:
Pfizer takes adverse events that are potentially associated with the Pfizer-BioNTech COVID-19 Vaccine very seriously. Pfizer closely monitors all such events and collects relevant information to share with worldwide regulatory authorities. Based on ongoing safety reviews performed by Pfizer, BioNTech and health authorities, there is no evidence to conclude that tinnitus 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 deaths that are unrelated to the vaccine, are unfortunately likely to occur at a similar rate as they would in the general population.
Read Johnson & Johnson’s full statement:
The safety and well-being of every individual who receives a Johnson & Johnson product remains our top priority. Any adverse event report about individuals receiving Johnson & Johnson’s single-shot COVID-19 vaccine, as well as our own assessment of the report, is shared with the European Medicines Agency, U.S. Food and Drug Administration (FDA), the World Health Organization (WHO) and other appropriate health authorities where our vaccine is authorized. We strongly support raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated. We continue to work closely with the FDA on assessing potential updates to the Fact Sheets for our COVID-19 vaccine to capture the latest information from our clinical trial program, as well as post authorization experience, and amended versions are made available at www.janssencovid19vaccine.com
In terms of tinnitus in our clinical trial program, there were six cases of tinnitus in the Phase 3 ENSEMBLE vaccine group and none in the placebo group, as of February 26, 2021. A review of the cases revealed no pattern in terms of temporal association with the vaccine. All participants had underlying medical conditions (such as history of tinnitus and migraine, history of hypertension, seasonal allergies, and hypothyroidism) or used medications that offered a more plausible alternative cause for the event than the vaccine. None of these events have reported further complications such as hearing loss, and this information is included in the current Fact Sheet for our COVID-19 vaccine.
Regarding your last question, you can find further information on the safety of COVID-19 Vaccines here.
As the CDC notes, the benefit/risk of COVID-19 vaccines is positive, millions of people in the United States have received COVID-19 vaccines under intense safety monitoring, and the authorized vaccines have been proven to protect against severe illness, hospitalization and death.