Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: severe tinnitus/tinnitus was reported as worsened; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the left upper arm on 19Mar2021 (batch/lot number: EN6207; expiration date: 31Jul2021) as a single dose for COVID-19 immunisation. Medical history included ongoing arthritis, ongoing intermittent tinnitus - she has a history of noise exposure and intermittent tinnitus in the past but was certainly unremarkable, she shrunk before the vaccine - she was five seven her whole life and then thinks she was only five six. Family history included hearing loss in her mother, grandmother, and uncle but that was with advanced age. There were no concomitant medications. Historical vaccine included BNT162B2 first dose on 26Feb2021 via injection in her left upper arm (lot number: E and then either I or 1 9266; expiration date unknown) for COVID-19 immunisation. The patient experienced severe tinnitus on Mar2021, tinnitus was reported as worsened. She received the second dose of the Covid vaccine on 19Mar2021 and reported a day or two later, she started experiencing tinnitus. She stated that she has been on and off steroids for the tinnitus. She asked if there has been a correlation identified between the vaccine and tinnitus. She asked was this a side effect of the vaccine. She was asking for any information such as studies, articles, awareness and frequency, regarding tinnitus being experienced after the vaccine. She was calling about the COVID 19 vaccine. She stated she was formally a retired audiologist she was calling because she was wondering what information Pfizer has about the onset of tinnitus. She stated after the second vaccine, she has developed significant tinnitus and as an audiologist she has trained people about tinnitus. She asked was this a symptom of the vaccine. She stated she knows tinnitus was a side effect of the COVID virus but was unsure if it was a side effect of the vaccine. She stated as a matter of fact she went to the national adverse reaction to report her reaction but not the particular Pfizer website. She stated she turns 51 next week and was currently 50. She stated she was five six as she has shrunk. She clarified she shrunk before the vaccine and stated she was five seven her whole life and then thinks she was only five six. She stated her doctor does not know she has this side effect. She stated she was going to see an ear nose throat friend but she was waiting. Severe tinnitus: She stated this started between 1 and 2 days after she received the vaccine which was on 19Mar2021 so either 20Mar2021 or 21Mar2021. She stated it may have got worse she had taken a short round of steroids and the tinnitus got better after the first two days and then the tinnitus returned and had no response to the steroids and she has done this twice. She stated the first two days of steroid usage she feels relief then the tinnitus comes back and she said to heck with it and stopped the steroid. She stated the tinnitus was a constant bilateral high frequency pure tone just very high pitch. She stated this was medically significant because it was a significant finding but not life-threatening. First dose was an injection in her left upper arm and received on 26Feb2021 unknown NDC number and expiry date. She stated the lot number was E and then either I or 1 9266. She stated it was actually not her turn in to get the vaccine but School System had extra doses and opened it up to anyone and everyone not just 1A or 1B. She stated she was 50 with no medical significant comorbidities other than arthritis and since the vaccine was opened up to the general public she was also eligible to get the second dose. She stated she believes the COVID 19 vaccine was related to the severe tinnitus because the onset was immediate and she has had tinnitus from other noise exposure but this was very different and not intermittent and does not come and go it was a different pitch too. She stated there has been no changes, no medication changes so everything else remained steady almost immediately after the vaccine her ears started ringing and she sort of ignored it and her ears were screaming loud a significant very loud even in the presence of background noise just a constant high pitch noise. She stated the tinnitus was impacted only 2 days from the steroids and then no impact after. She stated she considered taking a third dose and was still doing experiments. She stated was this something Pfizer was aware of and was there any information about monitoring people. She stated she knows there has not been a vaccine for that long and there may not be long term resolution but she wanted to report and ask what information Pfizer may already have. She stated the first steroid she started approximately 9 days after the onset and she had Medrol left over from her knee. She clarified the name as Medrol dose packs. She stated she thinks it was a 6, 5, 4, 3, 2, 1 Medrol dose pack that she had left over and she was able to set a series of 4, 3, 2, 2, and 1 but she threw packaging away and it was not a current medication as it was dated a couple years ago but she figured she would see if it would work and the first couple days it did but then not so much. Medrol dose packs unknown manufacturer, NDC number, lot number, expiry date. She stated moving forward her husband was a doctor and wrote Prednisone 10 mg and she was supposed to take 30 mg twice a day for 10 days and she took 30 mg once a day since she did not read the bottle and so she took 30 mg once a day for 5 days. She stated the same thing happened the first two days resolved and then nothing. Prednisone unknown manufacturer, NDC number, lot number, expiry date. She stated so she was actually considering taking 60 mg for 10 days and try to hit the tinnitus to see if she has an impact. She stated her concern/whole point to take the vaccine was to get antibodies and the body can recognize it but now a week and 2 weeks out she has taken a steroid which was suppressing her immune system and what does that do to the immune system. She stated the tinnitus was significant and she does not have a quiet moment and it was a cruel injustice as she used to train people and spent hours and hours counseling and now she was experiencing it. She stated it was significant enough to call and see if there was anything Pfizer knows more. She stated the first dose was given at 12:30 to 13:00 and the second dose was around 11:45 to 12:00. The adverse event did not require a visit to the emergency room and physician's office. No prior vaccinations (within 4 weeks). The outcome of the event was not recovered.