Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Sleep disorder, Tinnitus
Clinical narrative: developed ringing in ears which got worse mid August; Only way caller could sleep was sitting up because the ringing was so bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 16Jun2021 as dose 2, single (Lot number: EW0183) at the age of 70 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Vaccine Name: Pfizer COVID-19 vaccine, Lot Number / Expiry Date: EW0183, No. of Previous Doses: 0, Date: 25May2021), administration date: 25May2021, when the patient was 70-year-old, for COVID-19 immunization; Smallpox shot (Had a smallpox shot when caller was a child and just remembers getting sick from it.), for immunization, reaction(s): "getting sick from it". The following information was reported: SLEEP DISORDER (non-serious) with onset Jul2021, outcome "unknown", described as "Only way caller could sleep was sitting up because the ringing was so bad"; TINNITUS (non-serious) with onset Jul2021, outcome "recovering", described as "developed ringing in ears which got worse mid August". The events "developed ringing in ears which got worse mid august" and "only way caller could sleep was sitting up because the ringing was so bad" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus, sleep disorder.  Additional Information: Caller is calling about the vaccine for the Covid, confirms caller is calling about the Pfizer COVID-19 vaccine, has vaccination card in front of him. Was hoping for side effect to go away and side effect has not gone away. Got 1st dose on 25May2021, and 2nd dose on 16Jun2021, and then would say roughly a month later developed ringing in ears which got worse mid August. Only way caller could sleep was sitting up because the ringing was so bad. Caller had gone to the ear doctor and ear doctor checked caller's hearing and hearing was baseline. Caller is 71 years old, so not perfect hearing, but considered normal for caller's age. Caller mentioned the ringing to the ear doctor, and thought maybe the ringing was this or that, hard to tell. Caller suspected the ringing was probably from the vaccine. Developed ringing in ears which got worse mid August: Start date of adverse event: Caller noticed some ringing after the 2nd dose, maybe a week or 2 weeks after the 2nd dose, maybe mid Jul2021, not that significant that the ringing drew attention. The first week in Aug2021 the ringing was really loud, more pronounced. Stop date of adverse event: Ongoing, not as pronounced, after 4 or 5 months the ringing wasn't quite as bad. This Mar2022 or Apr2022 the ringing was a little less as well. Thinking the ringing now somewhat was not as bad, but somewhat goes with the weather, like if the weather is really windy. Learn what's worse and what's not. Full moons and weather have an impact on the ringing. The ringing was still significant but has improved maybe 50% less than what the ringing was. When caller can't sleep at night for 3 or 4 nights without sitting up, late Aug2021 was the worst, was impossible to sleep, not much could be done about it. Test results as there wasn't anything, ear doctor just tested caller's hearing. No vaccines administered on same date with the Pfizer vaccine considered as suspect. Prior Vaccinations (within 4 weeks), No list of any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). AE(s) following prior vaccinations: Had a smallpox shot when caller was a child and just remembers getting sick from it. Other than that, whole life caller had been fine with vaccines. Relevant Tests: Caller had gone to the ear doctor and ear doctor checked caller's hearing and hearing was baseline. Caller is 71 years old, so not perfect hearing, but considered normal for caller's age.  Did go to an ear doctor, within (Institution name withheld) also. There wasn't anything, ear doctor just tested caller's hearing. Did have one question on the vaccine, how long does the vaccine stay in the system? Was the vaccine still in caller's system to be causing the 50% ringing in ears? Would that be expected to continue to reduce or is the vaccine out of the system a year later? In another 2 or 3 weeks it would be a year since caller's last dose, is there some residual of that shot that could be causing the ringing? Upon bringing the agent onto the line to complete the warm transfer, caller states that he would like to add one more thing to the report. On 14Jan2022, caller's doctor prescribed to a drug for the hearing symptoms which was amitriptyline 10mg, and doctor told caller if caller had problems sleeping for caller to take the medication before bed to help with caller's ears.  No follow-up attempts are possible. No further information is expected.