Received Jun 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | NA0589 | IM / LA |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA0589 | OT / LA |
Lost her hearing in one ear; Tinnitus, ringing in ear; This is a spontaneous report received from a Pharmacist. A 76-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 30Apr2026 as dose 1, single (Lot number: NA0589, Expiration Date: 23Jun2026) at the age of 76 years intramuscular, in left deltoid arm for covid-19 immunisation, Device Lot Number: NA0589, Device Expiration Date: 23Jun2026. NDC number of Comirnaty: 00069252810. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: 21Sep2024, when the patient was 74-year-old, for Covid-19 immunization; BNT162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: 10Oct2025, when the patient was 75-year-old, for Covid-19 immunization; Moderna (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunization. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 01May2026, outcome "unknown", described as "Lost her hearing in one ear"; TINNITUS (non-serious) with onset 01May2026, outcome "unknown", described as "Tinnitus, ringing in ear". The events "lost her hearing in one ear" and "tinnitus, ringing in ear" required physician office visit. Clinical course: The reporter (pharmacist) stated that one of his patient that came in took the COVID Vaccine the 2025-2026 that presentation of the Comirnaty never frozen 12 plus from their pharmacy on 30Apr2026. On the next day (01May2026) she lost her hearing in one ear, and then she started to have tinnitus, ringing in ear. So, she had an adverse reaction to the COVID Vaccine. She said she went to the doctor, and upon examination doctor says there is no vaccine or anything associated with the ear. So, now she is claiming like that is a part of the vaccine. The vaccine was prescribed by a doctor. The patient got many time the COVID Vaccine, most of the time they were Moderna. She got Pfizer vaccine only 2 times. For the first time when she got Pfizer vaccine was 21Sep2024 and the second time she got Pfizer vaccination was 10Oct2025 and then the last time is the 30Apr2026. The patient is taking multiple medications (reporter do not know the name). When asked about causality the reporter stated they would not make a comment on that because they do not know and they do not know the patient condition and did not see. The patient did not receive any other vaccine on the same date as the Pfizer vaccine. Do not know if the patient was taking any other medications within 2 weeks prior to the event onset.; Sender's Comments: The event deafness unilateral is conservatively assessed as related to the suspect drug BNT162B2 OMICRON (LP.8.1) based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.