Symptomtext
Unilateral hearing loss; This is a spontaneous report received from a contactable reporter(s) (Physician). A 32-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2022 as dose 3 (booster), single (Lot number: FH8027) at the age of 32 years for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 07Jan2022 as dose 1, single (Lot number: NK45F), in arm for immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: TRIUMEQ; BIKTARVY; HCTZ. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6200), administration date: 09Apr2021, when the patient was 32-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6204), administration date: 19Mar2021, when the patient was 31-year-old, for COVID-19 immunization. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 23Mar2022, outcome "not recovered", described as "Unilateral hearing loss". The event "unilateral hearing loss" required physician office visit. Therapeutic measures were taken as a result of deafness unilateral.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.What treatment received for the adverse event was Steroids, no improvementPrior to vaccination, was the patient not diagnosed with COVID-19.Since the vaccination, has the patient not had been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Deafness unilateral" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.