Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Computerised tomogram, Deafness unilateral, Immunisation, Magnetic resonance imaging
Clinical narrative: totally deaf in my left ear; tinnitus in left ear but it is a swooshing sound; booster; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 25Sep2021 13:00 (Lot number: FE3592) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "History of Ulcers" (unspecified if ongoing); "Had collagenous colitis years ago" (unspecified if ongoing); "Known allergy: PCN" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose lot number=EN6201, Prev dose vaccine location=Left Arm), administration date: 20Feb2021, when the patient was 54 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose lot number=EN6208, Prev dose vaccine location=Left arm), administration date: 13Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (disability) with onset 25Sep2021 13:00, outcome "unknown", described as "booster"; DEAFNESS UNILATERAL (disability, medically significant) with onset 25Sep2021 15:00, outcome "not recovered", described as "totally deaf in my left ear"; TINNITUS (disability) with onset 25Sep2021 15:00, outcome "not recovered", described as "tinnitus in left ear but it is a swooshing sound". The events "totally deaf in my left ear" and "tinnitus in left ear but it is a swooshing sound" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: angiogram: unknown results; computerised tomogram: unknown results; magnetic resonance imaging: unknown results; ultrasound doppler: unknown results; MRA: unknown results. Therapeutic measures were taken as a result of deafness unilateral, tinnitus.Clinical course: Facility type vaccine: Pharmacy or drug store. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. Adverse event: ''Within 2 hours I started to get what seems like tinnitus in left ear but it is a swooshing sound. Within 2 weeks, I am totally deaf in my left ear.'' Ae resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage]. No covid prior vaccination. Covid not tested post vaccination.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Immunization , deafness unilateral and Tinnitus 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 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.