Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness transitory, Discomfort, Dizziness, Head discomfort, Photophobia
Clinical narrative: I've never experienced sudden hearing loss as frequently or tha's lasted as long as it has now.; It gets muted and starts ringing; Eyes became a little more sensitive to light; I felt slightly dizzy; A pressure/tickle sensation in my head; I wouldn't describe it as tingle as it was more of a tickle back of my left eyeball and a little of the back of my left upper arm & left wrist; This is a spontaneous report from a contactable other HCP (patient). A 29-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 11Jun2021 as dose 1 single (at the age of 29-year-old) for COVID-19 immunization at Pharmacy or Drug Store. Medical history was not reported. Patient previously took sulfa product used for unknown indication and experienced drug allergy. Concomitant medications within 2 weeks of vaccination included bupropion hydrochloride (WELLBUTRIN), vitamins nos (MULTIVITAMIN [VITAMINS NOS]). Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jun2021, patient hearing had been going out intermittently in her left ear. Specifically, this past time it went out twice in 10 min and the second time it lasted for about a whole minute. It gets muted and starts ringing. She knew Wellbutrin had tinnitus as a side effect, but she had been on Wellbutrin for years with no changes in her dose. She had never experienced sudden hearing loss as frequently or that's lasted as long as it has now. This evening on 20Jun2021, experienced three episodes of hearing loss/ringing in my left ear. The longest episode lasted for probably about a minute (which is way longer than she had ever experienced before). After the hearing loss, she noticed her eyes became a little more sensitive to light and she felt slightly dizzy and a pressure/tickle sensation in her head which then became more focused towards the back of my left eyeball and a little of the back of my left upper arm & left wrist (very strange). No pain or numbness. She would not describe it as tingle as it was more of a tickle. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the adverse events. The outcome of the events was not recovered.   Information on the lot/ batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event Deafness transitory and suspect drug BNT162B2 cannot be excluded. 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.