Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Deafness neurosensory, Inappropriate schedule of product administration, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: Sudden instantaneous sensorineural hearing loss in left ear; Sudden instantaneous sensorineural hearing loss in right ear; Administration date=17Feb2021, dose number=2/date=31Jan2021, prev dose dose number=1; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 (Lot number: EN6201) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "Acid reflux" (unspecified if ongoing), notes: acid reflux; "Acquired hallux rigidus" (unspecified if ongoing), notes: acquired hallux rigidus; "Insomnia" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM]; LISINOPRIL. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Meloxicam, reaction(s): "Known allergies: Meloxicam"; Drysol, reaction(s): "Known allergies: Drysol"; Androderm, reaction(s): "Known allergies: Androderm". Vaccination history included: Bnt162b2 (DOSE 1, Batch/Lot No: EL9264, Location of injection: Arm Left), administration date: 31Jan2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: DEAFNESS NEUROSENSORY (disability, medically significant) with onset 14Apr2021, outcome "recovered with sequelae", described as "Sudden instantaneous sensorineural hearing loss in right ear"; DEAFNESS NEUROSENSORY (disability, medically significant) with onset 03May2021, outcome "unknown", described as "Sudden instantaneous sensorineural hearing loss in left ear"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Feb2021, outcome "unknown", described as "Administration date=17Feb2021, dose number=2/date=31Jan2021, prev dose dose number=1". The event "sudden instantaneous sensorineural hearing loss in right ear" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: audiogram: (2021) unknown results; magnetic resonance imaging: (2021) unknown results; sars-cov-2 test: (14Jan2022) positive, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of deafness neurosensory.  Clinical course: Sudden instantaneous sensorineural hearing loss in right ear on 14Apr2021 with no concurrent accident, injury or illness. Sudden instantaneous sensorineural hearing loss in left ear on 03May also with no concurrent accidents, injuries or illnesses. Medications the patient received within 2 weeks of vaccination were Nexium, Lisinopril. The treatment received for the adverse event was MRI, repeat audiometric testing, high dose steroid. Facility where the most recent COVID-19 vaccine was administered by patient was other. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient diagnosed with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 since the vaccination. AE occurred on 14Apr2021 resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient Recovered with lasting effects.  No follow up attempts are possible. No further information is accepted.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events deafness neurosensory cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.