Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Magnetic resonance imaging head, Tinnitus, Tympanometry
Clinical narrative: asymmetric right nerve hearing loss progressively worsening post second shot; Ringing in right ear. Persistent after about ten days following second shot. Same pitch.; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6200), via an unspecified route of administration, in right arm on 19Feb2021 14:00 (at the age of 68-years-old) as dose 2, single for covid-19 immunization. Medical history included high blood pressure, known allergies: Shrimp and Lobster only, hernia lower right and never smoked. Concomitant medications included losartan potassium; amlodipine; tamsulosine; ezetimibe and high blood pressure medications. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration, in right arm on 28Jan2021 16:00 (at the age of 68-years-old) as dose 1, single for covid-19 immunization. The patient had no other vaccine within four weeks and had other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021 14:00, the patient had ringing in right ear. Persistent after about ten days following second shot. Same pitch. No difference morning or night. Twenty-four hours per day. Horrible. The patient was advised that begin steroids to see if we can resolve this issue. It was suggested Prednisone 5 mg tablets taking 3 orally daily in the morning for 5 days, and then 2 orally daily in the morning for 5 days and then one orally daily in the morning for 5 days. Otherwise to return in about 3 weeks post completion of the Prednisone to see if it resolves his problem. Current problem: Right ear ringing - When was the last time you had your hearing tested- Several years. On 28May2021, the patient had asymmetric right nerve hearing loss progressively worsening post second shot. It was treated by hearing aid amplification. The patient under-went lab tests and procedures which included magnetic resonance imaging head: on 21May2021 sensorineural hearing loss, unilateral, right ear, with unrestricted hearing on the contralateral side, tympanometry: on 16Apr2021 Asymmetric high frequency nerve hearing loss, tympanometry: on 28May2021 this shows deteroriation of hearing right ear with asymmetric hearing loss advised hearing aid evaluation right ear. Physical exam: Ears: The ears were examined with the operating microscope. canals and tympanums normal. Nasal exam: Shows slight congestion. Oral cavity: Oropharynx: Normal. Audiometric evaluation: Hearing evaluation was ordered. Audiomettic evaluation shows asymmetric high frequency nerve hearing loss right ear compared to the left. Impression: Asymmetric right high frequency nerve hearing loss possibly due to some inflammatory process possibly related to covid shot. Physical Findings: Otolaryngeal: No difficulty understanding speech Ability to communicate normal. General Appearance: Well-appearing. Head: Head was normocephalic Inspection Of head and face for overall apprearance, scars, lesions, masses. Neck: Palpation: Of the neck revealed no abnormalities Neck was examined for masses, appearance, tra-cheal position, crepitus. Thyroid: Is normal. Ears: General/bilateral: Outer Ear: Normal. External Auditory canal: Normal. Tympanic Membrane: Both tympanic membranes were examined with operating microscope. Nose: General/bilateral: External Deformities: No external nose deformities. Cavity: Nasal cavity examined using specuium See dictation. Nasal mucosa abnormal See dictation. Oral Cavity: General condition was good. Lips: Showed no abnormalities. Salivary Glands: Examination showed no abnormalities. Pharynx: Oropharynx: Normal. Plan: Prednisone 5 mg tablet as di-rected 3 po q am for S days, then 2 po q am for 5 days, then 1 po q am until finished, 15 days, 0 refills. Reason for Exam: Diagnosis: sensorineural hearing loss, unilateral, right ear, with unrestricted hearing on the contralateral side. Interpretation: Exam: MRI IAC w brain mr w wo contrast Exam: 21May2021 03:51 PM. Technique: Multiplanner images of the brain without and with contrast. Contrast: 20ml of Multihance. Findings: Normal midline structures. ventricles and relationships at the foramen magnum. No abnormal signal or enhancement at the pontine angle or canals. No fluid in the middle ear cavities or mastoid air cells. NO significant abnormal intra or extra-axial signal or enhancement. No significant susceptibility changes. Normal appearance of the pituitary gland and parasailer structures. The orbits are normal. No scalp or calvarias lesions. Impression: No significant abnormality. The adverse event required visit to physician office. The patient received treatment for events. The reporter assessed the seriousness for the events as serious- Persistent/significant disability/incapacity. Device Date was 17May2021. Outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of Bnt162b2 cannot be excluded for the reported hearing loss unilateral and tinnitus.    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.