Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness neurosensory, Dizziness, Ear, nose and throat examination, Fatigue, Feeling abnormal
Clinical narrative: Patient had significant impairment of daily activities. She had dizziness random episodes while driving, sitting, which were not positional; mild SN hearing loss; tinnitus; Dizziness; Fatigue; arm hurt; she was feeling weird; This is a spontaneous report from a contactable physician (patient). This physician reported in response to HCP letter sent via email follow that included:  This 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0167) via intramuscular route in right deltoid on 30Apr2021 at 16:45 on a Friday (at the age of 39-year-old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. No pertinent family history was reported. She had no other vaccinations that day or in the four weeks prior. She did not start new medications. The patient experienced dizziness on 30Apr2021, deafness, tinnitus in May2021, fatigue, pain in extremity, she was feeling weird, loss of personal independence in daily activities on an unspecified date. Reporter called as patient who said that she was calling about the Pfizer COVID-19 vaccine because she took the first dose the 30Apr2021 and felt dizzy within 10-15-minute period, so she stood there a few minutes or whatever and then came home, and then she was still having dizziness. She said that the dizziness was not when she was moving, it was when was sitting doing work, she felts dizzy and felts fatigued. She said she was going for testing, but the reason she was calling was her second dose was scheduled for Friday and she did not think she would be able to take it then, so she would like to know how did this work. She said that they would be doing blood work and a brain MRI or something, she had an appointment with a neurologist, and she did not want to take it with the testing, without the results. Reporter said that it was given at a State government site, she set up her appointment through a website. She asked if she needs to call them to tell them she was not coming for a second dose and wants to ask if she would be able to get her second dose after the time when she knows if she was normal to get it. Reporter said her dizziness began before 5:00PM, she was feeling weird and dizzy so they put ice packs on her head for a few minutes and it was no good, she thought this was not good, it was also hot there so maybe there was something to do with it, and they said wait 15 minutes so she sat there, then slowly came home. She says she thought maybe it would go away. She says this was the main thing, her arm was also hurting, but this is normal she guesses everyone had that. She says her arm hurt for two days and then was fine after that. She says her dizziness or fatigue she did not take anything for, she did not know what to do, she thought maybe water would help. Patient had dizziness immediately after vaccine and had been persisting every day. Tinnitus started 2 weeks later with mild sensorineural hearing loss on audiology testing. No prior medical issues. Labs, MRI without contrast were normal VNG testing from ENT pending. MRI with contrast internal auditory canal pending. Patient had significant impairment of daily activities. She had dizziness random episodes while driving, sitting, which were not positional. Lab data was normal, MRI was normal. VNG test from ENT and MRI IAC with contrast was pending. Adverse event was resulted in physician office visit. Ice packs treatment received for event feeling abnormal and dizziness. Reporter said she looked it up online and it said you could get the second dose of the vaccine up to 28 days or 9 weeks or something like that, she just wanted to know if she could get it at a later date if everything was normal, like her labs or everything. Seriousness criteria was reported as persistent /significant disability/incapacity for dizziness, tinnitus and mild SN hearing loss. Reporter consider the Pfizer product had a causal effect to the adverse event. The outcome of event deafness, tinnitus, dizziness was not resolved and for rest of events was unknown.   No follow-up attempts are possible. No further information is expected.  Follow-up (15Jun2021): This is a spontaneous follow-up report from a contactable physician (patient). This physician reported in response to HCP letter sent via email follow that includes: Lab data was updated.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Sensorineural hearing loss,dizziness,tinnitus and Activities of daily living impaired 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.