Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Nasal congestion, Otitis externa, Pain in extremity, Temperature intolerance
Clinical narrative: Awoke this am with neurosensory deafness in Rt ear./ total hearing loss in right ear; tinnitus in Right Ear; mild cold intolerance; frontal headache (sinus like); stuffiness/Nasal congestion; postnasal drip; arm soreness; headache; myalgia; tiredness/episodic fatigue; This is a spontaneous report from a contactable physician. A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. Medical history included Mild seasonal allergies, Mild eczema, and Unexplained low prolactin. The patient's concomitant medications were not reported.  The patient was 9 days out from first dose of the Pfizer vaccine. Awoke this am with neurosensory deafness in right ear. Started high dose steroids this evening. Wanted to know if there was someone at Pfizer who could advise if possibly vaccine related and what is impact of steroids on immune response to vaccine and if he should get the next shot on the 19th. On 29Dec20, patient received first dose of Pfizer BioNTech SarsCoV2 Vaccine. On 30Dec2020, day 1, patient experienced arm soreness, headache, myalgia, and tiredness (1 -2 on scale of 10). On day 2-4 no issues full activity especially swimming (noted water in ear). On day 5 or 6 in Jan2021, onset of mild cold intolerance, episodic fatigue, frontal headache (sinus like), stuffiness, postnasal drip. Day 7 after swimming on LEFT ear sensation of swimmer and airplane air. Postnasal drip, Nasal congestion. Afrin nasal spray at night (Note attributed upper airway issues to possible CPAP use which was creating dryness in mouth etc.). On 06Jan2021, day 8 late night noted need to turn up volume slightly on tv, at bedtime noticed pronounced tinnitus in Right Ear. On 07Jan201, day 9 post vaccine, awoke with total hearing loss in right ear. ENT consult. Severe neurosensory hearing loss right ear. Started 60 mgs Prednisone by 8 pm (12 hours post deafness/24 hrs. post onset symptoms. Post oral steroid progress. Day 1 08Jan2021 onset of tinnitus intermittent cracking popping (Prednisone 60mgs); Day 2 09Jan2021 intermittent buzz/ electrical type static (Prednisone 50 mgs); Day 3 10Jan2021 return of tone (could hear alarm beeps) and discern some speech with TV headphones at volume (Prednisone 50mgs); Day 4 11Jan2021 Improved detection and discrimination of voices using speaker. Can hear voices close by with a buzz or "broken speaker" at certain tones. (Prednisone 30mgs) (Celebrex 100mgs bid); Day 5 12Jan2021, detection of sounds and voice improved but volume down and word discretion able but poor. Some nasal congestion, postnasal drip persists but mild. Patient never had any issues with vaccines, received influenza and shingles first dose in Sep, Anti-Thyroid Peroxidase antibody elevation detected in 2011 (140 on Dec2011 repeat of 174 on Mar2012 (nl is less than 35). Anti-Thyroglobulin negative. Never any evidence of hypothyroidism. Mild seasonal allergies/ Mild eczema. Unexplained low prolactin. Patient was beyond recovery of hearing the critical issue is what decisions to make about my next dose of vaccine so as to achieve full protection from SARS CoV2, patient was particularly interested to understand immune response at this point as to any guide. The outcome of the event Awoke this am with neurosensory deafness in Rt ear/total hearing loss in right ear was recovering while the outcome of the other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The possible causality between the reported neurosensory deafness in the right ear occurred after swimming / 9 days after the first dose of COVID 19, and the administration of BNT162B2, cannot be fully denied.   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 RA, IEC, as appropriate.