Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: fatigue and arm soreness of the left deltoid; fatigue and arm soreness of the left deltoid; Sensorineural Hearing Loss (SSNHL) After Administration of the COVID-19 Vaccine; This is a literature report for the following literature source(s): A 41-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing); "tympanoplasty" (unspecified if ongoing); "ossicular chain reconstruction" (unspecified if ongoing); "cholesteatoma", start date: 2016 (unspecified if ongoing); "hearing loss" (unspecified if ongoing), notes: left worse than right. The patient's concomitant medications were not reported. Past drug history included: Fremanezumab-vfrm for migraine, notes: 225 mg subcutaneously. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: DEAFNESS NEUROSENSORY (hospitalization, medically significant) with onset 27Feb2021, outcome "not recovered", described as "Sensorineural Hearing Loss (SSNHL) After Administration of the COVID-19 Vaccine"; MYALGIA (hospitalization, medically significant), FATIGUE (hospitalization), outcome "unknown" and all described as "fatigue and arm soreness of the left deltoid". The patient underwent the following laboratory tests and procedures: Audiogram: (unspecified date) revealed a moderate, notes: sloping to a severe essentially sensorineural hearing loss with poor speech discrimination and TypeA tympanogram in the right ear and a moderate sloping to a profound conductive/mixed hearing loss with excellent speech discrimination and Type A tympanogram in the left ear; (01Mar2021) hearing was consistent; (15Mar2021) consistent with the previous audiogram; (19Mar2021) amoderately severe sloping, notes: a severe sensorineural hearing loss with no measurable speech discrimination (very distorted and caused pain) and Type A tympanogram in the right ear; (31Mar2021) moderate, notes: sloping to a profound sensorineural hearing loss with poor speech discrimination and Type A tympanogram in the left ear; (19May2021) a moderately severe sloping, notes: to a severe sensorineural hearing loss with no measurable speech discrimination (very distorted and caused pain) and Type A tympanogram in the right ear and a moderate sloping to a profound conductive/mixed hearing loss with excellent speech discrimination and Type A tympanogram in the left ear; (unspecified date) moderate, notes: sloping to a severe essentially sensorineural hearing loss with poor speech discrimination; Magnetic resonance imaging: (05Mar2021) unremarkable; Magnetic resonance imaging head: (05Mar2021) unremarkable. Therapeutic measures were taken as a result of deafness neurosensory, myalgia, fatigue. Clinical course: Reported as, Patient with migraines and history of left worse than right, hearing loss, presented to the otolaryngology outpatient clinic following 1 day of audio-vestibular symptoms of bilateral sudden sensorineural hearing loss. The patient received the Pfizer-BioNTech COVID-19 vaccine on 28Jan2021, and the onset of symptoms occurred on 27Feb2021, 30 days following the second dose. Other pertinent symptoms at the initial receipt of the Pfizer-BioNTech COVID-19 vaccine were fatigue and arm soreness of the left deltoid. Her past medical history before arriving at the otolaryngology outpatient clinic was migraine, which has been controlled on fremanezumab-vfrm (Ajovy) 225 mg subcutaneously monthly and a tympanoplasty and ossicular chain reconstruction in the middle ear due to a cholesteatoma back in 2016. During the 2016 examination the patient presented with hearing within normal limits sloping to severe sensorineural hearing loss with good speech discrimination in the right ear and a mild sloping to moderately severe conductive/mixed hearing loss with good speech discrimination in the left ear. During the initial examination, on 01Mar2021, the patient presented with a sudden change in hearing from her right ear, tinnitus, dizziness and vertigo. The ear canals were patent, non-inflamed and the tympanic membrane was visualized. A complete audiological evaluation was conducted at that time. The results revealed a moderate sloping to a severe essentially sensorineural hearing loss with poor speech discrimination and Type A tympanogram in the right ear and a moderately severe rising to moderate sloping to a profound conductive/mixed hearing loss with excellent speech discrimination and Type A tympanogram in the left ear. Hearing had decreased from a previously documented audiogram from 04Jun2020. The patient was treated with oral prednisone as described in detail in the below treatment section and was instructed to follow up in 2 weeks. The patient returned on 15Mar2021, after finishing the prescribed dose of corticosteroids with no relief of audio- vestibular symptoms and unremarkable ear canals, to complete a follow up audiogram. The audiogram revealed a moderate sloping to a severe essentially sensorineural hearing loss with poor speech discrimination and Type A tympanogram in the right ear and a moderate sloping to a profound conductive/mixed hearing loss with excellent speech discrimination and Type A tympanogram in the left ear. The hearing was consistent with the previous audiogram from 01Mar2021. The risks and benefits of intratympanic injections were reviewed with the patient and she consented to move forward with the injections for 3 consecutive weeks. The process of administration is described below in the treatment section. Additionally, an MRI of the brain and internal auditory canals (IACs) with and without contrast was prescribed and completed on 05Mar2021 in which results were unremarkable. On 19Mar2021 and 24Mar2021, the patient returned to clinic with no/minimal improvement in hearing for her second and third intra-tympanic injection and the same administration process was followed. On 31Mar2021, the patient returned for a follow up audiogram after all intra-tympanic steroid injections for right ear were completed. The audiogram revealed a moderate sloping to a profound sensorineural hearing loss with poor speech discrimination and Type A tympanogram in the right ear and a moderately severe rising to moderate sloping to a profound conductive/mixed hearing loss with excellent speech discrimination and Type A tympanogram in the left ear. The audiogram was consistent with the previous audiogram from 15Mar2021. At this time the patient was recommended to make an appointment for a Hearing Aid Evaluation to further discuss options to improve the patient's hearing and to take otic drops for 1 week and subsequently follow up in 2 months. On 19May2021, the patient returned for 2-month follow up with the physician to have an audiogram completed. She presented with worsening right-sided tinnitus with fluctuation and associated tingling of the right side of the face post right sided sudden sensorineural hearing loss. The audiogram revealed a moderately severe sloping to a severe sensorineural hearing loss with no measurable speech discrimination (very distorted and caused pain) and Type A tympanogram in the right ear and a moderate sloping to a profound conductive/mixed hearing loss with excellent speech discrimination and Type A tympanogram in the left ear. Pure tone thresholds were consistent with previous audiological findings, however, there was a significant decrease in her speech discrimination, in which the patient could not repeat back any of the bi-syllabic words presented to her. At this time, she was recommended to continue use of her hearing aids and to follow up with a neuro-otologist if symptoms persist. Treatment: The patient was initially treated with an oral prednisone 60 mg daily for 7 days, 40 mg daily for 3 days, 20 mg daily for 3 days, 10 mg daily for 3 days with minimal improvement starting on 01Mar2021. Subsequently, the patient was treated with dexamethasone once every 4-5 days with no further improvement. The first dose was given on 15Mar2021, the second dose was given on 19Mar2021 and the third and final dose was given on 24Mar2021. During each weekly visit, the tympanic membrane was visualized under binocular microscopy. Topical Phenol solution was applied to the tympanic membrane in the anterior-inferior quadrant. A small myringotomy was then made in the anesthetized portion. A secondary myringotomy was made in the posterior-inferior quadrant. Using a 27-gauge needle, Dexamethasone 10 mg/ mL was injected into the middle ear space. The patient was kept in the supine position and instructed not to swallow. The patient was then discharged after a short observation period. Once all injections were completed the patient was also prescribed .3% ofloxacin to instill 5 drops by otic route twice daily into the affected right ear. After all medical treatments were explored, the patient was recommended to be evaluated for bilateral hearing aids or a CROS (contralateral routing of signals) device. Outcome and Follow-Up: There was no clear etiology for the audio-vestibular symptoms that was found, however, it was hypothesized that the symptoms could have been secondary to the administration of the Pfizer-BioNTech COVID-19 vaccine. Furthermore, there was a need for further investigation to determine whether previous middle-ear related hearing loss could predispose patient to audio-vestibular symptoms secondary to the administration of the Pfizer-BioNTech COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported events deafness neurosensory, myalgia, fatigue and suspect BNT162B2 cannot be excluded.This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.