Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear discomfort, Tinnitus
Clinical narrative: Hearing loss in left ear; Tinnitus in left ear; Aural fullness; This literature-non-study case was reported in a literature article and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in left ear) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (Hearing loss in left ear) (seriousness criterion medically significant), TINNITUS (Tinnitus in left ear) and EAR DISCOMFORT (Aural fullness). At the time of the report, DEAFNESS UNILATERAL (Hearing loss in left ear), TINNITUS (Tinnitus in left ear) and EAR DISCOMFORT (Aural fullness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEAFNESS UNILATERAL (Hearing loss in left ear), TINNITUS (Tinnitus in left ear) and EAR DISCOMFORT (Aural fullness) to be possibly related.    Concomitant medications were not provided.   This study includes 30 patients with post-vaccination otologic symptoms.  Most of the patients were still undergoing treatment, which may include oral, IT steroids, and/or antivirals. In all cases magnetic resonance imaging of the internal auditory canals was also ordered. The extent of hearing recovery and/or symptom resolution is currently unknown. Their pre-treatment audiograms, with the PTA and WRS recorded, have given them a good baseline with which to document any treatment effect, as well as review outcome versus specific treatment given, to be reported in the future. The extent of hearing recovery and/or symptom resolution is currently unknown.  Author discusses that although an increased incidence does not by itself prove causation, the trend here does bring up concern that in some patients, there may be a post-vaccination change in hearing.  Author concluded that currently, there are no known definite correlations between sudden hearing loss or other otologic manifestations with COVID-19 vaccination and that the clinic has noticed  a two-fold increase in diagnosis of idiopathic SNHL in a 30-day period in 2021 compared with the same interval 2 years ago, but cannot say if this specifically correlates to the pandemic or may represent an uncommon, but real AE not reported before this.  Company comment: This literature-non-study case concerns a 64 year-old male patient with no reported medical history, who experienced the unexpected serious (medically significant)  event of hearing loss in left ear, and the unexpected non-serious events of tinnitus and aural fullness. The events occurred about 7-10 days after the second dose of mRNA-1273 vaccine. No further information on clinical course, investigations performed and treatment received on this specific patient was available in the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-337903, MOD-2021-337994, MOD-2021-337995, MOD-2021-337996, MOD-2021-337997, MOD-2021-337998, MOD-2021-337999, MOD-2021-338000, MOD-2021-338001, MOD-2021-338002, MOD-2021-338003, MOD-2021-338005, MOD-2021-338006, MOD-2021-338007, MOD-2021-338008, MOD-2021-338009, MOD-2021-338010 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Upon internal review on 13-Jun-2023, significant correction was performed to upgrade the event deafness unilateral to serious medically significant. Report type was updated to Literature-non-study.