Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Hearing loss in left ear; This literature-study case was reported in a literature article and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in left ear) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Concurrent medical conditions included Meniere's disease (Duration: 12 years and status was stable) and Autoimmune inner ear disease (Duration: 12 years and status was stable).    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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEAFNESS UNILATERAL (Hearing loss in left ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Hearing loss in left ear) outcome was unknown. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEAFNESS UNILATERAL (Hearing loss in left ear) 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 case concerns an 83 year-old male patient with history of Meniere's disease and autoimmune inner ear disease, who experienced the unexpected serious event of  Hearing loss in left ear. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The patient's advanced age and history of Meniere's disease and autoimmune inner ear disease may have contributed to the event.   This case was linked to MOD-2021-337903, MOD-2021-337994, 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-2021-338004, MOD-2021-338005, MOD-2021-338006, MOD-2021-338007, MOD-2021-338008, MOD-2021-338009, MOD-2021-338010 (Patient Link).; Sender's Comments: This case concerns an 83 year-old male patient with history of Meniere's disease and autoimmune inner ear disease, who experienced the unexpected serious event of  Hearing loss in left ear. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The patient's advanced age and history of Meniere's disease and autoimmune inner ear disease may have contributed to the event.