Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear discomfort, Tinnitus
Clinical narrative: Hearing loss in right ear; Tinnitus; Aural fullness; This literature-non-study case was reported in a literature article and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in right ear) in a 39-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 first 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 right ear) (seriousness criterion medically significant), TINNITUS (Tinnitus) and EAR DISCOMFORT (Aural fullness). At the time of the report, DEAFNESS UNILATERAL (Hearing loss in right ear), TINNITUS (Tinnitus) and EAR DISCOMFORT (Aural fullness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEAFNESS UNILATERAL (Hearing loss in right ear), TINNITUS (Tinnitus) and EAR DISCOMFORT (Aural fullness) to be possibly related.    Concomitant medications were not provided.   This study includes identifying 18 patients with post-vaccination otologic symptoms. In this case, patient had no prior hearing loss associated issues. The adverse effect was seen in right ear. The days to onset of symptoms was set as between 10-14 days.  Lab test included were the mean pure tone average (PTA) was 52.2 ± 30.6 dB HL for the affected ear, and 21.2 ± 12.5 dB HL for the unaffected ear. The word recognition score (WRS) was 60.6 ± 38% for the affected ear, and 90 ± 23.0% for the unaffected ear.  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.  Company comment:  This literature-non-study case concerns a 39 year-old male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of hearing loss in right ear, tinnitus, and aural fullness. The events occurred about 10-14 days after the first 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-2021-338004, MOD-2021-338005, MOD-2021-338006, MOD-2021-338007, MOD-2021-338008, 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.