Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Hearing Loss right ear; This literature-study case was reported in a literature article and describes the occurrence of DEAFNESS (Hearing Loss right ear) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Otologic Manifestations After COVID-19 Vaccination: Ear Clinic Experience. 2021;42(9):e1213-8     Concurrent medical conditions included Autoimmune inner ear disease (Duration was 22 years and status was stable) and Meniere's disease (Duration was 22 years and status was stable).    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 (Hearing Loss right ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Hearing Loss right ear) outcome was unknown. Possible      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 (Hearing Loss right ear) to be possibly related.    Concomitant medications were not provided.  Treatment information was not reported.  This study includes identifying 30 patients with post-vaccination otologic symptoms. In this case, patient had prior hearing loss associated issues. The adverse effect was seen in right ear. The days to onset of symptoms was set as between 4-5 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 case concerns a 49-year-old, male with a history of Autoimmune inner ear disease and Meniere´s Disease, who experienced the unexpected event of Deafness. The event occurred approximately 4-5 days after the first dose of mRNA-1273 Moderna vaccine. The rechallenge is unknown (information regarding 2nd dose was not provided). The event was considered related to the product per the reporter´s assessment. Autoimmune inner ear disease and Meniere´s Disease could be potentially confounders for the events. The benefit-risk relationship of mRNA-1273 Moderna vaccine in 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-2021-338000, 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 a 49-year-old, male with a history of Autoimmune inner ear disease and Meniere´s Disease, who experienced the unexpected event of Deafness. The event occurred approximately 4-5 days after the first dose of mRNA-1273 Moderna vaccine. The rechallenge is unknown (information regarding 2nd dose was not provided). The event was considered related to the product per the reporter´s assessment. Autoimmune inner ear disease and Meniere´s Disease could be potentially confounders for the events. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.