Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden hearing loss
Clinical narrative: sudden severe hearing loss in right ear; This spontaneous case was reported by a non-health professional and describes the occurrence of SUDDEN HEARING LOSS (sudden severe hearing loss in right ear) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 004M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Presbyacusis (moderate hearing loss bilateral due to age). Concomitant products included ALBUTEROL [SALBUTAMOL], FUROSEMIDE, LISINOPRIL, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), RIVAROXABAN (XARELTO), METOPROLOL and DILTIAZEM for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SUDDEN HEARING LOSS (sudden severe hearing loss in right ear) (seriousness criterion medically significant). The patient was treated with PREDNISONE (oral) for Hearing loss, at a dose of 1 dosage form. At the time of the report, SUDDEN HEARING LOSS (sudden severe hearing loss in right ear) had not resolved.            Patient take injectable steroid as a treatment drug on 2-Dec-2021. She takes lisinopril 20 mg twice daily. Patient take oral prednisone for two weeks. She went to her primary care doctor and was immediately referred to an Ear, nose, and throat specialist. The doctor said there was no guarantee and were hoping it was a viral thing and her hearing will come back. She had moderate hearing loss in both ears due to age but nothing like what was occurring.  Company comment included This case concerns a 79 year old female patient with medical history of Presbycusis - bilateral moderate hearing loss, who experienced the serious, unexpected event of sudden hearing loss 2 days after the third dose of mRNA 1273 vaccine. Patient had sudden severe hearing loss on the right ear, she was referred to an ENT specialist and was given 2 weeks of prednisone which did not relieve the symptoms. One month after the vaccine, she had an intratympanic steroid therapy on the affected ear. Doctor did not guarantee relief of symptoms, she has a hearing test scheduled and another follow up.  The patient's age and presbycusis remain as a confounders to the event.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 79 year old female patient with medical history of Presbycusis - bilateral moderate hearing loss, who experienced the serious, unexpected event of sudden hearing loss 2 days after the third dose of mRNA 1273 vaccine. Patient had sudden severe hearing loss on the right ear, she was referred to an ENT specialist and was given 2 weeks of prednisone which did not relieve the symptoms. One month after the vaccine, she had an intratympanic steroid therapy on the affected ear. Doctor did not guarantee relief of symptoms, she has a hearing test scheduled and another follow up.  The patient's age and presbycusis remains as a confounder to the event.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.