Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Computerised tomogram, Deafness unilateral, Ear, nose and throat examination, Otorrhoea
Clinical narrative: Fluid on her left ear; Loss of hearing on her left ear; Loss of hearing with tinnitus which can be overpowering; Panic attacks; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS UNILATERAL (Loss of hearing on her left ear) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 028A21A and 036A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had never tested COVID positive or diagnosis. Patient had no past medical history.  Previously administered products included for Product used for unknown indication: Flu vaccine in October 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Penicillin allergy, Depression (Since 15 years of age) and Anxiety (Since 15 years of age). Concomitant products included BUPROPION for Depression and Anxiety.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced DEAFNESS UNILATERAL (Loss of hearing on her left ear) (seriousness criterion medically significant), TINNITUS (Loss of hearing with tinnitus which can be overpowering) and PANIC ATTACK (Panic attacks). On 06-Jan-2022, the patient experienced OTORRHOEA (Fluid on her left ear). The patient was treated with AZITHROMYCIN (Z-PAK) for Ear discharge, at a dose of For 4 days or a week. At the time of the report, DEAFNESS UNILATERAL (Loss of hearing on her left ear), TINNITUS (Loss of hearing with tinnitus which can be overpowering), PANIC ATTACK (Panic attacks) and OTORRHOEA (Fluid on her left ear) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2022, Ear, nose and throat examination: Patient might have gotten the virus which caused shingles leading to hearing loss. On 24-Mar-2022, Acoustic stimulation tests: 2nd hearing test concluded that hearing will not come back. On an unknown date, Computerised tomogram: No lesions were seen.         Treatment included Oral steroids for on and a half week, Steroid injections on left ear for 6 sessions, A dual hearing aid. Patient initially consulted with Primary care physician on 06-Jan-2022 and was prescribed with Z-pack as patient had Fluid on her left ear, was advised that if things did not get better, patient had to see specialist. No improvement was observed hence on 27-Jan-2022, patient consulted to ENT Specialist who prescribed Oral steroids for one and half week, there was no improvement on 01-Feb-2022. Patient was given Steroid Injection on left ear for 6 Sessions on 01-Feb-2022, 03-Feb-2022, 07-Feb-2022, 10-Feb-2022 among the scheduled dates. CT scan was also performed to rule out any tumors. On 24-Mar-2022, a 2nd Hearing test was done and patient was told that her hearing would not come back. Patient had not experienced similar events in the past, AE caused patient to seek Office visit.  Company comment: This is a spontaneous case concerns a 51-year-old female patient, with no relevant medical history who experienced the unexpected, serious (medically significant) event of Deafness unilateral which occurred at an unknown interval after receiving the third dose of mRNA1273. Tinnitus and ear discharge were reported as additional events in the case and may be associated with the deafness unilateral The patient had loss of hearing on her left ear accompanied by tinnitus after vaccination. The following month the patient consulted her primary care physician due to fluid on her left ear and was prescribed with Azithromycin (Z-pak), she was also instructed to see a specialist if symptoms did not improve. Approximately 3 weeks later she consulted an ENT specialist and was prescribed with oral steroids for one and half weeks, it was also reported that the patient might have contracted a virus that caused shingles leading to hearing loss. The following month the patient came in for follow up without improvement of symptoms and was treated with steroid injection in the left ear for 6 sessions. CT-scan was reported to have been performed however the results were not provided. About 6 weeks after the last steroid injection the patient returned for the second hearing test and was told her hearing would not return. At present the patient's deafness has not resolved and is currently on dual hearing aid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerns a 51-year-old female patient, with no relevant medical history who experienced the unexpected, serious (medically significant) event of Deafness unilateral which occurred at an unknown interval after receiving the third dose of mRNA1273. Tinnitus and ear discharge were reported as additional events in the case and may be associated with the deafness unilateral The patient had loss of hearing on her left ear accompanied by tinnitus after vaccination. The following month the patient consulted her primary care physician due to fluid on her left ear and was prescribed with Azithromycin (Z-pak), she was also instructed to see a specialist if symptoms did not improve. Approximately 3 weeks later she consulted an ENT specialist and was prescribed with oral steroids for one and half weeks, it was also reported that the patient might have contracted a virus that caused shingles leading to hearing loss. The following month the patient came in for follow up without improvement of symptoms and was treated with steroid injection in the left ear for 6 sessions. CT-scan was reported to have been performed however the results were not provided. About 6 weeks after the last steroid injection the patient returned for the second hearing test and was told her hearing would not return. At present the patient's deafness has not resolved and is currently on dual hearing aid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.