Age: 67.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Acoustic stimulation tests abnormal, Deafness bilateral, Tinnitus
Clinical narrative: hearing loss; tinnitus; This spontaneous case was reported by an other health care professional and describes the occurrence of DEAFNESS (hearing loss) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 31-Mar-2022 to an unknown date for an unknown indication.    On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Sep-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced TINNITUS (tinnitus). On an unknown date, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant). At the time of the report, TINNITUS (tinnitus) and DEAFNESS (hearing loss) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: moderate hearing loss in both ears.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient previously had 1st dose of Moderna vaccine on 21-Jan-2021, 2nd dose from Moderna on 15-Feb-2021 and 3rd dose from Moderna booster vaccine on 29-Oct-2021. No concomitant medications were reported.  After 5 days of bivalent dose administration, in the evening, patient realized she had severe tinnitus, it was not there before, it came all of a sudden. Patient went to the doctor, took hearing test with ENT which showed moderate hearing loss in both ears. Patient had hearing aids which were not helpful. Patient never had COVID-19.   No treatment details were reported. Company comment: This spontaneous case concerns a 67-year-old female patient, with no relevant medical history, who experienced the unexpected and serious (medically significant) event of DEAFNESS after the mRNA-1273.222 vaccine, considered as the fifth dose of the vaccine schedule. The exact onset of the event was not reported; hence, latency could not be properly assessed. Five days after vaccination, she experienced sudden severe tinnitus. She consulted with no abnormal findings in her ears. A hearing test showed moderate hearing loss in both ears and hearing aids did not improve it. Previously she received 3 doses of mRNA-1273 vaccine and a PFIZER BIONTECH COVID-19 VACCINE as a booster dose (Interchange of vaccine products & Revaccination with different COVID-19 vaccine). No further clinical information was available for medical review. Patient´s age could be a risk factor for deafness and concomitant Pfizer vaccine remains as a confounder.. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.