Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram, Deafness neurosensory, Tinnitus
Clinical narrative: I experienced an acute sensory neural hearing loss in my left ear/my ear felt full like there was a sudden air pressure change; Initially, all I could hear was buzzing; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS NEUROSENSORY (I experienced an acute sensory neural hearing loss in my left ear/my ear felt full like there was a sudden air pressure change) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In October 2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS NEUROSENSORY (I experienced an acute sensory neural hearing loss in my left ear/my ear felt full like there was a sudden air pressure change) (seriousness criterion medically significant) and TINNITUS (Initially, all I could hear was buzzing). At the time of the report, DEAFNESS NEUROSENSORY (I experienced an acute sensory neural hearing loss in my left ear/my ear felt full like there was a sudden air pressure change) and TINNITUS (Initially, all I could hear was buzzing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: brain tumor and visible nerve damage was not observed..         Concomitant medications were not reported.   It was reported that approximately 11 days later of booster shot, patient experienced an acute sensory neural hearing loss in her left ear. Initially, all she could ear was buzzing and her ear and felt full like there was a sudden air  pressure change. She sought medical attention immediately. She was referred to an ENT. After multiple audiological exams, physical examination and a cat scan a brain tumor and visible nerve damage was not observed. The ENT recommended hearing aids to boost her residual hearing. She could not help thinking her loss was due to a negative reaction to the booster.   No treatment medication was provided by the reporter.  Company comment: This spontaneous case concerns a 66-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of deafness neurosensory 11 days after the third dose of mRNA-1273.222. Patient experienced an acute sensory neural hearing loss in her left ear, which initially presented with tinnitus and air pressure change sensation. Patient was referred to an ENT who performed multiple audiological exams, physical examination and a CT scan which discarded a brain tumor and nerve damage. The ENT recommended hearing aids to boost her residual hearing. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.