Received Feb 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 4 | 82B22A | IM |
Low blood pressure; tinnitis/hearing loss/dizziness; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS NEUROSENSORY (tinnitis/hearing loss/dizziness) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 82B22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 1, Lot number: - 030M20A, expiry date: - 01-Aug-2021.) on 10-Feb-2021, Moderna covid-19 vaccine (Dose 2, Lot number: - 040A21A, expiry date: -24-Aug-2021.) on 10-Mar-2021, Moderna covid-19 vaccine (Dose 3 and Lot number: - 048F21A.) on 08-Nov-2021. Past adverse reactions to the above products included No adverse effect with Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine. Family history included Hearing loss. On 27-Aug-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. In 2022, the patient experienced DEAFNESS NEUROSENSORY (tinnitis/hearing loss/dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOTENSION (Low blood pressure). At the time of the report, DEAFNESS NEUROSENSORY (tinnitis/hearing loss/dizziness) and HYPOTENSION (Low blood pressure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: Right Ear - Normal-Moderately Severe Sensorineural Sloping Hearing Loss; Left Ear - Normal-Moderately Severe Sensorineural Sloping Hearing Loss. Word Recognition: Right ear - 100% at 60dBHL; Left ear - 100% at 60dBHL. DPOAES revealed 6/12 frequencies present in the RE 2/12 frequencies present in the LE.. On an unknown date, Otoscopy: Clear ear canals, bilaterally. On an unknown date, Tympanometry: Normal TM mobility, middle ear pressure, and ear canal volume, bilaterally. Pure tone testing (Symmetric).. Concomitant product use was not provided by the reporter. Patient reported that she had intermittent symptoms of buzzing, that she initially noticed about two years ago. Patient denied any symptoms of otalgia, otorrhea, and aural fullness while confirming dizziness due to low blood pressure. Patient was seen for an initial audiological evaluation. Patient reported that she was seen about one month prior was not given any details regarding hearing. She noticed that tinnitus symptoms were stronger. He had tinnitus in both ears for years that sounds like high pitch tome feel more prominent in his right ear. Patient confirms his right ear always had some aural fullness and occasional ache. Occasional dizziness that was like blood pressure related. Parents could not hear very well, noise exposure from recreation without the use of hearing protection. Patient otorrhea. Treatment information was not provided. Reporter causality was not reported.; Reporter's Comments: Company comment: Family history of hearing loss could be a risk factor for the event deafness neurosensory. The benefit-risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: Hearing loss
Test Name: hearing test; Result Unstructured Data: Right Ear - Normal-Moderately Severe Sensorineural Sloping Hearing Loss; Left Ear - Normal-Moderately Severe Sensorineural Sloping Hearing Loss. Word Recognition: Right ear - 100% at 60dBHL; Left ear - 100% at 60dBHL. DPOAES revealed 6/12 frequencies present in the RE 2/12 frequencies present in the LE.; Test Name: Otoscopy; Result Unstructured Data: Clear ear canals, bilaterally; Test Name: Tympanometry; Result Unstructured Data: Normal TM mobility, middle ear pressure, and ear canal volume, bilaterally. Pure tone testing (Symmetric).