Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Ear discomfort, Excessive cerumen production
Clinical narrative: Hearing loss in left ear; Felt something was not right in left ear; Wax in ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss in left ear) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced EAR DISCOMFORT (Felt something was not right in left ear) and EXCESSIVE CERUMEN PRODUCTION (Wax in ear). In March 2021, the patient experienced DEAFNESS (Hearing loss in left ear) (seriousness criteria disability and medically significant). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. On 27-Feb-2021, EXCESSIVE CERUMEN PRODUCTION (Wax in ear) had resolved. At the time of the report, DEAFNESS (Hearing loss in left ear) had not resolved and EAR DISCOMFORT (Felt something was not right in left ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: abnormal (abnormal) audio test in a week, but there was no change.         Concomitant medications were not reported. It was stated that the next day after second dose, patient felt something was not right in her left ear, like a block when drive up a hill and come down. Patient thought she had wax in her ear and she went to her family physician who cleaned her ear. However, she could still not hear very well. Her laboratory data included MRI on 21-Mar-2021 and audio tests. She went to see the audiologist, who said there was a problem with her hearing. She received two unspecified steroid injections in her ear and was prescribed a taper-down prednisone course for a little less than three weeks. She was given the choice to wear a hearing aid because her hearing was still not well. She was using a hearing aid since 23-Sep-2021.  Company comment: This is a spontaneous case concerning a  73 year old female patient of unknown age with no reported relevant medical history, who experienced the unexpected serious as per disability event of Deafness. The event occurred 1 month and 1 day after the first dose and 1 day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). Patient received steroid treatment and is now using a hearing aid. The rechallenge was not applicable. Patient´s age is a confounder for the event. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Updated reporter information, patient demographics, laboratory data, dose details, treatment information,  event details, and seriousness-disability.; Sender's Comments: This is a spontaneous case concerning a  73 year old female patient of unknown age with no reported relevant medical history, who experienced the unexpected serious as per disability event of Deafness. The event occurred 1 month and 1 day after the first dose and 1 day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). Patient received steroid treatment and is now using a hearing aid. The rechallenge was not applicable. Patient´s age is a confounder for the event. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.