Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Deafness unilateral, Tinnitus
Clinical narrative: Asthma; Hearing loss(felt clogged, electronic vibration, white noise, crackling sounds); Weird noises in her left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss(felt clogged, electronic vibration, white noise, crackling sounds)) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced TINNITUS (Weird noises in her left ear). On 15-Mar-2021, the patient experienced DEAFNESS UNILATERAL (Hearing loss(felt clogged, electronic vibration, white noise, crackling sounds)) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHMA (Asthma). On 22-Mar-2021, DEAFNESS UNILATERAL (Hearing loss(felt clogged, electronic vibration, white noise, crackling sounds)) had resolved. At the time of the report, TINNITUS (Weird noises in her left ear) and ASTHMA (Asthma) outcome was unknown.            Concomitant information not provided  On 14/Mar/2021, she had weird noises in her left ear. The next day she had hearing loss (felt clogged, electronic vibration, white noise, crackling sounds). On 17/Mar/2021 she went to ENT who told her she was not the first patient of the day that came in with hearing loss due to vaccination. She was diagnosed with hearing loss of 60 percent in left ear for word recognition. Her speech reception threshold in left ear was AIR 30 decibels (dB), pure tone average left Air 28 decibels Hearing Level (dB HL), bone 25 dB HL. Her right ear was normal at Air 17 dB HL. She saw a specialist the same day and was examined. He gave her 60 mg/day of prednisone for 7 days. She went back a week later, and her results were word recognition at 100%, but she still has clicking and white noise in the ear. Speech recognition air 20dB pure tone average air was 18 dB HL, bone 17 dB HL. Tympanogram diagnostics done on 17/Mar/2021 showed ear canal volume left 1.25, right 2.27. A week later it was 1.66 in left, right was 1.43.  Action taken with mRNA-1273 in response to the events was not Applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD21-082695, MOD21-082690, US-MODERNATX, INC.-MOD-2021-092733, US-MODERNATX, INC.-MOD-2021-092583 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD21-082695: MOD21-082690: US-MODERNATX, INC.-MOD-2021-092733: US-MODERNATX, INC.-MOD-2021-092583:Crosslinked (MOD21-082668)