Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: I started getting hearing issues, hearing never returned its lost permanently; After the second dose I was sick for 8 days, on and off; Poor balance; I had fever, chills, fatigue; I had vomiting and was throwing up for a week; Having nausea; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (I started getting hearing issues, hearing never returned its lost permanently) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE ARROW) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ILLNESS (After the second dose I was sick for 8 days, on and off), BALANCE DISORDER (Poor balance), PYREXIA (I had fever, chills, fatigue), VOMITING (I had vomiting and was throwing up for a week), NAUSEA (Having nausea), CHILLS (Chills) and FATIGUE (Fatigue). On 18-Jun-2021, the patient experienced DEAFNESS (I started getting hearing issues, hearing never returned its lost permanently) (seriousness criterion medically significant). At the time of the report, DEAFNESS (I started getting hearing issues, hearing never returned its lost permanently), ILLNESS (After the second dose I was sick for 8 days, on and off), PYREXIA (I had fever, chills, fatigue), NAUSEA (Having nausea), CHILLS (Chills) and FATIGUE (Fatigue) had not resolved and BALANCE DISORDER (Poor balance) and VOMITING (I had vomiting and was throwing up for a week) outcome was unknown.            Treatment included Steroids Otic. The patient was sick for 8 days, had nausea, chills fever and fatigue. The most serious side effect was permanent hearing loss. The symptoms were ongoing, Patient had nausea, vomiting, poor balance,  was throwing up for a week.  Company comment -This case concerns a  71-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of deafness. The events occurred approximately 4 months after the second dose of Moderna Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna Covid-19 Vaccine, is not affected by this report.; Sender's Comments: This case concerns a  71-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of deafness. The events occurred approximately 4 months after the second dose of Moderna Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna Covid-19 Vaccine, is not affected by this report.