Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Diarrhoea, Ear infection, Tinnitus
Clinical narrative: Diagnosed with hearing loss in left ear 2 months after second dose / Has to wear hearing aid 2 months after second dose; Bad case of ear infection 2 months after second dose / Left ear issues unresponsive to medications 2 months after second dose; Diarrhea 2 months after second dose; Left ear buzzing really bad 2 months after second dose; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Diagnosed with hearing loss in left ear 2 months after second dose / Has to wear hearing aid 2 months after second dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concurrent medical conditions included Diabetes.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced TINNITUS (Left ear buzzing really bad 2 months after second dose). On 27-May-2021, the patient experienced EAR INFECTION (Bad case of ear infection 2 months after second dose / Left ear issues unresponsive to medications 2 months after second dose) and DIARRHOEA (Diarrhea 2 months after second dose). In June 2021, the patient experienced DEAFNESS (Diagnosed with hearing loss in left ear 2 months after second dose / Has to wear hearing aid 2 months after second dose) (seriousness criterion medically significant). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at an unspecified dose and frequency; AMOXICILLIN, CLAVULANIC ACID (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) for Ear infection, at an unspecified dose and frequency and CEFDINIR for Diarrhoea, at an unspecified dose and frequency. At the time of the report, DEAFNESS (Diagnosed with hearing loss in left ear 2 months after second dose / Has to wear hearing aid 2 months after second dose), TINNITUS (Left ear buzzing really bad 2 months after second dose), EAR INFECTION (Bad case of ear infection 2 months after second dose / Left ear issues unresponsive to medications 2 months after second dose) and DIARRHOEA (Diarrhea 2 months after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient visited an ENT specialist whom prescribed high dose steroids for 2 weeks. She received 4 steroid injections in the left ear drum, over time. The steroid injection made the hearing in the left ear worst.  Company comment: This case concerns a 73-year-old, female patient with previous relevant medical history of cancer and diabetes, who experienced the unexpected event of deafness. The event occurred on an unknown number of days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the events happened after the second dose. The medical history of cancer and diabetes remains a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 73-year-old, female patient with previous relevant medical history of cancer and diabetes, who experienced the unexpected event of deafness. The event occurred on an unknown number of days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the events happened after the second dose. The medical history of cancer and diabetes remains a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.