Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Deafness, Tinnitus
Clinical narrative: Deafness in one ear/Hearing loss beign reported by others; Tinnitus; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS (Deafness in one ear/Hearing loss beign reported by others) in a 72-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and INSULIN GLARGINE, LIXISENATIDE (SOLIQUA) solution for injection for Type 2 diabetes mellitus.    Concurrent medical conditions included Type 2 diabetes mellitus.   In 2020, the patient started INSULIN GLARGINE, LIXISENATIDE (SOLIQUA) (unknown route) 15 international unit once a day. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Deafness in one ear/Hearing loss beign reported by others) (seriousness criterion medically significant) and TINNITUS (Tinnitus). At the time of the report, DEAFNESS (Deafness in one ear/Hearing loss beign reported by others) and TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  On an unknown date, latency: unknown, patient had deafness in one ear/hearing loss being reported by others. Patient reported two pens that the dose selector can turn but when she tried to push the injection button the plunger won't go down, it won't work. She stated she performed a successful safety test, but the insulin only came out in a little, tiny drop which was not the typical, larger amount. Patient replaced the needle a second time. Patient was requesting replacement of two pens. Patient stated that on an unknown date, her neurologist examined after she lost hearing and developed tinnitus wer (tinnitus, latency: unknown). Treatment details were not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment-This spontaneous case concerns an elderly  female patient aged 72 years with relevant medical history of Type 2 diabetes mellitus on SOLIQUA reported, who experienced the unexpected serious (medically significant) event of Deafness(reported as Deafness in one ear/Hearing loss being reported by others) in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date were provided. Patient had received a dose of Tozinomeran and a dose of mRNA-1273 vaccine on unknown dates. She also experienced nonserious event of Tinnitus. No further information on detailed clinical course, investigations, treatment of the events was available in the report.  Outcome of the events was unknown at the time of report. Relevant medical history remains a confounder to the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns an elderly  female patient aged 72 years with relevant medical history of Type 2 diabetes mellitus on SOLIQUA reported, who experienced the unexpected serious (medically significant) event of Deafness(reported as Deafness in one ear/Hearing loss being reported by others) in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date were provided. Patient had received a dose of Tozinomeran and a dose of mRNA-1273 vaccine on unknown dates. She also experienced nonserious event of Tinnitus. No further information on detailed clinical course, investigations, treatment of the event was available in the report.  Outcome of the events was unknown at the time of report. Relevant medical history remains a confounder to the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.