Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tinnitus
Clinical narrative: hearing loss got worse after her Moderna bivalent vaccine; now she cannot hear anything in her right ear/suffered moderate to severe hearing loss, hearing loss got worse after her Moderna bivalent vaccine and now she cannot hear anything in her right ear.; Tinnitus; head cold over the weekend; Patient felt achy the next day; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS UNILATERAL (now she cannot hear anything in her right ear/suffered moderate to severe hearing loss, hearing loss got worse after her Moderna bivalent vaccine and now she cannot hear anything in her right ear.) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hearing loss (Hearing loss in ight ear.) in 2014. Previously administered products included for Drug use for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE), ROSUVASTATIN, VITAMIN D [VITAMIN D NOS] and RISEDRONATE SODIUM (RISEDRONATE) for an unknown indication.    On 06-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Oct-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). On 07-Oct-2022, the patient experienced PAIN (Patient felt achy the next day). On 08-Oct-2022, the patient experienced NASOPHARYNGITIS (head cold over the weekend). On 09-Oct-2022, the patient experienced TINNITUS (Tinnitus). On 07-Nov-2022, the patient experienced DEAFNESS UNILATERAL (now she cannot hear anything in her right ear/suffered moderate to severe hearing loss, hearing loss got worse after her Moderna bivalent vaccine and now she cannot hear anything in her right ear.) (seriousness criterion medically significant). On an unknown date, the patient experienced CONDITION AGGRAVATED (hearing loss got worse after her Moderna bivalent vaccine). At the time of the report, DEAFNESS UNILATERAL (now she cannot hear anything in her right ear/suffered moderate to severe hearing loss, hearing loss got worse after her Moderna bivalent vaccine and now she cannot hear anything in her right ear.) had not resolved and TINNITUS (Tinnitus), PAIN (Patient felt achy the next day), NASOPHARYNGITIS (head cold over the weekend), CONDITION AGGRAVATED (hearing loss got worse after her Moderna bivalent vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.            The patient reported that she was seeing a specialist and was receiving high dose oral steroids (once monthly) and steroid injection in her right ear. The patient was seeing an audiologist and had been told that she had suffered moderate to severe hearing loss.  Company comment: This spontaneous case concerns a 61-year-old female patient , with relevant medical history of deafness(patient had experienced hearing loss in her right ear in 2014), who experienced the unexpected serious (medically significant) event of Deafness unilateral (reported as now she cannot hear anything in her right ear) that occurred approximately one month after receiving the third dose of mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. Tinnitus and condition aggravated (hearing loss got worse after her Moderna bivalent vaccine) were reported among other non-serious events. The next day after receiving the vaccine patient felt achy and head cold. Three days after vaccination she experienced Tinnitus. Patient was receiving high dose oral steroids and steroid injection in her right ear.  The patient was consulting an audiologist and has been told that she has suffered moderate to severe hearing loss. The hearing loss got worse after her Moderna bivalent vaccine and now she cannot hear anything in her right ear. Patient had also received two doses of COMIRNATY previously (Interchange of vaccine products/COVID-19 immunisation). The outcome of the event was Not recovered. Patients' medical history of Deafness and non-serious event of Tinnitus remain as confounders for the event Deafness unilateral. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 Vaccine in not affected by this report.; Sender's Comments: This spontaneous case concerns a 61-year-old female patient , with relevant medical history of deafness(patient had experienced hearing loss in her right ear in 2014), who experienced the unexpected serious (medically significant) event of Deafness unilateral (reported as now she cannot hear anything in her right ear) that occurred approximately one month after receiving the third dose of mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. Tinnitus and condition aggravated (hearing loss got worse after her Moderna bivalent vaccine) were reported among other non-serious events. The next day after receiving the vaccine patient felt achy and head cold. Three days after vaccination she experienced Tinnitus. Patient was receiving high dose oral steroids and steroid injection in her right ear.  The patient was consulting an audiologist and has been told that she has suffered moderate to severe hearing loss. The hearing loss got worse after her Moderna bivalent vaccine and now she cannot hear anything in her right ear. Patient had also received two doses of COMIRNATY previously (Interchange of vaccine products/COVID-19 immunisation). The outcome of the event was Not recovered. Patients' medical history of Deafness and non-serious event of Tinnitus remain as confounders for the event Deafness unilateral. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 Vaccine in not affected by this report.