Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Ear pain, Loss of personal independence in daily activities
Clinical narrative: Hearing loss; Ear pain; Symptoms are keeping him from living a functional life; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS (Hearing loss) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AC7148B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Moderna (Lot Number: 025B21A, Dose 1), Moderna (Lot Number: 034F21A, 1st Booster Dose), Moderna (Lot Number: 005C21A and Dose 2). Past adverse reactions to the above products included No adverse event with Moderna, Moderna and Moderna. Concurrent medical conditions included Allergy to antibiotic (Amoxicillin) and Allergy to antibiotic (Keflex).    On 04-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant), EAR PAIN (Ear pain) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Symptoms are keeping him from living a functional life). At the time of the report, DEAFNESS (Hearing loss), EAR PAIN (Ear pain) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Symptoms are keeping him from living a functional life) had not resolved.            No concomitant medication was provided.  On an unknown date, patient had received 1st dose of moderna with lot number 025B21A. On an unknown date, patient had received 2nd dose of moderna with lot number 005C21A. On an unknown date, patient had received 1st booster dose of moderna with lot number 034F21A.    It was reported that patient had experienced side effects from the new Moderna booster. Patient explained that 7 to 10 days after receiving the booster he started having hearing loss and ear pain.   Reportedly, patient would like for Moderna to advise a treatment or a health specialist for the symptoms that he had and cannot wait more time with this pain he was having a really hard time.   Treatment medication was not provided by the reporter.  Company Comment: This spontaneous case concerns a 48-year-old female patient, with no relevant reported medical history, who experienced the unexpected serious (medically significant) event of DEAFNESS, which occurred 7 days after receiving the fourth dose of mRNA-1273 BIVALENT .222 vaccine, along with non-serious events ear pain and loss of personal independence in daily activities. The outcome was reported as not resolved. It was reported that the patient started having hearing loss and ear pain 7 to 10 days after receiving the booster. Diagnostic workup or treatment information were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 48-year-old female patient, with no relevant reported medical history, who experienced the unexpected serious (medically significant) event of DEAFNESS, which occurred 7 days after receiving the fourth dose of mRNA-1273 BIVALENT .222 vaccine, along with non-serious events ear pain and los sof personal independence in daily activties. The outcome was reported as not resolved. It was reported that the patient started having hearing loss and ear pain 7 to 10 days after receiving the booster. Diagnostic workup or treatment information were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.