Age: 61.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Tinnitus
Clinical narrative: On the morning of 18Oct2022, patient was unable to hear out of right ear/hearing loss/mild hearing loss in left ear; And was experiencing tinnitus like symptoms; On the morning of the 17Oct2022, patient reported what he thought was a blockage in right ear; Initial side effects were soreness around the injection site; On Sunday, 16Oct2022, patient noticed a slight irritation in right ear but assumed water in ear from swimming; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLULAVAL QUADRIVALENT, on 26Sep2022 as dose 1, single; OMEGA-3 FATTY ACIDS; ACETAMINOPHEN; CETIRIZINE HCL; VITAMIN C [ASCORBIC ACID]; COLLAGEN; D3; MONTELUKAST SODIUM; ALPRAZOLAM; CANNABIS. Vaccination history included: BNT162b2 (Dose 4 (Booster), Single, Batch/Lot No: FK9893, Route of Administration: Intramuscular), administration date: 02Jun2022, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (Booster), Single, Batch/Lot No: FG3527, Route of Administration: Intramuscular), administration date: 09Nov2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Batch/Lot No: ER8732, Route of Administration: Intramuscular), administration date: 13Apr2021, when the patient was 59-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Single, Batch/Lot No: EN6199, Route of Administration: Intramuscular), administration date: 22Mar2021, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 16Oct2022, outcome "not recovered", described as "Initial side effects were soreness around the injection site"; EAR DISORDER (non-serious) with onset 16Oct2022, outcome "not recovered", described as "On Sunday, 16Oct2022, patient noticed a slight irritation in right ear but assumed water in ear from swimming"; EAR DISCOMFORT (non-serious) with onset 17Oct2022, outcome "not recovered", described as "On the morning of the 17Oct2022, patient reported what he thought was a blockage in right ear"; TINNITUS (non-serious) with onset 18Oct2022, outcome "not recovered", described as "And was experiencing tinnitus like symptoms"; DEAFNESS UNILATERAL (medically significant) with onset 18Oct2022, outcome "not recovered", described as "On the morning of 18Oct2022, patient was unable to hear out of right ear/hearing loss/mild hearing loss in left ear". The events "on the morning of 18oct2022, patient was unable to hear out of right ear/hearing loss/mild hearing loss in left ear", "on sunday, 16oct2022, patient noticed a slight irritation in right ear but assumed water in ear from swimming", "on the morning of the 17oct2022, patient reported what he thought was a blockage in right ear", "and was experiencing tinnitus like symptoms" and "initial side effects were soreness around the injection site" required physician office visit. Therapeutic measures were taken as a result of deafness unilateral, ear disorder, ear discomfort, tinnitus, vaccination site pain. Clinical information: Clinical information: No COVID tested post vaccination or prior. other vaccine received in four weeks. More than 3 dose received. Facility type vaccine Pharmacy or drug store. Scheduled appointment with physician for that afternoon on the 18Oct2022. Physician examined patient and found no obstructions or issues with ear canal. Upon reviewing vaccination status, the physician stated that he was aware of patients with similar symptoms that also occurred following a recent COVID vaccination shot. The physician's diagnosis was that the patient had received too much of the vaccine and the hearing loss, tinnitus was a side effect. The physician prescribed Prednisone (10mg) and Ultra B-complex.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.