Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Musical ear syndrome, Nausea, Noninfective encephalitis, Paraesthesia, Tinnitus
Clinical narrative: inflammation of the brain; Severe headache; muscle weakness; vertigo; nausea; tingling and numbness of hands and legs; fatigue; dizziness; tingling and numbness of hands and legs; ringing in ears; hearing sounds of music or buzzing in my head; hearing sounds of music or buzzing in my head; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: El1284, Location of injection: Arm Right), administration date: 06Jan2021, when the patient was 30-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN5318, Location of injection: Arm Right), administration date: 27Jan2021, when the patient was 30-year-old, for Covid-19 Immunization. No other vaccine in four weeks. No Known allergies. No covid prior vaccination. The following information was reported: HEADACHE (non-serious) with onset 01Jun2023, outcome "not recovered", described as "Severe headache"; DIZZINESS (non-serious) with onset 01Jun2023, outcome "not recovered"; FATIGUE (non-serious) with onset 01Jun2023, outcome "not recovered"; MUSICAL EAR SYNDROME (non-serious) with onset 01Jun2023, outcome "not recovered", TINNITUS (non-serious) with onset 01Jun2023, outcome "not recovered" and all described as "hearing sounds of music or buzzing in my head"; NONINFECTIVE ENCEPHALITIS (medically significant) with onset 01Jun2023, outcome "not recovered", described as "inflammation of the brain"; MUSCULAR WEAKNESS (non-serious) with onset 01Jun2023, outcome "not recovered", described as "muscle weakness"; NAUSEA (non-serious) with onset 01Jun2023, outcome "not recovered"; TINNITUS (non-serious) with onset 01Jun2023, outcome "not recovered", described as "ringing in ears"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 01Jun2023, outcome "not recovered" and all described as "tingling and numbness of hands and legs"; VERTIGO (non-serious) with onset 01Jun2023, outcome "not recovered". The events "inflammation of the brain", "severe headache", "muscle weakness", "vertigo", "nausea", "tingling and numbness of hands and legs", "fatigue", "dizziness", "ringing in ears" and "hearing sounds of music or buzzing in my head" required physician office visit. Therapeutic measures were taken as a result of noninfective encephalitis, headache, muscular weakness, vertigo, nausea, paraesthesia, fatigue, dizziness, hypoaesthesia, tinnitus, musical ear syndrome, tinnitus. Severe headache and inflammation of the brain, muscle weakness, vertigo, fatigue, nausea, tingling and numbness of hands and legs, dizziness, ringing in ears, hearing sounds of music or buzzing in my head. There is covid tested post vaccination. AE treatment: Gabapentin, Indomethacin, Oxcarbazepine.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event noninfective  encephalitis  and suspect BNT162B2 cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.