Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Noninfective encephalitis
Clinical narrative: Hearing loss in right ear; Inflammation in brain; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; ibrutinib (IMBRUVICA), from 03Aug2020 (Batch/Lot number: unknown) to 29Aug2022 at daily (unk unk, daily (560 dosage form, every 1 days)), oral for mantle cell lymphoma; cilgavimab, tixagevimab (EVUSHELD), (Batch/Lot number: unknown) for product used for unknown indication. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: NONINFECTIVE ENCEPHALITIS (medically significant) with onset 2022, outcome "not recovered", described as "Inflammation in brain"; DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "Hearing loss in right ear". The action taken for ibrutinib and cilgavimab, tixagevimab was unknown.  Clinical course: It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The patient reported that two weeks after Evusheld injection about five months ago as of 04Oct2022, she experienced inflammation in brain. She was getting better but had hearing loss in right ear and tinnitus. As per patients physicians decision Imbruvica therapy had been stopped on 29Aug2022. Patient had no known allergies. Patient did not agree to have physician contacted. Primary reporter did not have the lot number information, because the packaging was discarded.   Causality: The reporter considered "inflammation in brain" and "hearing loss in right ear" related to BNT162b2.  The reporter's causality for the event of Hearing loss in right ear and Inflammation in brain with Ibrutinib Film-Coated Tablet was Not Provided, with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility, with Evusheld (Cilgavimab; Tixagevimab) was Not Provided. AbbVie's opinion was that the causality for the event(s) of Hearing loss in right ear and Inflammation in brain with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided, Evusheld (Cilgavimab; Tixagevimab) was Not Provided, Ibrutinib Film-Coated Tablet was Not Assessable.  IMBRUVICA: Brain inflammation and Hearing loss unilateral, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer/BioNTech: Hearing loss unilateral, Market Authorization Holder (MAH). Pfizer/BioNTech:  Hearing loss unilateral, Non-Health Care Professional, Global Introspection, Possible. Pfizer/BioNTech:  Brain inflammation, Market Authorization Holder (MAH). Pfizer/BioNTech:  Brain inflammation, Non-Health Care Professional, Global Introspection, Possible. Evusheld:  Hearing loss unilateral, Market Authorization Holder (MAH). Evusheld: Hearing loss unilateral, Non-Health Care Professional, Global Introspection, Not Reported. Evusheld:  Brain inflammation, Market Authorization Holder (MAH). Evusheld: Brain inflammation, Non-Health Care Professional, Global Introspection, Not Reported. IMBRUVICA:  Brain inflammation, Market Authorization Holder (MAH), Global Introspection, Not assessable. IMBRUVICA:  Hearing loss unilateral, Market Authorization Holder (MAH), Global Introspection, Not assessable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the nature of the events "inflammation in brain" and "hearing loss in right ear", a causal relation between the reported events and the administration of the vaccine BNT162b2 cannot be excluded. The 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 notified to RAs, Ethics Committees, and Investigators, as appropriate.