Age: 80.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Antibody test, Condition aggravated, Deafness, Drug specific antibody absent, Immune system disorder
Clinical narrative: After COVID-19 shots platelets dropped down over 100 points; Had no immunity; Did not develop antibodies with Imbruvica (ibrutinib); Hearing loss gradually gotten worse after COVID-19 shots; Hearing loss gradually gotten worse after COVID-19 shots; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4525591-00.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 14Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 04Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 80 years, all intramuscular for covid-19 immunisation; ibrutinib (IMBRUVICA), (Lot number: 1160081), oral. The patient's relevant medical history included: "Hearing loss", start date: 2012 (ongoing), notes: started almost ten years ago. The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 2021, outcome "not recovered" and all described as "Hearing loss gradually gotten worse after COVID-19 shots"; PLATELET COUNT DECREASED (medically significant), outcome "unknown", described as "After COVID-19 shots platelets dropped down over 100 points"; IMMUNE SYSTEM DISORDER (medically significant), outcome "unknown", described as "Had no immunity"; DRUG SPECIFIC ANTIBODY ABSENT (medically significant), outcome "unknown", described as "Did not develop antibodies with Imbruvica (ibrutinib)". The patient underwent the following laboratory tests and procedures: Antibody test: Patient did not develop antibodies; Platelet count: Dropped down over 100. The action taken for ibrutinib was unknown.  Clinical course: Solicited report by a consumer of an 80-year-old female with events of hearing loss gradually gotten worse and non-serious after COVID-19 shots platelets dropped down over 100 points/had no immunity/did not develop antibodies with Imbruvica (ibrutinib) In 2021. The patient had a relevant medical history of ongoing hearing loss. Patient had hearing loss that started almost ten years ago, and it had gradually gotten worse. When she received her COVID 19 shots her platelets dropped down over 100 points and had no immunity and did not develop antibodies. She was not sure if Imbruvica may have any cause. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's assessment of the causal relationship of "hearing loss gradually gotten worse after covid-19 shots" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "after covid-19 shots platelets dropped down over 100 points", "had no immunity" and "did not develop antibodies with imbruvica (ibrutinib)" related to BNT162b2.  Causality for Imbruvica (Ibrutinib): The reporter's causality for the event(s) of hearing loss gradually gotten worse, after COVID 19 shots was not provided. The reporter's causality for the event(s) of after COVID 19 shots platelets dropped down over 100 points/had no immunity/did not develop antibodies unknown onset with Imbruvica (Ibrutinib) was a reasonable possibility.  RA opinion is that there is no reasonable possibility that the events of hearing loss gradually gotten worse and after COVID 19 shots platelets dropped down over 100 points/had no immunity/did not develop antibodies unknown onset are related to Imbruvica (Ibrutinib). RA's opinion is that the events of after COVID-19 shots platelets dropped down over 100 points/had no immunity/did not develop antibodies unknown onset and after COVID-19 shots platelets dropped down over 100 points/had no immunity/did not develop antibodies unknown onset are not assessable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events - Immune system disorder, platelet count decreased, condition aggravated, deafness and the suspect drug BNT162b2 cannot be excluded. The case will be reassessed once new information is available.  Based on the available information, the reported event drug specific antibody absent is assessed as UNRELATED to the suspect drug BNT162b2, as it is related to the other suspect drug ibrutinib.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.