Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Scan, White blood cell count, White blood cell count decreased
Clinical narrative: Passed out; Right Foot surgery; White blood cell decreased; Bad knee; scabbing on arm; 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-163-4414679-00 (AbbVie).  A 64-year-old male patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years intramuscular for covid-19 immunisation; ibrutinib (IMBRUVICA), since 03Jul2021 (ongoing) (Lot number: 1161127) at 420 mg 1x/day (420 mg, 1x/day (1 in 1 d)), oral for chronic lymphocytic leukaemia. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: moderna first shot (Dose 1. He did not feel well after the shot and had to go to hospital), administration date: 01May2021, when the patient was 64-year-old, for Covid-19 immunization, reaction(s): "did not feel well"; Janssen covid-19 vaccine (Dose 2; Route of Administration: Intramuscular), administration date: 2021, for Covid-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (hospitalization, medically significant) with onset Dec2021, outcome "unknown", described as "Passed out"; FOOT OPERATION (medically significant), outcome "unknown", described as "Right Foot surgery"; WHITE BLOOD CELL COUNT DECREASED (medically significant), outcome "unknown", described as "White blood cell decreased"; ARTHROPATHY (medically significant), outcome "unknown", described as "Bad knee"; SCAB (non-serious), outcome "unknown", described as "scabbing on arm". The patient was hospitalized for loss of consciousness (hospitalization duration: 9 day(s)). The patient underwent the following laboratory tests and procedures: Routine labs: Unknown; Scan: Unknown; White blood cell count: Decreased, notes: went from 191,000 to 20,000. The action taken for ibrutinib was dosage not changed. Therapeutic measures were taken as a result of foot operation, arthropathy.  Clinical course: The patient's white blood cell count went from 191,000 to 20,000. In Jul2022, he had knee replacement surgery because he had a bad knee. He passed out after booster shot and spent nine days in the hospital. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Imbruvica (Ibrutinib): The reporter's causality for the event(s) of right foot surgery, passed out after covid19 booster shot, bad knee, scabbing on arm and white blood cell decreased was not provided. The opinion was that there was no reasonable possibility that the events of right foot surgery, passed out after covid19 booster shot and bad knee are related to Imbruvica (Ibrutinib). The opinion was that the event of scabbing on arm was not assessable. The opinion was that there was a reasonable possibility that the event of white blood cell decreased is related to Imbruvica (Ibrutinib).  The reporter considered "passed out" related to BNT162b2. The reporter's assessment of the causal relationship of "right foot surgery", "white blood cell decreased", "bad knee" and "scabbing on arm" 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.  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 information in the case report and a plausible temporal relationship,  a possible causal relationship between the  reported events loss of consciousness , right foot operation, white blood cell decreased, bad knee and scabbing on arm and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.