Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Inappropriate schedule of product administration, Myalgia
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4344022-00 (RA). A 77 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Jun2021 (Batch/Lot number: unknown) at the age of 77 years as dose 2, single and intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunization; ibrutinib (IMBRUVICA), oral since 2018 (ongoing) (Batch/Lot number: unknown) at 140 mg 1x/day (140 mg (1 in 1 d)) for chronic lymphocytic leukaemia; dabigatran etexilate mesilate (PRADAXA) (Batch/Lot number: unknown). Relevant medical history included: "Chronic Lymphocytic Leukemia" (unspecified if ongoing). Concomitant medication(s) included: Losartan; Iron; Metoprolol; Vitamin B12 [Cyanocobalamin]. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset Sep2021, outcome "not recovered", described as "Atrial fibrillation"; ADVERSE DRUG REACTION (non-serious), outcome "recovered", described as "Drug side effect"; BLOOD PRESSURE INCREASED (non-serious), outcome "not recovered", described as "blood pressure increased"; ARTHRALGIA (non-serious), outcome "not recovered", described as "shoulder pain"; DIZZINESS (non-serious), outcome "not recovered", described as "dizziness"; ASTHENIA (non-serious), outcome "not recovered", described as "energy decreased/feeling of weakness"; MYALGIA (non-serious), outcome "not recovered", described as "muscle pain"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Jun2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The patient underwent the following laboratory tests and procedures: blood pressure measurement: up to 160s; increased. The action taken for ibrutinib was dosage not changed; for dabigatran etexilate mesilate was unknown. It was unknown if patient was enrolled in a Covid-19 vaccine trial. Causality of BNT162B2: The reporter's assessment of the causal relationship of the events with the suspect product 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. Causality for ibrutinib (IMBRUVICA): The reporter(s) causality for the event(s) of drug side effect, atrial fibrillation and dizziness with Imbruvica (ibrutinib) was a reasonable possibility. The reporter(s) causality for the event(s) of shoulder pain, feeling of weakness/energy decreased, muscle pain, blood pressure increased, and Inappropriate schedule of vaccine administered was not provided. Causality for dabigatran etexilate mesilate (PRADAXA): The reporter's assessment of the causal relationship of the events with the suspect product PRADAXA was not provided at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As per Limited information in the case report a casual association between reported events with the suspect product 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.