Sex: M
Vaccine: COVID19, UNK
Symptoms: Brain neoplasm, Magnetic resonance imaging, Pneumonia, Pulmonary fibrosis, White blood cell count
Clinical narrative: scar tissue on lungs; Pneumonia; White blood cell count low; inoperable brain tumor; 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-163-4518336-00.  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; ibrutinib (IMBRUVICA), (Batch/Lot number: unknown), oral for chronic lymphocytic leukaemia. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN NEOPLASM (medically significant) with onset 2019, outcome "unknown", described as "inoperable brain tumor"; WHITE BLOOD CELL COUNT DECREASED (medically significant) with onset 2022, outcome "unknown", described as "White blood cell count low"; PULMONARY FIBROSIS (medically significant), outcome "unknown", described as "scar tissue on lungs"; PNEUMONIA (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (unspecified date) Unknown Result; White blood cell count: (2022) Low. The action taken for ibrutinib was unknown. clinical course: Solicited report by a consumer of a 57-year-old male with events of inoperable brain tumor and scar tissue on lungs and non-serious sick with pneumonia and white blood cell count low with Imbruvica (Ibrutinib). There was no reported medical history. On unknown dates, the patient experienced scar tissue on lungs and sick with pneumonia. In 2019, the patient experienced inoperable brain tumor. In 2022, the patient experienced white blood cell count low. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. In 2019 the patient was diagnosed with an inoperable brain tumor. The physician was watching him and doing magnetic resonance imagings. He got sick with pneumonia and ended up in bed right away after his first Ccvid-19 vaccine. He was in bed for five weeks at that time it left scar tissue on his lungs. In 2022 his physician was concerned that his white blood cell count was low. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the information was not available in the patient's file.  Causality for Imbruvica (Ibrutinib): The reporter's causality for the event(s) of inoperable brain tumor, scar tissue on lungs and sick with pneumonia with Imbruvica (Ibrutinib) was no reasonable possibility. The reporter's causality for the event(s) of white blood cell count low with Imbruvica (Ibrutinib) was a reasonable possibility.  Causality as per reporter for Pfizer BioNTech COVID-19 vaccine (Tozinameran) (Tozinameran) with brain tumor and white blood cell count low was not reported; lung scarring and pneumonia was possible.  The reporter's assessment of the causal relationship of "inoperable brain tumor" and "white blood cell count low" 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 "scar tissue on lungs" and "pneumonia" related to BNT162b2.  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 provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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.