Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Allergic cough, Atypical pneumonia, Blood uric acid, Blood uric acid increased, Body temperature
Clinical narrative: Bruising of trunk; Lung disorder; Allergic cough; Pollen allergy; Uric acid high; Investigation abnormal; Fatigue; Low grade fever; Walking pneumonia; Generalized aching; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer (manufacturer control number: 21K-163-4076601-00) from a contactable consumer (patient).  A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 05Mar2021 (at age of 67 years old, Batch/Lot number was not reported) as single dose for covid-19 immunisation; ibrutinib (IMBRUVICA, tablet), oral from 09Aug2021, at 20 mg (420 mg,1 in 3 wk), 1 in 1 Every other day), oral from 06Sep2021 to 06Sep2021, at 20 mg (420 mg,1 in 3 wk), 1 in 1 Every other day) for CLL (Chronic lymphocytic leukemia). Medical history included CLL (Chronic lymphocytic leukemia), high uric acid levels, chronic kidney disease and cataract surgery. It was unknown if patient was enrolled in a covid-19 vaccine trial. Concomitant medication included allopurinol taken for high uric acid levels. The patient previously received first dose of bnt162b2, dose 1 intramuscular on 12Feb2021 (at age of 67 years old) as single dose for covid-19 immunisation. The patient experienced generalized aching, walking pneumonia, lung disorder, allergic cough, pollen allergy, uric acid high, investigation abnormal, covid-19 antibody test negative, fatigue, low grade fever in 2021, bruising of trunk on 09Sep2021. Events were reported as non-serious. In 2021, the patient experienced pneumonia/walking pneumonia, lung issues, cough might be related to pollen allergies, cough might be related to pollen allergies, high uric acid levels, numbers going down, no covid antibodies, feeling fatigue, low grade fever and aching all over. On 09Sep2021, the patient experienced bruise on the torso. The action taken in response to the events for bnt162b2 was not applicable, for ibrutinib was unknown. In 2021, the pneumonia/walking pneumonia, feeling fatigue, low grade fever and aching all over resolved. The outcome of events bruising of trunk, allergic cough, uric acid high was not recovered, the outcome of rest events was unknown.  Causality for Skyrizi (Risankizumab): The reporters causality for the event(s) of bruise on the torso and high uric acid levels with Imbruvica(ibrutinib) was a reasonable possibility. The reporters causality for the event(s) of pneumonia/walking pneumonia, lung issues, cough might be related to pollen allergies onset in 2021, cough might be related to pollen allergies onset in 2021, numbers going down, feeling fatigue, low grade fever and aching all over was not provided. the reporters causality for the event(s) of no covid antibodies with imbruvica(ibrutinib) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events - fatigue, pyrexia, pain with the suspect product (bnt162b2) was unrelated.  The reporter's assessment of the causal relationship of the other 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.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events of atypical pneumonia, contusion, lung disorder, allergic cough, seasonal allergy, blood uric acid increased, investigation abnormal,- fatigue, pyrexia, pain is assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.  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.