Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Chondrocalcinosis pyrophosphate, Fatigue, Gout, Pain in extremity
Clinical narrative: Pseudogout; Gout; Spleen disorder; Tiredness; Pain in arm; Blood sugar decreased; This is solicited report received from a Non-contactable consumer. This is a non-interventional study report from the marketing program marketing program received from a non-contactable consumer (patient). A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot number was not reported) via intramuscularly on an unspecified date as single dose for COVID-19 immunization; ibrutinib (IMBRUVICA, tablet), orally from Mar2019 (Batch/Lot number was not reported) which was ongoing, at an unspecified dose for non-hodgkins lymphoma and marginal zone lymphoma. There was no reported medical history. The patient was not taking any concomitant medications. Patient had no relevant medical history and known allergies. On unknown date in 2019, she had gout in right foot and she was put on steroids, prednisone, was taking for seven days. She took stiolto respimat 2.5, 2 puffs in the morning which didn't help at first but is doing alright now. In March the patient experienced Pseudo gout in left hip was painful and Low blood sugar and non-serious Gout In right foot, Spleen acting up, Tired and Arm sore with Imbruvica (IBRUTINIB). On unknown dates, the patient experienced Gout In right foot, Spleen acting up, Tired and Arm sore. In March 2021, the patient experienced Pseudo gout in left hip was painful and low blood sugar. On unknown date in April 2021, the patient Was in hospital for five days, because she had pseudogout in left hip (Involved or prolonged inpatient hospitalization) which was painful. In hospital they drained fluid and calcium from hip twice, first time didn't get much, then had flouroscopy with second time. She was on levaquin for pain, because they thought her spleen was acting up, that's where her cancer is. blood work at hospital showed sugar was low, they thought she had diabetes but it was because she hadn't eaten anything in two days related to waiting on a discussion on what to do for hip pain. She had both Pfizer shots, first shot made arm sore and was tired. The patient underwent lab tests and procedures which included blood glucose decreased which was low on Mar2021 (date unspecified). Relevant test/lab data for other events were unknown. The action taken in response to the events, for ibrutinib was dose not changed. Outcome of the events were unknown.   For IMBRUVICA causality was reported as, the reporter's causality for the event(s) of pseudo gout in left hip was painful, low blood sugar, gout in right foot, spleen acting up, tired and arm sore was not provided. (withheld) opinion is that there is no reasonable possibility that the events of pseudo gout in left hip was painful, low blood sugar, gout in right foot, spleen acting up, tired and arm sore are related to Imbruvica (ibrutinib).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of pseudogout. The case will be reassessed once new information is available. 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