Age: 61.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Peripheral swelling, Rash papular, Ultrasound scan
Clinical narrative: Thinning eye lashes and eye brows; Small red bumps on skin to face and arms; Nausea; Diarrhea comes and goes sometimes; Muscle cramps in legs; Neuropathy peripheral; Swelling in right leg/Swelling to right arm; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer from AbbVie, (MFR Control No: 21K-163-3913083-00). A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), first dose in Jan2021 and second dose in Feb2021; both intramuscular as single dose at age of 61 years old for covid-19 vaccination; ibrutinib (IMBRUVICA, tablet), oral from an unspecified date (Batch/Lot number was not reported) and ongoing, at 420 mg, 1x/day for chronic lymphocytic leukemia. Medical history included hypertension from an unknown date. Concomitant medications included pentoxifylline; silodosin; ubidecarenone (COQ10); cetirizine hydrochloride (ZYRTEC); lovastatin; amlodipine; morniflumate (FLOMAX); chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX), and concomitant therapy of chaga mushrooms. The patient previously took morphine and experienced morphine allergy, took amoxicillin;clavulanic acid (AUGMENTIN) and experienced augmentin allergy. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced neuropathy peripheral, and swelling in right leg/swelling to right arm in Feb2021, thinning eye lashes and eye brows, small red bumps on skin to face and arms, nausea, diarrhea comes and goes sometimes, and muscle cramps in legs on an unspecified date. The patient underwent lab tests and procedures which included ultrasound: unknown results on an unspecified date. The action taken in response to the events for ibrutinib was dose not changed. The outcome of event muscle cramps in legs was not resolved, outcome of other events was unknown.  The reporter's causality for the events of thinning eye lashes and eye brows, swelling in right leg/swelling to right arm, small red bumps on skin to face and arms, neuropathy peripheral and muscle cramps in legs with ibrutinib was not provided, the reporter's causality for the events of nausea and diarrhea comes and goes sometimes with ibrutinib was a reasonable possibility.  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.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported 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