Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: right foot was swollen, red and painful; right foot was swollen, red and painful; right foot was swollen, red and painful; Every joint hurt; could hardly get out of the car; did not feel well; blood bister on foot/blood blisters on skin, all over that came and went; was sweating last night; right leg swollen and neuropathy after having Pfizer; right leg swollen and neuropathy after having Pfizer; Problems with nails, hair; Problems with nails, hair; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-5180086.  A 64-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2, single (Batch/Lot number: unknown) at the age of 64 years intramuscular for covid-19 immunisation; ibrutinib (IMBRUVICA), since 01Aug2020 (Batch/Lot number: unknown), oral for chronic lymphocytic leukaemia. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer biontech covid-19 vaccine (Dose 1, single, Intramuscular), for Covid-19 Immunization. The following information was reported: ARTHRALGIA (hospitalization) with onset 2023, outcome "unknown", described as "Every joint hurt"; NAIL DISORDER (non-serious), HAIR DISORDER (non-serious) all with onset 2023, outcome "unknown" and all described as "Problems with nails, hair"; BLOOD BLISTER (hospitalization) with onset 2023, outcome "unknown", described as "blood bister on foot/blood blisters on skin, all over that came and went"; MOBILITY DECREASED (hospitalization) with onset 2023, outcome "unknown", described as "could hardly get out of the car"; MALAISE (hospitalization) with onset 2023, outcome "unknown", described as "did not feel well"; PERIPHERAL SWELLING (hospitalization), PAIN IN EXTREMITY (hospitalization), ERYTHEMA (hospitalization) all with onset 2023, outcome "unknown" and all described as "right foot was swollen, red and painful"; NEUROPATHY PERIPHERAL (medically significant), PERIPHERAL SWELLING (non-serious) all with onset 2023, outcome "unknown" and all described as "right leg swollen and neuropathy after having Pfizer"; NIGHT SWEATS (non-serious) with onset 07Aug2023, outcome "unknown", described as "was sweating last night". The patient was hospitalized for peripheral swelling, pain in extremity, erythema, arthralgia, mobility decreased, malaise, blood blister (hospitalization duration: 2 day(s)). Clinical course: it was reported that all over that came and went with Ibrutinib Capsule, Hard. Pfizer BioNTech COVID-19 vaccine was also considered suspect. The patient had problems with nails, hair and used biotin for it. He had blood blisters on skin all over that came and went. He had a really bad reaction after covid-19 second vaccination. His right leg was swollen and he had neuropathy. On his way to work, he did not feel well and could hardly get out of the car. His every joint hurt. His right foot was swollen, red and painful. In 2023 he had blood blisters on his foot. He was in the hospital for two days. He was put on a step down steroid and antibiotic. On night of 07Sep2023, his sweating was so bad that his sheets were soaked and so was his neck. These side effects or symptoms were similar to taking Imbruvica but his physician was unsure. The patient was treated with Biotin. The action taken for ibrutinib was unknown. Therapeutic measures were taken as a result of peripheral swelling, pain in extremity, erythema, arthralgia, mobility decreased, malaise, blood blister, neuropathy peripheral, peripheral swelling, nail disorder, hair disorder, night sweats.   Causality: The reporter's causality for the event(s) of Every joint hurt, Problems with nails, hair unknown onset, blood bister on foot, blood blisters on skin, all over that came and went, could hardly get out of the car, did not feel well, right foot was swollen, red and painful unknown onset, right leg swollen and neuropathy after having Pfizer unknown onset, was sweating last night with Ibrutinib Capsule, Hard was Not Provided The reporter's causality for the event(s) of right leg swollen and neuropathy after having Pfizer unknown onset with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility The reporter's causality for the event(s) of Every joint hurt, Problems with nails, hair unknown onset, blood bister on foot, blood blisters on skin, all over that came and went, could hardly get out of the car, did not feel well, right foot was swollen, red and painful unknown onset, was sweating last night with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided  Agency's opinion was that the causality for the event(s) of Problems with nails, hair unknown onset, blood bister on foot, blood blisters on skin, all over that came and went, was sweating last night with Ibrutinib Capsule, Hard was Not Assessable Agency's opinion was that the causality for the event(s) of Every joint hurt, could hardly get out of the car, did not feel well, right foot was swollen, red and painful unknown onset, right leg swollen and neuropathy after having Pfizer unknown onset with Ibrutinib Capsule, Hard was No Reasonable Possibility Agency's Alternative Etiology for right leg swollen and neuropathy after having Pfizer with Ibrutinib Capsule, Hard: More likely related to reaction after second dose of Pfizer BioNTech COVID-19 vaccine.  Agency's Alternative Etiology for did not feel well with Ibrutinib Capsule, Hard: More likely related to reaction after second dose of Pfizer BioNTech COVID-19 vaccine.  Agency's Alternative Etiology for Every joint hurt with Ibrutinib Capsule, Hard: More likely related to reaction after second dose of Pfizer BioNTech COVID-19 vaccine.  Agency's Alternative Etiology for right foot was swollen, red and painful with Ibrutinib Capsule, Hard: More likely related to reaction after second dose of Pfizer BioNTech COVID-19 vaccine.  Agency's Alternative Etiology for could hardly get out of the car with Ibrutinib Capsule, Hard: More likely related to reaction after second dose of Pfizer BioNTech COVID-19 vaccine with joint pain, pain and swelling in leg and neuropathy.   The reporter considered "right leg swollen and neuropathy after having pfizer" related to bnt162b2, bnt162b2 omi ba.4-5.   The reporter's assessment of the causal relationship of "right foot was swollen, red and painful", "every joint hurt", "could hardly get out of the car", "did not feel well", "blood bister on foot/blood blisters on skin, all over that came and went", "problems with nails, hair" and "was sweating last night" with the suspect product(s) bnt162b2, bnt162b2 omi ba.4-5 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 information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative and known drug safety profile, the events are assessed as related to the suspect drug. 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.