Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Lethargy, Malaise, Mobility decreased, Pruritus
Clinical narrative: LEG WOUND THAT BECAME SEPTIC; INFECTION IN THE LEG WOUND; LEG THAT GOT INFECTED DEVELOPED CELLULITIS/leg had turned red; NOT BEING ABLE TO GET UP AS OFTEN AS SHE; FATIGUE/TIRED; SKIN IS DRY AND ITCHY; SKIN IS DRY AND ITCHY; Immunoglobulin M high; Lethargic; Temporomandibular joint; SICK/felt really sick; Stomach pain; This is a solicited report facilitated collect based on the information received by Pfizer from AbbVie Inc. (MFR Control No. 21K-163-3842176-00). A non-contactable consumer (patient) reported that a 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; ibrutinib (IMBRUVICA), oral from 2021 (Batch/Lot number was not reported) to 2021, at 420 mg,1 in 1 D, oral from Feb2021 (Batch/Lot number was not reported) to Mar2021, at 420 mg,1 in 1 D, oral from 26Apr2021 (Batch/Lot number was not reported) to 2021, at 140 mg,1 in 1 D, oral from 2021 (Batch/Lot number was not reported) to 2021, at 140 mg,2 in 1 D, oral from 2021 (Batch/Lot number was not reported) to 2021, at 280 mg,1 in 1 D, oral from 03Aug2021 (Batch/Lot number was not reported) to an unspecified date, at 140 mg,1 in 1 D for Chronic Lymphocytic Leuk Of B-Cell Type Not Achieve Remis Cll. Medical history in Nov2020 included fall that resulted in a leg wound, resulted in a severe cut, tripped and cut her foot and had a lot of bleeding. The patient's concomitant medications were not reported. The patient was with events of infection in the leg wound that became septic and infection in the leg wound and non-serious fall that resulted in a leg wound, not being  able to get up as often as she should, fall which resulted in a severe cut, cut on leg that got infected developed cellulitis, headaches, fatigue/tired, tripped and cut her foot and had a lot of bleeding, igm is to high, skin is dry and itchy, stomach pain, lethargic, temporomandibular joint and sick with imbruvica (ibrutinib). On unknown dates in 2021, the patient experienced not being able to get up as often as she should, fatigue/tired, tripped and cut her foot and had a lot of bleeding in Nov2021, in 2021 igm was to high, skin was dry and itchy, stomach pain lethargic, temporomandibular joint and sick. In Nov2020, the patient experienced fall that resulted in a leg wound and fall which resulted in a severe cut, in 2021, the patient experienced infection in the leg wound and cut on leg that got infected developed cellulitis In Mar2021, the patient experienced infection in the leg wound that became septic. On 10May2021, the patient experienced headaches. in 2021, the infection in the leg wound that became septic and infection in the leg wound resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date of 2021, patient received 1st dose COVID-19 Vaccine manufactured by UNKNOWN, lot number. UNKNOWN, expiration date UNKNOWN. On 10May2021, patient received 2nd dose COVID-19 Vaccine manufactured by UNKNOWN, lot number UNKNOWN, expiration date UNKNOWN. The patient reported that she had a fall that resulted in a leg wound in November 2020. She was being seen for wound care at the hospital and a few weeks ago that is in MAR 2021 for four days, she developed an infection . In the leg wound that became septic. She had been off the Imbruvica since developing the infection. The patient had cut on leg that got infected and developed into cellulitis and went unnoticed. The patient has taken to hospital in March 2021 because leg had turned red. The patient was admitted for 4 days for sepsis. physician reduced Imbruvica to 140mg on 26-Apr-21. The medication has been on hold until today. Dose is being verified with prescriber. The Patient had a fall which resulted in a severe cut. She said the wound was not properly treated and she ended up with sepsis in the hospital. The patient was doing weekly blood test to make sure her WBC was okay. Her leg was bandaged and she goes to a wound care center. She has also been experiencing headaches and fatigue since not being able to get up as often as. she should (as reported) The patient stated Imbruvica is still on hold, as she still has the infection. The Patient reported that she tripped and cut her foot and had a lot of bleeding. The wound become infected and she was admitted to the hospital for 3 days (also reported as 4 days) for sepsis. Her medication was held at the time. She was now goes for wound care and the infection has cleared from her system. At the time she was also taking 50mg of prednisone. She also reports that her IGM was too high but her red blood cells and white blood cells were ok. Her skin was dry and itchy. Patient also reported stomach pain and being tired or lethargic. The patient reported she had temporomandibular joint (TMJ) and this contributes to her headaches. She said they were not that bad, and they were manageable. Patient said at the higher dose she felt really sick, so her provider switched her to a low dose of 140mg/ day. The patient said she handles the lower dose way better. Patient Record indicated patient was previously taking 420MG Tablet and patient decreased to 140MG Tablet then increased to 280MG Tablet and then decreased 140MG Tablet. The patient was treated with prednisone. Causality for IMBRUVICA(IBRUTINIB) The reporter's causality for the event(s) of infection in the leg wound that became septic, infection in the leg wound, fall that resulted in a leg wound onset in november 2020, not being able to get up as often as she should, fall which resulted in a severe cut, fall that resulted in a leg wound onset in nov2020, cut on leg that got infected developed cellulitis, headaches, fatigue/tired, tripped and cut her foot and had a lot of bleeding unknown onset, tripped and cut her foot and had a lot of bleeding unknown onset, igm is to high, skin is dry and itchy unknown onset, skin is dry and itchy unknown onset, stomach pain, lethargic, temporomandibular . joint and sick was not provided. abbvie's opinion is that there is no reasonable possibility that the events of infection in the leg wound that became septic, infection in the leg wound, fall that resulted in a leg wound onset in nov2020, not being able to get up as often as she should, fall which resulted in a severe cut, fall that resulted in a leg wound onset in nov2020, cut on leg that got infected developed cellulitis, headaches, fatigue/tired, tripped and cut her foot and had a lot of bleeding unknown onset, igm is to high and temporomandibular joint are related to imbruvica(ibrutinib). abbvie's opinion is that there is a reasonable possibility that the events of tripped and cut her foot and had a lot of bleeding unknown onset and sick are related to imbruvica(ibrutinib). abbvie's opinion is that the events of skin is dry and itchy unknown onset, skin is dry and itchy unknown onset, stomach pain and lethargic are not assessable. The last action taken in response to the events for ibrutinib was dose reduced to 140mg on 03Aug2021.  Therapeutic measures were taken as a result of the events included prednisone. The outcome of the leg wound that became septic and infection was recovered in 2021, other events was unknown.  The reporter's assessment of the causal relationship of the event 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 the company causality assessment.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the 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.