Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Joint injury, Tibia fracture
Clinical narrative: medial femoral condyle broken/thought hit knee on side of door; medial femoral condyle broken/thought hit knee on side of door; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4253215-00 (Abbvie).  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. Relevant medical history included: "Psoriatic arthritis moderate to severe chronic plaque psoriasis" (unspecified if ongoing); "orthoscopic surgery", start date: May2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TIBIA FRACTURE (medically significant), outcome "recovering", JOINT INJURY (medically significant) with onset 2021, outcome "unknown" and all described as "medial femoral condyle broken/thought hit knee on side of door". The action taken for adalimumab was unknown.   Clinical information: the patient experienced medial femoral condyle broken/thought hit knee on side of door. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect.  Causality for Humira (Adalimumab): The reporter's causality for the events of medial femoral condyle broken/thought hit knee on side of door and Knee injury was not provided. Since no determination has been received, the case is managed based on the company causality assessment.  AbbVie's opinion is that there is no reasonable possibility that the events of medial femoral condyle broken/thought hit knee on side of door unknown onset and medial femoral condyle broken/thought hit knee on side of door onset in 2021 are related to Humira(Adalimumab).  The reporter's assessment of the causal relationship of the events medial femoral condyle broken/thought hit knee on side of door and Knee injury with bnt162b2 was possible 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: As there is limited information in the case provided, the causal association between the reported events Tibial fracture, joint injury and the suspect drug BNT162B2 cannot be excluded. 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.