Sex: M
Vaccine: COVID19
Symptoms: Aneurysm thrombosis, Angiogram, Imaging procedure, Investigation, Peripheral artery aneurysm
Clinical narrative: popliteal aneurysm thrombosis; popliteal aneurysm thrombosis; This is a literature report.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Former Smoking" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing), notes: treated with percutaneous intervention on dual antiplatelet therapy; "antiplatelet therapy" (unspecified if ongoing); "percutaneous intervention" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunisation. The following information was reported: PERIPHERAL ARTERY ANEURYSM (medically significant), ANEURYSM THROMBOSIS (medically significant), all with latency 2 days after the suspect product(s) administration, outcome "recovered" and all described as "popliteal aneurysm thrombosis". The patient underwent the following laboratory tests and procedures: Angiogram: the thrombosis of the left popliteal artery, notes: Anteroposterior reconstruction of the femoropopliteal segments; the thrombosis of the left popliteal aneurysm, notes: measuring 1.9cm in diameter; Imaging procedure: a thrombosed 1.9-cm left popliteal artery, notes: aneurysm (PAA) with intact three-vessel runoff and focal dilation of the right popliteal artery to 10 mm without thrombosis; screening: Negative; revealed a diminished ipsilateral ankle brachial, notes: index; Ultrasound abdomen: Negative; Ultrasound scan: patient recovered well and remains without symptom, notes: after 4 months with a widely patent bypass graft on surveillance duplex. Therapeutic measures were taken as a result of peripheral artery aneurysm, aneurysm thrombosis.  Clinical information: The patient developed severe left foot pain and discoloration 2 days after his second dose of the BNT162b2 SARS-CoV-2 vaccine (Comirnaty,Pfizer- BioTech). After a protracted 1 month course, avascular evaluation revealed a diminished ipsilateral ankle-brachial index.Further imaging demonstrated  a thrombosed 1.9-cm left popliteal artery aneurysm (PAA) with intact three-vessel runoff and focal dilation of the right popliteal artery to 10mm without thrombosis. He was taken to the operating room for revascularization and underwent a distal superficial femoral artery to below-knee popliteal artery bypass with autologous vein graft and PAA ligation. After bypass grafting, the left dorsal is pedis pulse was restored. The patient recovered well and remains without symptoms after 4 months.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events aneurysm thrombosis and peripheral artery aneurysm and the suspect drug BNT162B2 cannot be 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.