Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Echocardiogram, Haematology test, Haemoglobin
Clinical narrative: He reported initially experiencing significant pain in his right great toe approximately 6 weeks prior to presentation after receiving the Pfizer-BioNTech (BNT162b2) vaccine; thrombectomy of the left popliteal, anterior/posterior tibial and peroneal arteries; limited range of motion of his toes; numbness; decreased strength; This is a literature report for the following literature source(s):   A 16-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "bilateral myringotomy" (not ongoing); "dental extractions" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (caused and prolonged hospitalization, medically significant), 21 days after the suspect product(s) administration, outcome "recovered", described as "He reported initially experiencing significant pain in his right great toe approximately 6 weeks prior to presentation after receiving the Pfizer-BioNTech (BNT162b2) vaccine"; PERIPHERAL ARTERY THROMBOSIS (caused and prolonged hospitalization, medically significant), 21 days after the suspect product(s) administration, outcome "recovering", described as "thrombectomy of the left popliteal, anterior/posterior tibial and peroneal arteries"; JOINT RANGE OF MOTION DECREASED (caused and prolonged hospitalization, medically significant), 21 days after the suspect product(s) administration, outcome "unknown", described as "limited range of motion of his toes"; HYPOAESTHESIA (caused and prolonged hospitalization, medically significant), 21 days after the suspect product(s) administration, outcome "unknown", described as "numbness"; ASTHENIA (caused and prolonged hospitalization, medically significant), 21 days after the suspect product(s) administration, outcome "unknown", described as "decreased strength". The patient was hospitalized and prolonged hospitalization for pain in extremity, peripheral artery thrombosis, joint range of motion decreased, hypoaesthesia, asthenia (hospitalization duration: 7 day(s)). The patient underwent the following laboratory tests and procedures: Angiogram: evidence of vasospasm of the posterior tibial, notes: and anterior tibial artery to the level of the ankle in the left lower extremity; demonstrated an occluded popliteal artery; Ankle brachial index: 0.55; improved, notes: On his last vascular surgery follow-up; Antiphospholipid antibodies: positive, notes: for antiphospholipid syndrome; positive, notes: for antiphospholipid syndrome; Beta-2 glycoprotein antibody: positive, notes: for antiphospholipid syndrome; positive, notes: for antiphospholipid syndrome; Blood immunoglobulin G: positive, notes: for antiphospholipid syndrome; positive, notes: for antiphospholipid syndrome; Blood immunoglobulin M: positive, notes: for antiphospholipid syndrome; positive, notes: for antiphospholipid syndrome; Echocardiogram: negative, notes: for any intra-cardiac abnormalities; Haematology test: evaluated; Haemoglobin: 13 g/dl; Heart rate: 90, notes: Unit: bpm, Normal; International normalised ratio: 1.1; toe pressure: 0, notes: on the affected left foot; 1.21, notes: On his last vascular surgery follow-up; 81, notes: On his last vascular surgery follow-up; Pathology test: of the extracted thrombus was benign; Platelet count: 170 × 103 /mm3; Red blood cell sedimentation rate: 25, notes: Unit: mm/h, elevated, without any evidence of leukocytosis or thrombocytopenia; SARS-CoV-2 test: negative, notes: at an outside hospital prior to presentation; negative, notes: during admission and there was no evidence of thrombocytopenia through- out his hospital course; Ultrasound Doppler: a non-occlusive left popliteal artery thrombus on, notes: on lower extremities; patent posterior tibial artery at the foot; White blood cell count: 6.8 × 103 /mm3. Therapeutic measures were taken as a result of peripheral artery thrombosis, hypoaesthesia, asthenia.  Clinical course: He reported initially experiencing significant pain in his right great toe approximately 6 weeks prior to presentation after receiving the Pfizer-BioNTech (BNT162b2) vaccine. This right toe pain resolved, and he presented with left foot pain and numbness. His past medical history was significant for anxiety and depression. His past surgical history included bilateral myringotomy as well as dental extractions. His family history was not significant for any hypercoagulability or coagulopathy. CTA demonstrated evidence of vasospasm of the posterior tibial and anterior tibial artery to the level of the ankle in the left lower extremity. The patient was also found to have a non-occlusive left popliteal artery thrombus on lower extremity duplex ultrasound. TTE performed at the time was negative for any intra-cardiac abnormalities. The patient was tested negative for COVID- 19 at an outside hospital prior to presentation and laboratory findings were notable for an elevated erythrocyte sedimentation rate of 25 mm/h without any evidence of leukocytosis or thrombocytopenia. On presentation he was noted to be normotensive with a heart rate of 90 bpm and therapeutic on enoxaparin via anti-Xa monitoring. The patient had palpable bilateral popliteal pulses as well as bilateral palpable posterior tibial pulses with a weak left dorsalis pedis signal. He continued to exhibit pain in his left foot as well as decreased strength and limited range of motion of his toes. The patient was taken for a left lower extremity angiogram which demonstrated an occluded popliteal artery (Fig. 2). He underwent thrombectomy of the left popliteal, anterior/posterior tibial and peroneal arteries and subsequent catheter-directed suction thrombectomy of the anterior and posterior tibial arteries. At the completion, the patient had a multiphasic posterior tibial artery signal, despite poor angio-graphic flow into the foot. Post-operatively he had an ABI of 0.55 and a toe pressure of 0 on the affected left foot. The patient's left foot symptoms improved during admission and duplex ultrasound confirmed a patent posterior tibial artery at the foot. The pathology of the extracted thrombus was benign, and the patient was evaluated by hematology. His hematologic work-up proved to be positive for lupus anticoagulant including a positive beta 2 glycoprotein I (beta (2) -GPI), immunoglobulin (Ig) G, and IgM concerning for antiphospholipid syndrome. Repeat COVID-19 testing during admission was negative and there was no evidence of thrombocytopenia throughout his hospital course. The patient was transitioned from an unfractionated heparin drip to warfarin with an enoxaparin bridge and discharged on post-admission day 7. He was seen in follow-up by hematology with repeat positive lupus anticoagulant, beta (2) -GPI, IgG, and IgM suggestive of antiphospholipid syndrome. On his last vascular surgery follow-up (1-year post-presentation) his posterior tibial artery remains patent into the foot with an improved ABI and toe pressure of 1.21 and 81, respectively. Baseline demographic and clinical data of each patient: Age, years: 16, Gender: Male, Hemoglobin, g/dL: 13, White blood cell count, per mm3: 6.8 × 103, Platelet count, per mm3: 170 × 103, International normalized ratio: 1:1, Symptom onset after vaccination, days: 21, Location of thrombus: Popliteal artery, Hematologic testing: Positive lupus anticoagulant, Discharge anticoagulation: Warfarin; Sender's Comments: Based on the information in the case report, a possible causal relationship between the events pain in extremity, Thrombosis arterial leg ,hypoaesthesia, foot pain, joint range of motion decreased, asthenia 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.,Linked Report(s) : US-PFIZER INC-202300143474 Same article;drug/differnet patient;event;