Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, Oxygen saturation, Pathology test, Peripheral ischaemia, Physical examination
Clinical narrative: unknown cause of death; presented with 1 week of respiratory distress; multifocal pneumonia; acute kidney injury; occlusive thrombus at origin of left subclavian and focal occlusive thrombus at left brachial bifurcation extending into the ulnar artery with distal reconstitution of radial and ulnar arteries; occlusive thrombus at origin of left subclavian and focal occlusive thrombus at left brachial bifurcation extending into the ulnar artery with distal reconstitution of radial and ulnar arteries; This is a literature report for the following literature source(s):   A 78-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "remote transient ischemic attack" (not ongoing), notes: Not on treatment as well; "coronary artery disease" (unspecified if ongoing), notes: Not on treatment as well; "obstructive sleep apnea" (unspecified if ongoing), notes: Not on treatment as well; "remote tobacco use" (unspecified if ongoing); "gastric bypass" (unspecified if ongoing); "hysterectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (Manufacturer Unknown)), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE (Manufacturer Unknown)), for COVID-19 immunisation. The following information was reported: DEATH (death, hospitalization, medically significant), 10 days after the suspect product(s) administration, outcome "fatal", described as "unknown cause of death"; RESPIRATORY DISTRESS (hospitalization, medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown", described as "presented with 1 week of respiratory distress"; PNEUMONIA (hospitalization, medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown", described as "multifocal pneumonia"; ACUTE KIDNEY INJURY (hospitalization, medically significant, life threatening), 10 days after the suspect product(s) administration, outcome "unknown"; ARTERIAL OCCLUSIVE DISEASE (hospitalization, life threatening), PERIPHERAL ISCHAEMIA (hospitalization, life threatening), all with latency 10 days after the suspect product(s) administration, outcome "unknown" and all described as "occlusive thrombus at origin of left subclavian and focal occlusive thrombus at left brachial bifurcation extending into the ulnar artery with distal reconstitution of radial and ulnar arteries". The patient underwent the following laboratory tests and procedures: Angiogram: demonstrated diffuse ground-glass opacities, notes: concerning for multi-focal pneumonia; near occlusive thrombus at the origin of left, notes: near occlusive thrombus at the origin of left subclavian as well as focal occlusive thrombus at the left brachial bifurcation extending into the ulnar artery with distal reconstitution of the radial and ulnar arteries; Blood creatinine (0.5-1.4): 2.2 mg/dl; 1.1 mg/dl, notes: compared to her baseline one year prior; Blood pressure measurement: ranging between 160 and 170, notes: SBP ranging hypertensive; Echocardiogram: was performed without any evidence of intra, notes: cardiac thrombus or embolizing pathology and the pathology of the extracted thrombus was benign; Haematology test: Positive lupus anticoagulant; Haemoglobin: 9.5 g/dl; Heart rate: 80, notes: Units: bpm; International normalised ratio: 1.4; Oxygen saturation: 95 to 100, notes: (SpO2); Pathology test: of the extracted thrombus was benign; physical examination: her left hand was cool to the wrist with decreased, notes: grip strength compared to the right but with preserved sensation and motor function; Platelet count: 303 x10 3/mm3; Respiratory viral panel: Negative; Negative; SARS-CoV-2 test: Negative; Negative; Ultrasound Doppler: She had a monophasic brachial signal by doppler, notes: ultrasound as well as faint monophasic signals at the radial, ulnar, and palmar arch locations; White blood cell count (3.8-10.6): 18.7 x10 9/l, notes: leukocytosis. Therapeutic measures were taken as a result of respiratory distress, pneumonia, acute kidney injury, arterial occlusive disease, peripheral ischaemia. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: The patient family history was not significant for any hypercoagulability or coagulopathy. The patient received her 3rd dose of the Pfizer-BioNTech (BNT162b2) vaccine 10 days prior to her presentation and subsequently began experiencing acute onset fevers and dyspnea as well as left hand pain. And for pneumonia she was placed on piperacillin/tazobactam, as well as occlusion at the origin of her left subclavian artery. A left upper extremity angiogram was performed at an outside hospital prior to her presentation and demonstrated a near occlusive thrombus at the origin of left subclavian as well as focal occlusive thrombus at the left brachial bifurcation extending into the ulnar artery with distal reconstitution of the radial and ulnar arteries. On evaluation, the patient was hypertensive with SBP ranging between 160 and 170 mmHg with a heart rate of 80 bpm. She was placed on bilevel positive airway pressure (BiPAP) at 80% fraction of inspired oxygen with an oxygen saturation (SpO2) of 95-100% on pulse oximetry. The patient reported rest pain in her left hand with associated coolness and weakness that improved since the initiation of an unfractionated heparin drip at the outside hospital. On physical examination, her left hand was cool to the wrist with decreased grip strength compared to the right but with preserved sensation and motor function. She had a monophasic brachial signal by doppler ultrasound as well as faint monophasic signals at the radial, ulnar, and palmar arch locations. Given her preserved sensory and motor function as well as her tenuous respiratory status, the patient was maintained on medical management until she stabilized for surgical intervention. On admission day 2, her respiratory status declined necessitating intubation with subsequent loss of signals to her left hand. The patient underwent revascularization via left brachial thrombectomy and placement of a stent graft at the origin of the left subclavian artery. An incision at the antecubital fossa allowed for exposure and control of the brachial, radial and ulnar arteries. The brachial artery inflow remained sluggish despite Fogarty embolectomy of mixed red and white thrombus proximally, at which point a retrograde angiogram via the arteriotomy demonstrated occlusion of the subclavian artery origin. The occlusion was traversed with a glidewire and predilated with a 4 mm balloon, after which a 7X39 mm balloon-expandable stent graft was deployed. At this point the inflow at the brachial artery was brisk along with a palpable left radial pulse and a palmar arch doppler signal on completion. Post-operatively her left upper extremity remained well-perfused with a palpable radial pulse. Repeat COVID-19 testing and respiratory virus panels were negative without any evidence of thrombocytopenia throughout her admission. TTE was performed without any evidence of intra-cardiac thrombus or embolizing pathology and the pathology of the extracted thrombus was benign. The patient was evaluated by hematology and subsequent hypercoagulability work-up was concerning for underlying lupus anticoagulant. Unfortunately, she continued to decline post-operatively from a pulmonary, renal, and hemodynamic standpoint with increasing need for vasopressor support. Infectious workup remained negative during her hospital course, the patient was made comfort measures only and expired on post-admission day 4.; Sender's Comments: Based on the known the information available the Causal relation between the events DEATH, RESPIRATORY DISTRESS, PNEUMONIA, ARTERIAL OCCLUSIVE DISEASE, PERIPHERAL ISCHAEMIA, ACUTE KIDNEY INJURY  and suspect drug cannot be excluded completely The impact of this report on the benefit/risk profile of the Pfizer drug 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-202300143473 Same article/drug and different patient/event;; Reported Cause(s) of Death: unknown cause of death