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Write-up: Ischemic stroke; Embolism pulmonary; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-2021052029. A 78-years-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 19Apr2021 (Lot Number: EW2246) as 2nd dose, single for covid-19 immunisation. Medical history included Early cognitive disorders, Type 2 diabetes mellitus, Hypertension arterial, Reflux esophagitis, Regenerative iron deficiency anaemia. No COVID HISTORY. Concomitant medications included esomeprazole, diltiazem, bisoprolol, hydrochlorothiazide, ramipril, metformin, tramadol, paracetamol. The patient previously received first dose of bnt162b2, on 23Mar2021 (Lot Number: ER9470) as 1st dose, single for covid-19 immunisation. 17 days after Dose 2, on 06May2021, the patient was sent to the Emergency Room by their general practitioner due to a change in their general state with dyspnoea, date of onset not provided. The clinical examination was without any significant particularity (35.7?C; 133/77mmHg; Heart rate 128/minute; saturated oxygen 99% in ambient air; respiration rate 28/minute; Glasgow Coma Scale 15 despite spatial-temporal disorientation; Glc cap. 3g/l; symmetrical vesicular murmur with no rattle, neurological examination with no signs of localisation). Heart rate slowed spontaneously to sinus rhythm at 90/minute. The blood panel revealed anaemia (probably related to the oesophageal pathology), hyperleucocytosis (19.8g/l), moderate renal insufficiency (MDRD 56ml/minute) and, above all, hypoxia-hypocapnia, suggesting a pulmonary embolism, although the calves are supple and not painful. The platelets are normal at 387g/l. Prothrombin time 70%, activated partial thromboplastin time 0.8. This hypothesis is confirmed by computed tomography angiography: multiple endovascular lacunar images compatible with right middle and lower lobar pulmonary embolism. The patient is placed on Apixaban, and admitted to hospital. The patient had a slightly agitated night (got up, fell, incoherent remarks). In the afternoon of 07May2021, (Day 18 from Dose 2), while starting an erythrocyte transfusion, the respiratory insufficiency worsens with saturated oxygen at 80% in ambient air, appearance of crepitants at mid-field (Furosemide, high concentration oxygen), increase of cognitive disorders with agitation, no hemodynamic alteration. Platelets on 07May2021: 386g/l. Upon being taken into care around 16:45: 35.7?c; 60/40mmHg ; heart rate 94/minute; saturated o2 85% on FiO2 84% ; Respiratory rate 28/minute; Glasgow Coma Scale 3; Visual Analogue Scale 15; Glc cap. 5.09g/l Conduct: non-invasive ventilation (NIV) with face mask; Noradrenalin; cardiac echocardiogram done: no right or left myocardial failure. Sudden neurological deterioration with Glasgow Coma 3, the appearance of a left mydriasis while an anticoagulant treatment had just been started: a cerebral computed tomography scan is requested. Progression:The gazometry on non-invasive ventilation is catastrophic with significant acidosis. The computed tomography scan showed a large right parietal-occipital hypodensity indicating an ischemic stroke. No cerebral haemorrhage. No mass effect or parenchymal expansive process. Ventricular system, cortical sulci and basal cisterns are unremarkable. Vasculodegenerative leukopathy. Death is recorded at 18:25 at the end of carrying out the computed tomography scan. The declarant concludes a thrombotic storm with severe pulmonary embolism then ischemic stroke despite the prescription since the day before of Apixaban in a hypertensive, type II diabetic man who had received the second injection of Comirnaty vaccine 17 days earlier. Regenerative iron deficiency anaemia which could not be investigated but probably related to oesophageal pathology on hiatus hernia (history of oesophagitis). Moderate renal insufficiency. Coma then asystole leading to death. According to the declaring resucitator, the clinical signs seemed very unusual. He suggested a hypothesis of a paradoxical embolism linked to a permeable oval foramen, but the localisation of the cerebral vascular accident does not favour this hypothesis. Further, the pulmonary embolism was not massive. Awaiting information on a possible blood sample for a thrombophilia test and anti-PF4 antibody level test (but unlikely to have been carried out in this very rapidly unfavourable context). In summary: pulmonary embolism followed by a massive ischemic stroke 17 days after the 2nd dose of COMIRNATY in a 78-year old patient, leading to his death; normal platelets, no dose of anti-PF4 antibodies." The patient died on 07May2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Embolism pulmonary; Ischemic stroke
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