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Write-up: Death unexplained/massive pulmonary embolism in the context of neoplastic COVID +; Massive stroke related to intracardiac thrombus; massive pulmonary embolism in the context of neoplastic COVID +/Covid19 PCR performed: positive/CT scan compatible with covid 19 infection; massive pulmonary embolism in the context of neoplastic COVID +/Covid19 PCR performed: positive/CT scan compatible with covid 19 infection; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, FR-AFSSAPS-DJ20210104. A 75-year-old female patient received bnt162b2 (COMIRNATY, lot number: EM0477), via intramuscular on 14Jan2021 at single dose for COVID-19 vaccination. Medical history included stage IIIB colon adenocarcinoma- (pT3N1aM0) from Aug2020 and unknown if it was ongoing with rectosigmoid resection on 27Aug2020 and ileostomy closure on 09Oct2020. HTA (arterial hypertension), ACFA (complete arrhythmia by atrial fibrillation), Non-insulin-dependant diabetes, Dyslipidemia, Obstructive pyelonephritis in renal colic, Hypothyroidism, right acoustic neuroma (operated on in 2014 with sequelae facial palsy), and all unknown if they were ongoing and notion of allergy to iodine. The patient followed in particular for an adenocarcinoma of the colon treated with simplified LV5FU2 (cisplatin, 5-fluorouracil, leucovorin) as an adjuvant with a 4th treatment carried out in a day hospital on 14Dec2020. The patient is non-DPD deficient. The patient lives at home with her husband, a household helper, a nurse who comes several times a week. Autonomous for toilet and meals. The report of the day hospitalization of 14Dec2020 mentioned: INTERCURE: G1 asthenia throughout the intercure, improvement in BP, better general condition. CLINICAL REVIEW: WHO 1-2, BP 117/70 mmHg, HR 102 bpm, afebrile, 97% AA saturation. Weight 62 kg stable. Normal clinical examination. She received her cure of LV5FU2. She was hospitalized on 17Dec2020 for a stroke in the territory of the right posterior cerebral artery, with thrombus in P1, not revascularized (fall from her bed at 6 a.m., her husband noting a left hemicorporeal deficit and dysarthria). An MRI is immediately performed which reveals an ischemic stroke of the posterior arm of the right internal capsule and of the diffusing right internal and occipital temporal cortex. On the TOF, we find an occlusion of the posterior cerebral artery from the beginning and an occlusion of the right internal carotid artery with slow cerebral artery and permeable middle cerebral artery. EDTSA carried out on 18Dec2020: "The echo-Doppler anomalies presented can be compatible either: with an obliteration of the right internal carotid artery downstream of the portion visualized by echo-Doppler (which is difficult to assert because on indirect arguments), if this is the case, it looks old since ''''with good replacement of the cerebral arteries via the anterior communicating artery or with a stenosis of the right siphon without occlusion of the internal carotid artery explaining the velocities preserved in right MCA". Cerebral MRI of 21Dec2020: Ischemic stroke made up of the right posterior superficial Sylvian territory and the superficial and deep territories of the right posterior cerebral artery. Recanalization of the right internal carotid artery and the right posterior cerebral artery of fetal origin. During the stay, she improved neurologically, with partial regression of motor impairment, total regression of visual impairment and dysarthria. Upon discharge, she presented a NIHSS score of 2, with a slight drop in her left upper limb before 10 seconds, and sensitive extinction. There persist ataxia of the lower limbs and facial paralysis which were sequelae respectively of an old cerebellar lesion and a neuroma. The patient is anticoagulated by LMWH tinzaparin sodium (INNOHEP), due to the occurrence of a stroke under ELIQUIS, her known AF, and the neoplastic context. INNOHEP will be continued in the long term. She was leaving for her home on 24Dec2020. Patient finally admitted to Follow-up and Rehabilitation Care on 30Dec2020. Decision with the patient not to resume adjuvant chemotherapy given the loss of autonomy and an unfavorable benefit-risk balance. Similarly contraindication to any colonoscopy. Exploration of an adrenal adenoma accidentally discovered on the control hepatic MRI. Hypercalcemia on 31Dec2020 prompting the administration of Pamidronate. On 12Jan2021: Positive orthostatic hypotension test. Concomitant medications included oxazepam (SERESTA) from Dec2020, atorvastatin calcium (ATORVASTATINE ARROW), tinzaparin sodium (INNOHEP) from 22Dec2020 for Atrial fibrillation, enalapril maleate (ENALAPRIL EG), calcium phosphate monobasic, magnesium glycerophosphate, phosphoric acid, sodium phosphate dibasic (PHOSPHONEUROS) from 19Jan2021, bisoprolol fumarate (BISOPROLOL SANDOZ), pantoprazole sodium sesquihydrate (PANTOPRAZOLE MYLAN) from Dec2020, dexamethasone from 19Jan2021, sitagliptin (JANUVIA), amoxicillin, clavulanate potassium (AUGMENTIN) from 19Jan2021, cinacalcet hydrochloride (MIMPARA) from 12Jan2021, apixaban (ELIQUIS), enalapril maleate, lercanidipine hydrochloride (LERCAPRESS), esomeprazole, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL), alprazolam. Notification from a hospital specialist concerning this patient who died as a result of vaccination with COMIRNATY. Vaccination by COMIRNATY on 14Jan2021 with good immediate tolerance. The same day realization of a transthoracic ultrasound which was programmed: LVEF conserved at 50% in SB on an enlarged LV (SIV and PP 11mm) not dilated. Bi-atrial expansion with left atrium 86 ml / m? and right atrium 21 cm?. No increase in left ventricle filling pressures. Central minimal mitral insuffisiency. Tricuspid aortic valve, mean gradient 2 mmHg. Moderately impaired RV function, no PH with PAPS estimated at 30-35 mmHg. Breathable dilated IVC. Free pericardium. Transesophageal echocardiography: Left auricle not free with impaired emptying rate, no thrombus directly visualized but significant spontaneous contrast. Bubble test: No patent foramen ovale found. On 15Jan2021: Well clinically. No headache, no cough, no transit disorder following the Covid vaccination. Good constants, afebrile. On 16Jan2021: Appearance of a cough. She was reviewed in hospitalization oncology day on 18Jan2021 for reassessment. CLINICAL EXAMINATION: WHO 3 with above all significant loss of autonomy. Consciousness normal, higher functions a little slowed down and tendency to drowsiness. BP 106/67 mmHg, HR 89 bpm, afebrile, 97% AA saturation. Weight 60 kg (-2 kg). Staggering walk with loss of balance, must hold on to furniture. On 18Jan2021: No fever, no diarrhea, no other symptom found apart from the cough. Covid19 PCR performed: positive. On 19Jan2021: blood pressure 140/70 mmHg, pulse 60 / min, respiratory level: FR at 15 / min, Rhinorrhea, expectorating cough, no dyspnea, no chest pain, no anosmia or ageusia, asthenia, no headache auscultation with clear reduction of MV on the left base, elimination of vibrations and dullness therefore: possible pleural effusion. At the cardio level: no palpitation, no sign of HF, or sign of DVT, regular auscultation without noticeable breath. At the digestive level: no diarrhea, no nausea or vomiting, no abdominal pain, palpation within the standards. Note that the patient does not want to go to intensive care in the event of deterioration, she does not want intubation. At the end of the morning, episode of loss of contact with return to full consciousness for several minutes, it is possible that she was suffering from epilepsy after his stroke with lowering of the epileptogenic threshold on COVID / fever. No brain imaging. On the other hand, in view of the saturation: initiation of dexamethasone and AUGMENTIN + realization of an emergency chest scanner today (on 19Jan2021). CT scan compatible with covid 19 infection (minimal degree of involvement <10%). On 20Jan2021 at 11:30 am the consultation word mentions: better today, FR at 22 / min, no anosmia or ageusia, no diarrhea, no dyspnea, no chest pain, no sign of cardiac insufficiency no sign of DVT or VTE. Auscultation with the same anomalies as yesterday (clear drop in MV in left base) therefore monitoring. The same day on 20Jan2021, call from a licensed nurse around 2:35 p.m. for a patient found on the ground, not reactive. Arrival of the doctor in the room: patient in a state of clinical death, facial cyanosis, no pulse, no breathing, no heart rate. Total asystole. Time of death recorded 14:45. Most likely in no flow for 15 minutes. Patient who had refused resuscitation care yesterday in the event of degradation (refusal of CPR and intubation) so in this context no resuscitation procedure started. Opinion of the doctor in charge of the patient since entry into Follow-up and Rehabilitation Care: presence of an intracardiac thrombus with great certainty according to cardiologists. Possible cause of death: massive pulmonary embolism in the context of neoplastic COVID +, Massive stroke related to intracardiac thrombus. Exclusive role of COVID (see respiratory distress) very unlikely because no major respiratory damage in this patient, correct respiratory rate and saturation. AF was fairly stable (no recent ECG either). Unexplained death notified because the participatory role of the vaccine cannot be completely excluded. The patient died on 20Jan2021. An autopsy was not performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: massive pulmonary embolism in the context of neoplastic COVID +; Massive stroke related to intracardiac thrombus; Massive stroke related to intracardiac thrombus; massive pulmonary embolism in the context of neoplastic COVID +; massive pulmonary embo
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