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Write-up: Coagulation disorder; Cardiovascular disorder; Vaccine was administered after 1h of relapse RBPA; 3x abundant with secondary hypovolaemic shock and death as a result; further decreasing hemoglobin; Arterial blood gas showed substantial lactate; This is a spontaneous report from physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB BE-FAMHP-DHH-N2021-75441 and received via Regulatory Authority. A 94-year-old male patient received BNT162B2 (COMIRNATY Solution for injection, lot no: EMO477, expiry date not reported), via an unspecified route of administration on 08Jan2021 at a single dose for covid-19 immunization. Medical history included Aorta neurysm CNI stage IV and prostate carcinoma. Concomitant medication included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]), bicalutamide (BICALUTAMIDE), calcium carbonate, colecalciferol (STEOVIT FORTE), propylene glycol (SYSTANE COMPLETE), acetylsalicylic acid (ASAFLOW) , iron, pantoprazole; all on unspecified dates for unspecified indications. Patient had nutritional supplement: Fortimel creme vanilla. On 08Jan2021, male patient suffered from cardiovascular disorder, coagulation disorder, rectal blood loss (vaccine was administered after 1h of relapse rbpa),hypovolaemic shock (3x abundant with secondary hypovolaemic shock and death as a result) ,lactate blood increase (Arterial blood gas showed substantial lactate) and hemoglobin decreased (further decreasing hemoglobin) during treatment with COMIRNATY. The patient died on 14Jan2021. An autopsy was not performed. Clinic comment: Patient was admitted to the emergency department on 8/1/2021 at 8am with a one-time large haemorrhage per anum. On PPA examination in the emergency department, no more blood was seen. The patient was stable in the ER (hemoglobin 8.5, previously 9.5) and it was decided to vaccinate the patient (vaccine administered around 12.30 pm in the ER). 1 hour later, haemorrhage per anum detected again. 3 episodes of extensive blood loss leading to secondary hypovolemic shock and death (around 16:30-17:00) despite transfusion. In consultation with the family no further endoscopy was done. Asaflow, listed in the concomitant medication alongside other drugs, had been used for years and taken until the day before. Aortic aneurysm was still present. The reporter does not rule out rupture of this aneurysm as a possible cause of death, but this is not consistent with the location of the haemorrhage, according to the reporter. No autopsy is planned and no further information is expected. According to the reporter and the head doctor of the hospital, the vaccine probably did not contribute to the evolution (the bleeding was already present before vaccination). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death
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