arrest cardiac; 3rd degree av block occurs; asthenia; nausea; vomiting; diarrhea; off label use; interchange of vaccine products; this is a spontaneous report received from a contactable reporter(s) (physician) from the regulatory authority. regulatory number: it-minisal02-843389. a 45 year-old male patient received bnt162b2 (comirnaty), administration date 10feb2022 (lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. the patient's relevant medical history and concomitant medications were not reported. vaccination history included: moderna (dose 2), administration date: oct2021, for covid-19 immunisation, reaction(s): "asthenia", "loss of consciousness", "drowsiness"; covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunisation. the following information was reported: off label use (death, medically significant) with onset 10feb2022, outcome "fatal", described as "off label use"; interchange of vaccine products (death, medically significant) with onset 10feb2022, outcome "fatal", described as "interchange of vaccine products"; cardiac arrest (death) with onset 12feb2022, outcome "fatal", described as "arrest cardiac"; atrioventricular block (medically significant) with onset 12feb2022, outcome "unknown", described as "3rd degree av block occurs"; asthenia (non-serious) with onset 10feb2022, outcome "unknown", described as "asthenia"; nausea (non-serious) with onset 10feb2022, outcome "unknown", described as "nausea"; vomiting (non-serious) with onset 10feb2022, outcome "unknown", described as "vomiting"; diarrhoea (non-serious) with onset 10feb2022, outcome "unknown", described as "diarrhea". the events "arrest cardiac", "3rd degree av block occurs" were evaluated at the emergency room visit. the patient underwent the following laboratory tests and procedures: computerised tomogram: (unspecified date) no results; echocardiogram: (unspecified date) results below, notes: no evidence of pulmonary embolism, cardiac akinesia; fibrin d dimer: (12feb2022) 3549 ng/ml; neurological examination: (12feb2022) no success; specialist consultation: (12feb2022) no success. therapeutic measures were taken as a result of cardiac arrest, atrioventricular block. actions taken (cardiopulmonary resuscitation started, performed 2 defibrillations then development of asystole, administered 5 mg of adrenaline then intubated. arrives in the emergency room at 13:10 with resuscitation maneuver in progress, asystolic, cardiac akinesia ecmo va-veno-arterial extracorporeal membrane oxygenation positioning is carried out with arterial cannula 15 f in the right femoral artery and venous cannula 25 f in the left femoral vein, start ecmo at 13:24. completely still and initial thrombotic apposition in the left ventricle and aorta. despite very serious hemodynamic instability, he is accompanied by radiodiagnosis. at 2:50 pm he enters always asystolic ward, complete biventricular akinesia with thrombus in the left ventricle and ascending aorta with immobile aortic valve. he is declared dead at 3:10 pm.). the patient date of death was 12feb2022. the reported cause of death was cardiac arrest, off label use, interchange of vaccine products. it was not reported if an autopsy was performed. reporter comment: the patient presented a first adverse reaction after the administration in october of the second dose of moderna vaccine characterized by asthenia, drowsiness and loss of consciousness. subjected to neurological and cardiovascular tests in the emergency room without success. the second reaction almost immediately after the administration of the third pfizer vaccine dose as described above. senders comments: i asked the reporter to retrieve the vaccine batch and expiration date. as soon as i receive it, i will insert the data in the pharmacovigilance report. no follow-up attempts are possible; information about lot/batch number cannot be obtained. no further information is expected.; reporter's comments: the patient presented a first adverse reaction after the administration in october of the second dose of moderna vaccine characterized by asthenia, drowsiness and loss of consciousness. subjected to neurological and cardiovascular tests in the emergency room without success. the second reaction almost immediately after the administration of the third pfizer vaccine dose as described above.; reported cause(s) of death: cardiac arrest; off label use; interchange of vaccine products

test name: body ct; result unstructured data: test result:no results; test name: echocardiogram; result unstructured data: test result:results below; comments: no evidence of pulmonary embolism, cardiac akinesia; test date: 20220212; test name: fibrin d dimer; result unstructured data: test result:3549 ng/ml; test date: 20220212; test name: neurological examination; result unstructured data: test result:no success; test date: 20220212; test name: cardiological examination; result unstructured data: test result:no success

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