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Write-up: Back pain/pain coming in pulses to the right side of his back; Feeling cold; fever; bad taste in the mouth; suspicion of a thrombosis on the vascular side; arrhythmia/the rhythm changed from sinus rhythm to ventricular fibrillation; Ventricular fibrillation; Interchange of vaccine products; Interchange of vaccine products; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB FI-FIMEA-20213714. A 60-year-old male patient received 2nd dose (initial Pfizer dose) of BNT162B2 (COMIRNATY, Batch/Lot Number unknown) via an unspecified route of administration on 25May2021 (at the age of 60-year-old) as single dose for COVID-19 immunisation. Medical history included severe arteriosclerosis obliterans and coronary heart disease. Familial hypercholesterolemia and coronary heart disease. Coronary artery bypass grafting was first performed at the age of 26 in 1987, then bypass surgery again in 2005. In addition, the lower limb arteries have had to be operated, as well as the carotid arteries on both sides of the neck. Concomitant medications were not reported. The patient previously received 1st single dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) for COVID-19 immunisation. Patient had a terrible pain coming in pulses to the right side of his back within a few days (in May2021). they fetched a painkiller injection against the back pain from the health center on 01Jun2021, but it only helped for a while. patient had to the hospital in ambulance in the morning on 02Jun2021 where his heart stopped. He was resuscitated for 40 min. and finally the heart was set in motion. To intensive care unit - but on 05Jun2021 upon waking up he died. The doctor said the vaccination certainly had an effect on what happened, but it could not be proven. Patient was 60-year-old and belonged to the risk group due to his illnesses. On 27Jul2021 follow up from reporter, it was reported that the back pain was weird. It came to the so-called healthy side (right) and was alternating and was really intense. The pain was such that patient already said sometimes he could not stand it. A day or two after the vaccination, patient said he was just feeling like he had a fever. A bad taste in the mouth and was feeling cold all the time. Patient did not get fever easily so the thermometer did not show it. The health station doctor who wrote the referral to the ambulance said that at no point did patient have any signs of heart problems, nor were they experienced at home. Reporter did not know exactly what happened there when not everything was told and he had made a reminder about this, and reporter was still waiting for an answer. There, in the emergency room, patient''s heart stopped anyway and he was resuscitated according to the death certificate for 40 min. Reporter only got information from the doctor about what happened in the afternoon at about one 1 pm. On the phone reporter was told that the resuscitation lasted 30 mins. Patient was kept anesthetized connected to the machine and when they started to wake him up and took the equipment off he died. Although it was known that he might not survive, reporter was not informed of it. The doctor called when patient was already dead. When reporter visited there earlier and talked to the doctor and asked about the effect of the Covid vaccination in this case, the answer was that it certainly did contribute, but it could not be proven. The back apparently was not examined at all, although that was the reason why he was taken there. The back physician thought that in the images which were taken there was not anything that could have caused pain in the right side. He said that new images should be taken upon recovery and also raised a suspicion of a thrombosis on the vascular side. Death certificate: A 60-year-old man with severe arteriosclerosis obliterans and coronary heart disease. Familial hypercholesterolemia and coronary heart disease. Coronary artery bypass grafting was first performed at the age of 26 in 1987, then bypass surgery again in 2005. In addition, the lower limb arteries have had to be operated, as well as the carotid arteries on both sides of the neck. Now came to the hospital due to severe back pain, at the emergency department went unresponsive and immediately resuscitation was started. Resuscitated for a total of about 40 minutes, receiving ample adrenaline and amiodarone during resuscitation. Defibrillation for ventricular fibrillation many times. The Return of spontaneous circulation was achieved and the patient was then treated under temperature control in the intensive care unit. At the intensive care unit hemodynamics have been moderately stable as long as the patient was asleep. Discussed with cardiology, due to severe arteriosclerosis obliterans disease, patient was not suitable for arterial dilation treatments, although there was a possible narrowing in the coronary arteries. After further discussion with a thoracic surgeon, the patient was also not suitable for bypass surgery because all the veins had already been used. Decided not to resuscitate anymore. On 05Jun2021 waking up was started, upon waking began to have signs of arrhythmia. After extubation, the rhythm changed from sinus rhythm to ventricular fibrillation, through which the asystole. Not resuscitated. Official time of death was on 05Jun2021 15:51. The outcome of the event Atherosclerotic cardiovascular disease was fatal, of other events was unknown. The patient died on 05Jun2021 15:51. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : FI-NAM-19900040; Reported Cause(s) of Death: arrhythmia/the rhythm changed from sinus rhythm to ventricular fibrillation
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