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Life Threatening? No
Write-up: Death; Asphyxiation; This is a spontaneous report received from a contactable physician via regulatory authority. Regulatory authority report number CH-SM-2021- 14151. A 34-years-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 27Mar2021 (Batch/Lot Number: unknown) as single dose (at the age of 34) for covid-19 immunisation. Medical history included neurofibromatosis, type 1 (von Recklinghausen''s disease) (surgery several times about 15 years ago in the neck and cervical spine region (C3-D1 stabilization in 2001)), hemithyroidectomy from 2008 to an unknown date. She had no known allergies. The patient''s concomitant medications were not reported. On 27Mar2021 she received the first administration of COMIRNATY without any problems. On 29Mar2021 (the day of her death) she first accused severe pain in her left arm, later she declared that she felt her neck swelling on the left. Her parents noticed a swelling that grew "visibly", to the point of compromising the airways. After alarming the emergency sercice they started a heart massage. Upon arrival of the rescuers, an asystole and a complete obstruction of the upper respiratory tract was found. An intubation was attempted which was not feasible, followed by a successful cricotomy, but despite the resuscitation with 100% oxygen for 15'' there was no sign of recovery (always in asystole). The parents specifically asked not to extend the resuscitation maneuvers any longer. Given the rapid evolution of the swelling, the hypothesis is that of an arterial hemorrhage. The doctors explained to the parents the need to perform an autopsy to know the exact cause of death but they were against it and therefore it was not performed. The patient''s illness in Jul2020 was defined as stable. The patient experienced death on 29Mar2021, fatal asphyxiation on 29Mar2021. An autopsy was not performed. This case was reported as serious with seriousness criterion Results in death. A causal relationship between COMIRNATY and the events death and Asphyxiation was assessed as being unlikely. Sender''s comment: Sudden death of a young patient known for neurofibromatosis two days after administration of Comirnaty. Death occurred from asphyxia due to an obstruction of the airways. Sudden arm pain, latency time (2 days) and unilateral swelling speak against a possible anaphylactic allergic cause due to the vaccine. In the first hypothesis there is a possible arterial dissection with bleeding that has obstructed the soft parts with consequent asphyxiation. Neurofibromatosis as a risk factor for arterial dissection: Update (1): "Other manifestations - .... Other vascular lesions may cause stenosis of major vessels, including the internal carotid, resulting in moyamoya disease. In rare instances, arterial dissection can occur, sometimes leading to life-threatening hemorrhage. " Therefore, despite the absence of an autopsy to support the hypothesis of haemorrhage, given the patient''s disease (neurofibromatosis) and the elements that speak against edema on anaphylaxis, we judged the causal correlation with the vaccine as unlikely. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender''s Comments: In concurring with the reported physician, the reported fatal event of Asphyxiation represents an intercurrent medical condition and unrelated to bnt162b2 .; Reported Cause(s) of Death: Asphyxiation
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