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Write-up: Exitus letalis, septic shock during COVID-19 pneumonia; suspected septic and cardiogenic shock in the setting of bacterial superinfected Covid-19 pneumonia; suspected septic and cardiogenic shock in the setting of bacterial superinfected Covid-19 pneumonia; suspected septic and cardiogenic shock in the setting of bacterial superinfected Covid-19 pneumonia; Exitus letalis, septic shock during COVID-19 pneumonia; This is a spontaneous report received from a contactable pharmacist via a regulatory authority. Regulatory authority report number CH-SM-2021-15010. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included Dementia of the Alzheimer''s type NOS, Atrial fibrillation paroxysmal from 2018 to an unknown date , Aneurysm of ascending aorta, Ischemia cerebrovascularfrom 21Dec2018 to an unknown date , Lumbar pain syndrome , Acute renal failure with stage1. The patient''s concomitant medications were not reported. The patient experienced exitus letalis, septic shock during covid-19 pneumonia on an unspecified date, exitus letalis, septic shock during covid-19 pneumonia on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The patient died on an unspecified date. It was not reported if an autopsy was performed. outcome of events was fatal.The 94-year-old male patient received his second vaccination dose of Comirnaty (Tozinameran; lot no. unknown) on 31Mar2021 for immunisation against COVID-19. On 19Apr2021, the patient was hospitalised and tested positive for Sars-CoV2. During the course, the patient became increasingly haemodynamically and respiratory unstable with suspected septic and cardiogenic shock in the setting of bacterial superinfected Covid-19 pneumonia. Therapy with Dexamethasone, Remdesivir, Piperacillin/Tazobactam, Amoxicillin/Clavulanic acid and Klacid (Clarithromycin) was initiated. In addition, acute renal failure stage I according to KDIGO was diagnosed. According to the presumed will of the patient, intensive medical measures such as intubation were waived and, in view of the poor prognosis, palliative therapy was initiated, under which the patient died. In addition, paroxysmal atrial fibrillation since 2018, cerebrovascular ischaemic insult in the mediastinal area on the right in a "wake-up" constellation on 21Dec2018, ectasia of the ascending aorta, dementia and lumbospondylogenic pain syndrome were known as relevant previous diseases. We have no further information on this case.A causal relationship between Comirnaty and COVID-19 Pneumonia and Vaccination Failure was assessed as being possible.This case was reported as serious (fatal outcome). Sender''s comment: a regulatory authority prescribing information for Comirnaty (tozinameran) states under Warnings/Precautions that vaccination with Comirnaty may not protect everyone who is vaccinated. There is a temporal relationship between the use of Comirnaty and COVID-19 infection (vaccine failure). In summary, we formally assess the causality between the use of Comirnaty and COVID-19 infection (vaccination failure) as possible on the basis of the temporal relationship and the documentation in the drug information. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death
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