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Life Threatening? No
Write-up: Pallor of skin; haematoma of left arm; Shivering; pain of whole upper left extremity; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SK-SUKLSK-20214306. An 87-year-old male patient received his first dose of BNT162B2 (COMIRNATY) (tozinameran, Batch/lot number ET6956) intramuscular on 27Apr2021 for Covid-19 immunization. Relevant medical history included triple vessel bypass graft, type 2 diabetes mellitus and chronic lower limb ischaemia. Concomitant medications were not reported. On 28Apr2021 the patient experienced tremor (shivering), pale skin, hematoma of two thirds of the left shoulder, pain of the whole left upper limb. On 30Apr2021 around 16:00 there was an escalation of shoulder pain and patient''s relatives transported him to the hospital, admitted for hospitalization. On 01May2021 at 08:50 a.m. the patient was pronounced as dead. After death the autopsy was not done. The physician has little information on cause of death, "the only available reported information were from inspection of a body after death: Ia: Heart failure, unspecified, Ic: Chronic ischaemic heart disease, II: Poisoning by anticoagulant antagonists (vitamin K)". The outcome of all events was reported as fatal. Sender Comment: Because of insufficient information on this case and missing autopsy, the causal relationship can not be assess. The physician was not able to assess the causality because of little information on this case and missing autopsy. The physician considered the time relationship to vaccine administration. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: pain of whole upper left extremity; pallor of skin; hematoma of left arm; Shivering
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