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Life Threatening? No
Write-up: Lung embolism; Feeling unwell; Neck swelling; This is a spontaneous report downloaded from the regulatory agency WEB [DK-DKMA-WBS-0054206]. The case was received from a contactable physician via The regulatory Agency, additional safety reference number DK-DKMA-ADR 24940761. An 88-year-old female patient received the first dose of bnt162b2 (COMIRNATY, batch/Lot Number: ER2659; Expiration Date: 30Jun2021), via an unspecified route of administration on 01Mar2021 as SINGLE DOSE for Covid-19 immunisation. The patient''s medical history were Adrenogenital syndrome, Adrenal cortical insufficiency, Constipation and Dermatophytosis of nail, iron deficiency (all concurrent medical conditions). Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) for constipation from 14Feb2018 to 13Mar2021; dexamethasone for adrenal insufficiency from 14Feb2018 to 13Mar2021; dexamethasone for adrenogenital syndrome from 23Jan2020 to 13Mar2021; ciclopirox (ONYTEC) for dermatophytosis of nail from 15May2020 to 13Mar2021; ferrous sulfate (FERRO DURETTER) for iron deficiency from 14Feb2018 to 13Mar2021. The patient experienced feeling unwell, neck swelling and lung embolism on 13Mar2021. No treatment or medical procedure performed for the events reported. The lung embolism was reported as being Fatal. The patient died on 13Mar2021. The outcome of event neck swelling was not recovered; for feeling unwell was unknown. An autopsy was not performed. There was no information regarding test results. Causality: The reporter stated that the patient had the age where embolism / acute myocardial infarction occurs, so it probably had nothing to due with the vaccine. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the available information the event is most likely related to the patient''s predisposition to an inter current or underlying condition due to advanced age hence event assessed as unrelated to the suspect drug.; Reported Cause(s) of Death: Lung embolism
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