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Write-up: Death within 24 hours of vaccine; Livedo reticularis; Hypotension; Respiratory rate increased; Peripheral coldness; Loss of consciousness; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-EYC 00236256. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), subcutaneous on 20Dec2020 at first single dose for covid-19 immunization. Medical history included malaise from Dec2020, Started 2 days prior to vaccine; cold sweat from Dec2020, started 2 days prior to vaccine; dyspnoea from Dec2020, started 2 days prior to vaccine; feeling cold from Dec2020, started 2 days prior to vaccine; lethargy from Dec2020, started 2 days prior to vaccine; hyperhidrosis from Dec2020, started 2 days prior to vaccine, peripheral vascular disorder from 1982, peripheral ischaemia from 1982, Critical left foot ischemia; essential hypertension from 2003; myocardial ischaemia from 2005; Chronic kidney disease from 2006; myelopathy from 2007; Acute myocardial infarction in 2012; Mitral valve incompetence in 2012; Cardiac failure in 2013; Post thrombotic syndrome in 2015; Vascular dementia in 2017; Aortic stenosis in 2017; humerus fracture in 2019, Closed fracture distal right humerus; Postmenopausal haemorrhage 2019, unidentified cause; abdominal abscess in Jul2020, chronic, . Concomitant medication included acetylsalicylic acid (ASPIRIN), atorvastatin (MANUFACTURER UNKNOWN), bisoprolol fumarate (MANUFACTURER UNKNOWN), bumetanide (MANUFACTURER UNKNOWN), codeine phosphate, paracetamol (CO-CODAMOL) , colecalciferol (MANUFACTURER UNKNOWN), dimeticone (MANUFACTURER UNKNOWN), docusate sodium (MANUFACTURER UNKNOWN), doxycycline hyclate (MANUFACTURER UNKNOWN), glyceryl triacetate (MANUFACTURER UNKNOWN), isosorbide mononitrate (MANUFACTURER UNKNOWN), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXIDO), melatonin (MANUFACTURER UNKNOWN), macrogol (MICRALAX MACROGOL), paracetamol (MANUFACTURER UNKNOWN), senna spp. (SENNA SPP.), tramadol hydrochloride (MANUFACTURER UNKNOWN). The patient previously took trimethoprim, penicillin and ace inhibitors and angiotensin ii receptor blockers and experienced adverse drug reaction, not specified. On 21Dec2020, the patient experienced death within 24 hours of vaccine, livedo reticularis, hypotension, respiratory rate increased, peripheral coldness, loss of consciousness. The events were serious as it lead to death. The patient underwent lab tests and procedures which included body temperature of 38.1 on 21Dec2020. The patient died on 21Dec2020. It was not reported if an autopsy was performed. Details were as follows: Death within 24 hours of first vaccination dose occured. Patient had been unwell two days prior to the vaccination. New onset dyspnoea at rest and lethargy were noted. No fever at that time was noted. Noted to be cold, clammy and sweaty and this persisted for the following two or three days. No doctor notified of these developments. Over the following two days patient remained in a similar condition. She remained cold, clammy and dyspnoeic. Few observations appear to have been taken over this time; I do not know if she was fevered at any point due to lack of data. She was administered her first Covid-19 vaccine dose on 20Dec2020. On the morning of 21Dec2020, she was found unrousable in bed. Paramedics were called. She was noted to be cold and mottled, temperature was 38.1, low blood pressure (BP) and high respiratory rate. She died a couple of hours later. The case was reported to the procurator fiscal (PF) as cause of death was unknown, and death happened within 24 hours of a new vaccine, also with some concerns over patient care after she became unwell, not notifying general practitioner (GP) of deterioration in health. Post mortem was agreed by PF, but date not known. The other outcome for death within 24 hours of first vaccination dose was not known (NK) if death caused by vaccine. The patient was unwell prior to the dose. Cause of death was reported as unknown. The reporter did not know if the Pfizer COVID-19 vaccine caused or accelerated or contributed to this patient''s death. The patient''s deterioration was not informed until after her death. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death
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