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Write-up: Cardiac arrest; Respiratory arrest; Unresponsive to stimuli; did not feel well; cyanosed; right bundle branch block; collapsed; Pulseless electrical activity; Hypothermic; Bradycardia; This is a spontaneous report received from a contactable pharmacist by Pfizer from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-ADR 24547306 and GB-MHRA-WEBCOVID-20201224141239. A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EJ0553), via an unspecified route of administration on 16Dec2020 17:22 at single dose for COVID-19 vaccination. Medical history included chronic kidney disease, myocardial ischaemia, neuropathy peripheral, osteoarthritis, angina pectoris, cardiac failure, chronic obstructive pulmonary disease, diabetes mellitus and benign prostatic hyperplasia, all from an unspecified date and unknown if ongoing; gout, dyspepsia, constipation, hypercholesteremia, dry eye, pulmonary embolism, analgesic therapy, diabetic neuropathy and hypercholesterolaemia. Patient had not had symptoms associated with COVID-19. Patient had not been tested/or has had an inconclusive test for COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included allopurinol for gout, amoxicillin for chronic obstructive pulmonary disease, umeclidinium bromide, vilanterol trifenatate (ANORO) for chronic obstructive pulmonary disease, apixaban for pulmonary embolism, bisoprolol for cardiac failure, carbocisteine for chronic obstructive pulmonary disease, codeine phosphate, paracetamol (CO-CODAMOL) for analgesic therapy, duloxetine for diabetic neuropathy, furosemide for cardiac failure, insulin human injection, isophane (HUMULIN I) for diabetes mellitus, lansoprazole for dyspepsia, isosorbide mononitrate (MONOMIL XL) for angina pectoris, prednisolone for chronic obstructive pulmonary disease, salbutamol for chronic obstructive pulmonary disease, senna alexandrina for constipation, simvastatin for hypercholesterolaemia, guaraprolose (Systane eye drops) for dry eye and tamsulosin for benign prostatic hyperplasia. It was reported: Patient was vaccinated on 16Dec2020 at 17:22, he remained in the vaccination hub for 15 minutes to rule out any anaphylaxis or side effects. He felt fine after 15 minutes so went home. Within 30 minutes of going home he didn''t feel well and collapsed in the garden. An ambulance was called at 18:21 and arrived on the scene at 18:27. The ambulance documented in their notes the reason for the call was patient did not feel well 30 minutes after having the vaccine and collapsed. Patient did not complain of chest pain prior to collapse. Patient became unresponsive to stimuli at 18:50, low respiratory effort after collapse, patient went into respiratory arrest at 18:55 and went into cardiac arrest at 18:57. Advanced life support was given to the patient. Patient was pronounced dead at hospital emergency department at 20:14 on 16Dec2020. Cause of death was noted as cardiac arrest. Patient had not tested positive for COVID-19 since having the vaccine. Patient initially breathing independently with 5 liters nasal specs. Patient stated he couldn''t breathe before collapse so administered 6 liters via mask, respirations dropped to 8 per minute before respiratory arrest. Patient appeared cyanosed, assisted ventilation throughout, good rise and fall of chest, good equal air entry bilaterally. Circulation, initial radial pulse felt thread and slow HR (heart rate) 40 bpm (beats per minute), 12 lead ECG (electrocardiogram) showed bradycardia, right bundle branch block. Patient went into cardiac arrest at 18:57, witnessed by crew so immediate compressions commenced. Patient in PEA (pulseless electrical activity) rhythm throughout. Initially alert and orientated but appeared distressed. Became unresponsive at 18:50. Patient was hypothermic, so dose interval for adrenaline was doubled. Full ALS (advanced life support) protocol followed throughout. Patient died at the hospital on 16Dec2020 at 20:14. The cause of death was reported to be cardiac arrest. It was not reported if an autopsy had been performed. At the time death the outcome of the following events was reported to be not recovered: collapsed, respiratory arrest, unresponsive to stimuli, did not feel well. The outcome of the following events was unknown: pulseless electrical activity, hypothermic, right bundle branch block, cyanosed, bradycardia. No seriousness criteria were provided for the non-fatal events. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest
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