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Life Threatening? Yes
Write-up: Sudden death in the evening; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency. Regulatory Authority Report Number: DK-DKMA-WBS-0031912, Safety Report Unique Identifier DK-DKMA-ADR 24689105. This is a spontaneous case, received on 03Feb2021 from a physician with follow-up received by telephone from the reporting physician before transmitting version 001 to EV, which describes the occurrence of Sudden death (Sudden death in the evening) in a 69 year old female patient trested with COMIRNATY (tozinameran). A 69-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY, Lot # EK9788) at single dose on 30Jan2021 for covid-19 immunisation. Medical history included ongoing living in nursing home, ongoing constipation, ongoing dystonia, ongoing osteoporosis, ongoing hypertension, ongoing pain, esophageal acid reflux, Parkinson''s disease, stiffness, cramps calf, nausea, angina pectoris, neuropathic pain, patient complained about abdominal pain (maybe gastric acid) in jan2021 and ongoing in the week prior to her death ongoing, swallowing disorder (problems with her swallowing muscles), facial nerve disorder unspecified treated with Clostridium botulinum, type A toxin (BOTOX). Past medication included Clostridium botulinum, type A toxin (BOTOX). Concomitant medication included domperidone (MOTILIUM) oral 10 mg, as needed (when needed, max one time a day) from 09Sep2016 for nausea, benserazide hydrochloride, levodopa (MADOPAR QUICK 62,5) oral 1 DF, as needed (max twice a day) from 21Aug2019 for stiffness, benserazide hydrochloride, levodopa (MADOPAR 62.5, strength 50mg + 12.5mg) 8 DF, daily from 09Sep2016 for Parkinson''s disease, acetylsalicylic acid (HJERDYL) oral 75 mg, daily form 12Sep2012 for Anticoagulant therapy, sodium picosulfate (ACTILAX) oral 7.5 mg/ml, as agreed with the physician from 01Oct2018 for Constipation, paracetamol (PARACETAMOL ORIFARM) oral 3000 mg, as needed (1000 mg morning, midday and evening and when needed) from 05Jun2018 for pan, esomeprazole magnesium (ESOMEPRAZOL MYLAN 20 mg) oral 20 mg, daily for Esophageal acid reflux, cyanocobalamin (BETOLVEX, 1 mg) oral 1 mg, daily from 11Sep2020 for Vitamin B12 deficiency, bendroflumethiazide, potassium chloride (BENDROZA 2.5+573 mg) oral 2 DF, daily from 26Aug2019 for Diuretic therapy, amlodipine besilate (AMLODIPIN TEVA, 10 mg) oral 10 mg, daily form 19Sep2018 for Hypertension, magnesium (MAGNESIUM, 360 mg) oral 360 mg, daily for Cramps calf, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) oral 1 DF, as needed from 26Nov2012 for Constipation, colecalciferol (VITAMIN NOS, 35ug) oral 70 ug, daily from 18Sep2018 for Vitamin D deficiency, biperiden lactate (AKINETON, 2 mg) oral 1 mg, daily from 21Aug2019 for Dystonia, alendronate sodium (ALENDRONAT SANDOZ, 70 mg) oral 70 mg, weekly form 20May20109 for Osteoporosis, nicotine polacrilex (NICORETTE COOLDROPS 2 mg) oral as agreed with the physician. for Smoking cessation therapy, pregabalin (PREGABALIN ACCORD, 75 mg) oral 225 mg, daily from 25Apr2019 for Neuropathic pain, glyceryl trinitrate (NITROLINGUAL) sublingual 0.4 mg, as needed from 27Jan2021 for Angina pectoris, potassium chloride (KALEORID, 750 mg) oral 3000 mg, daily from 16Sep2018 for Potassium supplementation, morphine sulfate (CONTALGIN, 10 mg) oral 40 mg, daily (10 mg morning, 20 mg midday and 10 mg evening) form 27Oct2020 for pain, ascorbic acid, calcium carbonate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine hydrochloride, tocopherol (APOVIT MULTI VOKSEN multi-vitamin preparation) 1 DF, daily as a dietary supplement. The patient was treated with Diuretic therapy, Anticoagulant therapy, Potassium supplementation, and Smoking cessation therapy and for Vitamin D deficiency. The patient previously took botox for facial nerve disorder, comirnaty for covid-19 immunisation. The patiente was vaccinated with the 1st dose of COMIRNATY (batch number: EJ6797) at single dose on 03Jan2021 for covid-19 immunisation. On 30Jan2021 the patient suddenly died in the evening. Sudden death was reported by the physician as life threatening and fatal. No treatment was reported and no medical procedure was performed. Cause of death was reported as unknown cause of death. The police has been informed by the physician for the purpose of inquest. The physician believes that an autopsy has been performed. and results were not provided Causality (reporting physician): The reporting physician does not offhand believe that the patient''s death is caused by Comirnaty, but he can not exclude it. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death; Unknown cause of death
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