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Life Threatening? No
Write-up: Muscle spasms; Consciousness decreased; Confusion; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uwzpw5, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00028161. A 78-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 25Mar2021 11:17 (Lot Number: ER9480) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included, multimorbid, living in a nursing home, and occasionally confusion, there was no change in the patient''s condition before or after vaccination, hepatic cirrhosis (idiopathic, advanced), tiredness/ fatigue, Sick sinus syndrome (pacemaker), renal failure grade III , oedema (Pronounced edemas feet, abdomen, truncus), chronic obstructive pulmonary disease (COPD), Heart failure, coronary artery bypass from 2004, recent immune thrombocytopenia (Thrombocyte count 118-106). Concomitant medication(s) included prednisolone and bumetanide (BURINEX), both taken for an unspecified indication, start and stop date were not reported. The day after vaccination on 26Mar2021, the patient was hospitalized due to decreased consiuousness, ongoing muscle spasms and confusion. Treated with midazolam 5 mg in each nostril, which made the muscle spasms more intermittent. At hospitalization it was not possible to get in touch with the patient, and he remained unreachable. The patient died three days on 28Mar2021 at 05:30 am after vaccination. Patient with competence to give consent for vaccination. The patient underwent lab tests and procedures which included Glasgow coma scale: 3 on 26Mar2021. The outcome was fatal of events after treatment given. It''s was unknown if autopsy have been done. Event assessment: Regional Pharmacist / Comirnaty / All Events / Possible Reporter Comment: There was no change in the patient''s condition before or after vaccination, but the day after vaccination the patient was hospitalized due to decreased consiuousness and ongoing muscle spasms. Died three days after vaccination. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: decreased consiuousness; muscle spasms; confusion
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