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Life Threatening? Yes
Write-up: death; deterioration of the general condition; Heavy subcutaneous bleeding; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is HR-HALMED-300044751. A 91-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY, lot number: EJ6796) via an unspecified route of administration on 09Jan2021 at 30 ug single for COVID-19 immunisation. Medical history included chronic renal insufficiency (chronic kidney. Insuf.,not ongoing), macrocytic anemia (not ongoing), carotid artery stenosis (not ongoing), arterial hypertension (not ongoing), depression (not ongoing), cerebral infarction (post CVI, I63) from 2007 (not ongoing). Concomitant medications included bisoprolol fumarate (CONCOR), ramipril (TRITACE), lorazepam (LORSILAN), furosemide (FURSEMIDE). The patient experienced heavy subcutaneous bleeding on 14Jan2021, deterioration of the general condition on 14Jan2021, death on 21Jan2021. Treatment of side effects was Oral compensation of K. The patient underwent lab tests and procedures in Jan2021 which included creatinine (ref. 63-107 umol/l): 143, Serum potassium (K, ref. 3.9-5.1 mmol/L): 2.8, urate (ref. 134-337 umol/l): 920, Hemoglobin (119-157 g/l): 102, Thrombocyte count (158- 424 x10 9/l): 96, Red blood cell count (ref. 3.86 - 5.08 x10 12/l): 2.4. It was unknown if autopsy was performed. Outcome of all events was fatal. Seriousness criteria was reported as death and life-threatening. Reporter comment: Reporter relatedness assessment: Possible. Sender Comment: 08Mar2021:Additional data was requested. Relatedness of drug to all events assessed by Regulatory Authority as Unassessable /Unclassifiable (Method of assessment: WHO-UMC Causality) Additional information on drug ADR is adequately labelled: No. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Reporter relatedness assessment: Possible.; Reported Cause(s) of Death: Heavy subcutaneous bleeding; deterioration of the general condition; Unknown cause of death
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