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Life Threatening? No
Write-up: Stroke; This is a spontaneous report from a contactable consumer from the Regulatory Authority NL-LRB-00468663. Additional identifier is NL-LRB-00470487. An 89-year-old female patient (reporter) received 1st dose of BNT162B2 (COMIRNATY, lot# EJ6789) at single dose on 13Feb2021 via an unknown route for COVID-19 immunisation. Medical history included cardiac arrhythmia, deep venous thrombosis arm (low in thrombosis) for more than 30 years, diabetes (mild degree). The patient had just recovered from erysipelas on her legs. She had received a course of antibiotics for this. However, this treatment had ended about 10 days before the vaccination. Patient had no previous COVID-19 infection. Concomitant drug included acenocoumarol tablet 1mg daily, atenolol, atorvastatin (ATORVASTATINE) tablet 40mg, losartan tablet 50 mg, omeprazole magnesium (LOSEC MUPS) 10mg, and metformine hydrochloride. Patient experienced stroke on 21Feb2021 with seriousness criteria of death "168 hours" (as reported) after administration of covid-19 vaccine. Patient died in hospital. Diagnostic procedure was MRI scan. Confounding factors was cardiac arrhythmia. No autopsy was done. No letter of resignation or autopsy report received. No complaints or side effects immediately after the corona vaccination. The outcome of stroke was fatal. The event clinical course was as follows: patient was still felt fine on Saturday evening. Reporter suspected (but not sure) that the vaccination may have caused the clot in her thrombosis arm (which she had had for more than 30 years) to break loose. It could be a coincidence. But the MRI scan showed that she suffered a severe stroke in her brain stem in her sleep and fell into a coma as a result of this and died later that day from the consequences. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: stroke
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