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Write-up: Reduced general condition; Hypotension; This is a spontaneous report from a contactable physician downloaded from the regulatory a. This is a report received from the regulatory authority. Regulatory authority report number was FR-AFSSAPS-TO20210224. A 94-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EM0477), intramuscular in the right deltoid on 08Jan2021 as a single dose for COVID-19 vaccination and furosemide (LASILIX SPECIAL), oral from an unspecified date at 1 dosage form once a day for arterial hypertension. Medical history included pulmonary arterial hypertension and heart failure; both from unknown dates and unknown if ongoing. Concomitant medications included bisoprolol hemifumarate (MANUFACTURER UNKNOWN), amiodarone hydrochloride (CORDARONE), potassium chloride (DIFFU K), apixaban (ELIQUIS), levothyroxine sodium (LEVOTHYROX), pantoprazole (MANUFACTURER UNKNOWN), and ramipril (MANUFACTURER UNKNOWN); all taken for unspecified indications from unknown dates and unknown if ongoing. On 16Jan2021, the patient experienced reduced general condition and hypotension; both serious for being fatal. The clinical course was as follows: The patient had onset of drop in blood pressure (88/60) on 16Jan2021. On 17Jan2021, blood pressure was 90/60. On 18Jan2021, the physician decreased the dose of furosemide (unspecified if the last dose of original regimen was on 17Jan2021 or 18Jan2021). On 19Jan2021, the patient presented a feeling of discomfort and an increase in edema of the lower limbs and blood pressure was 10/60 (as reported). On 20Jan2021, the patient died, and the cause of death was reported as reduced general condition. An autopsy was not performed.; Reported Cause(s) of Death: Reduced general condition
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