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Life Threatening? Yes
Write-up: Dyspnoea/shortness of breath; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB manufacturer report number NL-LRB-00496928. This is the first of two reports. An 83-years-old female patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 26Mar2021 (Lot number: ET3674) as single dose for covid-19 immunization. Medical history was not reported. Concomitant medications included desloratadine; amlodipine; colecalciferol; edoxaban; temazepam. The patient previously received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 19Feb2021 as single dose for covid-19 immunization and on 05Mar2021, she experienced malaise, general physical health deterioration and abdominal pain. The patient did not have previous COVID-19 infection. On 26Mar2021, 3 hours after the 2nd vaccination, the patient experienced dyspnoea that caused death, life threatening and caused or prolonged hospitalization. A few hours after 2nd vaccination increasing shortness of breath. The patient underwent lab tests and procedures which included in Nov2020, patient still completely normal left ventricular function (70%), and now in 2021 she had a very poor left ventricular function (15%). In 2021, patient had diagnostic procedures of ECG, lab, echocardiogram with unknown results. Treatment measures for dyspnoea was treated with Hartfalenmedicatie. The outcome of the event was fatal. It was not reported if an autopsy was performed. This report was assessed by the reporting physician was serious. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Dyspnoea/shortness of breath
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