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Life Threatening? Yes
Write-up: pneumonia; Three individuals had died after vaccination against corona/ Heart failiure; Disease progression; Cough; felt ill; Fever; The initial case was missing the following minimum criteria: (no first-hand knowledge). Upon receipt of follow-up information on (19Jan2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer and additional reporter: physician downloaded from the Medicines Agency (MA) Regulatory Authority-WEB. This is a report received from the Medicines Agency. The regulatory authority report number is IS-IMA-1502. A 94-year-old female patient received the bnt162b2 (COMIRNATY; Lot Number: EJ6796 and Expiration Date: 30Apr2021), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient''s medical history included hypertension, Alzheimer''s disease, pneumonia, Ischemic cardiomyopathy; all from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced the following events and outcomes: three individuals had died after vaccination against corona/ heart failure (death, hospitalization, medically significant, life threatening) on 04Jan2021, disease progression (death, hospitalization, life threatening) on 31Dec2020, pneumonia (death, hospitalization, medically significant, life threatening) on an unspecified date, cough (death, hospitalization, life threatening) on 31Dec2020, felt ill (death, hospitalization, life threatening) on 31Dec2020, fever (death, life threatening) on 31Dec2020 (also reported :30Dec2020); all of which had a fatal outcome. Narrative as received: "This case was received via e-reporting system by IMA from a physician. A 94-year old female with Alzheimer''s disease, HTN and ischaemic cardiomyopathy was vaccinated with COMIRNATY on 29Dec2020. No concomitant medications were reported. On 31Dec2020 the patient experienced fever (37.8), coughing and felt ill. Two days later the patient experienced heart failure and passed away on 04Jan2021. The patient was also diagnosed with pneumonia but not treated for pneumonia after consultation with the patient''s family due to the patient''s condition." The patient died on 04Jan2021 due to heart failure and pneumonia. It was unknown if an autopsy was performed. Reporter''s comments: "Cause of death was declared as pneumonia and heart failure. Causal association with COVID-19 vaccine is due to time relationship, uncertain causality."; Reported Cause(s) of Death: Heart failure; Pneumonia
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