Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Cardiac failure congestive, Drug ineffective, Weight
Clinical narrative: COVID/respiratory acidosis/pneumonia/COVID-19 pneumonia; COVID/respiratory acidosis/pneumonia/COVID-19 pneumonia; Acute hypoxic respiratory failure; Congestive heart failure; This is a spontaneous report from a contactable other healthcare repofessional (LPN, but was the patient's domestic partner). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 55-year-old) as single dose for COVID-19 immunization. Medical history included diabetes, diagnosed with this over 20 years ago when he was in his diabetes. None prior vaccinations within 4 weeks. Family history included diabetes that ran in the family and cardiovascular disease. Concomitant medication was reported as none. Patient passed away on 15Sep2021 and he was vaccinated with the Pfizer COVID vaccines and he ended up getting COVID. He was placed on a ventilator on 13Sep2021 and then passed away on 15Sep2021. He had both doses of the Pfizer COVID vaccine in Apr2021. Patient didn't have a primary care provider but he was admitted to the hospital for pneumonia and they had found out that he had COVID when they were going to transfer him to a nursing home for physical therapy but at that time he didn't have a primary care provider. The patient was admitted to the hospital from 26Aug2021 to 15Sep2021. He had developed respiratory acidosis on 13Sep2021 and then placed on the ventilator. He was admitted to the hospital due to pneumonia and then they had discovered he had COVID while there. The patient's death certificate said that the cause of death was COVID-19 pneumonia, acute hypoxic respiratory failure, congestive heart failure. The patient underwent lab tests and procedures which included weight: 170 to 180 lbs on an unspecified date. The patient died on 15Sep2021 due to drug ineffective, COVID-19 pneumonia, acute hypoxic respiratory failure and congestive heart failure. An autopsy was not performed.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events drug ineffective, COVID-19 pneumonia, acute hypoxic respiratory failure and congestive heart failure and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Congestive heart failure; COVID/respiratory acidosis/pneumonia/COVID-19 pneumonia; COVID/respiratory acidosis/pneumonia/COVID-19 pneumonia; Acute hypoxic respiratory failure