Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Condition aggravated, Oxygen saturation, Renal failure
Clinical narrative: covid pneumonia; diagnosed with COVID-19; diagnosed with COVID-19; kidney failure; It was reported that the chronic kidney disease worsened and he went into kidney failure and was going to need dialysis but they had to choose about that and he never did the dialysis.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 92 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 12Feb2021 (Batch/Lot number: unknown) at the age of 91 years as dose 2, single and administered in arm, administration date 22Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "TIA" (unspecified if ongoing); "problems with one of the disks of his back" (unspecified if ongoing); "high cholesterol levels" (unspecified if ongoing); "Diabetes" (not ongoing), notes: The patient did not have diabetes anymore because his tests were fine; "Hypertension" (not ongoing), notes: he was not on pills anymore for that and the pills he took were bad for his kidneys; caller states he had not been on those pills for years; hypertension was diagnosed years ago; "chronic kidney disease Stage III" (not ongoing), notes: diagnosed many years ago; "Cancer" (unspecified if ongoing), notes: the patient had many cancers; "he lost so much weight" (unspecified if ongoing); "left renal cell carcinoma", start date: 2014 (unspecified if ongoing); "melanoma stage III in the right ear", start date: 2013 (unspecified if ongoing); "lymphoma" (unspecified if ongoing), notes: does not know if the patient had lymphoma or not but got chemotherapy for the lymphoma; "chemotherapy", start date: 2010 (unspecified if ongoing); "mantle cell lymphoma" (unspecified if ongoing), notes: they said it was mantle cell lymphoma; "chronic anemia", start date: 2010 (unspecified if ongoing); "Smoked cigars" (unspecified if ongoing), notes: Smoked cigars a little bit but that was many years ago.; "triglycerides" (unspecified if ongoing); "pain in his back" (unspecified if ongoing); "bowels" (unspecified if ongoing); "pain" (unspecified if ongoing). Concomitant medication(s) included: TRAMADOL taken for pain; ASPIRINE; LIPITOR; TYLENOL; COLACE taken for abdominal discomfort; MIRALAX; OMEPRAZOLE; MELATONIN. The patient was on three pills for his cholesterol and triglycerides and cannot think of the names. Past drug history included: Insulin for diabetes, notes: for a while years ago. Vaccination history included: Quadravalent flu shot (lot number: UJ517AA, anatomical location: Arm), administration date: 12Oct2020, when the patient was 91 years old, reaction(s): "weak", "fell". Prior Vaccinations (within 4 weeks) was none.  The following information was reported: VACCINATION FAILURE (death, hospitalization, medically significant), COVID-19 (death, hospitalization, medically significant) all with onset 25Aug2021, outcome "fatal" and all described as "diagnosed with COVID-19"; COVID-19 PNEUMONIA (death, hospitalization) with onset 25Sep2021, outcome "fatal", described as "covid pneumonia"; RENAL FAILURE (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "kidney failure". The patient was hospitalized for vaccination failure, covid-19, covid-19 pneumonia, renal failure (start date: 26Sep2021). The events "diagnosed with covid-19", "covid pneumonia" and "kidney failure" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: oxygen saturation: (2021) 46 %; sars-cov-2 test: (25Aug2021) positive; (25Sep2021) positive; respiratory rate: (2021) 55. Therapeutic measures were taken as a result of vaccination failure, covid-19, covid-19 pneumonia, renal failure. The patient got dexamethasone and they were going to give him Remdisivir but his kidney started failing so they could not give him that with the kidney failure and they did end up giving him antibiotics. The patient was not there soon enough to get monoclonal antibodies and he has been sick for about 4 days and had not been tested. The patient date of death was 05Oct2021. The reported cause of death was covid-19 pneumonia, vaccination failure, covid-19. No autopsy was performed. Clinical course: The patient was diagnosed with covid and the diagnosis date that led to his death was 25Sep2021 and he was also diagnosed with no symptoms but had a positive test on 25Aug2021 and she thinks that is impossible to have a month apart but was only tested that day as a routine test at another before he went to the 2nd and it was supposedly a rapid test on 25Aug2021 and one covid test they know for sure he had was on 25Sep2021.For the hospitalization the first day he felt awful and it was of course a Sunday so he did not need to go to the hospital until the next day and then it was urgent and he was put on a ventilator and they decided to pull the plug later and he wanted to be a full code but did not know what that all meant at age 92. He was hardly breathing when they got him to the hospital and they knew he had covid and did not bother running anymore tests. The patient was admitted to an Intensive Care Unit. He was awake and everything and was in the ICU and was on the ventilator immediately. Fairly soon after his admission he went into kidney failure. It was reported that the chronic kidney disease worsened and he went into kidney failure and was going to need dialysis but they had to choose about that and he never did the dialysis. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 , COVID-19 pneumonia, and Vaccination Failure, cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.  The events of renal failure, condition worsened, is assessed as possibly related to the suspect drug "BNT162B2" based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.  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: diagnosed with COVID-19; covid pneumonia; diagnosed with COVID-19