Received Jul 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
completed COVID-19 vaccination just over 3 weeks before his admission for COVID-19 pneumonia; completed COVID-19 vaccination just over 3 weeks before his admission for COVID-19 pneumonia; This is a literature report for the following literature source(s). A 70-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "end-stage renal disease" (unspecified if ongoing); "atrial fibrillation" (unspecified if ongoing); "heart failure with preserved ejection fraction" (unspecified if ongoing); "recurrent transudative right pleural effusions" (unspecified if ongoing); "chronic obstructive pulmonary disease" (unspecified if ongoing); "diabetes mellitus" (unspecified if ongoing); "cerebrovascular accident" (unspecified if ongoing); "right lower extremity deep venous thrombosis" (unspecified if ongoing); "left atrial thrombus" (unspecified if ongoing); "dialysis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, hospitalization, medically significant, life threatening), COVID-19 PNEUMONIA (death, hospitalization, medically significant, life threatening), all with latency 3 weeks after the suspect product(s) administration, outcome "fatal" and all described as "completed COVID-19 vaccination just over 3 weeks before his admission for COVID-19 pneumonia". The event "completed covid-19 vaccination just over 3 weeks before his admission for covid-19 pneumonia" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: index of <1.00, notes: SARS-CoV-2 spike protein, which revealed an index of <1.00; SARS-CoV-2 RNA: Positive, notes: The diagnosis was confirmed on repeat PCR testing 2 days later and again 10 days later; SARS-CoV-2 test: COVID-19, notes: 2 days later; COVID-19, notes: again 10 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19 pneumonia. The patient date of death was unknown. Reported cause of death: "then expired secondary to respiratory failure", "COVID-19 pneumonia", "Drug ineffective". It was not reported if an autopsy was performed. Clinical course: A 70-year-old (Redacted) male with end-stage renal disease on dialysis and history of atrial fibrillation, heart failure with preserved ejection fraction, recurrent transudative right pleural effusions, chronic obstructive pulmonary disease, diabetes mellitus, cerebrovascular accident, right lower extremity deep venous thrombosis, and left atrial thrombus developed shortness of breath, hypoxia, and altered mental status while receiving dialysis. He was sent to the emergency room and was found to have COVID-19 based on polymerase chain reaction (PCR) testing for SARS-CoV-2 RNA on nasopharyngeal sampling. The diagnosis was confirmed on repeat PCR testing 2 days later and again 10 days later. He required noninvasive bilevel ventilation on presentation. He was eventually transferred to the intensive care unit, where the patient was initially on noninvasive ventilation followed by mechanical ventilation and then expired secondary to respiratory failure. Like case 1, he had completed COVID-19 vaccination just over 3 weeks before his admission for COVID-19 pneumonia. The patient was also tested on day 2 of hospitalization for immunoglobulin G antibody against the SARS-CoV-2 spike protein, which revealed an index of <1.00. Patient Consent Informed consent was obtained from the patient and/or the patient's designated representative for publication of this case report.; Sender's Comments: The events of drug ineffective and COVID-19 pneumonia are considered related to BNT162b2, as the patient developed confirmed COVID-19 pneumonia approximately 3 weeks after vaccination, representing a reported breakthrough infection and lack of vaccine effectiveness. The patient's multiple underlying comorbidities may have contributed to the severity and fatal outcome. 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: then expired secondary to respiratory failure; Drug ineffective; COVID-19 pneumonia
Medical History/Concurrent Conditions: Atrial fibrillation; Cerebrovascular accident; Chronic obstructive pulmonary disease; Deep vein thrombosis leg; Diabetes mellitus; Dialysis; End stage renal disease; Heart failure with preserved ejection fraction; Left atrial thrombosis; Pleural effusion recurrent
Test Name: immunoglobulin G antibody; Result Unstructured Data: Test Result:index of <1.00; Comments: SARS-CoV-2 spike protein, which revealed an index of <1.00.; Test Name: SARS-CoV-2 RNA; Test Result: Positive ; Comments: The diagnosis was confirmed on repeat PCR testing 2 days later and again 10 days later; Test Name: polymerase chain reaction (PCR) testing; Result Unstructured Data: Test Result:COVID-19; Comments: 2 days later; Test Name: polymerase chain reaction (PCR) testing; Result Unstructured Data: Test Result:COVID-19; Comments: again 10 days later