Received Jul 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
Severe COVID-19 infections after vaccination; Severe COVID-19 infections after vaccination; This is a literature report for the following literature source(s): A 52-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 day and as dose 2, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "end-stage renal disease" (unspecified if ongoing); "dialysis" (unspecified if ongoing); "obesity" (unspecified if ongoing); "obstructive sleep apnea" (unspecified if ongoing); "antiphospholipid syndrome" (unspecified if ongoing); "bilateral pulmonary emboli" (unspecified if ongoing); "multiple deep venous thrombosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "Severe COVID-19 infections after vaccination". The event "severe covid-19 infections after vaccination" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: showed vascular congestion as well as superimposed, notes: patchy focal infiltrates; Nasopharyngeal swab: coronavirus 2 (SARS-CoV-2) RNA on nasopharyngeal, notes: sampling; SARS-CoV-2 antibody test: Negative, notes: less than 1.00 from her second day of hospitalization revealed an index; SARS-CoV-2 test: she was found to have COVID-19, notes: coronavirus 2 (SARS-CoV-2) RNA on nasopharyngeal sampling; confirmed, notes: repeat PCR testing 2 days later. Therapeutic measures were taken as a result of vaccination failure, covid-19. The following death information was reported, despite no fatal outcome. The patient date of death was unknown. Reported cause of death: "on day 3 of her intensive care unit admission she developed cardiac arrest and expired.". It was not reported if an autopsy was performed. Clinical Course: A female with end-stage renal disease on dialysis with a medical history of obesity, obstructive sleep apnea, antiphospholipid syndrome, bilateral pulmonary emboli, and multiple deep venous thrombosis presented to the dialysis unit with 5 days of headache, myalgia, and progressive shortness of breath. She was sent to the emergency room, where she was found to have COVID-19 based on polymerase chain reaction (PCR) testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA on nasopharyngeal sampling, which was confirmed on repeat PCR testing 2 days later. Her chest radiograph showed vascular congestion as well as superimposed patchy focal infiltrates, and she required high-flow oxygen via nasal cannula. On day 2 of her admission, she was transferred to the intensive care unit, and on day 3 of her intensive care unit admission she developed cardiac arrest and expired. Of note, she had completed COVID-19 vaccination, with 2 doses of the Pfizer-BioNTech vaccine received 48 and 24 days before her admission. Serologic testing for immunoglobulin G antibody against the SARS-CoV-2 spike protein from her second day of hospitalization revealed an index of less than 1.00 (a negative result).; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported events COVID-19 and VACCINATION FAILURE cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer drug 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: on day 3 of her intensive care unit admission she developed cardiac arrest and expired.
Medical History/Concurrent Conditions: Antiphospholipid syndrome; Deep venous thrombosis NOS; Dialysis; End stage renal disease; Obesity; Obstructive sleep apnea; Pulmonary embolism
Test Name: chest radiograph; Result Unstructured Data: Test Result:showed vascular congestion as well as superimposed; Comments: patchy focal infiltrates; Test Name: nasopharyngeal sampling; Result Unstructured Data: Test Result:coronavirus 2 (SARS-CoV-2) RNA on nasopharyngeal; Comments: sampling; Test Name: Serologic testing for immunoglobulin G antibody against the SARS-CoV-2 spike protein; Test Result: Negative ; Comments: less than 1.00 from her second day of hospitalization revealed an index; Test Name: polymerase chain reaction (PCR) testing for severe acute respiratory syndrome; Result Unstructured Data: Test Result:she was found to have COVID-19; Comments: coronavirus 2 (SARS-CoV-2) RNA on nasopharyngeal sampling; Test Name: polymerase chain reaction (PCR) testing for severe acute respiratory syndrome; Result Unstructured Data: Test Result:confirmed; Comments: repeat PCR testing 2 days later