Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, SARS-CoV-2 test
Clinical narrative: she died of cardiac arrest; SYSTEMIC CAPILLARY LEAK SYNDROME; COVID-19 test was positive by RT-PCR; COVID-19 test was positive by RT-PCR; Compartment syndrome of all four extremities; AKI requiring CRRT; hemoconcentration; DIC; Liver failure; This is a literature report.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lower extremity weakness" (unspecified if ongoing); "fever" (unspecified if ongoing); "shortness of breath" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CARDIAC ARREST (death, medically significant), outcome "fatal", described as "she died of cardiac arrest"; CAPILLARY LEAK SYNDROME (medically significant, life threatening), outcome "unknown", described as "SYSTEMIC CAPILLARY LEAK SYNDROME"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), 3 weeks after the suspect product(s) administration, outcome "unknown" and all described as "COVID-19 test was positive by RT-PCR"; COMPARTMENT SYNDROME (medically significant), outcome "unknown", described as "Compartment syndrome of all four extremities"; ACUTE KIDNEY INJURY (medically significant), outcome "unknown", described as "AKI requiring CRRT"; HAEMOCONCENTRATION (medically significant), outcome "unknown", described as "hemoconcentration"; DISSEMINATED INTRAVASCULAR COAGULATION (medically significant), outcome "unknown", described as "DIC"; HEPATIC FAILURE (medically significant), outcome "unknown", described as "Liver failure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 80/60, notes: hypotensive; Laboratory examination: Normal; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of capillary leak syndrome, covid-19, compartment syndrome, acute kidney injury, haemoconcentration, disseminated intravascular coagulation, hepatic failure. The patient date of death was unknown. Reported cause of death: "died of cardiac arrest within 72 hours". It was not reported if an autopsy was performed.  Clinical information: After her 2nd-dose of Pfizer BioNTech SARS-COV-2 vaccine 3-weeksago presented with lower extremity weakness, fever, and shortness of breath. She was hypotensive (80/60) but the rest of the examination was normal. COVID-19 test was positive by RT-PCR. She remained hypotensive despite aggressive resuscitation with IV fluids, albumin, vasopressors, and steroids. She deteriorated quickly, developed ARDS requiring intubation, compartment syndrome of all four extremities, AKI requiring CRRT, hemoconcentration, DIC, and liver failure. She also received IV Ig but despite maximal support, she died of cardiac arrest within 72 hours.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 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: died of cardiac arrest within 72 hours