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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||EY2172 / 2||- / OT|
Administered by: Other Purchased by: ??
Symptoms: Diarrhoea, Fibrin D dimer, Haemoglobin, Pelvic venous thrombosis, Platelet count, Renal vein thrombosis, Vena cava thrombosis, Polymerase chain reaction
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Other Medications: INDAPAMIDE; ALLOPURINOL; GABAPENTIN; PANTOPRAZOLE; PARACETAMOL; KAINEVER
Preexisting Conditions: Medical History/Concurrent Conditions: Mesenteric ischaemia (surgery several years ago for arterial ischemia of the mesenteric with short bowel syndrome, not anticoagulated); Short-bowel syndrome (surgery several years ago for arterial ischemia of the mesenteric with short bowel syndrome, not anticoagulated)
Diagnostic Lab Data: Test Name: D-dimers; Test Result: Positive ; Test Name: Hemoglobin; Result Unstructured Data: Test Result:9 g/dl; Comments: 9 g/dl Iu international unit(s); Test Name: Platelet count; Test Result: 480000 uL; Test Name: PCR; Test Result: 8 mg/dl; Comments: 8 mg/dl Iu international unit(s)
CDC 'Split Type': PTPFIZER INC2021752289
Write-up: This is a spontaneous report from a contactable physician, regulatory authority number PT-INFARMED-T202105-3196. A 79-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 29Apr2021 (Batch/Lot Number: EY2172) as dose 2, 0.3mL single for covid-19 immunisation. Medical history included surgery several years ago for arterial ischemia of the mesenteric with short bowel syndrome, not anticoagulated. Concomitant medications included indapamide 2.5 mg; allopurinol 300 mg; gabapentin 400 mg; pantoprazole 40 mg; paracetamol; estazolam (KAINEVER) 2 mg. The patient previously took first dose of bnt162b2 (COMIRNATY, Batch/lot number: EW2239 ) at dose 1, 0.3mL single on 01Apr2021 for covid-19 immunization. The patient experienced iliofemoral venous thrombosis, vena cava and renal veins on 23May2021. The patient underwent lab tests and procedures which included fibrin d dimer: positive, haemoglobin: 9 g/dl Iu international unit(s), platelet count: 480000 ul, polymerase chain reaction: 8 mg/dl Iu international unit(s). Therapeutic measures were taken as a result of iliofemoral venous thrombosis, vena cava and renal veins, iliofemoral venous thrombosis, vena cava and renal veins, iliofemoral venous thrombosis, vena cava and renal veins. The patient died on 23May2021. An autopsy was not performed. The clinical course was reported as follows: Spontaneous notification refers to a case sent by a physician about an elderly male, 79 years old, who presented with a condition of "iliofemoral venous thrombosis, vena cava and renal veins" associated with the use of Comirnaty/mRNA vaccine against COVID-19 (with modified nucleoside), 30 mcg/0.3 ml (lots EW2239 and EY2172), for "SARS-CoV-2 infection prophylaxis", with the dosage of 2 doses (0.3 ml each) IM with one 28-day interval between each dose. Referred clinical history of "of surgery several years ago for arterial ischemia of the mesenteric with short bowel syndrome, not anticoagulated". No information on previous occurrence of infection with SARS-CoV-2 virus. The adverse reaction (ADR) appeared 52 and 24 days after the administration, respectively, of the 1st and 2nd dose of the suspected drug, with unknown duration. According to the notifier, "the patient was sent to Emergency Service due to a condition of shock with acute kidney injury (apparently in context, or accompanied by diarrhea). She had neutrophilic leukocytosis and AKIN-3 acute kidney injury (pCr 9), PCR 8. He underwent body CT, for maintaining anuria after volume replacement, which documented extensive iliofemoral venous thrombosis, vena cava and renal veins. He died after less than 24 hours." There was no reduction in dosage, suspension or reintroduction of the suspected drug, since the vaccination schedule was already complete. There is no suspicion of drug interactions. There are no data on past reactions to other drugs/vaccines or allergies. Specific treatment of the adverse reaction was carried out with "heparin, prophylactic antibiotics, fluids". ADR did not improve with treatment.There is reference to the use of the following common medications: pantoprazole 40 mg, allopurinol 300 mg, indapamide 2.5 mg, gabapentin 400 mg, Estazolam 2 mg, paracetamol. Additional data: Platelet values 480.000/uL, Hemoglobin 9 g/dL, no clotting alterations, namely. hypofibrinogenemia, PF4 not assayed, positive D-dimers, PCR 8 mg/dl. According to the notifier "We think that the vaccination may have contributed to this patient''s venous thrombosis, in a favorable terrain." The cause of death was acute renal failure due to vena cava and renal thrombosis. The notifier considers that the autopsy will have been dispensed with. Evolution of ADR: death. Relatedness of drug to reaction(s)/event(s) for event: Source of assessment: Notifier; Method of assessment: Unknown; Result of Assessment: Possible. Product notes: SARS-CoV-2 infection prophylaxis. Reporter''s comments: Concomitant drug-pantoprazole 40 mg, allopurinol 300 mg, indapamide 2.5, gabapentin 400 mg, kainever 2 mg paracetamol Medication Error Occurred?-no No follow-up attempts needed. No further information expected.; Reporter''s Comments: Concomitant drug-pantoprazole 40 mg, allopurinol 300 mg, indapamide 2.5, gabapentin 400 mg, kainever 2 mg paracetamol Medication Error Occurred?-no; Reported Cause(s) of Death: Renal failure acute ischaemic
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