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This is VAERS ID 1434438

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History of Changes from the VAERS Wayback Machine

First Appeared on 7/2/2021

VAERS ID: 1434438
VAERS Form:2
Age:
Sex:Female
Location:Foreign
Vaccinated:2021-05-19
Onset:2021-05-22
Submitted:0000-00-00
Entered:2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 1 - / OT

Administered by: Other      Purchased by: ??
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood chloride, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood lactic acid, Blood potassium, Blood sodium, C-reactive protein, Carbon dioxide, Cardio-respiratory arrest, Chest X-ray, Coagulation factor V level, Coagulation factor VII level, Coagulation factor X level, Echocardiogram, Electrocardiogram, Fibrin D dimer, Full blood count, Haematocrit, Haemoglobin, Heart rate, Myocardial infarction, Neutrophil count, Oxygen saturation, Platelet count, Prothrombin level, Prothrombin time, Respiratory rate, White blood cell count, Protein total, Fraction of inspired oxygen, Laboratory test, Blood alcohol, pH body fluid, Troponin, Angiogram, Investigation, Procalcitonin, Coma scale, Blood pressure measurement, SARS-CoV-2 test

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2021-05-23
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypothyroidism; Obesity (BMI: 40.26)
Preexisting Conditions: Medical History/Concurrent Conditions: Cannabis use (Occasional); Chest discomfort; Graves-Basedow disease (With orbitopathy, treated with Thyrozol and Levothyrox); Neck pain; Pulmonary embolism (With negative thrombophilia assessment (Proteins C and S not measured)); Thymectomy (For thymoma with global follicular lymphoid hyperplasia); Thymoma; Tobacco user (10 pack-years)
Allergies:
Diagnostic Lab Data: Test Date: 20210522; Test Name: alanine aminotransferase; Result Unstructured Data: Test Result:181; Test Date: 20210522; Test Name: alanine aminotransferase; Result Unstructured Data: Test Result:13.7; Comments: At 11:42 p.m.; Test Name: coronary angiography; Result Unstructured Data: Test Result:sub-occlusion of the proximal anterior ventricular; Test Date: 20210522; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:504; Test Date: 20210522; Test Name: Alcohol; Result Unstructured Data: Test Result:0.12 g/l; Test Date: 20210522; Test Name: PAL; Result Unstructured Data: Test Result:95; Test Date: 20210522; Test Name: bilirubin; Result Unstructured Data: Test Result:Normal; Test Date: 20210522; Test Name: calcium; Test Result: 1.8 mmol; Test Date: 20210522; Test Name: chlorine; Result Unstructured Data: Test Result:103; Test Date: 20210522; Test Name: creatine phosphokinase; Result Unstructured Data: Test Result:4437 IU/l; Test Date: 20210522; Test Name: creatinine; Test Result: 89 umol; Test Date: 20210522; Test Name: fibrinogen; Result Unstructured Data: Test Result:1.58 g/l; Test Date: 20210522; Test Name: Lactates; Result Unstructured Data: Test Result:14.1 mmol/L; Test Date: 20210522; Test Name: potassium; Result Unstructured Data: Test Result:4.6; Test Date: 20210522; Test Name: Blood pressure; Result Unstructured Data: Test Result:73/58; Comments: on noradrenaline; Test Date: 20210522; Test Name: sodium; Result Unstructured Data: Test Result:140; Test Date: 20210522; Test Name: partial pressure of carbon dioxide; Result Unstructured Data: Test Result:96; Test Date: 20210522; Test Name: partial pressure of carbon dioxide; Result Unstructured Data: Test Result:34; Comments: At 11:42 p.m.; Test Date: 20210522; Test Name: Chest radiograph; Result Unstructured Data: Test Result:cardiomegaly; Comments: interstitial infiltrate predominant on the left; Test Date: 20210522; Test Name: factor V; Test Result: 28 %; Test Date: 20210522; Test Name: factor VII; Test Result: 85 %; Test Date: 20210522; Test Name: factor X; Test Result: 69 %; Test Date: 20210522; Test Name: Glasgow; Result Unstructured Data: Test Result:3; Comments: not sedated; Test Date: 20210504; Test Name: CRP; Result Unstructured Data: Test Result:3.30 mg/l; Test Date: 20210522; Test Name: CRP; Result Unstructured Data: Test Result:0.6 mg/l; Test Date: 20210522; Test Name: Clearance TTE; Result Unstructured Data: Test Result:LVEF 5 to 10%, akinetic LV, undilated RV; Comments: Systolic function OK visually, venous ECMO cannula visualized in the IVC.; Test Date: 20210522; Test Name: Clearance TTE; Result Unstructured Data: Test Result:LVEF 5 to 10%, akinetic LV, undilated RV, systolic; Comments: LVEF 5 to 10%, akinetic LV, undilated RV, systolic function OK visually, venous ECMO cannula visualized in the IVC; Test Name: ECG; Result Unstructured Data: Test Result:extensive left ventricular necrosis; Comments: almost akinetic; Test Date: 20210521; Test Name: ECG; Result Unstructured Data: Test Result:Probable left anterior hemiblock; Comments: Sinus rhythm, left axis with probable left anterior hemiblock. Repolarization is normal.; Test Date: 20210522; Test Name: ECG; Result Unstructured Data: Test Result:asystole on admission; Comments: sinus, extended anterior ST + with inferior shift; multiple passages in FV; switch to TV 180 / min at 00:17; Test Date: 20210504; Test Name: D-dimers; Result Unstructured Data: Test Result:Normal ng/ml; Test Date: 20210522; Test Name: D-dimers; Result Unstructured Data: Test Result:less than 24,000 ng/ml; Test Date: 20210522; Test Name: fraction of inspired oxygen; Test Result: 100 %; Test Date: 20210522; Test Name: fraction of inspired oxygen; Test Result: 456 %; Comments: At 11:42 p.m.; Test Date: 20210504; Test Name: CBC; Result Unstructured Data: Test Result:Normal; Test Date: 20210522; Test Name: hematocrit; Test Result: 36.3 %; Test Date: 20210522; Test Name: hemoglobin; Result Unstructured Data: Test Result:11.5; Test Date: 20210522; Test Name: Heart rate; Result Unstructured Data: Test Result:112/min; Test Date: 20210504; Test Name: pulmonary radiological assessment; Result Unstructured Data: Test Result:Normal; Test Date: 20210504; Test Name: clinical examination; Result Unstructured Data: Test Result:normal; Test Date: 20210522; Test Name: PNN; Result Unstructured Data: Test Result:18,760; Test Date: 20210522; Test Name: oxygen saturation; Test Result: 9.4 %; Test Date: 20210522; Test Name: oxygen saturation; Test Result: 96.9 %; Comments: At 11:42 p.m.; Test Date: 20210522; Test Name: pH; Result Unstructured Data: Test Result:less than 6.8; Test Date: 20210522; Test Name: pH; Result Unstructured Data: Test Result:7.7; Comments: At 11:42 p.m; Test Date: 20210522; Test Name: platelets; Result Unstructured Data: Test Result:167,000; Test Date: 20210522; Test Name: Procalcytonin; Result Unstructured Data: Test Result:0.02 ng/ml; Test Date: 20210522; Test Name: protein; Result Unstructured Data: Test Result:49 g/l; Test Date: 20210522; Test Name: factor II; Test Result: 79 %; Test Date: 20210522; Test Name: prothrombin time; Test Result: 54 %; Test Date: 20210522; Test Name: Respiratory rate; Result Unstructured Data: Test Result:25; Test Date: 20210504; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210522; Test Name: SARS-CoV-2 test; Test Result: Negative ; Comments: At 11:42 p.m.; Test Name: Troponin; Result Unstructured Data: Test Result:459,000 ng/ml; Comments: maximum; Test Date: 20210522; Test Name: Troponin; Result Unstructured Data: Test Result:37,986 ng/ml; Test Date: 20210522; Test Name: WBC; Result Unstructured Data: Test Result:26,800 /mm3
CDC 'Split Type': FRPFIZER INC2021699868

Write-up: Cardio-respiratory arrest; Myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority Report Number : FR-AFSSAPS-2021069222. A 31-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular on 19May2021 (Lot Number: FA4598) as single dose for COVID-19 immunisation. Medical history included ongoing obesity (BMI: 40.26), ongoing hypothyroidism, Graves disease (With orbitopathy, treated with Thyrozol and Levothyrox ), Smoking (10 pack-years ), Cannabis use (Occasional), pulmonary embolism from Aug2015 (With negative thrombophilia assessment (Proteins C and S not measured) ), thymectomy (For thymoma with global follicular lymphoid hyperplasia (thymoma discovered in the aftermath of pulmonary embolism) ), thymoma with global follicular lymphoid hyperplasia, neck pain from 04May2021, chest discomfort from 04May2021. No diabetes, no hypertension, no dyslipidemia, no family cardiovascular history, no contraception. The patient''s concomitant medications were not reported. The patient previously took thiamazole (THYROZOL) for basedow''s disease, levothyroxine sodium (LEVOTHYROX) for basedow''s disease. The patient experienced cardio-respiratory arrest (death, medically significant) on 22May2021, myocardial infarction (death, medically significant) on 22May2021. On 04May2021: consultation for neck pain and chest discomfort on deep inspiration in supine position. No dyspnea. The clinical examination is normal. Normal pulmonary radiological assessment. COVID test negative. Normal D-dimers. CRP 3.30 mg / l. CBC normal.On 07May2021: symptom improvement. On 19May2021: first dose Comirnaty (lot FA4598).On 21May2021: new consultation for neck pain radiating to the upper limbs, no fever, no symptoms. The ECG finds a sinus rhythm, left axis with probable left anterior hemiblock. Repolarization is normal.On 22May2021: Emergency medical services call at 8:02 pm by the mother for chest pain without respiratory distress with headache and pain in the jaw and left arm. Concept of occasional cannabis use during the day.8:46 pm: second call to the Emergency medical services for loss of consciousness: presence of gasp and cyanosis; witnesses at the request of the regulator. Arrival of firefighters at 8:55 pm: Arrival at 9:02 pm: asystole, urine loss, areactive bilateral mydriasis, intubation, intraosseous insertion in the humeral and tibia. Duration of noflow unknown (PC around 8:30 pm): Injection of 12 mg adrenaline in total. Transfer.In intensive care unit at 10 pm: heart rate at 112 / min; respiratory rate at 25; Glasgow at 3 not sedated; Bilateral areactive mydriasis, ROT (stretch reflex) abolished. Blood pressure at 73/58 on noradrenaline, BDC (heart murmurs) inaudible, pulse not perceived no sign of cardiac insects; cyanosis of the face, mottling up to mid-thigh, re-coloring time more than 3 seconds. ECG: asystole on admission. Post-sheave ECG: sinus, extended anterior ST + with inferior shift; multiple passages in FV; switch to TV 180 / min at 00:17. RP (chest radiograph): cardiomegaly, interstitial infiltrate predominant on the left. Clearance TTE (transthoracic echocardiography): LVEF 5 to 10%, akinetic LV, undilated RV, systolic function OK visually, venous ECMO cannula visualized in the IVC. WBC 26,800 / mm?, 18,760 PNN, hematocrit 36.3%, hemoglobin 11.5, platelets 167,000, TP (prothrombin time) 54%, factor II 79% factor V 28% factor VII 85% factor X 69%, D-dimers less than 24,000 ng / ml, anti-Xa UFH 0.09, fibrinogen 1.58 g / l, sodium 140, potassium 4.6, chlorine 103, protein 49 g / l, calcium 1.80 mmol, creatinine 89 ?mol, GOT (aspartate aminotransferase ) 504, GPT (alanine aminotransferase) 181, PAL 95, GGT (gamma glutamyl aminotransferase) 148, normal bilirubin, CPK (creatine phosphokinase) 4437 IU / L, troponin 37,986 ng / ml; CRP 0 6 mg / l, alcohol 0.12 g / l PCT (procalcytonin) 0.02 ng / ml.Blood gas under 100% FIO2 (fraction of inspired oxygen) on arrival: pH less than 6.8, PCO2 (partial pressure of carbon dioxide) 96, SaO2 (oxygen saturation) 9.4%, lactates 14.1 mmol / l.At 11:42 p.m .: pH 7.7, PCO2 34, PO2 456, SaO2 96.9%, ALAT at 13.7.PCR SARS-CoV-2 negative.At 10:30 p.m .: Right femoro-femoral ECMO-VCA pose; surgical reperfusion route; vasopressor support by noradrenaline and DOBUTAMINE IVSE; filling with NaCl, GELOFUSIN and albumin; sedation with midazolam and Fentanyl.Evolution: Emergency coronary angiography: sub-occlusion of the proximal anterior ventricular. Stenosis IVA 1:70 to 99%; Successful angioplasty with placement of a steel stent. Installation in refractory shock with collapse of the ECMO flow despite massive filling, large doses of amines; glypressin failure; initiation of a DIC, metabolic acidosis. Attempt of extra-renal purification without repercussions on hemodynamics. Echocardiography found extensive left ventricular necrosis, almost akinetic. The maximum troponin and dosed at 459,000 ng / ml. The evolution is unfavorable with inability to maintain an ECMO flow rate, ischemia of the lower limbs, major hemodynamic instability. The patient died the same day at 11 a.m.In total, refractory cardiopulmonary arrest on subocclusion of the proximal anterior ventricular vein with extensive necrosis of the left ventricle, complicated by post-resuscitation vasoplegic shock and multiorgan failure at D3 of Comirnaty in a young woman, having complained of chest discomfort without an ECG abnormality a few days before the injection. Therapeutic measures were taken as a result of events. Emergency Room Visit for the events. The patient died on 23May2021. An autopsy was not performed. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction; Cardio-respiratory arrest

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