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From the 11/19/2021 release of VAERS data:

This is VAERS ID 1315088

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Case Details

VAERS ID: 1315088 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Auscultation, Blood gases, Blood glucose, Blood lactic acid, Blood pressure measurement, Cardiopulmonary exercise test, Circulatory collapse, Coma scale, Computerised tomogram, Confusional state, Electrocardiogram, Heart rate, Hyperglycaemia, Intestinal ischaemia, Investigation, Lactic acidosis, Leukocytosis, Leukocyturia, Lipase, Liver function test, Metabolic acidosis, Multiple organ dysfunction syndrome, Nervous system disorder, Neurological examination, Neutrophil count, Oxygen saturation, PCO2 increased, Pancreatitis acute, Peritonitis, Platelet count, Pleural effusion, Portal vein phlebitis, Renal function test, Respiratory failure, SARS-CoV-2 test, Sputum test, Systemic inflammatory response syndrome, Tachycardia, Urological examination, Visual analogue scale, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (narrow), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Gastrointestinal perforation (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; Insulin-dependent diabetes mellitus (Familial: Insulin-dependent diabetes in the mother.)
Allergies:
Diagnostic Lab Data: Test Date: 20210421; Test Name: Auscultation; Result Unstructured Data: Test Result:BHA found on auscultation. No abdominal murmur per; Test Date: 20210422; Test Name: Auscultation; Result Unstructured Data: Test Result:Bilateral pleural effusions on auscultation; Test Date: 20210421; Test Name: blood gas; Result Unstructured Data: Test Result:shows metabolic acidosis with a PH at 7.30 with a; Test Date: 20210420; Test Name: Blood glucose; Result Unstructured Data: Test Result:2.98 g/l; Test Date: 20210422; Test Name: lactate; Result Unstructured Data: Test Result:, pH 7.28, lactates 5.3; Test Date: 20210422; Test Name: BP; Result Unstructured Data: Test Result:90 mmHg; Test Date: 20210421; Test Name: CARDIO-PULMONARY; Result Unstructured Data: Test Result:No RHJ or TJ found on inspection; Test Date: 20210422; Test Name: glasgow scale; Result Unstructured Data: Test Result:The Glasgow score is rated at 13 (Y3V4M6) without; Test Date: 20210421; Test Name: CT scan; Result Unstructured Data: Test Result:a CT scan is performed and shows an infiltration o; Test Date: 20210422; Test Name: CT scan; Result Unstructured Data: Test Result:An injected TAP CT scan is performed on 22Apr2021; Test Date: 20210421; Test Name: ECG; Result Unstructured Data: Test Result:ECG performed in principle: regular sinus tachycar; Test Date: 20210422; Test Name: heart rate; Result Unstructured Data: Test Result:120; Test Date: 20210421; Test Name: pulse rate; Result Unstructured Data: Test Result:114; Test Date: 20210420; Test Name: clinical/BISAP; Result Unstructured Data: Test Result:the patient is in pain, diffuse pain with pelvic d; Test Date: 20210422; Test Name: clinical/BISAP; Result Unstructured Data: Test Result:The seriousness of the disease is certain, BISAP 5; Test Date: 20210421; Test Name: HEPATO-ABDO; Result Unstructured Data: Test Result:Diffuse abdominal pain; Test Date: 20210420; Test Name: lipase; Result Unstructured Data: Test Result:3553 IU/l; Test Date: 20210422; Test Name: hepatic check; Result Unstructured Data: Test Result:No disturbance of BH (hepatic check) in the initia; Test Date: 20210421; Test Name: Neuro; Result Unstructured Data: Test Result:Conscious and well-oriented patient; Test Date: 20210422; Test Name: Neuro; Result Unstructured Data: Test Result:neurological failure with appearance of confusion; Test Date: 20210420; Test Name: PNN; Result Unstructured Data: Test Result:16.36 x10 9/l; Test Date: 20210421; Test Name: oxygen saturation; Test Result: 98 %; Test Date: 20210422; Test Name: oxygen saturation; Result Unstructured Data: Test Result:respiratory failure with 93% sat under 4L, FR 32. %; Test Date: 20210422; Test Name: platelet; Result Unstructured Data: Test Result:197 x10 9/l; Test Date: 20210423; Test Name: platelet; Result Unstructured Data: Test Result:88 x10 9/l; Test Date: 20210424; Test Name: platelet; Result Unstructured Data: Test Result:65 x10 9/l; Test Date: 20210420; Test Name: renal; Result Unstructured Data: Test Result:55; Test Date: 20210421; Test Name: renal; Result Unstructured Data: Test Result:71; Test Date: 20210422; Test Name: renal; Result Unstructured Data: Test Result:96; Test Date: 20210420; Test Name: COVID PCR test; Result Unstructured Data: Test Result:negative; Test Date: 20210420; Test Name: cytobacteriological examination of sputum; Result Unstructured Data: Test Result:An ECBU (cytobacteriological examination of sputum; Test Date: 20210421; Test Name: Pancreatitis SIRS; Result Unstructured Data: Test Result:3; Test Date: 20210421; Test Name: URO; Result Unstructured Data: Test Result:No SFU (functional urinary signs); Test Date: 20210421; Test Name: EVA; Result Unstructured Data: Test Result:7/10
CDC Split Type: FRPFIZER INC2021512385

Write-up: found small ischemia, ischemic small intestine; right colic associated with peritonitis; multi failure; neurological failure with appearance of confusion; neurological failure with appearance of confusion; respiratory failure; hemodynamic failure; lactic acidosis/pH 7.28, lactates 5.3; Bilateral pleural effusions; pylephlebitis of the splenic vein; tachycardia/Tachycardium at 114; leukocytosis; high PCO2; Acute pancreatitis; vomiting; abdominal pain; Hyperglycemia; leukocyturia; metabolic acidosis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB regulatory authority FR-AFSSAPS-RS20211119, Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021045921. A 73-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 20Apr2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included cholecystectomy in 2015. The patient''s had a history of Insulin-dependent diabetes. The patient''s concomitant medications were not reported. On 20Apr2021, the patient experienced 1st episode of vomiting plus abdominal pain post Comirnaty injection which was resolved rapidly. Second episode of sudden vomiting about 2 hours after injection. The patient consulted on 20Apr2021 at the facility. The patient went to emergency department. On the clinical level: the patient is in pain, diffuse pain with pelvic defense: a titration of morphine at 4 mg is performed. On the biological level: PNN increased to 16.36 G / L, lipasemia to 3553 IU / L with, however, normal hepatic assessment. Hyperglycemia was reported with a blood glucose level of 2.98 g / L (treated with insulin 10 Units). An ECBU (cytobacteriological examination of sputum) was performed and showed leukocyturia. A COVID PCR comes back negative on 20Apr2021. A blood gas produced on 21Apr2021 showed metabolic acidosis with a PH at 7.30 with a PCO2 at 32.5 and a PO2 at 108 + lactate at 4.4 mmol / L + HCO3- at 16.1. On the radiological level, a CT scan was performed and showed an infiltration of the pancreatic compartment with fluid effusion from the mesentery root, the pararenal and latero-conal spaces. No picture of gallstones. No sign of perforation. The scan without IV concluded with acute pancreatitis. The patient was transferred on 21Apr2021 to another ETB (Emergency Response Course) and to an adapted service in front of this pancreatitis presenting 3 SIRS criteria. Clinical examination on entry, HEPATO-ABDO with diffuse abdominal pain, no palpable mass, abdominal defense + pain on palpation. EVA(visual analog scale): 7/10, Good hydration: normal skin folds. BHA (hydroaeric noises) found on auscultation. No abdominal murmur perceived on auscultation. Pancreatitis SIRS 3: tachycardia + leukocytosis + high PCO2. CARDIO-PULMONARY result included no RHJ (hepato-jugular reflux) or TJ (jugular turgor) found on inspection, perceived peripheral pulse, lack of OMI (edema of the lower limbs) not taking the bucket, no added hiss or noise, no hissing and wheezing on auscultation, bilateral and symmetrical vesicular murmur and no sign in favor of DVT (deep vein thrombosis). NEURO reported conscious and well-oriented patient. No deficit of the cranial pairs nor sensory and motor disorder. UROLOGY reported no SFU (functional urinary signs), absence of bladder ball found on percussion / palpation. In the evening of 21Apr2021, the patient presented tachycardium at 114. SAT at 98% under 3.5 L of O2. Patient in great pain with VAS (visual analog scale) 7/10, morphine applied. Currently, carrying an NG Probe. ECG performed in principle with regular sinus tachycardia, slightly left axis, no ST or sign of BBG (left bundle branch block). Pr at 120 ms QTC calculated at 350 ms. Reminder tomorrow of MT for history and treatment in progress. In the morning of 22Apr2021, the patient with multi-failure, hemodynamic failure, FC 120, oliguria 300cc over 14 hours. Renal failure with appearance of an ARI (created on 20Apr2021 at 55), created on the evening of 21Apr2021 at 71 and 96 today (22Apr2021). The patient also had lactic acidosis with pH 7.28, and lactates 5.3. Neurological failure with appearance of confusion (incoherent speech today, disorientation, slowing ++). Respiratory failure with 93% sat under 4L, FR 32. Bilateral pleural effusions on auscultation. Diffuse abdominal defense. Rare BHA (hydroaeric noises). Diffuse abdominal pain, not relieved by morphine PSE 1mg / h. Increase to 1.5 mg / h, bolus of 3. Specialist advice given the seriousness of the picture of hydration +++ 1L of phy in free flow. And transfer to another service. The patient has no disturbance of BH (hepatic check) in the initial phase (ASAT 21, ALAT 22, GGT 25, PAL 89, bili 10). BH finding cytolysis at 50. No cholestasis. Indication nevertheless an abdominal ultrasound in order to rule out a possible lithiasic cause (ruled out by the echo on 22Apr2021). No alcohol consumption, calcemia and normal triglycerides. The patient was transferred to another department on 22Apr2021. The Glasgow score was rated at 13 (Y3V4M6) without focal deficit. There was moderate temporo-spatial disorientation. She presented sinus tachycardia at 130 bpm with mean arterial pressure kept at 90 mmHg. There were signs of peripheral hypoperfusion with cool extremities and slight mottling of the knees. There was no sign of right or left heart failure. Hematosis was altered with superficial polypnea at 25 cycles per minute without signs of struggle, and SpO2 at 91% under 6L of oxygen per minute. Cardiopulmonary auscultation finds a muffled vesicular murmur in the bases. Pulmonary x-ray shows bilateral atelectasis and pleural blunting. The abdomen was bloated, distended, and spontaneously painful and tender on palpation. Hydroaeric noises were not perceived. The nasogastric tube was productive. The patient benefits from the placement of a central venous catheter and an arterial catheter upon entry to monitor blood volume and allow a more detailed analysis of hemodynamics. Likewise, urinary catheterization makes it possible to more precisely quantify diuresis. NIV was introduced to combat atelectasis seen on auscultation. An injected TAP CT scan was performed on 22Apr2021 for evaluation at H48 and to explore the parenchyma and pulmonary vessels. She found acute Balthazar E-10 pancreatitis complicated by pylephlebitis of the splenic vein, abundant bilateral pleural effusion and bilateral contact atelectasis. The digestive loops were well vascularized. Curative anticoagulation with UFH(unfractionated heparin) was therefore started. The seriousness of the disease was certain, BISAP 5 and Balthazar E-10. The evolution was very quickly unfavorable. Respiratory failure requires the patient''s orotracheal intubation after rapid sequence induction (Cormack 1). The pleura were drained, bringing back a sero-hematic fluid negative in bacteriology. Hypoxia remained severe despite protective ventilation, high PEP and the appearance of bi-basal condensations led to a prone position on 23Apr2021. There was no response and the hemodynamics worsened, forcing this treatment to be stopped 3 hours later. Hepatic failure appears, suggesting a shock liver. The very rapid deterioration suggests a digestive complication such as ischemia or perforation. An exploratory laparotomy was indicated, but given the intensity of the organ failures, an AV ECMO is discussed with the surgeons to allow digestive surgery under good conditions. In view of the seriousness and the expected low benefit, the indication was not retained. The exploratory laparotomy was performed on 23Apr2021 and found small ischemia and right colic associated with peritonitis. The right colon and the ischemic small intestine are resected, mounted in the stoma. Hemodynamics and ventilation are difficult, filling and amines continued. Antibiotic therapy with CEFOTAXIME and METRONIDAZOLE is introduced, supplemented by a dose of AMIKACIN. However, the situation deteriorates further, the small stoma becoming necrotic and giving rise to suspicion of total ischemia of the digestive tract despite the treatments undertaken. This then becomes a therapeutic impasse. The family is met on several occasions to inform them of the diagnosis and the development of the situation until the therapeutic impasse. The patient died of her illness on 25Apr2021. In Total: acute fulminant pancreatitis, BISAP 5 and Balthazar E-10 without clear etiology found, complicated by digestive ischemia and associated peritonitis responsible for multiple organ failure and death. Pancreatitis occurring within 2 hours of the D1 of the COMIRNARTY vaccine and death within 5 days of the D1. Evolution of the results of Pq (platelets) during hospitalization (N 150-400 G / l): 197 on 22Apr2021 in the morning, 142 on 22Apr2021 evening, 88 on 23Apr2021, 65 on 24Apr2021 (the day before death ). The outcome of the events vomiting and abdominal pain was not recovered while unknown for the other events. The patient died on 25Apr2021. Autopsy requested by the family. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: found small ischemia; right colic associated with peritonitis; multi failure; neurological failure with appearance of confusion; neurological failure with appearance of confusion; respiratory failure; hemodynamic failure; acute pancreatitis


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