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This is VAERS ID 326697

Case Details

VAERS ID: 326697 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
   Days after vaccination:10
Submitted: 2008-10-01
   Days after onset:215
Entered: 2008-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Activated partial thromboplastin time shortened, Blood calcium normal, Blood creatinine normal, Blood glucose increased, Blood group O, Blood potassium increased, Blood sodium normal, Blood urea increased, Bradycardia, Bradypnoea, Cardio-respiratory arrest, Cyanosis, Death, Decreased activity, Dehydration, Grand mal convulsion, Haematochezia, Haematocrit decreased, Haemoglobin normal, Hyponatraemia, Hypovolaemic shock, Ileostomy, Ileus paralytic, Intestinal anastomosis, Intestinal dilatation, Intestinal obstruction, Intestinal resection, Intussusception, Irritability, Metabolic disorder, Pain, Pharyngeal erythema, Platelet count increased, Prothrombin time shortened, Pyrexia, Rales, Rectal haemorrhage, Respiratory distress, Resuscitation, Rhesus antibodies positive, Status epilepticus, Surgery, Tachycardia, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute renal failure (broad), Haemolytic disorders (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), 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), Hypovolaemic shock conditions (narrow), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-03-15
   Days after onset: 15
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cough, Meckel diverticulum
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 02Mar2008, see textunit; Abdominal X-ray, 08Mar2008, see textunit; Abdominal X-ray, 12Mar2008, see textunit; Blood glucose, 02Mar2008, 94mg/dl; Blood grouping, 02Mar2008, ORh+; Calcium, 02Mar2008, 9.2mEq/l; Creatinine, 02Mar2008, 0.8mg/dl; Hematocrit, 02Mar2008, 34.6%; Hemoglobin, 02Mar2008, 11.6mg/dl; Leukocyte count NOS, 02Mar2008, 20470mm3; Partial thromboplastin time pr, 02Mar2008, 29..9s; Platelet count, 02Mar2008, 710000mm3; Potassium, 02Mar2008, 5.8mEq/l; Prothrombin time, 02Mar2008, 10.6s; Sodium, 02Mar2008, 134mEq/l; Urea, 02Mar2008, 62.6mg/dl
CDC Split Type: B0538764A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included Meckel diverticulum. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 13 December 2007. Six days before hospital admission the subject had cough. On 18 February 2008 the subject received 2nd dose of ROTARIX (oral). On 28 February 2008, 10 days after vaccination with ROTARIX, the subject experienced vomiting (10 episodes) abdominal distention and fever. On 02 March 2008 the subject was admitted at the emergency room presenting hypo activity, hyperemic pharynx, tachycardia, fever, abdominal pain with distention, dehydration, rectal tact with expulsion of fresh bloody stool and rectal bloody. The same day relevant test included abdominal x-ray showing intestinal occlusion and intussusception. Therefore the subject underwent a surgery which revealed Ileo Ileocolic intussusception with a necrotic mass (Meckel diverticulum considered congenital anomaly) and 300 cc of peritoneal free liquid. Intestinal resection of 10 cm was made with term to term anastomosis without further surgical correction. However the subject had unfavorable clinical evolution. He presented epileptic status with general tonic clonic seizures, hyponatremia and hypovolemic shock. On 08 March 2008 the subject showed abdominal distention. The same day the abdominal x-ray showed lack of intestinal air and rectal ampoule. The subject underwent again a surgery which showed intestinal occlusion, dysfunctional term to term anastomosis, damaged ileum and 100 cc of peritoneal liquid. A terminal ileum resection was required with a new ileal anastomosis. Post surgical evolution of the 2nd surgery was favorable for 2 days. On 11 March 2008 the subject presented irritability, abdominal distention, painfulness palpation and gastrobiliar liquid flow by nasogastric tube. Abdominal X-ray showed absence of intestinal air and air fluid levels. On 13 March 2008 the subject underwent a 3rd surgery which showed paralyzed colon, big intestinal dilatation of ileum and jejunum. The last anastomosis of the 2nd surgery was occluded in 90% of the lumen, loop to loop bridas, 60 cc of free serohematic liquid in abdominal cavity, bridas lysis, loops decompression and ileostomy of 2 stomas. The subject was discharged of surgery in favorable conditions. However on 14 March 2008 the subject presented crackles and slight respiratory distress without fever or infection evidence. On 15 March 2008 the subject had suddenly alveolar crackles in both lungs, cyanosis, bradycardia, bradypnea and finally cardio pulmonary arrest without response to resuscitation for 50 minutes. The physician considered the events were disabling, life threatening. The subject was treated with surgery, ceftriaxone, metamizole, metronadizole, vancomycin, omeprazole, THIOPENTAL, diazepam, phenytoin, clindamycin, metoclopramide, octreotide, salmeterol xinafoate, dexamethasone, dopamine, albumin, insulin, FUROSEMIDE, KETOROLAC and blood. The physician considered the events were possibly related to vaccination with ROTARIX. On 15 March 2008 the subject died from intestinal obstruction, intussusception and metabolic disorder.

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