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This is VAERS ID 318885

Case Details

VAERS ID: 318885 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-02-22
Onset:2008-03-30
   Days after vaccination:37
Submitted: 2008-07-14
   Days after onset:106
Entered: 2008-07-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Anorexia, Blood chloride decreased, Blood creatinine normal, Blood glucose normal, Blood potassium increased, Blood sodium decreased, Dehydration, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Irritability, Lymphocyte percentage, Monocyte percentage increased, Mucous stools, Neutrophil count normal, Platelet count normal, Surgery, Vomiting, White blood cell count, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hemoglobin: 12 g/dl (normal range: 10-13); Hematocrite: 33.9% (normal range: 29-42); Leucocytes: 6800 mm3 (normal range: 6000-17500); Lymphocytes: 49.4% (normal rnage: 40-70); Monocytes: 21.2% (normal range: 5-7); Neutrophils: 29.1% (normal range: 13-35); Platelets: 557000 mm3 (normal range: 300000-700000); Glucose: 82 mg/dl (normal range: 70-110); Creatinine: 0.6 mg/dl (normal range: 0.1-0.6); Sodium: 133 mEq/l (normal range: 135-145); Potassium: 5 mEq/l (normal range: 3.5-4.5); Chloride: 87 mEq/l (normal range: 95-105); Abdominal X-Ray was perofrmed on 2 April 2008 and showed abnormal intestinal air distribution; intestinal loop distended and opaque image in pelvic fore. Surgery was done on 2 April 2008, Ileocolic intussusception was found with ischemia in ileon: resolution by taxis was performed and vascular recuperation of ileon was confirmed.
CDC Split Type: B0528138A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocolic intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history or allergy. On 22 February 2008, the subject received 1st dose of ROTARIX (oral). Lot number not provided. On 30 March 2008, 37 days after vaccination with ROTARIX, the subject experienced ileocolic intussusception with abdominal pain, irritability and hyporexia. Later vomiting and one day before her admission at emergency room, she manifested one "sanguinolent" stool. On 2 April 2008, the subject was hospitalized with mild dehydration, abdominal pain and distention. Rectal tact was with red stool and mucus. Laboratory tests performed on 2 April 2008 showed the following: Hemoglobin: 12 g/dl (normal range: 10-13), Hematocrit: 33.9% (normal range: 29-42), Leucocytes: 6800 mm3 (normal range: 6000-17500), Lymphocytes: 49.4% (normal range: 40-70), Monocytes: 21.2% (normal range: 5-7), Neutrophils: 29.1% (normal range: 13-35), Platelets: 557000 mm3 (normal range: 300000-700000), Glucose: 82 mg/dl (normal range: 70-110), Creatinine: 0.6 mg/dl (normal range: 0.1-0.6), Sodium: 133 mEq/l (normal range: 135-145), Potassium: 5 mEq/l (normal range: 3.5-4.5), Chloride: 87 mEq/l (normal range: 95-105). Abdominal X-ray was performed on 2 April 2008 and showed abnormal intestinal air distribution, intestinal loop distended and opaque image in pelvic fore. Surgery was done on 2 April 2008. Ileocolic intussusception was found with ischemia in ileon; resolution by taxis was performed and vascular recuperation of ileon was confirmed. Resection was not necessary. The subject was treated with paracetamol, ampicillin, omeprazole, metronidazole, amikacin, metamizole and ketorolac I.V. Clinical evolution was favorable and by franc improvement was discharged on 08 April 2008. On 8 April 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


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