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This is VAERS ID 315018

Case Details

VAERS ID: 315018 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
   Days after vaccination:57
Submitted: 2008-06-04
   Days after onset:43
Entered: 2008-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Barium enema abnormal, Enema administration, Flatulence, Gastrointestinal hypomotility, Haematochezia, Haematocrit normal, Haemoglobin normal, Intestinal mass, Intestinal obstruction, Intussusception, Lymphocyte percentage, Neutrophil percentage increased, Platelet count increased, Pyrexia, Vomiting, White blood cell count normal, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 23Apr2008, Abnormalunit; Barium enema, 23Apr2008, intussusceptionunit; Hematocrit, 23Apr2008, 35%; Hemoglobin, 23Apr2008, 12g/dl; Lymphocytes, 23Apr2008, 26%; Neutrophils, 23Apr2008, 73%; Platelet count, 23Apr2008, 543000/mm3; White blood cells, 23Apr2008, 6500/mm3
CDC Split Type: B0522112A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was under no other medication and had no relevant medical history nor allergy. She was healthy at the time of vaccination. Previous and/or concurrent vaccination included pneumococcal vaccine, unspecified; manufacturer unspecified; intramuscular; given on 2 April 2008. On 25 February 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 22 April 2008, 57 days after vaccination with ROTARIX, the subject experienced five times vomitings and fever. On 23 April 2008, the subject was hospitalised. The physical examination revealed a distended painful abdomen without peristalsis and palpable intestinal loop. The rectal tact revealed a mass and showed bloody stool on the explorer finger. The X-ray abdomen showed air-fluid levels and distended intestinal loop of superior left side. The diagnosis of intestinal obstruction by intussusception was made based on clinical data and abdomen X-ray. The fluoroscopic control revealed the ileocolic intussusception. The colon barited enema was successfully performed. The subject was hospitalised for 4 days. The subject was treated with paracetamol. The clinical evolution was favourable. On 26 April 2008, the events were resolved and the subject was discharged from hospital. The physician considered the events were unrelated to vaccination with ROTARIX.

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