This is VAERS ID 336187

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Appendicectomy, Dehydration, Gastrointestinal hypomotility, Haematochezia, Hypophagia, Intussusception, Irritability, Pharyngeal erythema, Pharyngeal oedema, Pyrexia, Somnolence, Surgery, Ultrasound kidney normal, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), 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, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Paracetamol; Chlorpheniramine
Current Illness: GRIPPE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 17Nov2008, see text; Leukocyte count NOS, 19Nov2008, high level; Ultrasound kidney, 19Nov2008, normal
CDC Split Type: B0551537A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocecal intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. Concurrent medical conditions included grippe treated with PARACETAMOL and CHOLPHENIRAMINE. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 1 August 2008. On 10 October 2008 the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 17 November 2008, 38 days after vaccination with ROTARIX, the subject started with 6 episodes of vomiting, fever, oral intake reduced with 1 bloody stool. The patient was admitted at ER on 17 November 2008 and showed at physical exam dehydration, somnolence, hyperemic pharynx, pharynx edema, abdominal distension and bowel peristalsis decreased. The next day the patient showed abdominal pain, irritability, more distension, absent peristalsis and rectal ampulla empty at rectal tact. The subject was hospitalised. Intussusception was diagnosed by abdominal x-ray. Surgery was done on 19 November 2008. Ileocecal intussusception was found, reduced by taxis with appendectomy without complications. Tests were performed on 17 November 2008 and showed the following results: Abdominal X-ray: dilated intestinal loops in right side abdomen, air-fluid levels and lack of air in pelvic fosse. Searching of entamoeba histolytic: positive in fresh stool with 90% polymorphonuclears and 10% monocytes Renal Ultrasound: normal; Leukocytes: high level. The subject was treated with PARACETAMOL, RANITIDINE, CO-TRIMOXAZOLE, METRONIDAZOLE and NALBUPHINE. On 24 November 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information requested therefore the case has been closed.