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This is VAERS ID 317781

Case Details

VAERS ID: 317781 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-05-19
Onset:2008-06-12
   Days after vaccination:24
Submitted: 2008-06-27
   Days after onset:15
Entered: 2008-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Abdominal pain, Anorexia, Appendicectomy, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium decreased, Blood thromboplastin normal, Blood urea normal, Decreased appetite, Dehydration, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intussusception, Neutrophil percentage decreased, Pallor, Platelet count increased, Prothrombin time normal, Somnolence, Surgery, Vomiting, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (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), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood glucose, 12Jun2008, 96mg/dl; Blood urea nitrogen, 12Jun2008, 13mg/dl; Chloride, 12Jun2008, 98mmol/l; Creatinine, 12Jun2008, 0.4mg/dl; Hematocrit, 12Jun2008, 30.3%; Hemoglobin, 12Jun2008, 7.7g/dl; Neutrophil percentage, 12Jun2008, 44.7%; Platelet count, 12Jun2008, 716,000/mm3; Potassium, 12Jun2008, 4.4mmol/l; Prothrombin time, 12Jun2008, 11.5sec; Sodium, 12Jun2008, 135mmol/l; Thromboplastin, 12Jun2008, 30.6sec; White blood cells, 12Jun2008, 7,000/mm3
CDC Split Type: B0526159A

Write-up: On 19 May 2008, she received the first dose of ROTARIX. This case was reported by a physician in the frame of a study and described the occurrence of ileocolic intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergy. On 19 May 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 12 June 2008, 24 days after vaccination with the 1st dose of ROTARIX, the subject experienced vomiting (6 episodes/24 hours), hyporexia, bloody stools (2 episodes/24 hours) and one episode of vomiting with bilious. On the same day she was taken to ER. On 12 June 2008, the subject was hospitalised. Physical exam reported somnolence, mild dehydration, painful abdominal mass in the right side, increased peristalsis and jelly-red stools during rectal examination with mild pallor. Lab tests were performed. On 13 June 2008 surgery was done; Ileocolic intussusception was resolved by taxis without complications and prophylactic appendectomy was performed. She had clinical improvement and was discharged on 16 June 2008 in good clinical conditions. The subject was treated with ampicillin, amikacin and paracetamol. On 16 June 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.


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