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This is VAERS ID 318408

Case Details

VAERS ID: 318408 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:2008-01-23
Onset:2008-06-16
   Days after vaccination:145
Submitted: 2008-07-07
   Days after onset:21
Entered: 2008-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Abdominal pain, Abdominal pain upper, Barium enema abnormal, Blood chloride increased, Blood potassium normal, Blood sodium increased, Crying, Dehydration, Gastrointestinal hypermotility, Haematocrit decreased, Haemoglobin decreased, Intussusception, Irritability, Lymphocyte percentage, Neutrophil percentage, Pallor, Platelet count normal, Prothrombin time normal, Pyrexia, Somnolence, Surgery, Ultrasound abdomen normal, Vomiting, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Tubulointerstitial diseases (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: Barium enema, 16Jun2008, intussusceptunit; Chloride, 17Jun2008, 110mmol/l, 98-107; Hematocrit, 17Jun2008, 30.2%, 37.7-53.7; Hemoglobin, 17Jun2008, 10.2g/dl, 12.2-18.1, Lymphocytes, 17Jun2008, 30%, 10-50; Neutrophils, 17Jun2008, 65%, 37-80; Platelet count, 17Jun2008, 205000/mm3, 142000-424000; Potassium, 17Jun2008, 4.5mmol/l, 3.5-5.1; Prothrombin time 17Jun2008, 11.3seg, 11-15; Sodium, 17Jun2008, 146mmol/L, 136-145; Ultrasound abdomen, 16Jun2008, Normalunit; White blood cell count, 17Jun2008, 6000/mm3, 4600-10200;
CDC Split Type: B0527456A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 11-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. Previous and/or concurrent vaccination ROTARIX ;GlaxoSmithKline;oral given on 17 September 2007. On 23 January 2008, the subject received 2nd dose of ROTARIX (oral), lot number. On 16 June 2008, 5 months after vaccination with ROTARIX, the subject experienced abdominal pain with continuous vomiting (6 episodes), irritability, crying and fever. The subject was brought to the emergency ward. Physical examination showed somnolence, pallor, mild dehydration, plain abdomen with pain in the upper right quadrant with an abdominal mass and increased and increased peristalsis. The Abdominal ultrasound did not put the intussusception in evidence. The contrasted colon enema showed an intussusception but was not able to resolve it. On 16 June 2008, surgery was performed, ileocecocolic intussusception was found and resolved by taxis without complication. On 17 June 2008, the laboratory test showed a slight decrease of partial thromboplastin time to 28.9 sec. The subject was hospitalised for 4 days. The subject was treated with RANITIDINE, metronidazole, amikacin and paracetamol. On 19 June 2008, the subject was discharged from hospital to finally be controlled as outpatient. On 26 June 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


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