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This is VAERS ID 320507

Case Details

VAERS ID: 320507 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-02-11
Onset:2008-06-27
   Days after vaccination:137
Submitted: 2008-07-25
   Days after onset:28
Entered: 2008-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Abdominal pain, Appendicectomy, Arachnoid cyst, Blood chloride decreased, Blood creatinine decreased, Blood glucose increased, Blood potassium normal, Blood sodium decreased, Blood urea decreased, Computerised tomogram normal, Gastrointestinal hypomotility, Haematochezia, Haematocrit increased, Haemoglobin normal, Intussusception, Irritability, Loss of consciousness, Nausea, Platelet count normal, Somnolence, Ultrasound abdomen abnormal, Ultrasound scan abnormal, Vomiting, White blood cell disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), 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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypoglycaemia (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cranial-encephalic trauma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Laboratory tests were performed on 28 June 2008 and showed the following results: Glucose: 114 mg/dl (normal range 70-110); Urea: 13 mg/dl (normal range 14-44); Creatinine: 0.3 mg/dl (normal range 0.6-1.3); Leukocytes: 6000/mm3 (normal range 4500-10000); Platelets: 19200 /mm3 (normal rang 150000-450000); Hemoglobin: 16 g/dl (normal range: 12-16); Hematocrit: 50.3 % (normal range: 38-47); Chloride: 96 mmol/1 (normal range: 100-108); Potassium: 3.8 mmol/1 (normal range: 3.6 - 5.2); Sodium: 132 mmol/l (normal range: 136-145); Abdominal ultrasound showed round image in ileocolic zone not distended of 40 x 27mm, decreased peristalsis and liquid intestinal loops. On 27 June 2008, a computerized axial tomography showed a left temporal arachnoid''s cyst not complicated without requires surgical treatment and a cranial X-ray showed no clinical alterations.
CDC Split Type: B0530201A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocolic intussusception in a 8-month-old male subject who was vaccinated with Rotarix (GlaxoSmithKline) for prophylaxis. Previous vaccination included live attenuated human rotavirus vaccine (GlaxoSmithKline, oral) given on 10 December 2007. On 11 February 2008, the subject received 2nd dose of Rotarix (oral). lot number not provided. On 26 June 2008, the subject suffered cranial-encephalic trauma without loss of consciousness just drowsiness. He was admitted to Emergency room on 27 June 2008 where exams were performed. On 27 June 2008, 4 months after vaccination with Rotarix, the subject started with vomiting, nausea, decreased gastrointestinal peristalsis, and irritability. One day later, without improvement, the subject experienced abdominal pain, one bloody stool and palpable mass in abdominal area. Abdominal ultrasound showed round image in ileocolic zone not distended. The subject was hospitalized for surgery and ileo-appendiculo-colic intussusception was found and corrected by taxis and appendectomy without complications. The subject was treated with metronidazole and paracetamol. On 5 July 2008, the events were resolved. The convalescence and abdominal recuperation were gradual and neurological conditions were favorable. The patient was discharge on 05 July 2008 in good clinical conditions. The physician considered the events were unrelated to vaccination with Rotarix.


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