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This is VAERS ID 335078

Case Details

VAERS ID: 335078 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
   Days after vaccination:3
Submitted: 2008-12-11
   Days after onset:24
Entered: 2008-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Activated partial thromboplastin time shortened, Alanine aminotransferase, Aspartate aminotransferase normal, Blood albumin decreased, Blood chloride normal, Blood creatinine increased, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea increased, Dehydration, Food intolerance, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit decreased, Haemoglobin normal, Intussusception, Irritability, Neutrophil percentage, Pallor, Platelet count increased, Protein total decreased, Prothrombin time normal, Pyrexia, Surgery, Ultrasound abdomen abnormal, Vomiting, White blood cell count normal, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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), Hostility/aggression (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (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? 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; 20Nov2008, See text; Activated partial thromboplast, 20Nov2008, 26.2Sec; Alanine aminotransferase, 20Nov2008, 41IU/L; Albumin, 20Nov2008, 4.2g/dL; Aspartate aminotransferase, 20Nov2008, 44U/L; Blood glucose, 20Nov2008, 99mg/dL; Blood urea nitrogen, 20Nov2008, 28mg/dL; Chloride, 20Nov2008, 99mEq/L; Creatinine, 20Nov2008, 0.7mg/dL; Hematocrit, 20Nov2008, 33%; Hemoglobin, 20Nov2008, 11g/dL; Neutrophil percentage, 20Nov2008, 59%; Platelet count, 20Nov2008, 597000/mm3; Potassium, 20Nov2008, 4.4mEq/L; Protein total, 20Nov2008, 072g/dL; Prothrombin time, 20Nov2008, 11.6Sec; Sodium, 20Nov2008, 137mEq/L; Ultrasound abdomen, 20Nov2008, See text; Urea, 20Nov2008, 60mg/dL; White blood cell count, 20Nov2008, 13900/mm3
CDC Split Type: B0549365A

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 male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant history or allergy. Concurrent vaccination included DTaP-IPV-HIB (manufacturer unspecified; intramuscular; unknown injection site) given on 14 November 2008; pneumococcal vaccine (manufacturer unspecified; intramuscular; unknown injection site) given on 14 November 2008. On 14 November 2008, the subject received 1st dose of ROTARIX (oral, lot number not provided). On 17 November 2008, 3 days after vaccination with ROTARIX, the subject experienced irritability, intolerance to oral feeding, gastro alimentary vomiting, bloody stools and fever. She received ambulatory treatment with clotrimazole, Acetaminophen and electrolytes without improvement. On 20 November 2008, the subject was hospitalised. Physical exam was with dehydration, pallor, abdominal distension and decreased bowel sounds. Lab tests were performed and showed the following: Glucose: 99 mg/dL; Urea: 60 mg/dL; Urea Nitrogen: 28 mg/dL; Creatinine: 0.7 mg/dL; Total Protein: 0.72 g/dL; Albumin: 4.2 g/dL; Alanine aminotransferase: 41 U/L; Aspartate aminotransferase: 44 U/L; Sodium: 137 mEq/L; Potassium, 4.4 mEq/L; Chloride: 99 mEq/L; Hemoglobin: 11 g/dL; Hematocrit: 33%; Platelet count: 597000/mm3; Leucocytes count: 13900/mm3; Neutrophils percentage: 59%; Prothrombin Time: 11.6 Sec; Partial Thromboplastin Time: 26.2 Sec. Abdominal X-ray was performed and showed air fluid levels and data of intestinal obstruction. Abdominal ultrasound was performed and showed right flank with tubular mass in longitudinal views (pseudo kidney) and a target appearance in transverse images probably ileocolonic intussusception, dilated bowels. On 20 November 2008, surgery was performed; ilececolic intussusception was found and reduced by taxis without complications. On 24 November 2008, the subject was discharged in good clinical conditions. On 24 November 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.

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