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This is VAERS ID 333142

Case Details

VAERS ID: 333142 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
   Days after vaccination:19
Submitted: 2008-11-24
   Days after onset:84
Entered: 2008-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abdominal mass, Abdominal pain, Barium enema abnormal, Blood creatine decreased, Blood glucose increased, Blood urea increased, Diet refusal, Gastrointestinal sounds abnormal, Haematochezia, Haematocrit normal, Haemoglobin normal, Inappropriate schedule of drug administration, Intestinal mass, Intussusception, Irritability, Neutrophil percentage increased, Pain, Pallor, Palpitations, Platelet count increased, Pyrexia, Rectal haemorrhage, Surgery, Vomiting, White blood cell count increased
SMQs:, Acute renal failure (broad), Acute pancreatitis (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), Pseudomembranous colitis (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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), 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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Barium enema, 01Sep2008, See text; Blood glucose, 01Sep2008, 114mg/dL; Creatinine, 01Sep2008, 0.4mg/dL; Hematocrit, 01Sep2008, 35.9%; Hemoglobin, 01Sep2008, 12g/L; Neutrophil percentage, 01Sep2008, 71.3%; Platelet count, 01Sep2008, 582000/mm3; Urea, 01Sep2008, 21mg/dL; White blood cell count, 01Sep2008, 19000/mm3
CDC Split Type: B0547121A

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 medical history or allergy. Concurrent vaccination included pneumococcal vaccine (manufacturer unspecified; intramuscular; unknown injection site) given on 13 August 2008. On 13 August 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 1 September 2008, 19 days after vaccination with ROTARIX, the subject experienced irritability, oral unacceptance, gastrobiliary vomiting (3), fever and bloody stools (5). The subject received ambulatory treatment with "Toprom", FLORATIL and PEPTOBISMOL without improvement. The subject was hospitalised. Physical exam with pallor, abdominal mass in left flank, pain to the palpation, incremented bowel sounds, Dance sign positive. Rectal mass and fresh blood in rectal tact. Laboratory tests were performed and showed the following: Glucose: 114 mg/dL; Urea: 21mg/dL; Creatinine: 0.4 mg/dL; Leucocytes: 19000/mm3; Hematocrit: 35.9%; Hemoglobin: 12 g/dL; Platelets: 582000/mm3; Neutrophils: 71.3%. Barium Enema was performed and showed inferior occlusion probably in the descending colon and sigmoid. Diagnosis of intestinal intussusception was made. 01 September 2008, surgery was performed: Ileocecocolic intussusception was found and reduced by taxis without complications. The subject was treated with BISMUTH and RANITIDINE. On 7 September 2008, the subject was discharged in good clinical conditions. On 7 September 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.

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