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This is VAERS ID 317780

Case Details

VAERS ID: 317780 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-02-10
Onset:2008-02-22
   Days after vaccination:12
Submitted: 2008-06-27
   Days after onset:125
Entered: 2008-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Appendicectomy, Band neutrophil count increased, Blood calcium increased, Blood chloride increased, Blood potassium increased, Blood sodium normal, Blood thromboplastin decreased, Decreased activity, Gastrointestinal hypermotility, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intussusception, Irritability, Pallor, Platelet count increased, Prothrombin time normal, Pyrexia, Surgery, Vomiting, White blood cell count increased
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (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), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Band neutrophil count, 22Feb2008, 14,700/mm3; Calcium, 22Feb2008, 10.4mg/dl; Cl, 22Feb2008, 116.4mmol/l; Hematocrit, 22Feb2008, 35.4%; Hemoglobin, 22Feb2008, 11.5g/dl; Platelet count, 22Feb2008, 520,000/mm3; Potassium, 22Feb2008, 5.25mmol/l; Prothrombin time, 22Feb2008, 14.1sec; Sodium, 22Feb2008, 144.9mmol/l; Thromboplastin, 22Feb2008, 28.7sec; White blood cells, 22Feb2008, 19,800/mm3
CDC Split Type: B0526175A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocolic intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history of allergy. Previous vaccination included ROTARIX (GlaxoSmithKline); oral given on 10 December 2007. On 10 February 2008, the subject received the 2nd dose of ROTARIX (oral). On 22 February 2008, 12 days after vaccination with the 2nd dose of ROTARAIX, the subject experienced irritability, continuous vomiting, bloody stools and fever. He was taken to ER the same day. Physical exam reported pallor, hypoactive, abdominal distension with higher volume in upper quadrants and increased peristalsis. The subject was hospitalised. Laboratory tests were performed. The subject was treated with erythromycin and RANITIDINE. On 23 February 2008, abdominal surgery was performed; Ileocolic intussusception was confirmed and reduced by taxis, prophylactic appendectomy also was done. After surgery, he evolved to clinical improvement and he was discharged on 28 February 2008 in good clinical conditions. On 28 February 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.


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