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This is VAERS ID 335536

Case Details

VAERS ID: 335536 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
   Days after vaccination:1
Submitted: 2008-12-17
   Days after onset:8
Entered: 2008-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Blood electrolytes normal, Diarrhoea, Diarrhoea infectious, Faeces pale, Full blood count normal, Haematochezia, Ileus, Intussusception, Lethargy, Mucous stools, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
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: Gastroenteritis
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 14Dec2008, bowel ileus; CBC, 14Dec2008, normal; Serum electrolytes NOS, 14Dec2008, normal
CDC Split Type: B0550437A

Write-up: This female subject was enrolled in a study 103366. On 08 December 2008, she received the 1st dose of ROTARIX (po). On 23 August 2008, the subject received a dose of ENGERIX B. On 04 September 2008, the subject received a dose of BCG (ID). On 30 October 2008, the subject received a dose of INFANRIX HEXA. Medical conditions at the time of the event included gastroenteritis. On 09 December 2008, one day after the 1st dose of ROTARIX, this three-month-old subject developed intussusception. The subject was hospitalised and the event was life-threatening. The subject was treated with Cotrimoxazole, ampicillin trihydrate, gentamicin sulphate, metronidazole and hydration therapy. The event improved on an unspecified date. The investigator considered that there was a reasonable possibility that the intussusception may have been caused by ROTARIX and that the event was possibly due to medical conditions. Investigator comments on 15 December 2008: loose bowel movement characterized as mucoid, blood streaked, yellowish occurring 8-9 episodes per day occurred 24 hours after ROTARIX administration. Consult done 3 days after ROTARIX administration, treated as infectious diarrhea given cotrimoxazole and oral rehydration solution. Current jelly stool noted few hours prior to admission. Hydration done and given oral antibiotics upon admission. 14 days prior to intussusception, the subject did not develop respiratory tract infection and had no change in feeding regimen (breast feeding). Abdominal ultrasound was not performed. On 14 December 2008, abdominal x ray showed bowel ileus. Air-fluid contrast enema and surgery were not performed. Symptoms from intussusception report form: vomiting, diarrhea, bloody stool or bright red stool, blood on rectal examination, red currant jelly stool, abdominal pain, lethargy.

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