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This is VAERS ID 384491

Case Details

VAERS ID: 384491 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2006-12-08
Onset:2007-04-14
   Days after vaccination:127
Submitted: 2010-04-07
   Days after onset:1089
Entered: 2010-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41DA194B / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Enema administration, Intussusception, Laboratory test abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? Yes
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: Unknown
Preexisting Conditions: At the time of ROTARIX administration, no other vaccine was administered, no concurrent medication was taken, no vomiting or diarrhea episode occurred.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0645472A

Write-up: This case was reported by the regulatory authority (reference RN0700227) and described the occurrence of intussusception of intestine in a 6.5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). At the time of ROTARIX administration, no other vaccine was co-administered, no concurrent medication was taken. At the time of events, the subject weighted 8 kg and measured 71 cm. On 08 December 2006, the subject received a 1st dose of ROTARIX (batch A41DA194B, oral). There was no vomiting or diarrhea episode at the time of vaccination. On 14 April 2007, four months after vaccination with ROTARIX, the subject was hospitalized for abdominal pain and vomiting without rectorrhagia due to an acute ileocolic intussusception (unspecified diagnostic test). Intussusception was reduced by air enema under general anaesthesia. Bowel movements passed normally on day two. The regulatory authority reported that the events were life threatening. According to the method of assessment, the relationship between vaccination with ROTARIX and the reported event was dubious.


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