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This is VAERS ID 384490

Case Details

VAERS ID: 384490 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-04-07
Entered: 2010-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Crying, Diet refusal, Enema administration, Intussusception, Ultrasound scan abnormal, X-ray abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Depression (excl suicide and self injury) (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, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound scan, intussusception; X-ray, intussusception
CDC Split Type: B0645429A

Write-up: This case was reported by a foreign regulatory authority (AM20090420) and described the occurrence of intussusception of intestine in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Medical conditions and concurrent medications were unspecified. The subject weighted 5.8 kg and measured 57 cm. On an unspecified date, the subject received a 1st dose of ROTARIX (batch unknown, oral). Three days after vaccination with ROTARIX, the subject was hospitalized for crying and refusal to eat. Ultrasound scan and X-ray showed intussusception of intestine, reduced by hydrosoluble enema. All the events resolved. According to the foreign method of assessment, the relationship between vaccination with ROTARIX and the reported events was dubious.


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