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This is VAERS ID 332984

Case Details

VAERS ID: 332984 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-09-29
Onset:2008-10-04
   Days after vaccination:5
Submitted: 2008-11-21
   Days after onset:48
Entered: 2008-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Anorexia, Crying, Fatigue, Haematochezia, Intussusception, Lethargy, Ultrasound scan abnormal, X-ray abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, see text; Diagnostic ultrasound, see text
CDC Split Type: B0542225A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 29 September 2008 the subject received unspecified dose of ROTARIX (oral) lot number not provided. On 4 October 2008, 5 days after vaccination with ROTARIX, the subject experienced intussusception which was resolved by single contrast enema. The physician considered the event was clinically significant (or requiring intervention). Relevant test results included abnormal ultrasound. On 4 October 2008, the event was resolved. The physician considered the event was possibly related to vaccination with ROTARIX. Follow up received on 20 November 2008: The physician that reported intussusception was not the physician who vaccinated the child. The reporter refused to give the name of the pediatrician who followed up the baby since birth. Then further details about vaccination could not be obtained. Five days post vaccination the subject developed lethargy, fatigue, loss of appetite, intractable crying and bloody stool. Relevant test included abdominal x-ray which demonstrated invagination of the intestine by air/liquid contrast enema. Abdominal ultrasound showed visible intussusception or soft tissue mass and demonstration of an intra-abdominal mass with specific characteristic features that is proven to be reduced by hydrostatic enema on post-reduction ultrasound.


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