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This is VAERS ID 316516

Case Details

VAERS ID: 316516 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Foreign  
Vaccinated:2008-04-11
Onset:2008-05-23
   Days after vaccination:42
Submitted: 2008-06-18
   Days after onset:26
Entered: 2008-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Appendicectomy, Gastrointestinal sounds abnormal, Haematochezia, Intussusception, Irritability, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (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? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0524213A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocolic intussusception in a 7-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (intramuscular) given on 7 May 2008; hepatitis B vaccine recombinant (intramuscular) given on 7 May 2008. First ROTARIX dose was given on 2 January 2008. On 11 April 2008, the subject received 2nd dose of ROTARIX (1 ml, oral). Lot number not provided. On 23 May 2008, 42 days after 2nd vaccination with ROTARIX, the subject experienced ileocolic intussusception, irritability, vomiting, bloody stools, bowel sounds decreased, current jelly stool. On 24 May 2008, a surgery was performed and yeyuno-ileo-ceco-colin intussusception was found without vascular compromise, reduction by taxis and prophylactic appendectomy was done with success. Post surgical clinical evolution was favorable, finally, she was discharged in good clinical condition. No laboratory and radiographics exams were reported in the clinical file. The subject was hospitalised for 5 days. The subject was treated with AMPICILLIN. On 27 May 2008, the events were resolved. The physician considered the events were not related to vaccination with ROTARIX.


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