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This is VAERS ID 319395

Case Details

VAERS ID: 319395 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-03-18
Onset:2008-06-01
   Days after vaccination:75
Submitted: 2008-07-16
   Days after onset:45
Entered: 2008-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Enema administration, Ileostomy, Infection, Intussusception, Large intestine perforation, Surgery
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Ischaemic colitis (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 20 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0529162A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of ileocolic intussusception in a 7-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included ROTARIX (GlaxoSmithKline, oral) 1st dose given on 15 January 2008. On 18 March 2008, the subject received 2nd dose of ROTARIX (oral). Lot number was not available. 3 months after vaccination with ROTARIX, the subject experienced ileocolic intussusception. ON 6 June 2008, the subject was admitted at emergency room and surgical intervention was done later pneumo-edema without success. Information about onset date, signs, symptoms, results of laboratory exams and x-ray were not available in the clinical chart. During surgery, ileocaecocolic position was found and perforation of transverse colon, reduction by taxis. Ileostomy at 30 cm of ileocaecal valve was done, resection was not necessary. The patient evolved with infection in the surgical injury without any other complication, clinical response was favorable. The subject was treated with amikacin, metronidazole, dipyrone (Metamizole), ketorolac trometamol (Ketorolac), omeprazole, clindamycin and cefotaxime. The patient was hospitalized for 20 days and the physician considered the events were disabling. Finally, he was discharged on 25 June 2008 with good oral acceptance and functional ileostomy. At the time of reporting the events were resolved with the following sequelae (ileostomy). The physician considered the events were unrelated to vaccination with ROTARIX.


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