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Life Threatening? Yes
Write-up: This case was reported by a physician in the time frame of a study and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergies. Concurrent vaccination included DTPa-IPV-HIB (manufacturer unspecified; intramuscular; unknown) given on 26 February 2008; hepatitis B vaccine recombinant (manufacturer unspecified; intramuscular; unknown) given on 26 February 2008 and pneumococcal vaccine, unspecified (manufacturer unspecified; intramuscular; unknown) given on 26 February 2008. On 26 February 2008 the subject received the 1st dose of ROTARIX (oral). On 1 March 2008, 4 days after vaccination with the 1st dose of ROTARIX, the subject experienced 4 vomiting, mucosanguinolent stools and abdominal distension. The subject was hospitalized. On 2 March 2008, laboratory tests were performed and showed the following: Hemoglobin 9.6 g/dL (normal range: 10-13); Leucocytes count: 18700/mm3 (normal range: 10000-15000); Platelets count: 179000/mm3 (normal range: 300000-700000); Hematocrit: 30.7% (normal range: 29-43); Lymphocytes percentage: 18% (normal range: 41-71). Abdominal X-ray was performed and showed big distension of intestinal loops and lack of air in rectal ampulla. Intussusception was suspected. The subject was sent to another hospital with pediatric attention. She was admitted at this hospital on 04 March 2008 with dates of more abdominal distension, nasogastric tube with billar material drainage, diminished peristalsis, painful abdominal mass on left side and more sanguinolent stools. Surgery was performed on 04 March 2008; intussusception in ileocecocolic position was found with small perforation (2cm). Resection of ischemic segment with term to term anastomosis (ileal-transverse-colon) was done without complication. After that the subject showed good recuperation without sepsis or complications. On 6 march 2008, laboratory tests were performed and showed the following: Sodium: 141 mEq/L (normal range: 135-145); Potassium: 5.9 mEq/L (normal range: 3.5-4.5); Calcium: 7.5 mEq/L (normal range: 8.8-11.2). On 11 March 2008, finally oral acceptance started. On 14 March 2008, the subject was discharged in good clinical condition without sequels. The subject was treated with Ranitidine, Amikacine, Ampicillin, Metamizole, nalbuphine, buprenorphine, Ketorolac, paracetamol, cefotaxime and metronidazole. On 14 March 2008, the events were resolved. The physician considered the events were disabling and life threatening. The physician considered the events were possibly related to vaccination with ROTARIX.
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