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Life Threatening? No
Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 7-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline. The subject was on no other medication and had no relevant medical history nor allergy. Previous vaccination included ROTARIX, GlaxoSmithKline; oral given on 9 January 2008. On 10 March 2008 the subject received 2nd dose of ROTARIX (oral). On 10 April 2008, 31 days after vaccination with the 2nd dose of ROTARIX, the subject started with abdominal pain, vomiting (10 episodes) initially gastric and after biliar, jelly bloody stools (2 episodes). Therefore the subject was brought to the emergency room. Physical examination showed pallor, irritability, abdominal pain, decreased peristalsis no-mass, rectal examination with jelly bloody stools. On 11 April 2008 the subject underwent a surgery where ileocecal intussusception of 10 cm was found. It could not be resolved by taxis therefore intestinal resection of approximately 14 cm was done with termino-terminal anastomosis 12 cm apart from ileocecal valve. No appendectomy was done. After surgery the subject evolved with clinical improvement. On 16 April 2008 the subject was discharged in good clinical conditions. The subject was treated with METAMIZOL, RANITIDINE, FUROSEMIDE and surgery. On 16 April 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.
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