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Life Threatening? Yes
Write-up: This subject was enrolled in foreign study to gather epidemiological back-ground data on the incidence of intussusception in a foreign country. This report describes the occurrence of ileocolic intussusception in a 6-month-old male subject who was vaccinated with ROTARIX. The subject''s family anamnesis is free of intussusception and any other intestinal disorders. The subject experienced no intestinal birth-defects. The subject''s medical history did not include any intraabdominal surgeries previously. According to follow-up information, received on 22 June 2007 by a physician who was not the vaccinating physician, the subject received the first dose of ROTARIX on 30 December 2006. Approximately 58 days later, on 26 February 2007, the subject was diagnosed with ileocolic intussusception. The subject was hospitalized and underwent fixation of ileus. On 05 March 2007 the events were resolved. The reporting physician, who was not the vaccinating physician, considered that the events were life-threatening. Follow-up information by the treating physician, including the hospital report, was received on 26 July 2007. According to this information the subject received the first and only dose of ROTARIX on 11 January 2007. This information was confirmed by supplying additional information including the lot number of ROTARIX. This information was confirmed on 20 August 2007 by phone. Approximately 46 days post vaccination with ROTARIX, on 26 February 2007, the subject was diagnosed with ileocolic intussusception. The hospital report described the events as follows: In the morning of 26 February 2007 the subject fell off his mother''s bed. The subject was crying for a while, but falling asleep again after a while. Then waking up again the subject was limp, refused drinking and was bleeding from the mouth. On examination by a physician, the subject was vomiting once and showed facial pallor. On the same day, on 26 February 2007, the subject was hospitalized for suspected commotio cerebri. Brain concussion was not verified. According to the hospital report the subject was diagnosed with bruise of head, intussusception, gastroenteritis and obstructive bronchitis. On admission to hospital, on 26 February 2007, the subject showed significantly reduced general condition and pallor. Traumatic signs were noticed on chin with dental gum injury above the front teeth as well as occipital right. Heart and lungs were normal. Abdomen was soft. Bowel sounds were lively and bowel content was very soft on palpation. The subject showed no signs of hepatosplenomegaly. Neurological examination was normal. Laboratory examination revealed signs of inflammation (white blood cell count of 11300/ul, which further increased to 20000/ul with shift of differential blood count towards left with band neutrophil percentage of 6 % and segmented neutrophil percentage of 38 %; as well as increased C-reactive protein of 11.4 mg/l, which further increased to 35.6 mg/l). Stool examination showed no rotaviral antigen. Blood culture was sterile. In hospital, the subject showed experienced diarrhea with bloody stools and further episodes of vomiting. On 27 February 2007 an abdominal ultrasound scan was performed and showed ileocolic intussusception in the right epigastric region with ileus and distinct ascites. Small intestine resection was performed on 27 February 2007. Subsequent to the surgery the subject''s symptoms improved. Abdominal ultrasound scan, performed on 02 March 2007, was normal. Post surgery, on 28 February 2007, the subject experienced obstructive bronchitis. Obstructive bronchitis resolved on treatment with Atrovent and Sultanol, and did not recur even after discontinuation of treatment with ipratropium bromide. After eight days, on 05 March 2007, the subject was discharged from the hospital in a good general condition. At that time he was treated with Perenterol. Follow-up information was received on 09 February 2009 from the reporting physician (not the vaccinating physician): According to this report, on 30 December 2006 the subject had received the first dose of ROTARIX. The reporting physician was unsure about the date, which was Saturday. On 07 February 2007 the subject had received the second dose of ROTARIX. Nineteen days later the subject had been hospitalized for intussusception. The treating physician considered that ileocolic intussusception with ileus and ascites was unlikely related to vaccination with ROTARIX. The reporting physician did neither specify the causal relationship of the diagnosed events (including bruise of head, gastroenteritis and obstructive bronchitis to vaccination with ROTARIX, nor the causal relationship of any of the other observed events and symptoms to vaccination with ROTARIX.
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