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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: This case was reported by a physician and described the occurrence of invagination of intestine in a 4-month-old male subject who was vaccinated with ROTARIX, (GlaxoSmithKline). On an unspecified date the subject received the 1st dose of ROTARIX (unknown). Approximately 8 days after vaccination with the 1st dose of ROTARIX, the subject experienced invagination of intestine. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Follow up information received on 29 November 2007 (the physician has been contacted by phone): The subject was hospitalised. The patient was operated: partial intestinal resection. Further information has been requested. Follow up information received on 08 February 2008: The subject had no family history of intussusception or bowel abnormalities. The subject had no previous intra-abdominal surgery. The subject had no history of intussusception or congenital intestinal malformation. On 3 October 2007, the subject received the 1st dose of ROTARIX (oral). On 9 October 2007, 6 days after vaccination with the 1st dose of ROTARIX, the subject refused to eat. He experienced vomiting with jet in 2 to 3 occasions. He had liquid stools with trace of blood in stools. On 11 October 2007, physical exam reported palpation of induration at the level of right hypochondrium. Abdominal echography was performed and showed the following: Evidence of small lamina of light fluid effusion, at the level of parieto-colic splint and Douglas. Absence of abnormality in the liver, spleen and 2 kidneys. Clear presence of a tube of invagination in a median transverse position with thickening of receptor colon at 8 mm of diameter. The wall was very hypo-echogenic showing intestinal edema. It was contained intestinal loop with its mesentery containing enlargement of lymph nodes in favour of ileo-cecal invagination. The mesentery was widely vasculared. Important stasis of small intestine upstream. Ileo-cecal invagination with the head located in medio-transverse with important right colic parietal edema. Enema with gastrophine was performed in order to reduce the ileo-cecal invagination and showed hyperaeration of small intestine with small distention without any argument in favour of pneumopertoneum. Rapid casting of the head of tube of invagination which was located after the right colic angle. Rapidly this angle was made opaque but despite 3 attempts, no more important reduction was obtained. On morphological level; it was noticed an abnormal mucography of 2/3 of proximal colon transverse in relation more probably with parietal edema. On 11 October 2007, laparotomy with ileo-cecal resection with ileo-colic anastomosis was done; Cecal perforation was discovered. The subject was hospitalised and the physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were resolved with following sequelae: ileo-cecal resection with ileo-colic anastomosis. The physician considered the events were possibly related to vaccination with ROTARIX. Follow up information received on 02 April 2010: This case was also reported by a regulatory authority (#NY20070349).
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