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Life Threatening? No
Write-up: This case was reported by a regulatory authority (#FI-NAM-20090077) and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject is the second child in the family. The subject''s mother had normal pregnancy. Cesarean section was planned because the mother''s previous childbirth experienced was a rough vacuum extraction. Birth weight: 3,940g. The baby has grown well so far and was on breast milk. She had a bowel movement every 4 days and had a large one a day before the onset date. On 24 July 2008, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 27August2008, 34 days after vaccination with ROTARIX, the subject the child started to cry in a shrieking manner, moaned all night and had a fever (38 deg. C). They came to the doctor, who noticed that the child was weak and lethargic, conscious and followed with her eyes. There was a fair amount of blood in the nappy. She was sent to the emergency for suspected intestinal invagination. The subject arrived on referral by doctor due to suspected invagination. The subject was hospitalized. General condition was moderate. Body temperature was 38.7 deg. C, blood pressure has not been taken yet. The girl was a little lethargic. However, she grabbed with her hands, the fontanelle was not bulging, followed with her eyes. A rapid heartbeat during auscultation, no murmurs. Symmetrical respiration sounds upon lung auscultation. The abdomen was soft and compliant during palpation; there was a sausage-like palpable mass on the lower abdomen. The liver seemed to be in the costal arch . A. fem. +/+. Normal skin turgor, warm periphery. Good capillary filling. The nappy was was full of bright blood. No tenderness during palpation per rectum, normal tonus. There was no blood on the glove. Clean anal region, no cuts during inspection. Specialist has also seen the subject. Clean skin. Blood samples and blood cultivation were taken. Abdominal ultrasound was ordered. There was clear finding indicating invagination. Plenty of retention in the ventricle. A nasogastric tube has been inserted. An air enema was successfully completed under general anesthesia. Most likely it was ileocecal invagination. The subject was transferred to be monitored in the recovery room. On 29 August 2008, the subject was discharged. At the time of reporting the outcome of the events was unspecified. Follow up at clinic in two months. This is all information received and available about this case. This case has therefore been considered closed.
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