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Life Threatening? No
Write-up: Information has been received from a physician concerning a female with reflux who was vaccinated with the first dose of ROTATEQ. Concomitant therapy included PREVACID. It was reported that the patient had intussusception. The patient had inconsolable crying episodes and fussiness 1 day after receiving her 2 month immunizations. The patient had a normal bowel movement on the morning of 12-Jun-2008 but had episodic crying and later had 3 small bowel movements with specs of blood with a low grade fever. There was no vomiting and the patient was on breast milk. The patient was admitted to the hospital on 12-Jun-2008 and discharged on 13-Jun-2008. It was reported that the patient had fluoroscopy for barium enema. It was reported that the patient recovered from these events on 13-Jun-2008. The reporter considered intussusception, inconsolable crying episodes, fussiness, low grade fever, 3 small bowel movements with specs of blood and episodic crying to be other important medical events. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested. 9/15/2008 D/C summary received for DOS 6/12-13/2008 with D/C DX: Intussusception. Pt presented with inconsolable crying and 3 BMs with blood. PE WNL except for crying. Barium enema done with no residual IS identified. It was felt that the IS was resolved. Pt admitted for observation, had no pain o/n and was able to advance diet. Pt had a slightly heme (+) stool post-procedure.
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