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Life Threatening? No
Write-up: Information has been received from a certified medical assistant concerning a 6 month old male, with no medical history and no allergies, who was vaccinated with a first and second 2 ml oral dose of Rotateq (Lot# 654422/0607F and 656187/1237F) on 16-JAN-2007 and 19-MAR-2007, respectively. Concomitant therapy included Tylenol as needed. On 28-APR-2007 the patient was taken to the emergency room and was transported to another facility that was equipped to handle children. The patient was hospitalized and underwent surgery to correct intussusception. It was reported that a nurse mentioned that the child was seen on 21-MAY-2007 for a well check up and was still recovering at that time. It was noted that the patient was due for a third dose of Rotateq, but the physician decided not to complete the series. No product quality complaint was involved. No other information was provided. The patient''s intussusception was considered to be an other important medical event by the reporter. Additional information has been requested. A lot check has been requested. 6/14/07 Received medical records via fax from CDC which reveal patient experienced abdominal pain w/bilious emesis x 1 day. Seen at outlying ER where UGI films were neg & stool was + for occult blood. Admitted 4/20-5/2/07. Taken to OR for operative reduction of ileocolic IS & appendectomy. Progressed well & d/c to home. FINAL DX: Intussusception. 6/14/07 Received medical records of ER visit via fax from CDC which reveals patient experienced congestion, bilious vomiting, fever & crampy intermittent abdominal pain w/difficulty sleeping. Transferred to higher level of care.
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