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Life Threatening? No
Write-up: Information has been received from a physician concerning a 17 week old female who in April 2007 and June 2007, was vaccinated PO with her first and second (lot# 656705/0241U) doses of Rotateq. Vaccinations at two months of age included "other 2 month recommended vaccines." On 05-JUL-2007 the patient was diagnosed with intussusception, was hospitalized and underwent emergency surgery. Subsequently, the patient recovered. It was noted that the patient did not have any adverse experience after the first dose two months earlier. There was no product quality complaint. The event was also considered to be an other important medical event (surgery) by the reporter. Follow-up information has been received from a physician indicating that the patient was vaccinated on 03-APR-2007 and 05-JUN-2007 with the first (lot# 655483/1116F) and second dose of Rotateq. Concomitant vaccinations administered on 05-JUN-2007 included a dose of PedvaxHIB, a dose of Pediarix and a dose of Prevnar. On 08-JUN-2007 the course of events were as follows: the patient had a two day history of diarrhea, non-bloody vomiting, decreased urinary output, was lethargic and sleepy, and had a low grade temperature. The patient presented to the emergency room on 10-JUN-2007 and was given fluids, blood work was done (results and specific tests not provided). On exam the patient had decreased bowel sounds and a doughy abdomen. A KUB was performed and showed decreased air in the colon. The passed a bloody mucous jelly stool in the ER. The patient was then transferred from the ER to another hospital for evaluation of intussusception. The patient was admitted to the hospital on 11-JUN-2007 and underwent surgery. Stool cultures performed while the patient was hospitalized were negative. The physician stated that the patient is "fine." On approximately 01-JUL-2007 (in the beginning of July), the patient seen by the surgeon who reported that the intussusception was "completely resolved." It was also noted that the surgeon "did not anticipate further problems." Additional information has been requested. 11/15/2007 Vax record received from PCP and info updated in VAERS database. 12/21/2007 MR received for DOS 6/11/2007 with DX: Acute Gastroenteritis. Dehydration. Somewhat lethargic. Child presented to ER with 2 day hx of diarrhea, vomiting, low grade fever, and decreased UO and energy level. PE (+) for sleepiness, doughy abdomen with decreased BS, and a tubular mass in the LUQ. Bloody stool noted during admission, but pt D/C same day. No D/C Summ written. Child transfered to higher level of care. 12/31/07 MR received from transfer facility for DOS 6/11-14/2007 with primary DX: Cecal polyp from ischemia. Presented as above. IS noted on contrast enema, partially reduced. Taken to OR for exploratory lap for Intussusception. IS was reduced. Polyp noted in ileocecal valve which appeared to be acting as lead point. A limited ileoceccectomy was also performed. D/C on post-op day 3 in stable cond.
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