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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a physician concerning a 6 month old female, with no medical history and no allergies, who was vaccinated with a first, second, and third oral dose of Rotateq (Lot# "1116D," 656188/1238F, and 656194/0024U) on 17-JAN-2007, 02-MAR-2007, and 15-MAY-2007, respectively. There was no concomitant medication. On 26-APR-2007 the patient was treated at the emergency room for intussusception and then released. No other symptoms were noted. Subsequently, the patient recovered. No product quality complaint was involved. the patient''s intussusception was considered to be an other important medical event by the reporter. A lot check has been requested. Additional ifnormation has been requested. 06/11/2007 MR received from CDC. Hospital record for ER admit on 4/25-27/2007 for c/o vomiting x6 which began the night prior. No stool noted that day. Also c/o fussiness and drinking less. PE: revealed an alert but mildly fussy infant with sunken eyes and dry mucus membranes. HR in the 140''s. Abdomen tender with guarding. pallor noted. Ped. surgery note 4/27 reveals infant tolerating po, voiding well, no blood noted in stools, abdomen soft and round. D/C to home. DX: Intussusception- Air enema reduced.
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