Information has been received from a registered nurse concerning a 10 weeks female patient with no allergies or drug reactions and no pertinent medical history who on 05-MAY-2011 was orally vaccinated with the first dose of ROTATEQ (Lot# and expiration not reported). There was no concomitant medication. Nurse reported that on 09-MAY-2011 the mother of the child noticed blood in the child's stool and took her to the ER. The child was evaluated and discharged from ER (No admission). The patient sought medical attention by an ER visit. At the time of reporting the patient's outcome was unknown. Follow up information has been received from a physician and medical records concerning a 10 weeks female patient (Weight: 6.5 kg and Height 63.8 cm) with a milk allergy with emesis (start date not provided, also reported by the physician as no pre-existing allergies), no known tobacco exposure, obstruction of left lacrimal ducts (07-MAR-2011), skin tags on anus or rectum which were evaluated by pediatric surgery (07-MAR-2011) and a family history of seizures and encephalitis with short term memory problems in mother, KEPPRA during pregnancy, heart disease and liver disease in paternal grandmother who on 05-MAY-2011 at 09:30 was orally vaccinated with the first dose of ROTATEQ (Lot# 669567/0204AA, expiration not reported). Also on 05-MAY-2011 at 09:30, the patient was intramuscularly vaccinated in the leg with the first dose of PREVNAR (manufacturer: Wyeth-Ayerst, lot # E88940); ACTHIB (manufacturer: Sanofi-Pasteur, lot # UH267AA); and PEDIARIX (manufacturer: GlaxoSmithKline, lot # AC21B285EA). The physician reported the patient was healthy and had no illnesses at the time of the vaccination. The patient's concomitant medication was TRIVISOL taken by mouth daily. The patient's past drug history was Hep B (26-FEB-2011). The physician reported no adverse events following prior vaccinations. The physician reported that on 10-MAY-2011, the patient began having diarrhea which was mucous stools, pink tinged, blood streaked and was hemoccult positive. On 10-MAY-2011, the patient was seen in the emergency room. At the time of reporting the patient had not recovered (date of recovery noted as 7 to 10 days). On 12-MAY-2011, the patient was seen in the physician's office with diarrhea that had started 2 days prior with 8 watery stools in the afternoon. The patient's stools were very watery with streaks of pink mucous. The patient had no ill symptoms, no change in feeding, no vomiting or change in spit up, no rash, no cough or congestion, no fussiness or pain, and/or no sleepiness. She was taken to the emergency and trauma center and was diagnosed with viral illness by one physician and another thought it could have been something else, however the patient's mother could not remember. On 12-MAY-2011, she had 3 looser stools which were less watery than before but still contained bloody or pink mucous streaks. The patient's mother thought the patient's stools were better than the previous days. The patient still had no additional symptoms. The patient's mother stated that the patient had a milk allergy with emesis with milk. The patient's past medical history noted a term birth female newborn that passed her hearing screen, normal neonatal "OC" and soft and non-tender abdomen with normal bowel sounds. The patient had hemoccult positive times two cards in the areas from pink mucous and green normal appearing stool sampled all positive. The physician's assessment was hemoccult positive diarrhea (ROTATEQ) versus cow milk protein allergy. The physician discussed both possibilities with the patient's mother and was told if the cause was the (ROTATEQ), the patient's stools should improve. The watery nature and improvement spoke toward (ROTATEQ) as the cause of the diarrhea. However, if the cause of the patient's diarrhea was cow's milk protein allergy the patient's stools would continue to be bloody and loose. The patient's mother was instructed to call the physician to discuss further and to update. The patient was switched to nutramigen. The physician noted that if the patient had cow's milk allergy, it would be a problem to give a ROTATEQ at future visits. At the time of the report the patient's outcome had not resolved. All telephone attempts to obtain follow-up information have been unsuccessful. All available medical records will be provided upon request. Additional information has been requested.