Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Culture stool negative, Dermatitis diaper, Eczema, Enterocolitis, Faeces discoloured
Clinical narrative: Information has been received from a physician concerning 5 infant patients who on an unspecified date, were vaccinated with a dose of ROTATEQ (dose, route and Lot# not specified). The physician reported that "2-3 weeks" after the patients were given the dose of ROTATEQ (dates unspecified), they experienced blood in their stool. The physician also reported that the patients also had poor weight gain. At the time of the report the patients' outcome were not reported. It was unspecified if the patients sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. All telephone attempts to obtain follow-up information has been unsuccessful. Follow-up information has been received from a physician and medical records concerning an approximately four month old male with a history of possible atopic dermatitis manifested by the presence of recurrent scaling of the hands, ears, upper arms, and chest since the first month of life; assessed variously as neonatal acne versus milia versus reaction to "J&J" (15-APR-2010) and as seborrheic dermatitis and eczema (15-JUN-2010); who "has been very sleepy then last night was more awake and sort of moaning through night; not much sleep" (25-MAR-2010), weight up 1 ounce since birth (25-MAR-2010), some spit up but no real emesis, fussy last night-maybe reflux (noted 25-MAR-2010), who on 12-MAY-2010, received a first dose of ROTATEQ, orally (Lot #664880-1473Y). On 15-JUN-2010, the patient presented with a left palm wound (not further specified). On 04-JUL-2010, a pediatrician noted the patient had streaks of blood in his stool, more spit up, and was more fussy/demanding. On 06-JUL-2010, the patient had bloody mucous in his stool again. It was noted that for a few days it was normal, but the stool was yellow and green. The patient's mother stated that the patient's development was changing, so she was not sure if fussiness was from that or if patient was just not feeling well. Assessment included possible milk protein intolerance versus allergy; weight gain had slowed significantly though not in obvious distress. Recommendation included "Gentle Ease," and the patient's mother to cut dairy out of the diet completely. On 14-JUL-2010, it was noted that the blood in patient's stools cleared; stool was still green. The patient refused a bottle with formula. The patient's mother stopped dairy, eggs, peanuts, soy. The pediatrician discussed elemental formulas (Nutramigen AA or Alimentum), and considered an allergy referral. On 19-JUL-2010, the patient received a second dose of ROTATEQ, orally (Lot #665664/0304Z). On 27-JUL-2010, the patient was seen for a follow-up visit. The patient had blood in stool and his mother requested testing; also complained of red rash on left eye and back of his neck. It was noted that the patient's mother ate a food that "triggered it," and now has blood in stool. He had none on "Monday" and patient had small amount of fresh blood first time mucous and blood. Assessment included eczema, anal fissure, and bloody stool. At an office visit, the patient was heme positive. Allergy testing was negative (see below). The reporting physician wondered "if vaccine played a role." On 08-AUG-2010, it was noted the patient had seemed better for about two weeks after the mother cut out dairy (about 04-JUL-2010), but on 05-AUG-2010, the patient had a small amount of blood in his stool, and on 08-AUG-2010, he had more mucous and blood. On 09-AUG-2010, the patient had blood in his stools with mucous, and was spitting up a lot. He was hemoccult positive in the office. Assessment included allergic enterocolitis, and a sample was sent to a lab for stool culture and ova and parasite. The stool culture was negative for E coli Shiga Toxin EIA, there was no Salmonella or Shigella recovered, and no Campylobacter species were isolated. On 13-AUG-2010, the patient was evaluated by an allergy specialist who indicated that as a consequence of the presence of a small amount of blood in the stool during the previous three weeks, and concern about possible milk allergy, the child had been placed on Nutramigen the previous week. Skin tests to a battery of foods, including milk, were negative. The patient had no history of weight loss, fever, vomiting, or diarrhea. The allergist doubted that the minimal hematochezia was related to a food allergy or to a serious underlying inflammatory process involving the small intestine or colon. Although he did not see evidence of an anal fissure, the allergist noted the bleeding may have come from mild perirectal inflammation or fissuring. On 19-AUG-2010, the pediatrician noted the patient's weight was up on Nutramigen, and he had diaper rash. All available medical records will be provided upon request. Additional information has been requested.