Age: 0.14
Sex: M
Vaccine: RV5
Symptoms: Mucous stools, Occult blood positive, Regurgitation, Stool analysis abnormal, Weight gain poor
Clinical narrative: Information has been received from a physician concerning an infant patient, who on an unspecified date, was vaccinated with a dose of ROTATEQ (dose, route and lot # not specified). The physician reported that "2-3 weeks" after the patient was given the dose of ROTATEQ (dates unspecified), patient experienced blood in stool. The physician also reported that the patient had poor weight gain. At the time of the report the patient's outcome, was not reported. It was unspecified if the patient sought medical attention. This is one of several reports from the same source. Follow-up information was received from the responsible physician via a vaccine adverse experience report and medical records concerning an 11 week old male infant with a history of jaundice at birth. His mother had irritable bowel syndrome. On 25-May-2010, the infant was vaccinated with his first dose of ROTATEQ orally (lot number 665275/0301Z). The responsible physician indicated the following: The patient had no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions. On 20-Jun-2010, the patient became fussy and had feeding issues, loose diarrhea, positive for microscopic blood. Treatment included a trial PPI +/- help, mom cut out dairy and meat, tried Nutramagen +/- help. The patient recovered. The physician noted it was not clear if vaccine played any role. Medical records revealed the following: On 30-Jun-2010, facial globin and lactoferrin were positive and pancreatic elastase was normal. On 08-Jul-2010, the patient was seen by a gastroenterologist due to abdominal pain, gas and blood and lactoferrin in his stool. He was being treated with omeprazole & sodium bicarbonate for presumed gastroesophageal reflux as well as probiotics (for about two months) without any change in his symptoms. His mother went on a dairy-reduced diet but was not dairy-free. Nutramagen (a hypoallergenic formula) was tried but the patient refused to take it. Per the patient's parents, he had been gassy with abdominal discomfort, particularly during feedings, "from early in life". He had been almost exclusively breast fed. Stools had been very loose, sometimes explosive, and had been mucousy. There was never visible blood. He had some regurgitation and choking but no frank vomiting. His parents tried MYLICON (made no difference). TYLENOL (helped a little) and gripe water (choked on it). The physician's impression: colicky symptoms, discomfort during feeding, loose, mucousy stools. Treated for gastroesophageal reflux without any real change in symptoms. Recent testing showed blood in stool. Physician felt "the patient almost undoubtedly has allergic colitis accounting for his symptoms. Gastroesophageal reflux could be playing a role as well". The mother was advised to go on a completely dairy-free diet/fully hypoallergenic diet and continue breast feeding since the patient was growing and gaining weight well (previously reported that the patient had poor weight gain). It was recommended the patient take infant vitamin with vitamin D and iron. The patient received his second dose of ROTATEQ orally on 22-Jul-2010 (lot number 665664/0304Z). Additional information has been requested.