Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Mucous stools, Nasal congestion, Occult blood positive, Pyrexia, Rash
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 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. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 07-JUN-2011 from a physician and medical records concerning a three month old male (14lb 4oz) who was vaccinated with oral ROTATEQ, the first dose given on 29-MAR-2010 (lot# 664873/1443Y), the second dose on 27-MAY-2010 (lot# 665275/0301Z) and the third dose on 04-AUG-2010 (lot# 665664/0304Z). No illnesses at time of vaccination. It was noted that the patient was seen 18-MAR-2010 for vaccine visit (hepatitis B vaccine, no further information or documation if vaccine was administered). On 05-06-2010 the mother reported the three month old patient had diarrhea with mucous for one week, chest congestion and runny nose for one month and not eating well continued (enfamil three to four ounces at feeding). She reported he had lots of sweating, Temperature 98.4. No improvement with acetaminophen. On examination: patient's weight 14.4 lb, hemangioma on back, tympanic membrane difficult to see but appeared normal, mild stuffy nose and stools were watery with mucus, no blood. Physician assessment: diarrhea, otherwise well; maybe upper respiratory infection or teething. Mother given hemoccult cards to check for blood and family to return the cards. Mother was also instructed to call if dehydration, vomiting or fever. Phone call note on 03-JUN-10, the patient's father reported patient only eating 13oz per day. It was noted scrotal ultrasound ordered to look for hernia (results not reported) and father concerned regarding patient's eyes crossing. Physician authorization for Ophthalmology and ordered AXIS 15mg/ml, 2 ml orally Bid. On 08-JUN-201 the physician reported concern regarding rash with AXID and ZANTAC 15mg/ml, 1 ml orally bid ordered. On 09-JUN-2010 positive results obtained for occult blood noted on quaiac stool #1 (occult blood stool #2 and #3 both had negative results). On 16-JUN-2010 the patient's father was notified by the physician regarding results of positive stool for blood and told that ZANTAC should help. Patient's father reported patient continued to not eat well and the patient's stool are once a day, described as green with black dots and diarrhea appearance. On 22-JUN-2010 the physician noted that the patient did not like nutramigen and began gentle ease. On 24-AUG-2010 patient seen with cough and fever. It was reported cough began two weeks ago and no fever at that time. Cough had increased over two weeks and temperature mostly around 102 and as high as 105 to 106 in middle of night. On examination: weight 18 lb. 10oz, temperature 99 (previously had TYLENOL,), rhinorrhea, no respiratory distress, right tympanic membrane was fine and left ear was flushed and irrigated tympanic membrane normal and not bulging. It was noted that patient's feeding was "ok" and no diarrhea. Physician assessment: fever and cough likely viral and observe over next few days and if fever persisted to call. Alternate acetaminophen and ibuprofen; instructed to observe for hydration and respiratory status and discuss possibility of laboratory work. The physician reported that the patient's diarrhea and difficulty feeding persisted for months; "no clear source, so consider that vaccine may have contributed." At the time of this report the patient had recovered. All available medical records will be provided upon request. Additional information has been requested.