Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Acidosis, Bacterial infection, Blood urea increased, Blood urine, Chromaturia
Clinical narrative: Initial report received on 15 December 2006 from an other manufacturer, report number WAES0610USA06268, who received the original report from a health care professional. This report is a follow up report to previously submitted reports by the other manufacturer on 13 October 2006, 30 October 2006, and 11 December 2006. Information has been received by the other manufacturer, from a registered nurse concerning a 9 week old male, with no concurrent illnesses, no medical history, and no allergies, who on 02 October 2006, at 13:00pm, was vaccinated with a first dose , left leg (route not reported) administration of IPOL, lot number Z0240, a first dose, left leg (route not reported) administration of Tripedia, lot number C2489AA, a first dose, right leg 9route not reported0 administration of Comvax, lot number 654538/0269T, a first dose, right leg (route not reported) administration of Prevnar, lot number B086910, and a first 2.0ml oral dose of Rotateq, lot number 654422/0607F. Reportedly, there were no adverse events following prior vaccinations. On 04 October 2006, the patient vomited one time and decreased appetite. He again vomited one time on 05 October 2006. He was seen in the physician's office the following day, on 06 October 2006, and had experienced loose stools two times that morning, with one episode of vomiting. Reportedly, two days later, on 08 October 2006, the patient presented with a four day history of diarrheal stool which looked rusty colored. It was noted that the patients mother could not exclude blood in the stool and the patient was admitted to the hospital. The following day, on 09 October 2006, the patient had ad differential diagnosis of viral illness (possibly from the Rotateq vaccine), bacterial enteritis, and intussusception. Diagnostic urinalysis showed pH 5.0 SP GR 1010, trace protein, no glucose, ketones, leukocytes, blood NHT, no culture. Laboratory work showed lymphocyte 37.0, serum blood urea 24, serum granulocytes 7.66, segmented neutrophil 47.0, CSF monocyte count 11.0. The patient had an abdominal X ray the following day that revealed normal bowel gas pattern with normal distribution, and no evidence of obstruction. It was reported that the patient was acidotic. On recheck, the patient fed well without emesis, had improved color, Cardio respiratory was brisk through, no tachycardia, abdomen was benign, and blood pressure was stable. The final diagnosis was primarily acidosis with additional dehydration, fever, and vomiting. On 12 October 2006, it was reported that the patient had been recently discharged from the hospital for gastroenteritis, and the patients mother had called the office indication that she was noticing some brick colored urine, but the child was not acting sick. The patient's mother was told to observe for now, and if discolored urine continued, to bring the patient in to the office for evaluation. On 13 October 2006, the patient was seen in the physicians office for hospital follow up, and possible blood in his urine. It was reported the patient was nursing for five minutes, taking in one to two ounces rather than the usual four ounces. There has been no fever since the hospital discharge. it was noted that the patient's weight had decreased by 15 ounces in one week and 23 ounces in 11 days. There had been no change in the frequency of the patient's stools since the discharge but they were still slightly watery, and there was trace blood found in the patient's urine. On 14 October 2006, the patient was again seen in the physician's office and there was no change in the patient's weight, and no further episodes of dark spots in the patient's diaper. Since the last visit, the patient's bowel movements were not as watery with greater volume, and he had at least four very wet diapers. The patient was not fussy and was alert. It was noted that feeding seemed off but overall nursing was okay. The plan was to continue breast feeding every two to three hours. It was reported that the patient recovered on 16 October 2006. Vomiting, diarrhea, and a acidotic dehydration were considered to disabling, life threatening, and other important medical events by the reporter (OMIC). A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.