Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Culture urine negative, Dehydration, Diet refusal, Dry mouth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 week male patient with a history of Abscess drainage for Methicillin-susceptible Staph Aureus in suprapubic area without incident at 1 month of age, circumcision and upper respiratory tract infection, on 11-NOV-2010 was vaccinated orally with the second dose of ROTATEQ (lot # 667861/1047Z). Concomitantly was vaccinated intramuscularly into the right leg with a second dose of PREVENAR 13 (lot # 914274) and into the left leg with the second dose of PENTACEL (lot # C3552AA/C3668AA). On 14-NOV-2010, the patient began vomiting and passed one black, tarry stool. He presented for evaluation the following day and was found to be tired, somewhat lethargic, and mildly dehydrated. He was ultimately found to have intussusception that required surgical intervention. The following information was obtained through follow-up and/or on 17-NOV-2010. The patient Care Plan (PCP) records received for Date of Services (DOS) 15-NOV-2010 with assessment: I) vomiting 2)mild dehydration, and 3) possible malrotation. The patient returned to PCP 4 days after vaccination with runny nose, vomiting, refusing formula, "tar" looking stool, decreased # wet diapers, fever, congestion, anterior fontanelle depressed, and not crying tears, mucus membranes tacky. The abdomen was soft and distended, the patient cried with palpation. The patient was cranky and alert. The patient was sent to hospital for rehydration and evaluation. On 17-NOV-2010 hospital records received for DOS on 15-NOV-2010 with diagnosis of intussusception. The patient went to emergency room with black, tarry stool, vomiting after each feeding (including water), last bout of emesis with green streaks, decreased energy, but consolable. Urine output decreased with sediment in last void, not producing tears, dry mouth. Tympanic membrances eryithematous, but no bulge and are mobile. The patient went to OR for intussusception reduction and appendectomy after contrast reduction failed. The patient developed fever (38.8 C) after surgical reduction, otherwise afebrile. The patient was still in hospital as of last records received. On 24-NOV-2010, the discharge summary was received for DOS 15-NOV-2010 with diagnosis of intussception. Abdominal ultrasound revealed intussusception. CBC and CMP were normal. Blood and urine cultures were negative. At the time of the report, the patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization and were considered to be immediately life-threatening. This was originally reported was not provided. The VAERS ID # is 409077. A lot check has been initiated. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 667861/1047Z were satisfactory. In addition, an expanded lot check investigation was   [Due to memory limitations, the remainder of this text could not be compared.]  performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics. Evaluation and Research and was released.