Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Intussusception, Irritability, Ultrasound abdomen abnormal, Vomiting, White blood cell count normal
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 6 month old male with no previous illness reported and mild eczema and cradle cap on 12-JUL-2011, was vaccinated intramuscularly with third dose of ROTATEQ (Lot # 668825/0525AA) into his right leg. The patient was also vaccinated with a third dose of PREVENAR (Lot # E97567) IM into his right leg, a third dose of ENGERIX B (Lot # AHBVB817BA) IM into his left leg and a third dose of PENTACEL (Lot # C3842AB) IM into his left leg. On 12-JUL-2011, the infant developed vomiting in the night. It was reported that the patient went to ER and follow up at the office. A 6 month male presented with vomiting, diarrhea (blood tinged), irritability (cyclic 10-15 minute every hour) 6 days prior to admission. It was reported that 2 days prior to admission symptoms improved. The day of admission symptoms aggravated and the patient was admitted to hospital. A barium enema was done for intussusception seen on CT scan. A repeated X-ray and sonogram showed recurrent intussusception that spontaneously reduced during observation in the intensive care unit. The patient was feeling well with no irritability and was discharged on hospitalization day (#2). The following information was obtained through follow-up and/or provided by the government. On 27-JUL-2011 and 22-AUG-2011, hospital and primary care physician (PCP) records received for date of service (DOS) 19-JUL-2011-22-JUL-2011 with discharge diagnosis of intussusception, S/P Barium enema reduction. The patient presented with 1 week history of intermittent vomiting, diarrhea. Seen in emergency room one time previously, the evening of immunizations 12-JUL-2011 and discharged. Intussusception noted on CT scan and barium enema (BE) done for reduction. Repeat X-rays and ultrasound (US) showed reoccurrence which spontaneously resolved. On an unspecified date, a serum alkaline phosphatase test was 123 and a white blood cell count was 16.7. A CT showed intussusception, an X-ray and an ultrasound showed recurrent Intussusception that spontaneously reduced during observation in pediatric intensive care unit (PICU). An abdominal ultrasound was positive for Intussusception (IS) and a BE was positive for Intussusception. It was reported that the patient was feeding well with no irritability at time of discharge on HD#2. PCP follow-up visit with normal exam. The events were considered to be serious. Intussusception seen on CT, Barium enema, Diarrhea (blood tinged), Day of admission symptoms aggravated, Irritability (cyclic 10-15 minute every hour) and vomiting were considered to be life-threatening by the reporter. The original reporting source was not provided. The VAERS ID# is 428157. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 668825/0525AA were satisfactory. In additional, an expanded lot check investigation was 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. No further information is available.