Age: 0.1
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability, Laparoscopy abnormal, Lethargy, Leukocytosis, Localised intraabdominal fluid collection
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 4 weeks old male patient with no known drug allergies, normal vaginal birth, "initial issue with weight gain" resolved and recent skin blisters, no pre-existing illness at time of vaccination, seen for 2 months well child visit with no history of recent illness, diarrhea, upper respiratory symptoms, no history of reflux, no siblings- first born and no contact with recent illnesses on 25-JUL-2011, was vaccinated PO with the first dose of ROTATEQ (lot# 668963/1199Z). Secondary vaccine suspect given on the same day included the second dose of RECOMBIVAX HB (lot# AHBVB9776A, is an invalid lot number for RECOMBIVAX HB IM, in the left arm. Concomitant vaccination included the first dose of PENTACEL (lot# C3910AA) given IM in the right arm and the first dose of PREVNAR 13 (lot# E23421) given IM in the left arm. It was reported that 4 days after vaccination, the patient was taken to the emergency department (ED) after one day of several episodes of vomiting. Last bowel movement was approximately 24 hours prior to presentation to the hospital. A barium enema revealed blockage. The patient was sent to the operating room immediately. A laparoscopic exploration discovered ilean intussusception. 10 cm was resected and both ends re-anastomosed. The patient hospital stay was complicated by an intra-abdominal infection which responded to piperacillin/tazibactam treatment. On 05-AUG-2011, the patient was discharged from hospital to home with parents. The patient had a diagnosis of small bowel-small bowel intussusception. On 07-SEP-2011, the patient presented with one day history of projectile vomiting following all feeds. Seemed dehydrated with decreased wet diapers. The patient was fussy and lethargy, had abdomen distended with creased bowel sounds and leukocytosis. A laparotomy was performed for small bowel intussusception resected with end to end anastomosis. The patient had a lateral laparotomy incision opened due to purulent debris. The patient had performed a KUB X-ray -abnormal, an abdominal ultrasound-abnormal for free fluid in abdomen and a white blood cell count (WBC) of 15, 00. The patient was discharged. The diagnosis was ileoileal intussusception with complete bowel obstruction. The patient presented for post hospital recheck. He was quite well, abdomen soft and non-distended. Incision, no evidence of erythema, drainage or infection. On 14-SEP-2011, the emergency room report and discharge summary were received. Additional information was abstracted. Diagnosis: small bowel-small bowel intussusception. Post-surgical visit discovered lead point due to omphalomesenteric duct remnant. Wound was nearly closed. Laboratories performed on the same date included fluoroscopy of abdomen which showed abnormal, Barium enema- abnormal and a chest x-ray -abnormal surgical path. Another laboratories performed included: RAD: acute abd min 2 view with PA CXR (chest x-ray) finding -air filled distended loops of small bowel consistent with small bowel obstruction US abd: findings: 1) dilated loops what appear to be small bowel, concern for high grade bowel obstruction. 2) moderate free fluid which was nonspecific finding. No evidence of focal complex fluid collections to suggest abscess formation. 3) no evidence of ileocolic intussusception. At the time of the report the outcome of the patient was unknown. The original reporting source was not provided. The VAERS ID # is 432904. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 668963/1199Z were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot 668963/1199Z met the requirements of the Center for Biologics Evaluation and Research and was released. All adverse events reported were considered to be immediately life-threatening by the reporter. No further information is available.