Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Enema administration, Gastrointestinal necrosis, Gastrointestinal sounds abnormal, Haematochezia, Ileectomy
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 month old male with gastrooesophageal reflux disease (GERD), gassiness, milk allergy, gastroenteritis and mild eczema and a history of left inguinal hernia repair in 20-JUN-2011 who on 16-AUG-2011 was vaccinated orally with the second dose of ROTATEQ (lot # 669992/0287AA). Concomitant therapy included the second dose of DAPTACEL (lot # C3944AA) given IM into right leg, the second dose of  ACTHIB (lot # UH410AA) given IM into right leg, the second dose of IPOL (lot # G1145) given IM into left leg and the second dose of PREVNAR 13 (lot # 916598) given IM into left leg and ZANTAC. There was no other medication. On 22-AUG-2011 the patient presented with vomiting and over the day became listless and had bloody stool in emergency room. The patient had ultrasound positive for intussusception and then had unsuccessful attempt at reduction with air contrast enema. Per hospital records 23-AUG-2011 to 27-AUG-2011 and 27-AUG-2011 to 28-AUG-2011: The patient was diagnosed with intussusception status post laparotomy converted to open reduction of intussusception with ileal resection and primary anastomosis. The patient's chief complaint was colicky abdominal pain; emesis; frankly bloody stools in emergency department. Physical examination: hypoactive bowel sounds and palpable mass on right side of abdomen. Unable to reduce intussusception by barium enema x3 in radiology or laparoscopically. The patient went to the operation room and had open reduction of the intussusception with an ileal bowel resection. Successful reduction was done by open incision with ileal resection (8cm segment of ileum found to be ischaemic/necrotic). Extensive intussusception visualized under fluoroscopy. The patient was discharged in stable condition to follow up with primary care physician and surgeon. The patient returned to emergency room same day of discharge with complaint of inconsolable crying, taut abdomen and emesis. The patient was readmitted. Work-up was negative. The patient was discharged in stable condition to follow up with surgeon. Laboratory tests included: PO4 2.9 mg/dl (low), chlorine 111 mEq/l (high), potassium 7.0 mEq/l (high), Ca 8.1 mg/dl (low), WBC 21.6 K/mm3 (high), platelet 546 K/mm3 (high), lymphocyte 19% (low), bands 16% (high). Ultrasound: positive for intussusception, likely ileocolic with free fluid. Repeat abdomen ultrasound: no evidence of recurrent intussusception. Ba enema showed non-reduced intussusception. The events were considered to be immediately life-threatening by the agency. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question 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 met the requirements of the Center for Biologics Evaluation and Research and was released. The original reporting source was not reported. The VAERS is 436762. No further information is available.