Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPH, PNC13, RV5, DTAPH, PNC13, RV5
Symptoms: Intussusception, Lethargy, Leukocytosis, Lymphocyte count increased, Mass
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the Company from the FDA under the Freedom of Information Act. A 16 week old female with no known drug allergy; no past hospitalization; no pertinent medical history and no previous illness who on 31-JAN-2011 was vaccinated with the second dose of ROTATEQ (dose not reported, lot # 669074/1526Z) by mouth. Second suspect therapy included the second dose of TRIHIBIT (dose not reported, lot # C3808AB) IM to the right leg and PREVNAR 13 (dose not reported, lot # E234419) IM to the left leg. On 01-FEB-2011 the patient was presented to ER with bilious emesis vomiting (4-5 times) and fever. The patient was lethargic or developed lethargy and was found to have an intussusception and Meckel's diverticulum. Mass was resected and reduced successfully. The patient had received 4-month-old immunizations on Monday. The parent reported no irritability or crying. Upon presentation, patient was in no obvious distress and temperature was 98.5  Fahrenheit. Examination noted that patient's abdomen was distended with good bowel sounds and was non tender to palpation. KUB revealed gaseous distention small bowel & colon and recommended clinical follow-up. While in the emergency room, the parent noted the patient was more lethargic and laboratory testing revealed leukocytosis. Blood glucose test showed 125, serum potassium test showed: 5.4, white blood cell count showed: 25.4, blood lymphocyte count showed 20, blood neutrophil count showed 73, urine culture showed no growth. Abdominal x-ray showed s. bowel w/air-fluid levels consistent w/ small bowel obstruction; abdominal ultrasound showed abnormal (distended loops of bowel-poss. intussusception or SB obstruction. In the emergency room, the patient received IV fluids, ZOFRAN and ROCEPHIN. The patient was admitted. On 29-APR-2011, primary care physician office records, x-ray report and vaccine record were received for dates of service 31-JAN-11 to 11-APR-11. Impression: intussusception. On 11-FEB-11, that patient was seen due to hospital follow-up for intussusception. The patient's incision was clean and intact, abdomen soft. The patient was next seen on 04-APR-2011 due to diarrhea and diaper rash. On 11-APR-2011, the patient was seen due to worsening diaper rash and blood in stool and the patient's examination noted bloody lesions on bottom. Patient was planned prescribed with nystatin, AQUAPHOR and QUESTRAN. At the time of reporting, the outcomes were unknown. The listing indicated that one or more of the events required hospitalization and was considered to be immediately life-threatening. No further information is available. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of (PRODUCT NAME). Additional information will be provided upon finalization of this manufacturing investigation. The original reporting source was nor provided. The VAERS ID# is 421245.