Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium enema abnormal, Blood urea nitrogen/creatinine ratio increased, Eating disorder
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 weeks old (also reported as 0.3 and 4 months old (contradicting information) male patient with no pertinent medical history and no previous illness who on 20-JUN-2011 was vaccinated with the second dose of ROTATEQ orally (lot number: 670241/0530AA) (dose not reported) and with the second dose of hepatitis Hib conj vaccine IM into the left leg (lot number: 666813/0254AA) (dose not reported). Concomitant vaccines included DAPTACEL IM into the right leg (AC21B285EA) and PREVNAR 13 IM into the right leg (lot number: 915671). The patient's symptoms were bilious emesis, currant jelly stools and lethargy. The patient was diagnosed with intussusception. The patient presented to office on 20-JUN-2011 for 4 month well child visit. The parents voiced no concerns. The patient was examined. On 13-JUL-2011 PCP office record and vaccine record was received for date of service 20-JUN-2011. The patient received immunizations. Plan to follow up at 6 month. Diagnosis was acute intussusception resolved. The patient presented to Emergency Room (ER) with complaining of vomiting, currant jelly stool and abdominal pain. The parents reported that on unspecified date the patient had been fussy since last PM, had been eating and drinking less, and had fever. The patient was reported to have had immunizations four days earlier. Upon ER presentation the patient's temperature was 98.6 degrees Fahrenheit. The patient was pale and was noted to be sleepy but arousable. On unspecified date, the patient received IV fluids (unspecified). The patient was diagnosed with intussusception, which was successfully reduced by barium enema. The patient was admitted for 23 hours observation. The next day, the patient was discharged home, after tolerating feeds. On unspecified date, abdominal plain film and Barium contrast enema were performed. BUN (serum blood urea nitrogen test) creat ratio was 32.3 (H). Barium enema routine and water soluble contrast enema was abnormal (contrast passed to mid-transverse colon at which point a filling defect was identified, representing the intussusception). This was reduced. Successful reduction of ileocolic intussusception was performed. The patient required an emergency room visit. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening by the reporter. The original reporting source was not provided. The VAERS ID# is 427144. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question 670241/0530AA 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. No further information is available.