Age: 0.2
Sex: M
Vaccine: RV5, DTAP, HIBV, RV5
Symptoms: Gastrooesophageal reflux disease, Haematochezia, Hypophagia, Infantile spitting up, Intussusception
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 2 month old male with a history of gastroesophageal reflux who on 27-JUN-2011 was vaccinated with the first dose of ROTATEQ (lot number 669523/1556Z) orally. Secondary suspect therapy included the first dose PEDVAXHIB (lot number 666243/1617Y) in his left leg. Concomitant therapy included the first dose of INFANRIX (lot number AC21B285BA) in his right leg and ZANTAC. The patient developed intussusception on 15-JUL-2011 and was admitted by Barium enema (x3 times). The symptoms began on 14-JUL-2011 with fussiness and spitting up more and by the next day he developed frankly bloody stool. The following information was obtained through follow up and/or provided by the government. On 27-JUL-2011 the patient's discharged summary as in-patient (H&P, surgery consult) and labs were received for date of service (DOS) on 14-JUL-2011. The discharged diagnosis was intussusception, partially reduced. The patient was received via transfer from another emergency room (ER) for surgical evaluation, due to complaint of one day history of bloody stools, loose watery, diarrhea, vomiting and fussiness. Upon admission, system exam review noted: positive for decreased oral intake, vomiting, bloody diarrhea, decreased urine output and diminished bowels sounds. The patient's temperature was 36.7 degrees C and O2 saturation was 100% room air. The patient appeared well hydrated. The patient was admitted and underwent an ultrasound of abdomen with findings suggestive of intussusception. The patient underwent barium enema x2 resulting in a partial reduction of the intussusception. The following information was obtained through follow up and/or provided by the government. On 27-JUL-2011 the records were received. Barium enema: intussusception at mid to right lateral trans. Colon. Intussusception moved to ascending colon, but not completely reduced with persistent intussusception at upper ascending colon. Abdominal ultrasound: abnormal (intussusception likely present at ascending colon or distal small bowel (prominent loop of bowel at right upper quadrant abdomen. Pyloric canal measurements pronounced-concerning for pyloric stenosis). His white blood count (WBC) was 17.3 (high), absolute neutrophil 10.1 (high), platelets 637 (high), mean platelet volume 6.4 (low), Troponin 5.7 (low). The follow up of the barium enema on 15-JUL-2011: incomplete reduction of intussusception demonstrated. Intussusception result in filling defect persisted. Surgery was consulted and felt the patient should be observed. After barium enema, surgery consult noted patient's abdomen was soft and there was no blood per rectum. Subsequently, the patient had a normal stool with no evidence of pain. The patient was discharged home and to follow up with physician. On 27-JUL-2011 the ER record received for DOS 29-JUL-2011. The impression was: irritable child. The patient presented to ER due to complaint of irritability. Exam noted that the patient had bowel sounds in all quadrants, no tenderness and belly soft. The patient was active and tolerated 5 ounces with no emesis. Record noted no irritability during stay. The patient was discharged home. On 29-JUL-2011 the primary care physician (PCP) office records (received on 13-JUL-2011 and 20-JUL-2011). The diagnosis was intussusception. The patient was seen in the office on afternoon of 13-JUL-2011 due to complaints of fussiness and spit up. The assessment was reflux. The plan was treatment with ZANTAC every 12 hours. The patient was seen on 20-JUL-2011 for follow up of ER visit the previous day. The patient was discharged two days earlier from hospital, but patient was fussy yesterday and was taken to ER for re-evaluation. Upon office follow-up, the parent reported that the patient was eating well, not vomiting and had no any bloody stools. The plan was re-check in 1 week or sooner if any problems. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 669523/1556Z 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. The originally reporting source was not provided. The VAERS ID number: 428162.