Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HIBV, PNC13, RV5
Symptoms: Surgery, Ultrasound abdomen, Ultrasound abdomen abnormal, Urine output decreased, Vomiting
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 a history of gastrooesophageal reflux disease and, flattened right occiput and nasolacrimal duct obstruction, who on 30-JUN-2010 was vaccinated with his second dose of ROTATEQ (lot # 668037/0595Z) by mouth in the right leg. Concomitant therapy included the second dose of ACTHIB (lot # UH079AA, IM), PREVNAR (lot # E60211) and the second dose of INFANRIX (lot # AC21B248CA, IM) in the left leg. On 15-AUG-2009 the patient experienced severe gallstone pancreatitis and was hospitalized. On 15-AUG-2009, amylase was 1453 U/L. On 17-AUG-2009, CT (computed axial tomography) scan showed: 1. Acute pancreatitis with diffusedly edematous gland; 2. Calculus in distal; 3. Contrated gall bladder with calculi. Endoscopic retrograde cholangiopancreatography (ERCP) showed 5 mm brown stone. MRCP showed: gallstones. Therapy with blinded therapy continued. The date of most recent dose prior to event was 14-AUG-2009. On 23-AUG-2009, the patient recovered from severe gallstone pancreatitis and discharged from hospital. The reporting investigator felt that severe gallstone pancreatitis was possibly related to study therapy. It was reported that the patient was hospitalized on 28-AUG-2009 and discharged on 01-SEP-2009 (details not provided). Follow-up information was received which reported that in August 2009, the patient had gallstone pancreatitis, which is status post Endoscopic Retrograde Cholangiopancreatography (ERCP). This was complicated by gastrointestinal (GI) bleeding, which was treated and resolved with local adrenaline injection. On 15-OCT-2009, the patient experienced moderate gallstone pancreatitis and was admitted to hospital for elective laparoscopic cholecystectomy. The lab data: on 16-OCT-2009 histology showed no malignancy. On 18-OCT-2009, the patient recovered and was discharged well. The last dose of study therapy prior to the event was taken on 14-OCT-2009. The action taken with blinded therapy was none. The reporting investigator felt that moderate gallstone pancreatitis was unlikely related to study therapy. Moderate gallstone pancreatitis was considered to be an other important medical event. It was reported that the 4 month old was diagnosed with intussusception- ileocolic, treated surgically. Rotavirus immunization given 1 week prior. It was reported that the patient awoke on 06-JUL-2010 with vomiting bile, then he became lethargic; he was taken to pediatrician's office at 2:45 PM on 06-JUL-2010, and then sent directly to Emergency Department by doctor. The patient was then flown by helicopter to another hospital, where he underwent emergency surgery on 07-JUL-2010 for open repair of intussusception. The patient was discharged from hospital today on 09-JUL-2010. The following information was obtained through follow-up or provided by the government. 7/19/2010 received PCP office medical records for 6/30/10 and 7/6/10, vaccine records and ER medical. The final diagnosis were: vomiting, diarrhea, GERD, flattened right occiput. Records indicate the patient gassy around feeding and spits up with coughing. The patient was treated with ZANTAC and thickened feeding. RTC on 06-JUL-2010 with bilious vomiting, arching of back, 1 diarrhea stool, lethargic, pale and irritability. The patient was sent to ER for IV fluids and eval. The patient was transferred to higher level of care. On 20-JUL-2010 received hospital medical records for 07-JUL-2010 to 09-JUL-2010, the final diagnosis were: Intussusception. Laparoscopically reduced Records revealed patient with bilious vomiting, decreased feeding, stools and urine output for 1 day. Surgical consult was done. Attempted air enema x 2 and contrast enema x 1, were unsuccessful. The patient was taken to OR emergently. The patient was postoperatively progressed well and tolerating PO feedings. The patient was discharged home. Lab Data included WBC: 14.8, segs 77%(H), lymphs 12%(L). Chem 7: CO2 20(L), glucose 132 (H), BUN 15(N), creatinine<0.2(L). Radiology, Abd X ray, and ultrasound were performed. The listing indicated that the patient needs ER visit, hospitalized, and one or more of the events were considered to be serious and immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 392560. No further information is available. 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.