Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laboratory test abnormal, Lethargy
Clinical narrative: This a consolidation of two reports, WAES0606USA03210 and WAES0607USA03095, concerning the same pt. Information has been received concerning a 12 week old female with no medical history who on the morning of 6/7/06 was vaccinated PO with the first 2.0 ml dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) (lot 652964/0145F). Concomitant vaccinations administered on that same included an IM dose in the right leg of Diphtheria toxoid (+) hep B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3 component (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX) (lot AC21B037BA), an IM dose in the left leg of Hib conj vaccine (652025/0540R) and a IM dose in the left leg of Pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot A98338B). There was no other concomitant therapy or illness at the time of vaccination. On the evening of 1/13/06 also reported as two weeks after vaccination, the pt presented with intermittent abdominal pain. The pt was also noted to be pulling her legs up and crying followed by her lying still and not moving. After 24 hours of this pain, the pt was brought in due to bloody stools. An acute abdominal series showed an obstructive picture. A diagnosis of ileocecal intussusception was made. A gastrogaffin enema could not reduce the intussuscepted bowel. The pt was hospitalized and immediately had her necrotic bowel resected in the operating room and was noted to be recovering in the PICU. At the time of this report, the pt was considered to be recovered. The pt was subsequently released from the hospital. The reporter also considered the ileocecal intussusception to be life threatening. Follow up information indicated that fixed tissue examination revealed histopathologic findings compatible with intussusception. The fixed tissue sample was negative by immunohistochemistry for rotavirus and adenovirus. From a stool sample, rotavirus VP4 gene was detected by RT PCR and probe hybridization with a probe specific for WC3 VP4 gene. This was consistent with the presence of vaccine virus rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) in the stool since conclusive since not enough product was obtained for sequencing. In contrast, RT PCR test for human rotavirus's were negative. Additional information was also received from a registered nurse indication that the pt had no allergies and had a family that was suffering from gastrointestinal distress. The RN reported that on approx 6/21/06, the pt was found to have blood in her stool. The RN considered the blood in stool to be disabling. Follow up information from the RN indicated that she did not feel comfortable relaying information and she insisted that she check with her high powers before giving any information. Subsequently, the RN indicated that she could not release any information. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. No further information is available.