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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: Information has been received from a nurse practitioner concerning a 16 week old female with no medical history who on 17-MAR-2008 and 07-MAY-2008 was vaccinated PO with 2.0 ml of the first and second doses of ROTATEQ (first dose lot # 659852/1665U and second dose lot # 659774/0140X). Concomitant vaccine therapy included on 17-MAR-2008 a dose of HEP B (lot #654436/1106F), IPOL, ACTHIB and PREVNAR. No concomitant drug therapy reported. On 19-APR-2008 the patient developed severe acute diarrhea and was hospitalized (19-APR-2008 - 25-APR-2008) for the treatment of urosepsis, septic shock. The patient required intubation for correction of the septic shock. The patient was diagnosed as having hydronephrosis by a renal ultrasound on approximately 19-APR-2008. The patient recovered (date unspecified) after receiving unspecified treatment. The NP felt that the diarrhea may have caused the urinary symptoms. On 15-JUN-2008 the patient experienced intussusception and was hospitalized. The patient recovered and was discharged on 17-JUN-2008. On 30-JUN-2008 the patient experienced intussusception, the barium enema was negative for intussusception but the ultrasound was positive and the patient was hospitalized until 02-JUL-2008. The NP reported that the third dose of ROTATEQ was held. The patient fully recovered on an unspecified date. The reporter considered the severe diarrhea, urosepsis, septic shock, hydronephrosis and both episodes of intussusception an other important medical event and immediately life-threatening. Additional information has been requested. 8/13/08-records received for DOS 6/30-7/2/08-DC DX: Vomiting. Intussusception. Presented with coughing, vomiting and nonbloody diarrhea. Positive upper respiratory infections. Previously seen on 6/15/08 for self reduced intussusception times 2 and was negative on barium enema and E. coli pyelonephritis on 4/08.
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