Age: 5.0
Sex: F
Vaccine: DTP, MMR, OPV, DTAP, MMR, OPV
Symptoms: Coma, Convulsion, Encephalitis, Pyrexia
Clinical narrative: On 1/25/00, pt recv'd MMR, DTAP, OPV vax. Subsequently, the pt dvlped a fever which progressed to seizures on 2/2/00. The pt went into a coma then had organ failure; discontinued from life support & died on 2/4/00. Reported cause of death.  Received on 10/16/2001: "Information has been received from a physician concerning an otherwise normal and healthy 5-year-old caucasian female who on 01/25/2000 was vaccinated SC in the left arm with a second dose of MMRII (Lot # 633011/1275J).  Concomitant vaccinations that same day included a fifth dose of acellular diphtheria toxoid/pertussis vaccine/tetanus (Acel-Immune) administered IM in the right arm, a fourth dose of oral poliovirus vaccine and tuberculin tine test (Mantoux).  It was noted that there were no concurrent conditions or past medical history.  Additional information received from the patient's mother indicated that on 02/01/2000, approximately 1-week post vaccination, the patient was given a dose of cefixime (Suprax) for the treatment of pharyngitis and "redness in the ear."  Eight hours later the patient developed a fever of 107F which progressed to grand mal seizures.  The patient was treated with ibuprofen (Motrin) and taken to a hospital.  During hospitalization, her "high" fever could not be controlled and a diagnosis of acute disseminated encephalomyelitis was made.  The patient "went into a coma then had organ failure and they discontinued life support and she died on 02/04/2000."  The reported cause of death was encephalitis.  The reporter stated a concern regarding the lot.  It was noted that the patient's mother has attributed the seizure and subsequent death to the administration of cefexime (Suprax)."  Upon internal review, multiple organ failure, coma, encephalopathy, grand mal seizures and acute disseminated encephalomyelitis were considered to be Other Medical Events. (OMIC)  Follow-up information received on 02/22/2000 indicated "an autopsy had been done, that there was evidence of no brain perfusion for at least a day prior to death, and that the brain was in a liquefied state at autopsy."  When the brain hardens, it will be sectioned histologically and PCR will be performed.  Additional follow up information received on 02/29/2000 indicated that the patient had experienced encephalopathy which was belived to be the cause of death.  Follow up information from a physician reported that on 03/16/2000 or 03/20/2000 a specimen was to be submitted to the Centers for Disease Control and Prevention for PCR analysis.  Follow up information received from a physician on 09/07/2000 indicated that the specimen which was sent to Baylor for PCR analysis "was negative for all enteroviruses tests as well as herpes simplex virus".  The rubella PCR done at the CDC was negative and the patient had positive IgG titers against measles virus.  It was noted an immunohistochemical analysis for mumps virus is pending from the CDC.  Follow up information received from a physician on 10/01/2001 indicated that the specimen that was sent to the CDC for PCR analysis was negative for both the measles and the mumps virus.  It was noted that the rubella PCR analysis "could not be done."  It was reported that the etiology of the child's illness has not been established.  Other business partner numbers include: MA2000-0086 and 0737-2000. A 15-day follow up report received 09/25/2000 adds: This is a corrected report. Acute disseminated encephalomyelitis has been added as an adverse event. This info was previously reported in the narrative only.