Age: 0.53
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Bradycardia, Cardiac arrest, Gastrointestinal haemorrhage, Hydrocephalus, Hypertension
Clinical narrative: This subject is an eight month old female, who was admitted to the hospital due to right cerebellar mass and 3rd and bilateral ventricular enlargement while enrolled in a Safety, Immunogenicity and Lot Comparability of CPDT Vaccine Absorbed When Administered with Other Recommended Vaccines at 2, 4, 6, and 15 to 16 months of age, Protocol Number P3T06. The subject received three doses of study vaccine; the last dose prior to the event was given on 6/25/02. The subject developed vomiting and became lethargic and was admitted to the hospital 54 days post immunization. She was found to have right cerebellar mas and 3rd and bilateral ventricular enlargement. The event of right cerebellar mass and 3rd and bilateral ventricular enlargment was reported by the investigator as unrelated to the study vaccine. Discharge summary and reports from the investigations done in the hospital have been requested by PPD. From additional information received on 12/11/02 from PPD, it was reported that this patient was hospitalized secondary to vomiting and was later diagnosed with ependymoma. The treatment options for this child are systemic chemotherapy. On 8/18/02, the subject was admitted to the hospital after three weeks of vomiting, lethargy, and progressive head tilt. Treatment included ventriculostomy with externalized drain for decompression. The subject was taken to surgery on 8/23/02 because of an acute development of the left sixth-nerve palsy and agonal respirations. Since surgery, the course has been complicated by a failed swallowing study, therefore, a Gastro-tube was placed without a Nissen fundoplication. The subject developed aspiration pneumonia on 9/1/02 and the treatment included clindamycin and Reglan. The subject has also experienced a small gastrointestinal bleed. The subject was given chemotherapy since this hospitalization and has had to be re-hospitalized several more times due to complications of the underlying ependymoma. From additional information received on 2/5/03 from PPD it was reported that this 13 month old subject who was previously diagnosed with ependymoma recently expired secondary to aspiration. This subject had been on experimental chemotherapy and was given a very poor prognosis. From additional information received on 2/13/03 via a MedWatch from PPD it was reported that this 14 month old subject experienced aspiration requiring hospitalization. On 2/2/03, the subject aspirated at home. Paramedics were called to the home. The subject was taken to the hospital where she was pronounced dead on arrival. On 10/9/03: As per investigator's site, no additional information is expected, therefore this case is considered closed.  Follow up on 10/22/2003: "On 10/09/2003: As per investigator's site, no additional information is expected, therefore this case is considered closed.  On 10/14/2003 a new version was created to correct latest received date to 10/09/2003." Discharge Summary received on 10/22/2003 states cardiac arrest. Medical records received on 10/22/2003 states hydrocephalus.