Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Blood pressure decreased, Blood pressure increased, Dyspnoea, Heart rate increased, Respiratory rate increased
Clinical narrative: This pt is a 7-month-old male with history of congenital heart disease, who was admitted to the hospital while enrolled in a Phase IV P3T08 (Daptacel) study. The pt received one dose of Daptacel, the last dose prior to the event was given on 04/15/2003. Infant received Infanrix for the first 2 doses of Primary series.  The pt developed an increased respiratory rate and marked difficulty breathing, 36 days post-immunization and was admitted to the hospital the same day. The pt had a known history of complex congenital heart disease, including total anomalous pulmonary venous return, complete AV canal, atrial septal defect, and ventricular septal defect, double outlet right ventricle, subpulmonic stenosis, and right aortic arch who presented in acute respiratory distress. The pt was admitted to hospital on 05/06/2003 for cardiac catheterization. He was being evaluated for a Glenn procedure after having had his modified BT shunt months ago. The child was discharged home on 05/15/2003 with the advice that the family contact a transplant center, as the hospital felt that his cardiac status would not tolerate the Glenn procedure. He was discharged home on an increased dose of Captopril. He had a baseline increased respiratory rate and then marked difficulty breathing after a 3 AM feed. He was taken to the ER where it was noted that his heart rate was 200, blood pressure 91/68, respiratory rate in the 80s. He was evaluated by a physician and taken to the pediatric intensive care unit. He initially was described as having only slightly prolonged capillary refill time but then his perfusion worsened over the next hour and he had poor peripheral pulses and his blood pressure decreased to 69 systolic. At that time, the pt's intraosseum was placed but the fluid began extravasating. The pt's heart rate then acutely decreased from the 200s to 120s and then he developed asystole. A code was called and the pt underwent cardiopulmonary resuscitation for approximately 45 minutes. At one point, after high-dose epinephrine, pulse was re-established but this lasted only a few minutes and then the pt lost his blood pressure and then rhythm despite continued resuscitation with drugs and cardiopulmonary resuscitation. The pt was pronounced at 8:28 AM. He was originally intubated by one physician and then reintubated by another physician because of possible ET tube plugging, although the ET tube was found not to be plugged. In fact the pt was difficult to ventilate because of probable increase in pulmonary edema due to his heart failure. He was resuscitated through a second interosseum that was placed by anesthesia.  The family agreed to an autopsy on this pt. The event of congenital heart disease was reported by the investigator as unrelated to the study vaccine.  From additional info received on 08/13/2003, requested by VAERS (ID #207581), previous hospital records, lab and diagnostic test results were provided:  12/30/02 follow-up of complex heart disease. Had 3.5 right modified BT shunt at CHO on 11/1/02 for asplenia with complete AVC, DOKV, TGV, PS and subPS, APVR to R-SVC without obstruction, secundum ASD and right arch. Post-op had L phrenic palsy requiring diaphragm plication. Home 12/14 on 27 calorie MBM, Lasix, digoxin, aldactone, NaCl, KCl, PenVK and ASA. Tires with feeds. O2 saturations now and at discharge high 80's. Exam shows mild-moderate retractions, 2-3/6 systolic and continuous murmur along LSB. Impression: anatomy as above with mild-moderate CHF. Will d/c NaCl and KCl. Lasix and aldactone to 5mg BID, digoxin to 0.5 ml BID. Hospitalization 1/02/03-01/12/03 Principal diagnosis: Citrobacter freundii bacteremia and respiratory distress. The pt was hospitalized in the Pediatric Intensive Care Unit from 01/02/2003 to 01/07/2003 at which point he was transferred to ward status and was hospitalized on the ward from the evening on 01/07/2003 to 01/12/2003, prior to transfer to another hospital intensive care unit.  Follow up on 04/21/04: "After a medical review of the case, a new version of the report has been generated to consider the Adverse event term "condition aggravated", since this is the immediate cause of the fatal outcome.  Bacteremia has been removed from the list of adverse events as the bacteremia occurred before vaccination and it is described within the pt medical history."