Age: 0.36
Sex: F
Vaccine: DTAP, HEP, IPV, UNK, DTAP, HBPV, HEP, IPV, PNC, TTOX
Symptoms: Encephalopathy, Hepatomegaly, Multi-organ failure, Pneumonia
Clinical narrative: This subject is a 9 month old female, who was enrolled in a Phase IV P3T08 (Daptacel) study. The subject received two doses of study vaccine; the last dose prior to the event was given on 12/27/02. The subject died of multiple system organ failure due to near-drowning, 163 days post-immunization. The event of drowning was reported by the investigator as unrelated to the study vaccine. Autopsy results are pending. From additional information received on 11/4/03 from the autopsy report: It was determined by an investigation that an autopsy would be necessary to establish the cause of death. Based on the known circumstances and cause of death, the manner of death is an accident. The drowning occurred in a wading pool. Follow up on 11/25/2003: "Information has been received from an investigator concerning a 9 month old Hispanic female patient who was enrolled in a phase IV diptheria toxoid/pertussis vaccine/tetanus (DAPTACEL) study.  On 12/27/2002, the patient was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown).  Concomitant vaccination on 12/27/2002 included a second dose of diphtheria toxoid/pertussis vaccine/tetanus (DAPTACEL), a dose of poliovirus vaccine (IPOL), a dose of Haemophilus influenzae vaccine (+) tetanus toxoid and a dose of Streptococcus pneumoniae vaccine (PREVNAR).  163 days post vaccination on 06/08/2003 at 15:52, the patient died.  The cause of death was "multi-organ failure due to near drowning."  Autopsy findings included: heavy lungs with hypostatic pneumonia and diffuse alveolar damage; ischemic encephalopathy; thymic involutional changes; congestive hepatomegaly; generalized visceral congestion; minor contisions of legs.  External examination revealed a normally developed, adequately nourished Hispanic female infant who appeared consistent with the reported age of almost ten months.  Internal examination revealed histology-sections of all major viscera were submitted per the SIDS protocol; X-rays-total body X-rays showed no recent healing fractures or bony malformations; "evidence-none"; CNS-vascular congestion, interstitial edema, diffuse changes of ischemic neuronal necrosis; lung-advanced changes of diffuse alveolar damange (hyaline membrane disease) with patchy acute pneumonia and scattered small airways filled by PMN's, interstitial emphysema, one section of right lung showed consolidation by frank acute purulent bronchopneumonia, a section of trachea showed mild chrinoc mucosal inflammation; larynx-chronic mucosal inflammation with focal acute inflammation and necrosis, mild chronic mucositis also noted in epoglottis; no significant histopathology in the heart, speen, pancreas, bone marrow, adrenal lymph node, pituitary, diaphragm, submandibular gland, liver, kidney, fallopian tube or ovary.  The case is closed.  The event of drowing was reported by the investigator as unrelated to the study vaccine. Other business partner numbers include 10380574, 2003-01431, P3T08.  Additional information is not expected.  This report no longer meets the criteria for submission because the relationship to study therapy has been changed."