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Life Threatening? No
Write-up: This subject is a two year old female, who expired due to asphyxiation while enrolled in a comparative post marketing safety study of Daptacel (Diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed) administered with other recommended vaccines according to the standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received four dosed of the study vaccine. The last dose prior to the event was given on 11/14/2003. Other vaccines administered on that day included a dose of ACTHIB, lot number W1452 (manufacturer lot number UA873AA), a dose of MMR lot number 0131N, a dose of Prevenar lot number 493505, a dose of VZV lot number 0344N. The routes and sites of administration were not provided. The subject presented to the ER in full code for probable aspiration of food. The subject subsequently deteriorated and resuscitation was unsuccessful. The subject expired due to asphyxiation 319 days post immunization. The coroners office determined that the cause of death was a bean in the subjects trachea. Autopsy results were not been requested. The event of asphyxiation was reported by the investigator as unrelated to the study vaccine. Further information is not anticipated, this case is considered closed. 3/7/06 Autopsy report received which states COD as asphyxia secondary to bean lodged in mid trachea./ss
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