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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: The subject is a female with the date of birth of 10/18/2000, who expired due to cancer 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 standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received the study vaccine on 5/13/2003. Other vaccines administered on that day included a dose of IPOL, lot number W01972, a dose of hepatitis A vaccine, lot number 0498N, a dose of MMR/measles, mumps and rubella vaccine, lot number 0858M, and a dose of VZV, lot number 0485N, manufacturer unknown. The routes and sited of administration were not provided. The subject suffered from a germ cell tumor. The tumor was resected and radiotherapy and chemotherapy were started. The subject was in palliative care when she expired 398 days post immunization. The subject did have a history of renal failure and pancytopenia. Autopsy information is pending. The event of cancer was reported by the investigator as unrelated to the study vaccine. 3/7/06 Multiple d/c summaries received which state patient had abdominal teratoma w/metastasis/ss
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