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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: A report was received from a physician via a medical representative concerning a 3 year old female. Her medical history, concurrent diseases, and concomitant medications were not reported. On an unknown date, she received nasal FLUMIST. The medical doctor mentioned that two to three years ago a previously healthy 3 year old female died within three days of receiving FLUMIST in her office. The medical representative was uncertain whether symptoms began shortly after dose or three days later. At an unspecified time period after FLUMIST, the patient started vomiting and collapsed. She was taken to hospital three days after receiving FLUMIST and died. The physician stated that all the tests were negative, and the child was afebrile. The medical representative was uncertain whether an autopsy was performed. She also stated that the doctor thought the death was related to FLUMIST. The official cause of death was cardiac arrest. On an unspecified date, the patient died from the event of cardiac arrest, and at the time of reporting the outcome of the event of collapse and vomiting was unknown. According to the reporter the adverse event of cardiac arrest was considered to be serious with the serious criteria of death and the adverse event of vomiting was considered to be non-serious. According to the company physician the adverse event of collapse was considered to be serious with the serious criteria of important medical event. According to the reporter the adverse events were causally related to the suspect drug of FLUMIST.
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