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Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: Initial report was received on 12 October 2011 from an investigator participating in the study under the reference number M5A11. A 17 month-old female patient with no reported past medical history experienced respiratory arrest due to aspiration (resulting from vomiting) 123 days after receiving dose four of PENTACEL, lot number C3747AB (route and site of administration not reported) on 27 April 2011. Additional vaccine history included a first dose of MMR, lot number 1644Z (route and site of administration not reported) received on 01 July 2011. According to the investigator, a representative from the coroner''s office was told that the "child likely choked on a ravioli as fed by a parent". No autopsy was performed as it was not a coroner''s case. The outcome was fatal. According to the investigator, the event was not related to the trial product. Documents held by sender: none. | ||||||||||||||||||||
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