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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a health professional who reported that a prefilled syringe (Lot # 654540/1162F) malfunctioned and the vaccine sprayed across the room. The patient did not miss being vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/6/2007. In follow-up it was reported by the nurse, that the patient did not receive any of the vaccine from the malfunctioning syringe. The patient received the GARDASIL from a completely new syringe. Follow-up information confirmed no known patient was identified or involved with the event. Therefore WAES #0701USA01666 is being deleted from our files. This report was previously sent in a quarterly submission to PLA V501 on 06-APR-2007. Additional information is not expected.
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