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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a nurse concerning an 18 year old female with no known allergies and no other pertinent medical history reported. On 18-AUG-2006, the patient was vaccinated intramuscularly in the deltoid with a 0.5 ml "single dose prefilled syringe" of HPV rLi 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0702F). There were no concomitant medication reported. On 18-AUG-2006, the patient developed severe injection site pain with HPV rLi 6 11 16 18 VLP vaccine (yeast) injection. The patient remarked that "it hurt and felt that the injection went to her head". The nurse reported that the patient felt faint immediately after the vaccination. The nurse had the patient lay down. It was reported that the patient "got up after 1 minute and said that she was ok.". The nurse reported that the "patient left the office immediately after this and the nurse was following up with the patient later today to make sure that the patient was ok." The nurse reported that she had not agitated the syringe prior to injection. The patient sought unspecified medical attention. There were no laboratory diagnostic studies performed. On 18-AUG-2006, the patient recovered from the events. Additional information has been requested.
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