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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a 23 year old female with no drug reactions/allergies and no medical history who on 29-MAR-2007 was vaccinated with her first dose of Gardasil, 0.5 ml, intramuscularly. There was no concomitant medication. On 29-MAR-2007 the patient fainted after receiving the first dose of the Gardasil. The patient sought unspecified medical attention. On 29-MAR-2007, the patient recovered from fainting. Additional information is not expected. Information has been received from a registered nurse concerning a 23 year old female with no pertinent medical history who on 28-MAR-2007 was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscular administration. Concomitant therapy included VALTREX. Subsequently, the patient fainted after receiving her initial dose of GARDASIL and recovered that same day. The nurse reported that the GARDASIL was improperly stored at room temperature for three weeks prior to use (approximately 07-MAR-2007). Approximately two months later (28-MAY-2007) the patient received her second dose of GARDASIL. It was reported that the patient''s second dose had been stored at room temperature for five days prior to use (approximately 23-MAY-2007). Product Quality Control (PQC) was not involved. Additional information has been requested.
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