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Life Threatening? No
Write-up: Information has been received from a physician concerning a 26 year old female who on 30-AUG-2006 was vaccinated intramuscularly in her right arm with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included ketorolac tromethamine (TORADOL). On 30-aUG-2006, the patient felt "dizzy" after the injection. The patient was then given a ketorolac tromethamine (TORADOL) injection and she "passed out" after receiving that injection (also reported as "dizziness followed by syncope"). It was reported that the patient was seeing the physician or her pain shot. The syncope occurred after her pain injection. The physician believed this was a vaso vagal response. It was reported that "it was not known if the patient was that she was scheduled to receive". The patient sought unspecified medical attention. It was reported that "she did not her second shot yet". On 30-AUG-2006, "a few minutes after", the patient recovered from the events. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/14/2006. Initial and follow up information has been received from a physician concerning a 26 year old white female with no other pertinent medical history reported. It was reported that the patient was seeing the physician for her pain shot. On 30-AUG-2006, the patient was vaccinated intramuscularly in her right arm with a 0.5 mL dose of GARDASIL (Lot # 653650/0702F). Subsequently, the patient felt dizzy immediately afterward. It was reported that the patient received a concomitant injection in her right hip reported as TORADOL and she passed out after receiving that injection. The patient developed loss of consciousness times 1 to 2 minutes, followed by diaphoresis, nausea and sedation event consistent with vaso-vagal reaction. The patient sought unspecified medical attention. On 30-AUG-2006, "a few minutes after", the patient had fully recovered from the events. No further information is available.
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