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Life Threatening? No
Write-up: Information has been received from a medical assistant concerning a 16 year old female patient with sulfonamide and azithromycin allergy who on 30-JUN-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# 659655/0940X). On 01-SEP-2009 the patient was vaccinated intramuscularly with the second 0.5ml dose of GARDASIL (lot# 663452/0671Y). Concomitant therapy included SPRINTEC. On approximately 07-JUL-2009 ("a week after administration of her first dose of GARADSIL"), the patient experienced fainting spells, stomach pains, weight loss of 16 pounds, swollen glands in the neck and fatigue. It was reported that the patient experienced the same symptoms but more intense after her second dose of GARDASIL administered on 01-SEP-2009. When she experienced a fainting spell, she was exhausted for the rest of the day. The patient still continued to have episodes of blacking out and stomach pain once or twice a week. The patient had been examined and had a complete work up from a neurologist, gastrologist and cardiologist. All tests were negative. At the time of this report, the patient was recovering. Follow up information has been received from the medical assistant who confirmed the dates and lot #s for the two doses of GARDASIL and reported that there were no concomitant vaccines were administered. She clarified that the events, experienced a week after the first dose, persisted then worsened after administration of the second dose. The events were considered as disabling since the patient could not attend school. It was unknown if the patient was hospitalized. The patient had not seen in their office since 01-SEP-2009. Fainting spells, stomach pains, weight loss of 16 pounds, swollen glands in the neck, fatigue and episodes of blacking out were considered to be disabling. Additional information has been requested.
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