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Life Threatening? Yes
Write-up: Information has been received from a registered nurse, concerning a 26 year old female patient with a low grade squamous intraepithelial lesion, cervical dysplasia and cervical intraepithelial neoplasia-1 (18-AUG-2006), who on 16-OCT-2006 was vaccinated with the first dose, 0.5ml, IM in the left arm, of Gardasil (Lot #654540/0800F). There was no concomitant medication. On 15-DEC-2006, at an office visit scheduled to determine if she was pregnant, the patient reported that she felt a small lump in her left breast that had been there since approximately 15-NOV-2006 ("approximately one month''). The nurse added that the patient was sent to the hospital for a pregnancy test, which was negative. On 09-JAN-2007, the patient had a mammogram of the left breast which recommended that she undergo a biopsy, and on 17-Jan-2007, an ultrasound guided core biopsy of the left breast was performed; on 19-Jan-2007, the biopsy result showed "invasive and intraductal breast carcinoma." On 20-Jan-2007 the patient was vaccinated with the second dose, 0.5 ml, IM in the left arm, of Gardasil (Lot #654540/0800F). On 21-MAR-2007, a repeat Pap smear result was positive for human papilloma virus, and the nurse added that the usual treatment to remove the abnormal cells with the loop electrosurgical excision procedure (LEEP), was not performed due to the patient''s breast cancer diagnosis. The nurse stated that the patient was scheduled to be seen by 2 surgeons for consideration and opinions of a bilateral mastectomy, and indicated that the patient would undergo chemotherapy following the surgery. The reporter considered the patient''s invasive and intraductal breast carcinoma and/or positive human papilloma virus results to be immediately life-threatening and an other significant medical event. Additional information has been requested.
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