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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This is in follow-up to repor (s) previously submitted on 4/6/2007. Information has been received from a physician via a company representative concerning a "very nervous" 17 year old female who on approximately 26, Feb 2007 ("earlier this week") was vaccinated IM with a 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not reported). On approximately 26, Feb 2007 ("after injection") the patient fainted. The patient sought unspecified medical attention and was reported as recovered (date not specified). Additional information has been requested. In follow-up it was reported by a registered nurse concerning a "very nervous", 17 year old, female, student, with allergy to codine and no illness at the time of vaccination, whose reported weight was 123 pounds who on 26-FEB-2007 was vaccinated intramuscularly (IM) into the left deltoid muscle with a 0.5 ml dose of GARDASIL (Lot # ''02634''). It was reported that the patient had a dizzy feeling and then had a fainting episode. the patient did not fal, she was in a chair and her mother caught her. The nurse stepped out to get the patient water because the patient asked for some. The patient "wet pants" and the patient "came around with ammonia". Her pulse and blood pressure were okay. The patient was crying afterwards and scared. The patient was put on a bed "with head up to elevate her head". The tow physicians saw the patient in the office. The patient recovered and was released to her mother. On 27-FEB-2007, a phone call was placed to the patient''s home. The patient''s mother reported that the patient slept all afternoon and into the night. She ate dinner and had breakfast and went to school. The nurse told the patient''s mother to call a or two before the next appointment to get a prescription for VALIUM, 20 mg and instructed to have the patient take the medication 20-30- minutes before the next appointment.
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