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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a health professional concerning her daughter an 18 year old female who in October 2007, was vaccinated with the first dose of GARDASIL (lot number not reported). There were no pertinent medical history and drug reactions/allergies. Concomitant therapy included RECOMBIVAX HB (unspecified). The healthcare worker reported that her daughter developed "stabbing head pain associated with a twitch" in approximately October 2007 about 2 weeks after she received her first dose of GARDASIL. The patient had been diagnosed with pseudotumor cerebri which limited her physical activity and she was hospitalized. The patient''s pseudotumor cerebri persisted. The patient underwent lumbar puncture to relieve fluid pressure. Multiple unspecified blood tests and diagnostic studies were performed with results not report. Pseudotumor cerebri was considered to be disabling, immediately life-threatening and an other important medical event by the healthcare worker. Follow up information was received from a healthcare professional who reported the patient was vaccinated with the first dose of GARDASIL on 28-FEB-2007, the second dose of GARDASIL on 15-OCT-2007, and the third dose of GARDASIL on 01-JUL-2008 (lot numbers not reported). Concomitant vaccine included MENACTRA received on 28-FEB-2007 and VAQTA (unspecified) received on 28-FEB-2007 and 15-OCT-2007 (lot number not reported). At the 28-FEB-2007 office visit, the patient had bronchitis. At the 15-OCT-2007 office visit, there was no mention of any adverse event. On 23-OCT-2007, the patient was seen for hives and ZYRTEC was given. On 30-OCT-2007, the patient complained of pins and needles all over, rash was gone. On 28-NOV-2007, the patient complained of blurred vision, and a neuro consult was directed. In November and December 2007, the patient was admitted to the hospital (no other details available). In November 2008, the patient was admitted for nausea, vomiting and headache (no other details). On 05-JUN-2009, the patient was last seen in their office. Additional information has been requested.
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