Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Antiphospholipid antibodies positive, Asthenia, Blood disorder, Blood product transfusion, Contusion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with penicillin allergy, easy bruiser, "ear tubes" and a history of dental extractions was vaccinated with a first dose of GARDASIL (lot# 661703/0651X) IM in the left arm on 02-Jan-2009. No other medications. The patient was doing fine after the first shot. She received the second series and on the next day, 11-MAR-2009, went to doctor from school complaining of blurred vision, sick to stomach and bad headache, fever and heart palpitations. Felt like was going to pass out. She went to doctor and had tests and was in bed for 3 days. Blood tests came back low, white, red and platelets. She was told to wait and be tested again in a few weeks. When tested again, she was sent to hospital and then diagnosed with ITP syndrome and was given medications. Did not work, so then was hospitalized because blood was so low, at serious risk for a stroke. She was given another dose of globin and spent night in hospital. A few weeks later, she took blood tests again, everything was still low, and she was put on highest dosage of prednisone for 3 weeks, blood levels raised and stabilized for a few weeks. Latest has been diagnosed with ITP/Evans Syndrome and she was told would probably turn into lupus. She would have to visit hospital on a regular basis to be monitored. A permanent disease, rheumatologist and blood disorder doctor from 2 major hospitals agree this illness was created by GARDASIL and written in their reports. On 10-AUG-2009, PCP medical records received 02-Jan-2009 to 18-MAR-2009. Assessment: low platelet count, hives/urticaria thighs and lower legs, itching after tanning session. She had started oral contraceptives. Heart palpitations, nausea, feverish, headache, ears hurt, lightheaded, looks pale. She was excused from PE. On 10-AUG-2009, hospital records and oncology/haematology consult and rheumatology consult from 09-APR-2009, to 27-APR-2009 was received. Assessment: thrombocytopenia, anemia, neutropenia, positive lupus anticoagulant, elevated PT/PTT. The patient presented with thrombocytopenia, anemia, excessive vaginal bleeding. Had bad "virus" with fever, cough, headache, poor sleeping and sweating. She missed school. IVIG therapy was given. Her hair was falling out. Her energy levels were decreased and had pale diffuse bruise, petechia over lower legs, tightness in legs and wheezing. On 10-AUG-2009, hematology consult, second opinion, rheumatology report from 21-APR-2009 to 19-MAY-2009 was received. Assessment: ITP/Evans syndrome would eventually turn into lupus. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The original reporting source was not reported. The VAERS ID# is 353026. No further information is available.