Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell schistocytes present, Tenderness, Thrombocytopenia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who on 14-AUG-2009, 26-JUL-2010 and 06-DEC-2010 were vaccinated subcutaneously with the first, second and third doses of GARDASIL, respectively. In December 2010, the patient was diagnosed with "Evans syndrome". The patient also had problems with excess bleeding during their period. They also had a low platelet count and bruising on her extremities. The patient was working with her healthcare professional to address the situation. Unknown therapy was given for the adverse event. The patient sought unspecified medical attention. Follow up information has been received from the physician and a registered physician's assistant in the form of medical records concerning a 16 year old female patient with no known drug allergy who on 14-AUG-2009 (lot # 662404/0312Y, expiration date: 30-Apr-2011), 26-JUL-2010 (666118/1539Y, expiration date: 10-Aug-2012) and 06-DEC-2010 (lot # 666596/0766Z, expiration date: 15-Oct-2012) were vaccinated intramuscularly (initially reported as subcutaneously) with the first, second and third doses of GARDASIL, respectively. The patient was also vaccinated with Hep A 1 and Tdap on (14-Aug-2009), and varicella 2 on (25-Aug-2009). The patient's concomitant medication was albuterol meter-dose inhaler as needed for the treatment of mild intermittent reactive airway disease, meningococcal conjugate vaccine (MCV4) and Hep A 2. On 14-Feb-2011, the physician reported the patient was seen in the office with a history of excessive menstrual bleeding and multiple bruises for the period since Jan-2011. The patient's history also noted petechiae and ecchymoses all over the patient's body including the face, extremities and oral mucosa. On the same day, the physician referred the patient to the hospital emergency room to rule out the diagnosis of idiopathic thrombocytopenic purpura where the patient's history also noted heavy menstrual bleeding, weakness and fatigue. In the emergency room, the physician reported the patient's complete blood count showed a platelet count of 2,000, hemoglobin of 9 and hematocrit of 26.3, therefore the patient  was admitted to the hospital for further treatment. Upon admission, the physician reported the patient was seen in consultation by gynecology who placed the patient on birth control pills which had improved the patient's menorrhagia. The physician's assistant reported the patient was seen in consultation by hematology who recommended steroidal therapy. The patient was placed on intervenous SOLU-MEDROL 2 mg/kg/day and ZANTAC which was started in the emergency room. The treatment of WinRho was also discussed with the hematologist who did not recommend this therapy secondary to causing a possible drop in the patient's hematocrit. The hematologist recommended no treatment with intravenous immunoglobulin, platelets, blood or NSAIDS but recommended APAP as needed. The hematologist recommended that the patient follow up as a out-patient on the following day. The physician's assistant discussed the hematologist's plan with the admitting physician who ordered the patient to be observed in the hospital pending the improvement of the patient's menorrhagia given the patient's low platelet count of 2,000. The physician ordered a repeat hematocrit, complete blood cell count and platelet count the following day. The hematologist recommended intravenous immunoglobulin, so the patient had received intravenous immunoglobulin 40 grams over a period of two days (dates not reported). On 19-Feb-2011, the patient's laboratory results showed a hematocrit of 26.0, platelet count of 138,000 and iron of 23. The patient had less menstrual bleeding, was not light-headed and was able to walk. The physician reported as the patient's platelet count had improved to 138,000, the patient was discharged home on 19-Feb-2011. The patient's discharge diagnosis was Evan's Syndrome. The patient's discharge medications were prednisone 30 mg twice daily x five days, ranitidine hydrochloride 150 mg twice daily, and LOESTRIN 24 Fe. The patient was instructed to follow up with hematology after four days. On 21-Feb-2011, the patient's laboratory results showed a positive antinuclear antibodies direct, hemoglobin of 9.3 g/dL, hematocrit of 28.3% and platelet count of 184 x10E3 / uL. On numerous dates, starting on 23-Feb-2011, the patient was see in the office by hematology with a diagnosis of Evan's syndrome. The patient's history was noted as having had "no more bleeding", and an increased appetite from steroids. The patient's physical examination noted fading bruises. The patient's laboratory evaluation showed a hemoglobin of 9.0 g/dL, hematocrit of 27.6%, platelet count of 192 10^3/uL, neutrophils of 80/1% and lymphs of 12.2%. The physician's interpretation of the patient laboratory results were lymphopenia, neutrophilia and anemia. The patient's medication noted a decrease in prednisone to 30 mcg. On 25-Feb-2011, the patient's laboratory results showed a hemoglobin of 9.8 g/dL, hematocrit of 29.6%, platelet count of 150 x10E3 / uL, neutrophils of 81%, lymphs of 10% and a negative antinuclear antibodies direct. On 28-Feb-2011, the patient was seen in follow up complaining of having had severe back pain, pain in the upper thigh, open thigh abscess with no erythema or swelling and a fever. The patient's laboratory evaluation showed a hematocrit of 30.0, platelet count of 79,000, and lymphs of 16%. The patient's medications listed gentamycin sulfate, clindamycin phosphate, SOLUCORTEF and prednisone 15. On 01-Mar-2011, the patient's laboratory results showed a hemoglobin of 9.7 g/dL, hematocrit of 29.9%, platelet count of 55 x10E3 /uL, neutrophils of 79%, and lymphs of 14%. On 02-Mar-2011, the patient was seen in follow up, she reported no back pain, no bleeding and an improved abscess. The patient's laboratory evaluation showed a hematocrit of 29.5, platelet count of 60,000, and lymphs of 13%. The patient's medications listed prednisone 15. On 08-Mar-2011, the patient was seen in follow up and complained of mild pain at abscess site-irritation, no fevers and no bleeding. The patient's physical findings noted a mild right groin redness and tenderness, which was healing. The patient's laboratory evaluation showed a hematocrit of 31.8, platelet count of 135,000, and lymphs of 16%. The patient's medications listed prednisone, decreased to 15. On 18-Mar-2011, the patient was seen in follow up reporting having had light menses. The patient's physical findings noted obesity and a healing labial abscess. The patient's laboratory evaluation showed a hematocrit of 33.3, platelet count of 100,000, and lymphs of 34%. The medications listed prednisone, decreased to 10 mg every other day and norethindrone acetate and ethinyl estradiol and ferrous fumarate. On 01-Apr-2011, the patient was seen in follow up and complained of emesis and diarrhea x 1 day. The patient's laboratory evaluation showed a hematocrit of 35.6, platelet count of 82,000, and lymphs of 34%. The medications listed prednisone 10, ranitidine hydrochloride and norethindrone acetate and ethinyl estradiol and ferrous fumarate. On 08-Apr-2011, the patient was seen in follow up and reported resolved groin lump. The patient's laboratory evaluation showed a hematocrit of 35.4, platelet count of 94,000, and lymphs of 40%. The medications listed prednisone, decreased to 5 every other day. On 28-Apr-2011, the patient was seen in follow up and complained of emesis, coughing, and more bruising The patient's laboratory evaluation showed a hematocrit of 36.4, platelet count of 20,000, and lymphs of 42%. The medications listed an increased prednisone to 40 times two, then 20 and ranitidine hydrochloride. On 06-May-2011, the patient was seen in follow up and complained of persistent old bruises on her hands and shin. The patient's laboratory evaluation showed a hematocrit of 39.8, platelet count of 24,000, and lymphs of 23%. The patient's medications listed prednisone 20, and IMURAN 100. On 26-May-2011, the patient was seen in follow up and reported no bleeding, no fevers, no emesis, and no headaches. The patient's laboratory evaluation showed a hematocrit of 37.3, platelet count of 23,000, and lymphs of 36%. The patient's medications were unchanged from the previous hematology visit. On 01-Jun-2011, the patient was seen in follow up and reported more bruising, and gingival oozing. The patient's medications listed an increase in prednisone to 80 mg The patient was also seen by hematology on the following dates: 08-Jun-2011, 15-Jul-2011, 25-Jul-2011, 08-Aug-2011, 22-Aug-2011 and 07-Oct-2011, and reported no bleeding, no headaches, no menorrhagia or other complaints. The patient's laboratory ranges on these dates and on 11-Nov-2011 were: hematocrit range of 37.6 to 43.3, platelet count range from 3,000 to 160,000, and lymphs ranges from of 26 to 39%. On 25-Jul-2011, the physician's interpretation of the patient's laboratory evaluation included thrombocytopenia and schistocytes. The patient's medications listed sirolimus and a decrease in prednisone to 10. At the time of the report, the patient's outcome was not recovered. All available medical records will be provided upon request. Additional information has been requested.