Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Urticaria, Virus culture negative
Clinical narrative: Information has been received from a physician concerning a 18 year old female with hypothyroidism, obesity and no allergies who on 16-JUL-2009 was vaccinated with her first dose of GARDASIL (lot # 661846/1312X). Concomitant therapy included SYNTHROID. On 25-JUL-2007 the patient developed urticaria of hands and lower extremities, malaise, and body aches. The urticaria then became confluent, widespread, and the patient developed fever of 103-104F and joint pain. The patient was admitted to the hospital on 11-AUG-2009 and was being evaluated for systemic hypersensitivity syndrome. Testing had revealed splenomegaly, hepatomegaly, elevated aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT), elevated erythrocyte sedimentation rate (ESR) 86, elevated C-reactive protein, and low C4 and C3. The patient was being treated with hydration and unspecified antihistamines. Additional information has been received from the physician who saw this 18 year old patient on 06-AUG-2009, ran viral cultures which were negative, hepatitis A and C negative, Hepatitis B-fully immunized. A sonogram showed hepatomegaly and splenomegaly which were also present on exam. The patient was given Clindamycin in case this was a toxin mediated reaction. The patient was also seen by dermatologist in Doctor's office. Dermatologist thought rash and symptoms could of resembled drug or vaccine induced reaction but not the Stevens-Johnson syndrome (SJS) since no mucous membranes involved. On 12-AUG-2009, the physician reported that no other vaccines were given at the time that GARDASIL vaccine was administered (by the pediatrician's office) on 16-JUL-2009. On 06-AUG-2009, "at her worst", the patient's values were as follows: AST 76, ALT 200, GGT 375, ESR 86, and C-reactive protein 23.9 mg/dL. On 11-AUG-2009, the patient's C4 was less than 2.9 and C3 was 59. The patient remained in the hospital on 12-AUG-2009. Treatment included IV BENADRYL and ZANTAC. No steroids had yet been administered. The patient sought medical attention in the hospital. The patient had not recovered. Systemic hypersensitivity syndrome was considered to be disabling by the physician. The Health Care Professional contacted during telephone follow-up could not supply the following information: Dose number (if applicable). No further information is available at this time. Additional information has been requested.  Medical records, discharge summary and ICD9 codes receeived For DOS 8/18-8/28. Final DX: Acute disseminated encephalomyolitis  One week s/p vaccine patient developed fever, disseminated ecchymotic rash. Not treated. fainting, weakness, electrolytes abn, hypertensivie. Admitted. Skin bx showed hypersensitivity rxn.  Develeoped pancytopenia, renal failure, tonic clonic seizures. MRI showed enceophalomyelitis. Steroid therapy. Issues resolved. D/C with planned follow up (hematology, oncology, neurology) ICD9 Codes: 276.52, 533.0, 323.81, 286.6, 584.9, 518.82, 458.9, 780.39, 276.9, 599.0, E949.9, 276.6, 437.4, 276.51, 284.1, 288.66, 780.2, 785.0, 244.9, 782.1, 784.7, 245.2, 790.6, 278.0