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Administered by: Private Purchased by: Private
Life Threatening? No
Write-up: Initial and follow-up information has been received from a nurse and a physician concerning a 24 year old female assistant manager with a drug allergy to DILANTIN who was vaccinated intramuscularly into the left deltoid with the first dose of Gardasil (lot # 657617/0684U) on 29-MAY-2007. Concomitant therapy included LEXAPRO and YASMIN. On 02-JUN-2007, the patient "became sick" and went to the emergency room (ER). It was reported that she experienced headache, elevated liver enzymes, fever, severe back pain and a complete blood count that revealed infectious process. The nurse reported that the patient had a variety of tests performed on her in the ER, including a liver function test (LFT) which showed that the patient''s liver enzymes were high. On 06-JUN-2007, the patient underwent the following laboratory test: Lyme disease enzyme-linked immunosorbent assay, negative; absolute blood band neutrophil count, 2.35 K/uL, blood lymphocyte count, 10%; mean corpuscular volume, 75 fL, serum Epstein-Barr viral capsid antigen immunoglobulin G antibody test, positive; serum alanine aminotransferase test (ALT (SGPT), 486 U/L; serum aspartate aminotransferase test (AST (SGOT), 311 U/L; mean corpuscular hemoglobin (MCH), 26 pg. On 06-JUN-2007, the patient also underwent an abdominal ultrasound. The physician''s impression was that there was no evidence of gallstones or dilated intra-, extrahepatic biliary ducts and there was a stable splenic cyst present. On 11-JUN-2007, the patient underwent the following laboratory tests: MCH, 26 pg, WBC count, 10.8 x 10E3/uL; AST (SGOT), 49 IU/L; ALT (SGPT), 147 IU/L. The nurse reported that the patient was doing better, but her liver enzyme levels were still elevated. At the time of the report, the outcome of severe back pain, headache, infectious process and fever were unknown. The reporting physician considered elevated liver enzymes, severe back pain, headache, fever, and complete blood count revealing infectious process to be other important medical events. Additional information is not expected. All available medical records will be provided upon request.
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