Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Influenza, Myalgia, Osteoarthritis
Clinical narrative: p/vax pt exp arthritis sx (achiness & swelling) in hips, knees, ankles;also exp flu-like sx;saw rheumatologist & underwent blood test & x-rays;rheumatologist stated had reactive arthritis;tx w/meds; Report 1999013144-1 describes reactive arthritis in a 47-year-old female who received an injection of LYMERIX.  This report was received from the vaccinee.  Follow-up information was received from a nurse practitioner.  Medical records were received as part of litigation proceedings.  Additional information was received from a newpaper reporter.  Concurrent medical conditions included severe premenstrual syndrome, fluid retention, penicillin allergy, family history of rheumatoid arthritis, arthritic pain in fingers and knee caps when taking MEGACE and ALDACTARIDE in 1987, and flu-like symptoms while taking ALDACTARIDE in 1987.  Aldactaride was discontinued on 04 June 1987.  Surgical history included two full-term ceserean sections and tubal ligation.  On 04 May 1999, the patient received her first 30 mcg injection of LYMERIX.  Approximately one to two weeks later, the patient reportedly experienced joint pain in her hips, knees, and ankles; flu-like symptoms; ankle edema; swollen feet; a viral syndrome, and stifness (NOS).  She "could scarcely walk up and down stairs."  The patient reported that she saw a rheumatologist and underwent unspecified blood tests and x-rays.  The patient stated that the rheumatologist said she had "reactive arthritis".  Medical records from the patient's gynecologist and gynecoendocrinologist indicated that the patient was complaining of multiple arthralgias at a 06 May 1999 office visit.  Antinuclear antibody titer and rheumatoid factor measured on 17 May 1999 were negative.  The patient had elevated eosinophils 7.4% (normal, 0-5%), elevated monocytes 600/cubic millimter (normal, 0-590/cubic millimeter), and elevated globulins 3.4 gm/dL (normal, 1.3-3.4 gm/dL).  The symptoms were treated with an anti-inflammatory (NOS), steroids, CELEBREX 100 mg twice daily for 1.5 weeks, and RELAFEN 750 mg every 12 hours. The information received on 09 June 1999 reported the pain was less severe, but the swelling presisted.  The informatoin received on 31 January 2001 did not provide an outcome.  In a news article published 25 June 2001, a reporter stated, "The stiffness and swelling has become so severe that she is dependent on anti-inflammatory drugs to keep her mobile."  The patient stated, "I just keep moving.  It doesn't get rid of the pain, but it keeps me from stiffening." The outcomes of the flu-like symptoms and viral syndrome were not provided.  The adverse events of reactive arthritis and joint pain do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.  Follow up information received July 17, 2001. In 1977, the patient began to experience discomfort in legs. Atrophy of the lateral aspect of her right thigh was noted. Although patient is left-handed and left-side dominant, her left thigh was smaller than her right thigh. The physician stated, "lesion may be bilateral." The physician recommended consideration of electromyelogram, exercise, and weight loss. On May 27, 1999, Lyme IgG/IgM ratio was 1.34 (positive, 1.10 or greater).