Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Paraesthesia, Pharyngolaryngeal pain, Pyrexia, Somnolence, Vision blurred
Clinical narrative: This report described the occurrence of Lyme arthritis and/or Lyme disease in a 40 year old female pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings. Medical records were subsequently provided. The pt received injections of LYMErix on 5/16/00, 6/27/00, and 5/1/01 "according to the client." Vaccination dates were not confirmed by medical records. On 9/3/03, the pt's attorney alleged that the pt "suffered knees, legs, and hand swelling, achiness, weakness, fevers, insomnia, fatigue and blurry vision beginning on 5/16/00 according to the client." Upon follow-up received 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment rresistant Lyme disease," with symptoms including "swelling of knees, legs, and hands, achiness, weakness , fever, insomnia, fatigue, and blurriness of her vision." The attorney further alleged that the pt suffered pain that was described as "debilitating at times" and which "severely limited her employment options and opportunities." According to the attorney, the pt was under the care of a rheumatologist, and received anti-inflammatory and other medications without relief and symptoms. The following info was provided via medical records. The pt's medical history included Lyme disease in 1993. In July 2001, the pt was examined for symptoms including pain in her knuckles and hands, swollen and achy knees, low grade fevers, shivering, sporadic sore throat, bitter taste in the morning, headaches, puffiness in eyes, fatigue that "is hindering her daily activities," and sleepiness. She reported that the symptoms had been ongoing "since the end of May," although she noted that the arm pain had been worse in November 2000, and that she had subsequently developed cervical spine pain, shoulder pain, low back pain, decreased arm strength, and arm throbbing, numbness and tingling (in January 2001, the pt was diagnosed with carpal tunnel syndrome). The pt experienced relief with prednisone therapy. She also complained of tick bites, although it was noted that her symptoms "predated the tick season." At the time of examination, the physician indicated that the pt had recently completed Lyme vaccine, and concurred with recent treatment with Zithromax for Lyme disease. General impressions included possible Lyme disease that was possibly vaccine-related. The pt underwent MRI following complaints of neck pain and numbness and pain in the right arm which revealed unremarkable cervical spine findings. Tests were positive for cytomegalovirus IgG antibody. Babesia Western blot was positive, but was of "unclear significance." Beginning in May 2001, she underwent physical therapy for a diagnosis of right lateral epicndylitis and neck pain, which she discontinued after seven visits. She continued to experience joint pain, neuropathy and paresthesias of the right arm and shoulder. She underwent accupuncture therapy for the neck and right arm. She was evaluated by a rheumatologist on 8/1/01 and 9/12/01, for polyarthralgias dating back to November 2000. She also complained of discomfort in hands with associated swelling, discomfort in the knees and feet, which had improved following two separate courses of Medrol Dosepak. Additional symptoms included headaches, palpitations, and sleeping difficulties. It was noted that "there is no history of rashes or tick bites." A general impression of fibromyalgia was given, without evidence of an underlying autoimmune or connective tissue disease. Ibuprofen as needed was recommended. She experienced persistent pain and swelling of the knees, and an x-ray revealed bilateral patellofemoral spurring. In June 2002, she began receiving Bextra for an impression of "patellofemoral syndrome." At that time, she was also receiving naproxen, Tylenol and Vioxx. She underwent placement of a PICC line on 8/2/02 for long-term IV access due to Lyme disease and began receiving IV ceftriaxone. Therapy with ceftriaxone was discontinued after approximately four weeks, and the pt complained of progressive return of symptoms including swelling, a burning sensation, and heart racing causing awakening from sleep. Upon re-evaluation on 9/4/02, continued IV therapy for possible Lyme disease was not recommended, and symptoms were noted to be inconsistent with Babesiosis. She was referred to a Lyme disease specialist, who reportedly recommended continued IV therapy. The physician noted that the pt had not had a "clearly positive" Lyme test and believed that her symptoms were possibly due to a noninfectious process, possibly fibromyalgia. Following the reported onset of Lyme disease, the pt experienced carpal tunnel syndrome (diagnosed 1/16/01)/ tennis elbow with associated neck pain, and right arm tendinitis. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. According to the most recent info received on 12/8/03, as of September 2002 the events associated with possible Lyme disease were unresolved. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.