Sex: F
Vaccine: LYME
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor, Rotator cuff syndrome, Small intestinal obstruction, Somnolence
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a female subject of unspecified age who was vaccinated with LYMERIX.  A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMERIX (unknown).  At an unspecified time after vaccination with LYMERIX, the subject experienced arthralgias, flu-like symptoms, fatigue, pain in her hands, knees, and feet, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX.  She also experienced decreased activities of daily life and decreased ability to participate in recreational activities.  At the time of reporting the outcome of the events was unspecified.  This information was received via a Statement of Injuries.  Follow up information was received on 08 August 2008 via medical records.  The subject was seropositive for Lyme disease in 1998, and received treatment with doxycycline for one month.  She was "reasonably well until 2000, when she began to feel poorly again".  A repeat Lyme test was "markedly" positive, and she was treated with an unspecified antibiotic, then received three LYMERIX vaccines after that.  On 05 April 2001, it was noted that since receiving LYMERIX, the subject had lightheadedness, tinnitus, lack of focus and concentration, palpitations, a weight gain of 45 pounds, profound fatigue, and difficulty staying awake, an assessment at that time was "? Lyme disease".  The subject was diagnosed with arthritis in her bilateral hands, bilateral feet, and right hip and seropositive Lyme disease.  On 16 November 2001, progress notes indicated "had positive C6 Peptide aC, which is interesting, which is Lyme disease from LYMERIX".  On 03 January 2002, she had completed CEFTIN and continued to experience fatigue, myalgias, and arthralgias as well as ocular swelling.  By 16 April 2002, she had completed therapy with MALARONE and ROCEPHIN.  She continued to experience some joint pain but was improved overall.  On 28 May 2002, she was noted to be status post LYMERIX vaccination with seropositive Lyme disease that was reportedly adequately treated and required no further antibiotics.  Between 20 August 2002 and 09 November 2004, she was seen for multiple complaints including insomnia, fever, profound fatigue, vertigo, diarrhea, joint pain, neck stiffness, myalgias, tinnitus, arthritis, weakness, malaise, decreased memory including short-term memory loss, and seropositive Lyme disease.  Treatment included ZITHROMAX, NEURONTIN for insomnia, CEFTIN, and ROCEPHIN.  She was also diagnosed with hip pain and osteoarthritis, back pain, and right sided radiculopathy.  On 12 February 2005, degenerative disc disease and mild spondylosis with central disc extrusion at L5/S1, and mild osteoarthritis of the right hip were identified by magnetic resonance imaging and x-rays.  On 21 February 2005, she was evaluated for joint pain in the hip and right thumb.  In April 2006, magnetic resonance imaging of the right heel showed plantar fasciitis and osteoarthritis.  On 27 June 2005, she presented for a physical therapy evaluation for complaints of low back and right lower extremity pain.  The subject reported that she had experienced a fall in June 2004.  The subject was evaluated on 05 April 2007 and 07 May 2007 for shoulder pain/ complaints including right shoulder impingement and rotator cuff tendonitis.  She received conservative management, including intraarticular injection, with overall improvement.  On 07 May 2007, she complained of bilateral knee pain and right knee buckling without associated trauma, and stretching and arch support were recommended.  On 19 March 2008, she was again seen for ongoing right shoulder complaints with increasing pain and loss of elevation.  Upon evaluation by her urologist on 01 April 2008, it was noted that the subject continued to have symptoms of Lyme disease including fatigue, tinnitus, arthralgias, and arthritis mainly in the elbows, wrists, knees, and feet.  In the course of review of medical records received on 08 September 2008, an incidental finding included abdominal pain with gastrointestinal bleeding.  Again in early January 2005, complaint of upper abdominal pain and vomiting was documented.  There was no information provided concerning the claimed events.  Follow-up information received on 03 November 2008 in the form of medical records indicated that on 06 March 2003, the subject presented to her physician's office with a chief complaint of lightheadedness, tinnitus, difficulty with concentration, palpitations, weight gain, profound fatigue, myalgias and pain about the proximal interphalangeal and distal interphalangeal joints of the hands, right forearm, along with severe right elbow pain.  The subject was evaluated extensively.  Her antinuclear antibody titers and rheumatoid factors were negative.  Her Lyme Elisa and Lyme Western Blot were markedly positive as was her C6 peptide assay.  The subject was treated with oral CEFTIN with no improvement.  Intravenous ROCEPHIN therapy was suggested.  Records suggested that the subject was diagnosed with Lyme disease.  No date was specified.  Information reviewed from a follow-up visit dated 18 November 2004 and again on 10 March 2005 indicated that the subject was continuing to battle Lyme disease.  At this same time, gastrointestinal problems and bleeds were mentioned, however, there was no indication of their relationship to the alleged events from Lyme vaccination.  They have been included as events at this time as it was suggested that the subject was hospitalized numerous times due to these conditions.