Age: 68.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Gastrointestinal disorder, HLA marker study, Immunology test, Joint swelling
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgias in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced arthralgias, myalgias, fatigue, joint swelling, foot pain, gastrointestinal problems, dizziness, eye problems, and rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMERIX. He also has 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 30 March 2009 via medical records. The subject had a history of spinal fracture and underwent thoracic spine surgery in December 1996 with a revision on 05 April 2000 due to thoracic spinal stenosis with lesion. He was followed regularly by an orthopedist, and was treated for associated back pain with ULTRAM. He also had an associated neurological problem, and as advised on 15 December 2000 that he would probably always have residual muscle dysfunction and residual symptoms. He received follow up for surgery on 15 December 2000 and was released from orthopedic care on that date. He had been diagnosed with osteoarthritis on an unknown date. The subject was vaccinated with LYMERIX on 08 March 1999, 07 April 1999, and 05 May 2000. On 19 March 1999, he was evaluated for a four day history of vomiting and diarrhea, and abdominal ache/decreased appetite. On 16 July 1999, he presented with aches and pains in the back, shoulders, and hips, and fatigue, and expressed suspicion of a recurrence of Lyme disease. Treatment included ELAVIL and CELEBREX; CEFTIN was added on 26 July 1999. Upon evaluation on 11 August 1999, the subject had a positive Western Blot IgM which the evaluating physician indicated could "be consistent with repeated Lyme disease; he certainly is repeatedly exposed". He was placed on doxycycline. In October 1999, the subject was hospitalized due to atypical chest pain, with diagnostic findings of tricuspid regurgitation and mild aortic insufficiency. Despite known valvular heart disease, the chest pain was diagnosed to be non-cardiac and possibly musculoskeletal in nature. On 06 March 2001, x-rays performed due to rib pain showed osteoporosis and he was referred for evaluation of a possible osteoporotic rib fracture. On 26 June 2001 the subject was evaluated for rib, back, and leg pain and general malaise, and was diagnosed with thoracic lumbar syndrome "possibly musculoskeletal versus neurologic". The subject was evaluated by an orthopedist on 21 January 2003 for  multiple joint pains including pain in his ribcage, ankles, knees, and shoulders. The subject believed that most of his symptoms were "related to where he was diagnosed to have Lyme's [sic] disease", and noted that he had received antibiotic therapy without full resolution of symptoms. He was referred to an infectious disease consultant due to concern that symptoms were indicative of residual Lyme disease. He was evaluated by an orthopedist on 25 April 2002, and at that time reported that he "had Lyme disease three times, he has had a back fusion of the cervical spine, and he has hand pain". Impression was of "significant osteoarthritis of multiple locations", and he was treated "as a fibromyalgia patient". On 04 April 2002, the subject was evaluated by a rheumatologist and reported history of Lyme disease three times, with positive Lyme titers and rash, treated with antibiotics. He was noted to be HLA-DR4 positive. The rheumatologist did not attribute the subject's pain to active Lyme disease, and instead indicated that the subject had osteoarthritis of the hands and pain over the heel. Anti-inflammatories/injections were not administered due to the subject's COUMADIN therapy. The rheumatologist connected "I was unable to identify a relationship between the Lyme vaccine and the current symptoms he is experiencing". On 26 April 2004, he underwent pre-operative medical evaluation for cataract surgery to treat worsening cataract. This report was assessed to be medically significant based upon follow up information.