Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Fibromyalgia, Full blood count normal, HLA marker study positive, Headache
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male 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). On an unspecified date after vaccination with LYMERIX, the subject experienced joint pain, muscle pain, headaches, flu-like symptoms, fatigue, in extremities, vision problems, memory loss, rashes, decreased activities of daily life, and rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism. 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 03 November 2008 in the form of medical records. Dates of LYMERIX vaccination were reported as 23 May 2001, 28 June 2001 and 08 July 2002 for 1st, 2nd, and 3rd doses. A rheumatology consultation dated 22 November 2004 indicated that the subject reported a history of Lyme disease, suspected to have begun following LYMERIX vaccination. The consulting physician did not have documentation to confirm this diagnosis at the time of evaluation. The consulting physician did not have documentation to confirm this diagnosis at the time of evaluation. The subject had reported that he developed arthralgia and myalgia sometime around 2002. He was treated for possible polymyalgia rheumatica in 2002 at 60 years of age with PREDNISONE for approximately 6 months. He had improvement in his pain although this recurred after he stopped the PREDNISONE. He had no complaints of visual problems, fevers or other such symptomology at that time. The subject stated that he was teated with DOXYCYCLINE for approximately 7 months with improvement of his symptomology. An evaluation dated 03 May 2005 revealed sternoclavicular joint arthralgia, mainly in the morning, which resolved during the day with resolved bilateral heel pain, might be due to spondyloarthritis. Follow-up information received o 09 April 2009 via medical records. On 04 November 2003, the subject presented wirh degenerative disc disease/ low back pain, fatigue, nocturia, decreased libido, rib soreness, and joint and muscle pain. He also noted a history of neck pain, paresthesias, decreased short term memry, and mood swings, and noted that he had received the first, second, and third doses of LYMERIX in May 2001, June 2001, and July 2002 with symptoms beginning approximately three months later. Assessment included clinical Lyme disease. Medications included DOXYCYCLINE and PLAQUENIL. He was followed through as recently as March 2004 for Lyme disease, low back pain, joint pain, occasional muscle pain, fatigue, neck pain, shoulder pain, and arthritis. In addition to PLAQUENIL and DOXYCYCLINE, he was treated with GLUCOSAMINE/CHONDROITIN and non-steroidal anti-inflammatory medications. The subject was evaluated on 30 June 2006 with a primary complaint of joint achiness, as well "a little" weakness in his muscles and joints. The subject reported that onset of symptoms occurred since he had Lyme disease in 2003 and 2004, he had been previously advised that he had "a mixture of fibromyalgia and rheumatoid arthritis". He also reported a history of intermittent back pain for many years. Assessment included 1) diffuse arthralgias "suspect more due to his very high work level and probably some underlying osteoarthritis, 2) previous Lyme disease and 3) slight benign prostatic hypertrophy. The event of possible rheumatoid arthritis was assesseed to be medically significant by GSK.