Age: 58.0
Sex: F
Vaccine: LYME
Symptoms: Rheumatoid factor negative, Spinal X-ray abnormal, Vaccine positive rechallenge, Vomiting, X-ray of pelvis and hip abnormal
Clinical narrative: Report 1999019267-1 describes joint and muscle pain in a 58 year-old female who received LYMERIX. The vaccinee has no known allergies or medical history. She has no history of Lyme disease. At the time of vaccination the vaccinee was reportedly an extremely healthy, active woman. The vaccinee takes vitamins {nos}. The patient expresses an HLA DR4 allele. On 01-Jun-99, the patient received her first dose of LYMERIX. She subsequently experienced mild flu-like symptoms. On 30-Jun-99, the patient received her second dose of LYMERIX. On approximately 02-Jul-99, she felt as if she had a 24-hour flu. She experienced achiness and soreness in hips/legs that "felt like arthritis". She experienced extreme joint and muscle pain all over her body. The vaccinee explained that she felt like she "went from 58 to 85". A doctor visit was required. The patient was treated with Medrol Dosepak. By September 1999, the vaccinee was hospitalized as reportedly she could not move her legs. "To this day" she continued to find it difficult to function, even on "significant doses" of prednisone and unspecified anti-inflammatories. As of 01-Feb-01, the outcome of the events is ongoing. The serious adverse events of 'joint pain' meets ICH criteria and is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. on 01 April 2009, GSK reference number A0600185A was identified as a duplicate of A0328640A and was voided. All future information will be reported to A0308640A. The following information was added from A0600185A: On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain, burning and swelling in her joints, fatigue, possible neurological injuries, possible autoimmune disease, and decreased activities of daily life. 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 01 April 2009 via medical records. The subject received the first dose of LYMERIX on 01 June 1999 in the left arm and the second dose on 30 June 1999 in the right arm. Following the first vaccine she developed generalized mild aching lasting less than 24 hours. Within 24 hours of the second LYMERIX vaccine she developed intestinal flu like illness with mild nausea and vomiting that resolved, followed several days later by aching predominantly of the pelvis and thigh muscles. Between August 1999 and September 1999, complaints included joint stiffness which developed approximately two weeks after receiving either the first or second dose of LYMERIX, degenerative disc disease, acute inflammatory arthritis, and polymyalgia rheumatica. According to rheumatology consultation on 07 September 1999, she had been in excellent health prior to LYMERIX vaccines. Assessment at that time included polymyalgia rheumatica, and the rheumatologist stated that he was unsure of the role in which LYMERIX played "in the development of the current picture. She was admitted on 08 October 1999 for further evaluation of muscle aches, fatigue, and joint stiffness "all of which had onset within 24 hours of her having received the second of the LYMERIX vaccines". She had reportedly experienced an "excellent" transient response to Medrol Dosepack followed by recurrence of symptoms. While hospitalized, she was treated with prednisone with improvement of musculoskeletal aching. Other findings included generalized arthralgias and stiffness, past resolved adhesive shoulder capsulitis, osteopenia, and osteoarthritis. She was discharged on Prednisone and Fosamax. In November 1999, the subject continued prednisone therapy for treatment of polymyalgias rheumatica which "question autoimmune disease related to LYMERIX". It was planned to taper prednisone and start Vioxx. She was seen for follow up of "LYMERIX induced polymyalgia rheumatica" on 06 January 2000 and 29 June 2000, and reported fatigue, migratory polyarthralgias and myalgias particularly in the low back and chest wall that she described as "debilitating at times". The evaluating physician questioned the possibility of rheumatoid arthritis and/or systemic lupus erythematosus. On 30 January 2006, diagnoses included degenerative joint disease and rheumatoid arthritis. Treatment included Arthrotec, vitamin B-12, and Decadron. A progress note dated 04 March 2008 indicated that the subject had an allergy/allergic reaction to LYMERIX. Complaints at that time included fatigue and severe lumbar back pain, and joint inflammation. She reported had a history of rheumatoid arthritis as well as osteoporosis and macular degeneration.