Sex: M
Vaccine: LYME
Symptoms: Borrelia burgdorferi serology positive, Constipation, Fall, Gait disturbance, General physical health deterioration
Clinical narrative: This case was reported via medical records forwarded by a lawyer and described the occurrence of multiple sclerosis in an adult male subject who was vaccinated with LYMERIX. The following information was received via medical records. On an unspecified date the subject received unspecified dose of LYMERIX. On 21 MAY 2002, the subject underwent right arthroscopic knee surgery (left knee arthroscopy performed on unspecified date). On 04 June 2002 he was seen for follow up of arthroscopic surgery, resulting in impression of mild degenerative arthritic changes under surface of right patella. On 25 July 2005, he presented for orthopedic examination resulting in an impression of degenerative arthritis in the great right toe as well as gout in the great right toe. The orthopedist advised that "most of his symptoms are coming from gout and not from his arthritis or dorsal lateral bunion". In June 2006, the subject was evaluated for change in speech pattern and reporting an "episode of words not coming out the way he wished them". On 30 June 2006, the subject was evaluated with complaints of difficulty reading approximately two weeks prior to examination, with stumbling over words and difficulty with word conduction rather than definite dysarthria. He also reported occasional right foot pain. In approximately June 2006 or July 2006, the subject was diagnosed with multiple sclerosis. A letter dated 12 July 2006 indicated that recent magnetic resonance imaging (on 22 June 2006 and 01 July 2006) demonstrated "convincing findings for multiple sclerosis, but no active disease". Treatment included COPAXONE and NALTREXONE. He was seen for follow up on 15 November 2006 without evidence of further  attacks of multiple sclerosis, and examination found no neurologic loss. On 27 June 2007, the subject was assessed with multifocal white matter disease and episodic speech impairment followed by left leg weakness consistent with a diagnosis of vascular disease or multiple sclerosis. On an unspecified date in 2007, the subject was hospitalized after presenting with fever, anemia, and a rash suspicious for Lyme on the knee. The subject's Lyme IgM was positive with negative Lyme IgG. Babesiosis was confirmed by serology, and treatment included doxycycline, one course of steroids (Medrol Pak), azithromycin, and atovaquone. The physician indicated performing a "literature review regarding expected serologic findings of patients who received Lyme vaccine". On 10 August 2007, the physician commented "the cause of his positive Lyme is not due to the vaccine", and that it was "very likely that he did have an early Lyme disease and Babesiosis without CNS (central nervous system) involvement". The subject was advised of the physician's opinion that he "does have multiple sclerosis AND had a recent infection with Babesia and probably Lyme disease". The subject's walking had reportedly worsened with some in-toeing and tripping. His main symptoms of multiple sclerosis at that time included balance and gait impairment, urinary frequency, and constipation. He reported occasional falls without trauma. On 07 November 2007, evaluation revealed worsening multiple sclerosis. The evaluating physician noted that it had not been long enough "to know whether this is becoming progressive MS or if he is just having one exacerbation on top of another with remission". Diagnosis were worsening multiple sclerosis, Lyme disease with possible central nervous system involvement, and Babesiosis "now worse despite one month of ceftriaxone". More aggressive therapy was recommended. A neurologist's note dated09 November 2007 indicated that the subject had two doses of LYMERIX "many years ago", and that "the positive Lyme serology could have been a consequence of the vaccination". By December 2007, he reportedly experienced significant problems as a result of multiple sclerosis, Lyme disease and Babesiosis, including generalized weakness, balance difficulties, and inability to ambulate without use of a walker or quad cane. He was using a manual wheelchair which he lacked ability to propel, and a motorized wheelchair was requested. On 13 December 2007, he was evaluated for IgG para-protein "of a very small nature", and for consideration of a bone marrow biopsy to rule out multiple myeloma or "some other underlying plasma cell dysplasia". It was noted that his neurologic disorder was "most consistent with multiple sclerosis". Impression included 1) probable multiple sclerosis, and 2) very small level IgG monoclonal gammopathy of unclear significance. On 20 December 2007 he underwent a bone marrow biopsy which demonstrated normocellular bone marrow with maturing tri-lineage hematopoiesis. Chromosome analysis on 24 December 2007 was within normal limits. The subject was evaluated on 10 March 2008. He had reportedly been treated with Tysabri beginning approximately January 2008, and the subject's neurologist reported concerns regarding progression of the disease. On 10 March 2008, treatment with Cytoxan was started. In a letter of medical necessity dated 10 April 2008, he was reported to have experienced deterioration of overall condition and utilized a walker and motorized wheelchair for mobility, and it was indicated that the subject would "benefit from the use of a lift chair in order to stand without falling, which has now become a major problem". This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.