Age: 22.0
Sex: F
Vaccine: LYME
Symptoms: Autoimmune disorder, Back pain, Balance disorder, Borrelia burgdorferi serology negative, Brain stem auditory evoked response abnormal
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with LYMErix (GlaxoSmithKline) for prophylaxis.  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 and swelling, fatigue, numbness, tingling, brain lesions, cognitive problems, muscle weakness, head pain, headaches, visual problems, flu-like symptoms, decreased activities of daily life, and rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMErix.  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 21 January 2008 via medical records.  On 07 April 2007, magnetic resonance imaging of the brain showed two abnormal lesions, which the subject's neurologist noted "may be the result of head trauma related to heading the ball on the soccer field".  At that time, the subject was 22 years old.  On 14 April 2004, the subject presented to a neurologist for evaluation of what happened to be femoral neuropathy or possibly L4 radiculopathy.  Complaints included low back pain, numbness and pain in the right leg, and leg weakness especially when climbing stairs or with knee exertion.  It was noted that the low back pain had developed approximately two months prior to examination, "after she began doing a lot of kick boxing".  Examination revealed full strength throughout "except for mild weakness of iliopsoas graded at 5 and of quadriceps graded at 4+ to 5-, all on the right side", absent right knee jerk, absent adductor jerks, hypesthesia to pin and touch especially over the pre-tibial region and slightly over the lateral aspect of the calf.  She was assessed to have femoral neuropathy on the right side of unclear etiology.  On the same date, magnetic resonance imaging of the brain showed no enhancing lesions.  On an unspecified date, she was diagnosed with a factor V Leiden deficiency.  Assessment was that the "new symptoms in the left face and left hand" suggested a brain parenchymal process and re-raised the issue of demyelinating disease.  Upon follow up on 16 June 2004, those symptoms were improving, with decreased numbness and improved strength of the right lower extremity.  New complaints included a tingling sensation around the lips on the left side of her mouth, ongoing for approximately one week at the time of examination.  This spread to include a numbness in a perioral distribution, as well as numbness in the fingertips of the left hand.  Additional symptoms included weakness of the hand when trying to grasp things.  On 17 June 2004, magnetic resonance imaging of the brain resulted in an impression that was "characteristic of demyelinating disease/multiple sclerosis".  On 28 June 2004, the subject underwent a lumbar puncture.  The subject was seen in follow-up by a neurologist on 12 July 2004, following a lumbar puncture that revealed oligoclonal band and evidence of IgG synthesis within the central nervous system compartment.  Lyme titers were negative.  The subject was noted to be doing "very well with physical therapy regarding her right lower extremity symptoms" and it was noted that "the symptoms on the left side of her face and arm seem to have resolved".  Physical examination revealed minimal weakness of the quadriceps of the right, and an abnormal sensation in the anterior leg on the right.  Right knee jerk was absent.  Therapy with low-dose naltrexone was initiated.  In approximately October 2004, the subject also developed numbness from the tops of her shoulders to under her arms and chest on the right side, described as "stings slightly".  By 21 October 2004, symptoms were improved, with slight numbness and no tingling or burning.  Upon neurology follow up on 19 January 2005, she continued to experience a numb sensation in her right flank, but there were no new abnormalities on examination.  On 20 January 2005 and 26 January 2005, diagnostic findings remained consistent with demyelinating disease, with a new right side brain stem lesion and improvement of the previously seen left centrum lesion, and findings consistent with a chronic demyelinating plaque on the cervical spine.  In approximately September 2005, the subject developed a buzzing in her left ear, accompanied by a sensation of being of balance and a sense of wobbliness when she walked.  She also lost her voice, which returned along with improvement of other symptoms.  She was evaluated by ear/nose/throat specialists who felt that symptoms were due to "vestibulitis related to a virus".  Follow up evaluation on 10 October 2005 with her neurologist was remarkable for some diminished hearing issues but indicated that she "may have had some associated blurring in the left eye".  The neurologist stated "I suspect that ear, nose, and throat doctors are correct and that this is a peripheral process".  New white matter lesions were identified on follow up imaging on 18 October 2005.  In late-December 2005, the subject experienced an episode of left leg numbness which resolved after one week.  She also reported occasional awakening due to left foot tingling, and occasional sensations of spasticity or pulling or tightness around the right knee.  On 29 December 2005, magnetic resonance imaging findings showed a mixed pattern of improvement and worsening of white matter lesions.  On follow up on 16 January 2006, she was receiving only naltrexone.  Her neurologist stated that the subject "has multiple sclerosis.  She is continuing to have active lesions and needs to be treated."  The subject and her family agreed to initiation of Copaxone on that date.  She was doing well on follow up on 27 December 2006, was continuing Copaxone and naltrexone as well as multivitamins, and her neurologist suspected relapsing-remitting multiple sclerosis.  A new demyelinating plaque was identified as recently as 09 May 2007 upon magnetic resonance imaging of the cervical spine.  This report was assessed to be medically significant by GSK based upon follow up information.