Age: 43.0
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness, Injection site pruritus, Injection site rash, Injection site warmth, Insomnia
Clinical narrative: This case was reported via medical records forwarded by a lawyer and described the occurrence of Lyme disease in an adult female subject who was vaccinated with LYMERIX vaccine. The patient received unspecified dose of LYMERIX vaccine on 06 July 1999. The patient had a history of headaches that were described as "disabling" as early as 1994. On an unspecified date she was diagnosed with degenerative arthritis. In February 1998 and June 1998 the subject complained of medial right knee and lateral right elbow pain, with diagnostic findings including a gangilion cyst on the knee. She was also diagnosed with a possible meniscal tear and early degenerative arthritis of the knee and lateral epicondylitis in the right elbow. In November 1998, the subject was noted to have bilateral upper extremity overuse tendonitis, cervical and lumbosacral syndrome with strain and sprain pattern, and cervical degenerative disc disease. In May 1999, the subject was receiving SKELAXIN, ASPIRIN, and IMITREX due to back and neck pain and headaches. On 14 February 2000, the subject received CORTISONE injection due to bilateral shoulder pain, and review of x-rays of the cervical and lumbar spine showed degenerative disc disease. The subject was noted to have been in an automobile accident on 19 February 2001, and on 26 February 2001 experienced back pain sometimes radiating down the right leg, and headaches which were reportedly improved. Neurologic exam was unrevealing, and it was noted that she continued to suffer form a mixed headache disorder with features of both migraine and tension headaches. On 26 March 2001, magnetic resonance imaging of the cervical and lumbar spine showed moderate cervical spondylosis, bilateral foraminal stenosis, moderate degenerative disc disease and osteoarthritis at L4/5 with mild stenosis of the central spinal canal. Physician's impression on 30 March 2001 included degenerative disc disease in cervical and lumbar spine in regions suspicious for upper extremity radiculopathy, and right shoulder strain and impingement. Treatment included VIOXX and/or ULTRAM. On 22 April 2002 she was evaluated for multiple joint complaints and musculoskeletal complaints including late effect of cervical and lumbar strain. On 29 August 2002 she was diagnosed with cervical sprain with mild underlying degenerative joint disease, and rotator cuff sprain of the right shoulder. On 18 June 2003, the subject was evaluated by a neurologist due to increasing headaches. She complained of ongoing neck and back pain. In approximately 2004, the subject developed Lyme disease. In June 2005 she was evaluated for right shoulder and left ankle symptoms, with assessment including right shoulder possible rotator cuff tear, and chronic lateral ankle instability of collateral left ankle ligaments. She was treated for Lyme disease from November 2005 to January 2006, including intravenous doxycycline and Rocephin via a peripherally inserted central catheter, and oral AZITHROMYCIN. On 29 March 2006, she presented with tingling in her feet and legs, and shaking in her hands. It was noted that her neurologic exam had not "changed appreciably in three years". In July 2006, she complained of persisting numbness in her legs, and on 12 July 2006 diagnosis included Lyme disease. The physician indicated the possibility of restless leg syndrome, and MIRAPEX was prescribed. A noted dated 01 November 2007 indicate that the subject had documented Lyme disease for three years, as well as migraines and bilateral lower extremity paresthesias. At the time of reporting the outcome of the event (s) was unspecified. Follow up information was received on 01 December 2008 via a statement of injuries, which alleged that the subject received LYMErix and experienced myalgias, muscle weakness, arthralgias especially of the jaw, ankles, hips, neck and low back, sleep disturbance, sore throat, colds, fever, memory loss, forgetfulness, floaters, light sensitivity, sound sensitivity, migraine, weight gain, rash, stomach cramps, food sensitivity, nausea, vomiting, metallic taste in mouth, inability to open mouth "all the way", cold intolerance, hot flashes, coordination decreased, anxiety, brain fog, frequent urination, thirst, itching, tingling of arms and legs, ringing in ears, and tremors in hands and arms. The statement further alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive sequella of an autoimmune, immune-mediated, or other biological mechanism, all caused by vaccination with LYMErix, including but not limited to those symptoms set forth above". At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 19 March 2009 via information obtained from an interview between the subject and the attorneys. The subject's history included migraines/headaches. The subject received the first, second, and third doses of LYMERIX on 04 June 1999, 06 July 1999, and 16 May 2000. Within two weeks of her first dose of LYMERIX, she developed flu-like symptoms, chills, and rash at the injection site. Rash was associated with itchiness and warmth and still flare-up occasionally. Between the first and second doses of LYMERIX, she developed low body temperature. At an unspecified time after her first and second doses of LYMERIX, she experienced fatigue. Immediately following her first or second dose of LYMERIX, she experienced "vivid" nightmares. Within a month of the first or second dose of LYMERIX, she experienced neck stiffness. In 1999, she developed difficulty swallowing (described as feeling like choking without having eaten anything). Following her second dose of LYMERIX, she developed tremors. In 2000, She experienced shakiness/shivers, excessive sweating, muscle weakness, and loss of coordination. She also described tingling/feeling like she was "plugged in ". In 2004, she developed right-sided facial palsy, which was assessed by GSK to be medically significant. In late-2006, she developed frequent urination. A "few years" after vaccination with LYMERIX, she experienced memory loss. On unspecified date(s), she experienced sleep disturbance/insomnia and migraines. Treatment included migraine medications, hormone treatments, AMBIEN, XANAX, SKELAXIN, NEURONTIN, DDAVP, unspecified medications, topical rash cream, and muscle relaxants, chiropractic treatment, and mouth guard (for TMJ symptoms). The events, with the exception of flu-like symptoms, were unresolved at the time of reporting.