Age: 29.0
Sex: F
Vaccine: LYME
Symptoms: Electromyogram abnormal, Fatigue, Full blood count normal, Headache, Hypoaesthesia
Clinical narrative: This case was reported via medical record that were forwarded by a lawyer and described the occurrence of arthralgias in a female subject who was vaccinated with LYMErix for prophylaxis. The subject was 29 years old at the time of vaccination with LYMErix, and was in her thirties at the approximate time of adverse event onset. The subject's medical history included a motor vehicle accident in 1992 with a low back injury, laminectomy/discectomy (L5 to S1), left lumbar radiculopathy, buttock/leg/low back/foot brain, headaches, and neck/shoulder/hand/arm pain. According to information obtained from medical records, the subject received her first and second doses of LYMErix on 17 May 2000 and on 26 June 2000 (unknown). Approximately two years after vaccination withy LYMErix, on 08 May 2002, the subject reported feeling "sick a lot" and headaches approximately three times per week. Assessment on that date included migraine headaches, arthralgias, myalgias, fatigue, and generalized joint pain. Physician's progress notes dated 06 May 2003 indicated that the subject carried a diagnosis of degenerative joint disease. On 22 May 2003, she was seen for an initial evaluation with a neurologist due to headaches, neck/shoulder/arm/hand pain, and low back/leg/foot pain. The event had been ongoing for approximately five years but had worsened in the three months preceding evaluation. She also complained of headaches/migraine pain with associated visual disturbances, photophobia, and phonophobia. Neurologist's impression on that date was of "triggered wave syndrome" with low back pain ongoing into the neck and head, causing headaches; bilateral low back pain with burning, numbness, and tingling and diffuse pain in the low back, legs, and feet; cervical pain and strain with bilateral brachial plexus irritation and inflammation involving the bilateral upper extremities, forearms, and hands sometimes associated with numbness and tingling; mixed migraine headaches with migraine features with and without aura, cluster, catamenial, and muscle contraction migraine. Treatment with Kadian was initiated. On 24 June 2003, examination revealed bilateral brachial plexus irritation. Additionally, she reported some numbness and tingling in the hands and forearms. Electromyography and nerve conduction study of the bilateral upper extremities showed abnormal findings consistent with a moderate to severe left carpal tunnel syndrome. On 08 July 2003, she was again evaluated by her neurologist, and reported that her low back, leg, and foot pain had been worsening and extended up her back into her shoulders. Examination revealed 2+ knee jerks and absent ankle jerk. Electromyography and nerve conduction study findings of the bilateral lower extremities were normal. On 25 May 2004, the subject presented to an infectious disease physician for evaluation for possible Lyme disease. She reportedly "had Lyme approximately four years ago with tick exposure history". Complaints included chronic pain and fatigue, and past medical history included degenerative disc disease of the spine and carpal tunnel. Impression was of "33 year old female with no signs of active Lyme disease", and the subject was referred for rheumatology work-up. On 19 July 2004 she was evaluated by a rheumatologist. Examination revealed a full range of motion of all joints with no synovitis. The subject failed to go for recommended diagnostic testing, and the rheumatologist expressed the impression "that she does not have a connective tissue disease and much of her symptoms are probably the result of cervical spasm with radiculopathy and perhaps overuse of narcotics". On 07 July 2006, the subject was hospitalized due to severe migraine headaches with nausea and vomiting that had been ongoing for approximately five days. Between her second LYMErix vaccine and the time of this report, the subject received multiple pain medications including Flexeril, OxyContin, Percocet, Voltaren, Vioxx, and hydrocodone/Lortab. She also received Imitrex, Esgic, and Zomig for migraines. At the time of reporting the outcome of the event was unspecified.