Age: 22.0
Sex: M
Vaccine: LYME
Symptoms: Palpitations, Paraesthesia, Pharyngolaryngeal pain, Polymerase chain reaction, Prothrombin time normal
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMErix (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMErix (unknown). At an unspecified time after vaccination with LYMErix, the subject experienced joint pain, joint swelling, shooting pains, diffuse muscle weakness, fatigue, possible autoimmune disease, activities of daily living impaired, neurological problem, cognitive dysfunction, tingling, numbness, throbbing back pain, gastrointestinal problems, heart problems, flu-like symptoms, anxiety, tremor, muscle stiffness, joint stiffness, generalized twitching to face and whole body shakes. At the time of reporting the outcome of the events was unspecified. This information was received on 07 January 2008 via medical records. The subject had a history of positive Lyme serology with fatigue, headaches, joint pain, and muscle pain in 1997, which improved following a course of doxycycline. The subject, who was a male in his twenties, received his first, second and third doses of LYMErix in July 1999, August 1999, and May 2000. In 2001, the subject developed tension around his right eye and then in the massetter muscle of the right side. In December 2003, he experienced "eight months stretch of flare-up" with fever, chills, and palpitations. He was diagnosed with supraventricular tachycardia. On an unspecified date, was diagnosed with Lyme disease. On 18 May 2004, therapy with doxycyline was started at 100 mg twice daily. On 01 July 2004, he complained of persisting Lyme symptoms included headache of increased frequency, mental fog, arthralgias "more at the spine", hypersomnolence, and fatigue. Assessment also included anxiety, depression, and neurasthenia/fatigue. A spinal tap in July 2004 showed elevated Lyme serologies. His dose of doxycycline was decreased to 100 mc once daily. By 13 July 2004, Lyme symptoms had worsened with forgetfulness, palpitations, irregular heartbeat, and headaches, and he was referred for a lumbar puncture. On 28 July 2004, a peripherally inserted central catheter (PICC) was placed and the subject was treated with Rocephin. Initially he experienced tachycardia and sweats, followed by improvement of symptoms. The final administration of Rocephin was given on 24 August 2004, after which the PICC was removed. Medications prescribed between 2005 and 2007 included metoprolol, Mepron, Provigil, Malarone, Plaquenil, Biaxin, Xanax, Neurontin, and intravenous immunoglobulin. On 23 September 2004, the subject presented for neurology evaluation with chief complaint of sleep difficulties, cycles of feeling overtired or hyperactive, sore throat, cognitive difficulties, chest wall pain, dyspnea, exercise intolerance, word finding difficulties, sleepiness while driving, and "blank staring". Review of systems was significant for mood swings. The neurologist assessed that the subject was experiencing regression of central nervous system (CNS) Lyme disease, with "significant" cognitive difficulties. Upon diagnostic testing, Lyme serology was reactive and HLA-B27 antigen was not detected. On 03 March 2005, a baseline ophthalmic examination performed prior to initiation of Plaquenil was normal. On 18 August 2005, the subject was referred for physical therapy due to low back pain "of both degenerative and arthritic nature". In February 2006, Mepron and Zithromax were prescribed for Babesia infection. According to the subject's neurologist, he was diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP) with numbness and burning of the bilateral lower extremities, fatigue, severe lower extremity pain, and joint pain. On 05 December 2006, electromyography findings included active and chronic superimposed distal polyneuropathy and left low lumbar radiculopathy. According to a note dated 29 December 2006, the subject was status post three doses of LYMErix, and his symptoms were unrelieved by oxycodone. He experienced a gait disturbance due to neuropathy and neuropathic pain which predisposed him to falls. Treatment with intravenous immunoglobulin (IVIG) was recommended at that time. By July 2007, the subject exhibited some clinical improvement in burning and numbness of the lower extremities, with persistent "extreme joint pain, intermittent fatigue, and gait disturbance. Continued IVIG was recommended, and doxycycline was prescribed at that time. Upon follow up on 07 November 2007, the subject reported that ibuprofen helped with episodes of headaches. Complaints included pressure in the eyes, memory problems, breathing problems, anxiety, and a "doom's day" sensation. He described "nerves feel alive and hyper", and that his exercise tolerance was improved. Neurologist's plan was to continue the subject's current medications including IVIg. This case was assessed to be medically significant by GSK based upon follow up information.