Age: 39.0
Sex: M
Vaccine: LYME
Symptoms: Myalgia, Nausea, Nervous system disorder, Nuclear magnetic resonance imaging brain normal, Paraesthesia
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 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, swelling, stiffness, flu-like symptoms, headaches, fatigue, dizziness, tingling in extremities, possible memory loss, 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 23 July 2007 via medical records. The subject was a 39-year-old male who was vaccinated with Lyme disease vaccine recombinant OspA (Lymerix, GlaxoSmithKline) on 29 April 1999 and 27 May 1999. The subject's medical history included ankle injury and ankle swelling, arthritis, benign positional vertigo, chronic otitis media, chronic sinusitis, degenerative changes of ankle, enuresis, grass allergy, hip degeneration, low back pain, Meniere's disease, osteoarthritis of hip (diagnosed August 1998) and hip pain, pollen allergy, pronated feet, shoulder dislocation, shoulder tendonitis, and bilateral subtalar fusion due to congenital bone abnormality. In November 1999, six months after vaccination with LYMErix, the subject experienced fatigue. Magnetic resonance imaging (MRI) of the brain on 14 May 2000 showed minimal subcortical white matter lesions. On 23 October 2000, he was evaluated for fatigue that limited his activity." Additional symptoms included headache, facial pressure, post nasal drainage, ear fullness and clicking, and cough. On 30 November 2000, the subject presented with a five day history of fairly severe right shoulder pain following sudden onset, accompanied by difficulty sleeping. Assessment included "tendonitis, ? rotator cuff tear". Naproxen was prescribed, and he was provided with exercise recommendations. He presented to the emergency room when right shoulder pain and upper trapezius pain became "unbearable". Diagnostic tests on 06 December 2000 showed foraminal narrowing at C3-4 and C5-6, and a small central disc herniation at C7 to T1. In January 2001 he presented for chiropractic treatment, and was advised of right shoulder girdle atrophy. On 04 June 2001, the subject was seen for a neuromuscular consultation and reported that shoulder pain was improved, although right shoulder atrophy and weakness persisted. He also described numbness over the right deltoid. He noted that he had "lifted luggage from the overhead (compartment)" several weeks before onset of pain and weakness. The neurologist expressed the impression that the subject "likely had brachial neuritis and is left with primarily deltoid weakness and atrophy." The subject continued to experience elbow pain, and was diagnosed in October 2001 with tendonitis. On 13 December 2001, the subject was evaluated for right elbow strain and shoulder weakness. Upon examination, he was noted to be recovering from left shoulder nerve dysfunction "possibly a reaction to a Lyme vaccine". He continued to experience shoulder numbness at the time of evaluation. On 08 February 2002, the subject was evaluated for right neck pain/ spasm with pinched nerve sensation. Treatment included cyclobenzaprine hydrochloride (Flexeril) and nabumetone. In March 2002, he complained of right elbow pain that was bothered by sports, and accompanied by tightness and soreness upon full elbow extension (which reportedly began in approximately January 1999, prior to LYMErix vaccination). Assessment was of "impingement of the olecranon tip, olecranon fossa." Progress notes dated 10 May 2002 revealed complaints of myalgias and arthralgias including the right shoulder and elbow, with the subject's "most significant concern"of weight loss in spite of normal appetite and food intake. The evaluating physician noted that the subject was receiving Maxzide at that time for treatment of Meniere's disease, and that weight loss could be occurring secondary to the diuretic. Maxzide was discontinued at that time. In a letter dated 26 June 2002, the subject's allergist reported that the subject stated he had been recently diagnosed with chronic Lyme disease. This case was assessed as medically serious by GSK based upon follow up information. At the time of reporting the outcome of the events was unspecified. The subject's symptoms of headache, facial pressure, post nasal discharge, ear fullness and clicking, and cough appeared to be associated with the subject's history of nasal and sinus symptoms. He also complained of fatigue and frequent sinus headaches associated with a diagnostic impression of active chronic sinusitis. In December 1999 he was evaluated for a vertigo sensation which was assessed as allergic rhinitis/ labyrinthine dysfunction and was treated with Antivert. In March 2000, allergist's impression was of benign positional vertigo and possible sinusitis resulting in dysequilibrium, sinus problems, facial pressure, and headaches treated with Claritin D. In December 2001 and January 2002, the subject was evaluated for intermittent dizziness with occasional nausea and vertigo that was considered to be associated with ongoing Meniere's disease. Treatment included prednisone and Valium for active Meniere's. These were considered to be incidental findings upon medical record review.