Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Polymerase chain reaction, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Sensation of foreign body, Serology normal
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a female subject on unspecified age who was vaccinated with Lyme disease vaccine recombinant (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). At an unspecified time after vaccination with LYMErix, the subject experienced joint pain, joint swelling, shooting pains, muscle weakness, fatigue, possible autoimmune disease, activities of daily living impaired, tingling, numbness, visual problem, insomnia, gastrointestinal problems, dizziness, anxiety, vertigo, swallowing problems, hand tremors, cognitive problems, memory loss, burning pain, headache, muscle tremor and possible neurological problems. 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 16 November 2007 via medical records. Medical history included bronchial asthma, heartburn, and panic disorder. The subject was assesses as having neuropathy and fibromyalgia as early as 13 April 1998. She also developed sinusitis accompanied by chills, fatigue, and body malaise in 1998. On 04 May 1999, she received her first LYMErix vaccine (0.5 cc, left arm). She reportedly became "somewhat" sick following her first LYMErix injection, and developed aching and became "fluish". On 06 July 1999, the 45-year-old subject was examined by an ear nose and throat specialist for complaints of 24 hours of a lump in her throat with soreness, repetitive throat clearing, mild dysphagia, and a "bile, acidy" taste, as well as intermittent hoarseness. Physical examination revealed significant posterior commissure edema bilaterally of the larynx with normal vocal cord motion, and reflux was suspected. Therapy with Prilosec was initiated. On 09 July 1999, the subject was again evaluated for sore throat, inability to swallow/ difficulty swallowing, and spitting up, and was diagnosed with throat hyperemia. Assessment also included pharyngitis and/or laryngitis. On 14 September 1999, she received her second LYMErix vaccine (0.5 cc, right arm). In September 1999, she was examined for "stomach problems", and she was referred for gastrointestinal evaluation. Following her second LYMErix vaccine, she reported that she developed lightheadedness and dizziness, vertigo, and inability to stand or walk and presented to the emergency room. On 21 September 1999, she was evaluated by an gastroenterologist for complaints of gas, gurgling, mucus in stools, and constipation. Assessment on that date was "likely element of (irritable bowel syndrome) IBS and need to rule out inflammatory and bowel disease. A colonoscopy performed on 28 September 1999 revealed a colon polyp, a few left-sided diverticulosis, and hemorrhoids. She also developed ringing in ears and would "fall to the ground", while continuing to experience vertigo. On 09 April 2001, the subject was evaluated and chostochondritis, in addition to upper respiratory infection and pharyngitis. Xanax was prescribed for anxiety. In 2002, Lyme titer results were reported to be equivocal, and she was treated with Zithromax, Mepron, hydroxychloroquine, and Cedax. On November 2005, the subject presented for neurology evaluation of "LYMErix vaccine reaction". During the course of treatment by the neurologist, symptoms included headaches, chest pressure, neck and shoulder stiffness, numbness, cognitive symptoms, word finding difficulties, spatial disorientation, getting lost when driving, lightheadedness, nausea, "true" vertigo, and depression. The neurologist characterized her symptoms as disabling, while noting that she "continued to work through the entire period". She reported awakening with panic attacks, and that symptoms worsened with Ambien. Magnet resonance imaging of the brain on an unspecified date was normal. Lyme disease test (ELISA) was reportedly positive on an unspecified date. On 26 January 2006, neurologist assessment was that the subject suffered "from a neurocognitive syndrome following the LYMErix vaccine that she has received in 1999", in addition to "myofascial syndrome with painful trigger points in the trapezius muscles. Examination on that date reportedly showed evidence of cerebella or inner ear involvement, and peripheral nerve involvement. She had previously received oral antispasmodics with "no effect" and physical therapy with "only transient relief". She also received "trigger point injections" (lignocaine, pupivacaine, and ketoralc) with improvement "for only several days", as well as Botox. Blood work confirmed HLA-DR4 MHC class II antigen, and Lyme test (ELISA) was positive. On 24 March 2006, treatment with Plaquenil and Biaxin were initiated. In a letter dated 26 March 2006, the neurologist noted that the subject suffered from intractable headaches, neck and shoulder pain "with a significant component of spasmodic torticollis". On December 1999 the subject experienced a "jamming injury to the left ring finger" followed by an "immediate droop to the fingertip", the injury was treated with splinting. In January 2000, the subject was diagnosed with influenza and was treated with Tamiflu. On 29 December 2000, the subject developed pain while playing tennis, and was diagnosed with a lumbosacral strain/ sciatica. These, and the events of laryngitis, upper respiratory infection, colon polyp, diverticulosis, hemorrhoids, and insomnia, were considered to be incidental findings upon review of medical records.