Age: 34.0
Sex: M
Vaccine: LYME
Symptoms: Biopsy colon normal, Biopsy small intestine normal, Borrelia burgdorferi serology positive, Breath sounds, CSF test normal
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain and swelling in an adult male subject 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). On an unspecified date after vaccination with LYMErix, the subject experienced joint pain and swelling, fatigue, sleep disorder, gastrointestinal problems, dizziness, headaches, ringing in ears, muscle pain and weakness, neck pain, memory loss, cognitive problems, numbness in extremities, and decreased activities of life. In addition, he suffers from 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 07 January 2008 via medical and pharmacy records. According to a Lyme serology information sheet completed by the subject, he was vaccinated with LYMErix in April 1999 and May 1999, but did not receive additional doses because he was "too sick." LYMErix was administered at the subject's place of employment, and the subject reported no history of Lyme disease prior to vaccination. Following his second vaccination with LYMErix, beginning in May 1999, the 34-year-old subject developed fever and/or flu-like symptoms and joint pain. In November 1999, the subject was diagnosed with Lyme disease. Additional events included neck stiffness, nausea, chronic fatigue syndrome, fibromyalgia, chronic insomnia, stress, anxiety, depression, and mental health/ memory problems. The subject reported that he received unspecified antibiotics for Lyme disease between November 1999 and January 2000, and from January 2001 through the time of completion of the Lyme serology information sheet. He reported that treatment was not successful, and that his symptoms began and slowly escalated following his second LYMErix vaccine. His symptoms reportedly remained constant, but with changes in severity. At the time of completion of the information sheet (date not provided), the subject's joint pain and fever/ flu-like symptoms were unresolved. Follow up information was received on 18 February 2008 via medical records. On 15 March 2000, the subject was evaluated for nausea, epigastric pain, and diarrhea, and diagnostic testing was negative for Helicobacter pylori and showed no evidence of microscopic colitis. In July 2000, he was evaluated in the emergency room, and underwent a lumbar puncture to rule out central nervous system (CNS) Lyme disease. Medications at that time included amitriptyline and Ambien. On 08 March 2001, he underwent a sleep study which revealed normal results; however, the previous night he reported that he had approximately three hours of sleep. Follow up information was received on 12 March 2008 via medical records. The subject was treated for Lyme disease with intravenous Rocephin beginning on 08 May 2001. The patient was discharged from the home health services on 06 June 2001, after reporting that he was instructed by his physician to "pull PIV (peripheral IV) and stop treatment, goals not being met". Follow up information was received on 21 March 2008 via medical records. The subject had a history of persistent nausea and upper abdominal discomfort in 1990. He subject was vaccinated with LYMErix on 15 April 1999 and 17 May 1999 through an employee health program. Following his second injection he developed some unexplained fatigue. In June or July 1999, he developed lightheadedness and minor stomach upset. While traveling by airplane in August 1999 he experienced "unexplained" vomiting which he had never had before. On 30 October 1999 he developed exacerbation of fatigue and onset of headaches, follow that night by a fever of 102 degrees Fahrenheit. The following day he experienced difficulty walking, and subsequent Lyme titers by ELISA were positive as "expected after the Lyme vaccine". He was evaluated on 31 October 1999 for complaints of severe headaches, sweats, and rigors. On that date he was assessed as having 1) congenital nerve palsy right side "incidental finding", 2) headache with febrile illness, questionable Lyme or ehrlichiosis, and 3) hematuria. Doxycycline was initiated on that date empirically. He was reportedly diagnosed with Lyme disease, fibromyalgia, and chronic fatigue syndrome. Treatment included doxycycline and Prilosec, and he experienced resolution of headaches and fever. In late November 1999 he developed insomnia. He received Elavil for sleep and exhibited symptoms suggestive of irritable bowel syndrome. He was seen for a gastrointestinal consult on 25 February 2000 due to altered bowel habits including diarrhea and constipation, with additional symptoms of headaches, bilateral low back pain, fatigue, weakness, anorexia without weight loss, insomnia and nausea. The evaluating gastroenterologist questioned "whether or not he has underlying inflammatory bowel disease with prominent extraintestinal manifestations such as arthritis and fatigue, versus irritable bowel syndrome worsened by the stress of some unknown intercurrent disease". Following his lumbar puncture on 23 July 2000, he experienced a fever of 100.2 degrees Fahrenheit which had "settled down" by 28 July 2000, and he continued to experience nausea, significant insomnia, and difficulty focusing (he also complained of a slight cough). A chest x-ray on 28 July 2000 revealed mild scoliosis. He was advised by his physician that he "probably does not have any underlying physical abnormality at the moment", and Paxil therapy was suggested for anxiety/ depression. Klonopin was initiated at that time. In December 2000, he complained of neck discomfort extending to the upper shoulder area, and was referred for physiotherapy. Assessment also included chronic fatigue and insomnia as well as possible Lyme disease. In approximately April 2001 the subject was diagnosed with disseminated Lyme disease and intravenous Rocephin was prescribed. In a letter dated 07 May 2001, the internist wrote "I believe (subject) has a combination of partially treated Lyme disease, exacerbated by vaccine, which triggered an autoimmune-like reaction". On 23 April 2002, examination of the cervical spine showed moderate degenerative spondylosis at the C5 to C6 level. According to a neurologist's summary dated 29 May 2002, the subject's symptoms developed after he received his second LYMErix vaccination and included difficulty sleeping, nausea, diarrhea, joint pain (mostly in knees), fatigue, low back pain, fluctuating cognitive difficulties, depression and mood swings, possible fibromyalgia, headaches, loss of appetite, upper gastrointestinal upset, "sharp" pains in his thighs, and anxiety. Treatment included doxycycline, amitriptyline, Celexa, Paxil, clonazepam, Ambien, tetracycline, Biaxin, Ceftin, and penicillin. In March 2001, the subject was assessed as having disseminated Lyme disease, and was treated with intravenous Rocephin which was discontinued due to abdominal pain. During the summer of 2001 he was off antibiotics and experienced improved sleep and headaches; however, in September 2001 his "symptoms were fully blown again". Mepron and Zithromax were started with an initial exacerbation of symptoms followed by improvement following discontinuation of this therapy regimen four weeks later. Biaxin and Plaquenil were started in October 2001 for approximately ten weeks with "some general improvement". A "significant deterioration" followed discontinuation of these medications. In January 2002 Mepron and Zithromax were re-started with the "same pattern of initial deterioration and later improvement". The subject was noted to be DR4 positive. A recent x-ray demonstrated some calcification and osteoarthritic changes. The physician commented that the subject "might have developed a post-vaccine immune disease". In late 2001 and 2002, the subject received physical therapy for neck pain that was assessed as "most likely arthritic in nature". A progress note dated 12 September 2002 indicated that the subject experienced continued fatigue, muscle aches, and insomnia and had received "an incredible amount of medications in the last couple of years" including tetracycline, penicillin, Ceftin, Biaxin, Rocephin, Zithromax, Mefloquin, and Plaquenil. The physician stated "I still do not believe that he has underlying Lyme disease and since he does have a low serum complement level, I think it is very reasonable for him to see a rheumatologist". He was noted to be HLA-DR4 positive. On 05 April 2003, the subject presented for follow up of back pain, cervical pain, and neck spasm that had been ongoing for approximately one year. He had been received Flexeril, and Bextra was added. The events of congenital nerve palsy, hematuria, and possible irritable bowel syndrome were assessed to be incidental findings upon medical record review. Follow up information was received on 28 March 2008 via medical records. The subject was evaluated on 17 June 2003 for "another opinion" regarding his symptoms including ongoing difficulty sleeping, fatigue, upset stomach, depression, anxiety, palpitations, neck pain, and joint pains and a recent diagnosis of chronic Lyme disease. Impression included "dizziness, suspect labyrinthitis". He returned for follow up on 08 July 2003, at which time the physician's impressions were 1) multiple constitutional symptoms, 2) suspected post-LYMErix vaccine syndrome, 3) suspected anxiety, depression, and 4) elevated ACE level, questionable etiology. On 25 August 2003, the subject reported increased fatigue that was possibly due to a higher dose of Zoloft, and he continued Klonopin, Flexeril, and Bextra. Upon follow up on 11 August 2005, he was "doing well at home and work", with a good appetite. He was sleeping well and admitted to an approximately 20 pound weight gain. Anxiety and depression were well controlled on Zoloft, and he was advised that an eventual taper and discontinuation of Zoloft could be implemented but "preferably under psychiatrist supervision". In December 2005 he expressed no arthritic complaints and was doing well with respect to anxiety while noting "some stress at work". On 13 February 2006, after decreasing his dose of Zoloft, he continued to do well with respect to anxiety. On 03 April 2007, he complained of stomach discomfort attributed to "increased stress and anxiety related to a new position" at work. He also experienced difficulty sleeping, inability to fall asleep, and "waves of depression". Impression included gastroesophageal reflux disease (GERD) and anxiety, and Zoloft was re-initiated in addition to initiation of Protonix. He continued to experience epigastric discomfort and anxiety, and Zoloft was re-filled in January 2008. Following discontinuation of Zoloft he admitted to some headaches and increased temper that subsequently improved. On 10 February 2004, the subject experienced sore throat and dysphagia and noted that his daughter had scarlet fever and strep throat approximately ten days earlier. On 20 April 2006 he developed aching in his groin that was possibly attributable to riding his bicycle. These events, and the events of suspected labyrinthitis, elevated ACE level and gastroesophageal reflux disease, were assessed to be incidental findings upon medical record review. Follow up information was received on 18 April 2008 via medical records. The subject was evaluated in a sleep disorder clinic on 03 November 2000 with complaints of sleep problems (insufficient and poor quality sleep), fatigue, and depression. He also admitted to some physiological hyperarousal with neck muscle tension, headaches, and overreacting to loud sounds, as well as some hyperarousal including worry. Impression was that "previous diagnoses that need to be considered in this current sleep presentation are chronic fatigue syndrome and dysthymic disorder". The sleep specialist also noted inadequate sleep hygiene with the patient spending "too much time in bed". Follow up information was received on 30 April 2008 via medical records. The subject presented for initial psychiatric evaluations on 03 and 17 September 2003 due to complaints including sleep problems, chronic illness, depression, and anxiety. He reported feeling fatigued since 1999 with trouble at work, nausea, severe headaches, and fever. He had previously received Celexa, and was on Zoloft at the time of examination. He described difficulty falling back to sleep, "brain fog", racing thoughts, increased anxiety, increased fatigue and decreased concentration, and reported that he had two "breakdowns" during business trips with a feeling of detachment and anxiety. The subject reported that his symptoms were only partially relieved by treatment for Lyme disease, and that his physician hypothesized that it was a possible reaction to LYMErix. Additionally, the subject described family and work stressors. Medications included Zoloft. Diagnoses included major depressive disorder (moderate), with notes to rule out hypochondriasis and/or obsessive compulsive disorder, and he was enrolled in regular psychotherapy sessions. On 03 December 2003, mood and functioning were improved, and he had reportedly discontinued Klonopin. By 14 January 2004, he reported that he continued to feel well with some occasional sleep disturbances. A follow up noted dated 27 April 2005 indicated that the subject was "feeling well" with good sleep, energy and appetite, increased weight, "adequate" libido, good functioning, euthymic mood, and no somatic concerns. He was released from psychiatric therapy at that time. The event of major depressive disorder was assessed to be medically significant by GSK.