Age: 32.0
Sex: F
Vaccine: LYME
Symptoms: Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Pain, Paraesthesia, Sleep disorder
Clinical narrative: This case was reported by a lawyer and describes the occurrence of peripheral neuropathy in a 41year old female patient who received Lyme disease vaccine recombinant OspA (LYMErix) injection for prophyalxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received LYMErix. At an unknown time after receiving LYMErix, the patient experienced " peripheral neuropathy, secondary to GI problems, memory loss, and severe back and neck pain". Time to onset, treatment and outcome were not reported. Follow up information was received on 02 March 2009 via information obtained form an interview between the subject and attorneys. The subject received the first dose of LYMERIX in March 1995, and the second dose and third doses of LYMERIX also in 1995, as part of a clinical study. In 1996, the subject developed joint inflammation and pain. In 1997 or 1998, she experienced night sweats which resolved in 2003 or 2004. In 1998 or 1999, she developed fatigue and malaise. In 1998 or 1999 she also developed a sleep disturbance that resolved in 2004 or 2005. In 1999 or 2000, she developed neuropathy in her feet, shooting pain, and nerve pain. In 2001 or 2002, she developed speech "issues", memory issues, and signs of dyslexia. She stated that a brain scan showed white matter lesions. She reported that she no longer had memory issues, that dyslexia issues were "rare", and that her speech issues resolved around 2004 to 2005. Treatment included chiropractice therapy, Trazodone, antidepressants, antibiotics, PLAQUENIL, NEURONTIN, BEXTRA, and anti-inflammatories including nonsteroidal anti-inflammatory medications (NSAIDS). This case was assessed by GSK to be medically significant based upon follow up information, with the exception of sleep disturbance, speech and memory issues, and night sweats, the events were unresolved at the time of this report. Follow up information was received on 18 March 2009 via study records. The subject was initially enrolled in protocol. The subject received LYMERIX vaccine administered on 09 February 1995, 28 March 1995, and 09 March 1996, on 28 February 1995, the subject developed moderate shoulder pain assessed to be possibly related to study vaccine that resolved with sequelae on 09 March 1995. On 28 February 1995, she developed headache assessed to be possibly related to study vaccine that resolved on 02 March 1995. On 30 July 1995, she developed left wrist tenderness assessed to be possibly related to study vaccine that resolved. On 11 March 1995, she developed intermittent shoulder pain assessed to be possibly related to study vaccine that resolved on 13 March 1995. On 04 April 1995 she developed intermittent shoulder pain assessed to be possibly related to study vaccine that resolved on 05 April 1995. Shoulder pain was treated with ADVIL. She was subsequently enrolled in studies. There were no adverse events found or reported upon postcard follow-up. Follow-up information was received on 25 March 2009 in the form of medical records. The subject was seen for a physical therapy evaluation for the treatment of a thoracic strain on 09 November 1998. The subject presented with findings of soft tissue density of the left thoracic paravertebral muscles, rotations of the midthoracic vertebrae, and decreased thoracic spine ROM. The subject was evaluated on 22 December 1998 following physical therapy treatments secondary to thoracic spine strain. The subject original complaints of a sharp pain in the left rib cage during inhalation and exhalation were no longer present. The subject did complain of a fatigued feeling of the thoracic muscles after a full day of working, however, the statement was made that this had improved and the subject felt it would continue to improve. It was reported that the subject had achieved her goals as originally stated in initial evaluation back on 09 November 1998. The subject was examined on 06 December 2000 for question of Lyme disease. The subject had a history of symptoms extending over 2 and a half to three years. The subject received Lyme vaccine in her past and did have a high probability for Lyme exposure. The subject additionally has suffered from endometriosis. She had an extensive travel history all over including spending a considerable amount of time in the southwest. Also mentioned were the subjects excessive night sweats. The subject was seen in evaluation on 10 January 2001 for her symptoms following vaccination with LYMERIX. The physician was trying to determine if the subject was suffering from Lyme disease, from the vaccine or a combination of the two. There was no clear explanation following evaluation. Evaluation continued on 28 April 2001. At that time, the subject complained of the following symptoms: sever fatigue, drenching sweats, atopic dermatitis from chemical exposure at work, occasional blurring of vision, frequent aphthous ulcers, dyspnea, occasional palpitations, IBS with menses, menstrual irregularity, increased PMS, severe neck and back pain, arthralgias of her knees, shoulders, neck and back, myalgias, mild tingling of the right hand and paresthesias of the right arm. Cognitive issues included short term memory loss, difficulty with word finding, losing her way in familiar places, mood swings and depression. The conditions were not specifically indicated as having a relationship to Lyme vaccine and therefore were not documented as events at this time. A follow-up exam on 17 November 2001 determined that the subject was suffering from Lyme disease. She had taken treatment with BIAXIN and PLAQUENIL and felt that after a few weeks most of her symptoms remarkably disappeared. The subject had improved on treatment. Treatment with NEURONTIN 500mg daily to twice daily was started. The subject was next seen on 23 March 2002. At that time, her condition was still controlled with BIAXIN, PLAQUENIL and NEURONTIN treatment, however, she reported some new problems possibly related to her treatment regimen. She complained of headaches radiating up from the neck, muscle fatigue, some trembling, and some night sweats. ZOLOFT was mentioned as a treatment and the subject was started on doxycycline. The subject was back for a follow-up visit on 13 July 2002. She discontinued the doxycycline as she felt it made her symptoms worse. Then she reported that her gastrointestinal tract was a problem, mostly with diarrhea. She complained of more paresthesias in her hands, more tremors, but few night sweats. She felt that her memory was improved. She mostly complained of pain and numbness. The subject was changed over to CEFTIN, 500mg twice daily and was also given some ULTRAM, 50mg once or twice daily. The subject was evaluated on 27 September 2002 due to chronic Lyme disease. At that time, she complained of difficulty with concentration and with dyslexia. She complained of numbness and tingling in her hands and feet, muscle fatigue and muscle tremors, pain in both feet and the thoracic spine region. She complained of focal weakness and night sweats. Medications included MIRCETTE and ULTRAM. Follow-up in October 2007 indicates that the subject continued to have complaints of pain in her neck, back and feet. Pain was described as a dull ache. She also noted stiffness in the morning. The subject was evaluated on 09 April 2003 following treatment for presumed Lyme disease. She reported that malaise and night sweats were resolved. She complained of pain in her back and her feet, headaches related to her back pain, numbness and tingling in her feet and generalized weakness. The subject had a follow-up visit on 28 July 2003. She reported that her neuropathy had improved. She complained that her feet still ache. Recent developments included joint swelling including the knees, shoulders and feet. She was treated with a course of steroids which improved her symptoms significantly. Current medications included PLAQUENIL, oral contraceptive, ibuprofen and VICODIN. Follow-up information was received on 24 April 2009 via medical records. Records included a series of quick evaluations dating from May 1998 through May of 2005. Numerous complaints were made over this time period and not all of the complaints were related to claimed events or to treatment with Lyme vaccine. The subject developed flu symptoms in February of 2001 and was diagnosed with a viral syndrome. On 29 September 2002, the subject was evaluated with complaints of night sweats, sleep disorder, right foot pain and headache. Neurological exam was planned to rule out chronic CNS Lyme. The subject was taking Trazodone. In early April 2003, the subject was seen for continuing symptoms. She complained of back and neck pain and chronic Lyme symptoms. In May 2003, the subject complained of chronic pain. The subject received VICODIN. The subject was seen on 25 June 2003 with polyarthritis. She noted swelling and pain in her knees, back and shoulders. She was sleeping better. She reported recurrent paresthesia pain in the right wrist and thumb. She was no MEDROL Dosepack. In August 2003, the subject continued to have back pain and reported sleep problems. She was taking Trazodone. Problems of back pain and autoimmune arthritis continued on 03 October 2004. The subject was taking VICODIN and BEXTRA in February 2004 for persistent symptoms of pain including recurrent foot pain. She also mentioned night sweats, sleep disorder and paresthesias. In March, foot pain was better, but throbbing back pain continued. On 29 April 2004, the subject reported back spasms resulting in pain and Lyme disease symptoms, but sleep had improved. On 14 August 2004, the subject made a report of pain between her chest and her back. On 18 August 2004 the subject reported epigastric pain with nausea. Symptoms persisted on 24 August 2004. A statement of injuries was received on 05 June 2009 via a lawyer and described the occurrence of joint pain in an adult female subject who was vaccinated with LYMERIX (GlaxoSmithKline). The statement indicated that on an unspecified date the subject received LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, joint swelling, muscle pain, muscle weakness, fatigue, memory loss, decreased activities of daily life, tingling in her extremities, cognitive problems, sleep disorder, night sweats, throbbing pain in the back and neck and neurological injuries, as well as "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX". At the time of reporting the outcome of the events was unspecified.