Age: 63.0
Sex: F
Vaccine: LYME
Symptoms: Night sweats, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Pain, Paraesthesia
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with LYMERIX. 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 and muscle pain throughout her body, back pain, imbalance, cognitive deficiency, fatigue, flu-like symptoms, headaches, possible memory loss, possible neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events was unspecified. This information was received via Statement of Injuries. Follow-up information was received on 08 April 2009 via medical records. The subject was reportedly a "participant in the original Lyme vaccine study and was indeed vaccinated". In the summer of 1999, the subject tested positive for Lyme disease with back and joint pain, and received a three week course of doxycycline. Between August 1999 and September 1999, the subject developed low back pain, headache, severe neck pain, a "feeling she was not lifting her feet", and trouble concentrating with abrupt onset over a week. In August 1999, she also experienced balance problems, falling, and memory problems. She had a positive Lyme test and was felt to be hypothyroid, and felt "about 40 percent better" after doxycycline treatment. The subject was vaccinated with the "booster" dose of LYMERIX on 04 May 2000. The following day, 05 May 2000, the subject reportedly felt like she had been "hit by a truck" with generalized soreness and back pain. She also experienced balance difficulty and feeling ill. She also experienced night sweats, burning in extremities, and imbalance. Treatment included intravenous Rocephin and doxycycline. On 15 June 2000, electromyography/nerve conduction studies were performed due to peripheral neuropathy and revealed no abnormalities. She presented for evaluation with a neurologist on 26 July 2000, at which time she was noted to have a ten year history of memory loss which she associated with depression. Complaints included a one year history of burning feet, hands with cold and burning paresthesias, right grip weakness, and falling due to "legs giving out". Presentation was assessed as "most suggestive of probable subacute dementia of the Alzheimer's type and possible dyesthesias secondary to Lyme". On 30 August 2000, treatment with intravenous Rocephin was initiated followed by a substantial decrease in pain. She presented to another neurologist for a second opinion on 18 September 2000 and reported weakness and nausea, but noted that memory and concentration were better. Folstein Mini Mental Status test score was 28/30. The neurologist commented "I do find the diagnosis of Alzheimer's troubling in the sense that she has significant insight into her deficits", and further testing was advised. She underwent a neuropsychological evaluation on 13 October 2000, 14 October 2000, and 27 October 2000, resulting in an assessment that the subject was experiencing a mild decline in executive and overall intellectual functions, and was exhibiting depressive symptoms despite antidepressant therapy. She was described as having very mild cognitive deficits "consistent with those accompanying a moderate to severe depressive episode". Characteristics associated with an Alzheimer's type dementia were not present. She was followed regularly between November 2000 and September 2003 for Lyme disease symptoms including intermittent polyarthralgias, myalgias, intermittent distal dysesthesias, which had substantially improved on 08 January 2002. Treatment included amitriptyline, tetracycline, Elavil, and Vioxx. In May 2002, she was receiving Mepron and Zithromax and indicated an improvement in memory, polyarthralgias, and "haziness". In September 2003, the subject continued receiving Zithromax and Mepron due to increasing short term memory with central nervous system (CNS) Lyme disease. She also noted difficulty concentrating, difficulty focusing, and slowness of speech. The subject was followed by a neuropsychiatrist between January 1999 and September 2004 for complaints including "cerebral Lyme", joint and muscle pain, nausea, fatigue (prior to 1999, she was followed by the same neuropsychiatrist for depression from as early as 1992). She was treated with unspecified intravenous medications for Lyme disease. On 03 July 2001, the subject reported that her Lyme disease was "cured, but I am not well". This report was assessed to be medically significant based upon follow up information.