Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Pain in extremity, Rash, Red blood cell sedimentation rate increased, Red blood cell sedimentation rate normal, Renal cyst
Clinical narrative: This case was reported by a  lawyer and described the occurrence of memory loss in a male subject of unspecified age who was vaccinated with LYMErix 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 memory loss, headaches, joint pain and swelling, flu-like symptoms, fatigue, decreased activities of daily life, rashes, gastrointestinal disorders, cognitive dysfunction, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-medicated, or other mechanism. 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 reported this case via the Vaccine Adverse Event Reporting System (VAERS # 176140). The subject was a 60-year-old male who was vaccinated with Lymerix for prophylaxis. The subject's medical history included back pain, Bell's palsy, benign prostate hypertrophy, chronic obstructive pulmonary disease, depression, hypertension, chronic lyme disease with positive Lyme titer, and motor vehicle accident resulting in a whiplash injury. He reportedly lived in a wooded area and experienced multiple tick bites. Concurrent medications included Zinc salt, Prozac, and Hytrin. In 1999 the subject received 1st dose and 2nd dose of Lymerix (unknown). The subject received the first LYMErix vaccine prior to 18 May 1999, and the second LYMErix vaccine between 18 May 1999 and 15 July 1999 (dates of vaccination illegible on medical records provided). On 09 November 1999, the subject complained of a one year history of left shoulder pain and one week history of dizziness. Assessment on that date was degenerative joint disease of the shoulder. Later the same month. November 1999, the subject continued to experienced painful joints with use and while sleeping, and examination revealed crepitation in the shoulders and knees. Assessment included degenerative joint disease of the shoulders and knees. By March 2000, he reported a two week history of knee pain. In May 2000, he received his third LYMErix vaccine, and he subsequently experienced fatigue and weight loss. He continued to experience joint problems through October 2001, when Celebrex was initiated. He was later placed on Relafen. Between November 1999 and 07 June 2001, orthopedic evaluations revealed degenerative joint disease of the left shoulder and left knee, rotator cuff tear, impingement and osteophytosis of the left shoulder, right lumbar radiculopathy, left shoulder impingement, internal derangement (left knee) with complex meniscal tear, osteonecrosis, and degenerative joint disease. On 12 February 2002, the subject presented for a rheumatologic consultation due to pain in shoulders, pain in left foot, morning stiffness with pain worsening throughout the day, and "Lyme disease". On 10 July 2002, the subject was evaluated by an orthopedist for persistent low back pain with right lumbar radiculopathy, in addition to persistent left shoulder and left knee pain. Assessment included impingement of the left shoulder, internal derangement of the left knee with osteonecrosis and degenerative joint disease, right lumbar radiculopathy, and carpal tunnel syndrome. On 15 September 2004, the subject stated that "Lyme has returned", and complained of pain in joints, headaches, and blurry vision. Testing for Lyme by Western Blot was positive for IgG antibodies and negative for IgM antibodies. On 25 October 2004, the subject was seen for an infections disease consultation with questions regarding "changing Lyme serologies". He complained of chronic Lyme disease with numerous joint pains, Gradually deteriorating memory, deteriorating vision, weight loss, and fatigue. He denied headaches, neuropathy, recent Bell's palsy, or acute inflammatory arthritic changes. He was significant for arthritis (date of onset not provided). The consulting physician mentioned the possibility of autoimmune disease and recommended a rheumatologic evaluation for assessment of positive rheumatoid factor. Assessment was that there was J"no indication for treatment of Lyme disease at this time." On an unknown date, doxycycline therapy was initiated. The subject discontinued doxycycline in 2005, but stated that he still felt sick. ON 11 January 2007, progress notes indicated that the subject complained of knee pain for years "but worse (for) two months." This case was assessed by GSK to be medically significant based upon follow up information. According to records, the subject experienced recurrent dizziness associated with blood pressure medications/history of hypertension. The subject reported that he did not take antihypertensive medications regularly, He was hospitalized for 20 January 2001 to  21 January 2001 for observation due to chest pain. In April 2005, the subject reported weakness, headache, and runny nose which reportedly began shortly after receiving Rabies vaccine following a bat bite. On 01 December 2006 an ultrasound showed a kidney cyst to which back pain was attributed. These were considered to be incidental findings upon medical record review.