Age: 65.0
Sex: F
Vaccine: LYME
Symptoms: Autoimmune disorder, Back pain, Blood uric acid normal, Borrelia burgdorferi serology negative, Chest pain
Clinical narrative: Report 2001013036-1 described weakness of the upper arms and lower legs in a 66-year-old female who received LYMERIX  for the prevention of Lyme disease. This report was received from the vaccinee and has been confirmed by a physician. The vaccinee's allergies were not specified. Her medical history included left knee meniscal tear with surgical repair in March, 2001. She had a left Baker's cyst which was injected with cortisone on 19 December 2000. She received BAYCOL, PRAVACHOL and NIACIN. The vaccinee did not have gout, psoriasis or Crohn's disease. She did not have a history of Lyme disease. There was no family history of rheumatoid arthritis or lupus. There was no illness at the time of vaccination. On 25 January 1999, the vaccinee received her first dose of LYMERIX. A "few" days later she "felt like crap". This feeling resolved. She then became familiar with a literature article. On 24 February 1999, the vaccinee received her second dose of LYMERIX. No adverse events occurred. Starting "[the] past winter", she began experiencing bilateral upper arm weakness, pain in back of knees with weakness, general weakness from knees to ankles with "tender spots", constipation, and diarrhea. She denied joint pain, but felt that her pain was "more in the muscle tissues." On 20 March 2000, the vaccinee received her third dose of LYMERIX. On 20 March 2000, she started complaining of nocturnal leg pain, which she attributed to PRAVACHOL. On 22 Mar 2000, she was switched to BAYCOL. On 30 Mar 2000, she discontinued BAYCOL because of the nocturnal leg pain, now with aching arms and thighs and shortness of breath. On 19 December 2000, the vaccinee was seen by the physician. The patient complained of aches "all over", especially in her left leg. She "was unable to do her normal activities". A Baker's cyst had been injected with cortisone by a rheumatologist, providing only two days relief. Tests [NOS] which required intravenous contrast were performed, and her right arm has hurt ever since. The patient was told that she had uric acid crystals in her urine, but her serum uric acid was normal at 6.0 mg/dl. She started to receive NIACIN OTC (over-the-counter). On 30 January 2001 her pain was mostly in her upper arms. She was receiving VIOXX and was started back on PRAVACHOL. She complained of muscle swelling and leg edema so the physician did a trial off the medication; she felt no better, and it was re-started. On 03 May 2001, the patient expressed concern that her symptoms were a reaction to LYMERIX. On 08 June 2001, she was seen by the physician. The patient wondered if her SYNTHROID might be the "culprit". The physician stated that the adverse events listed in this report could be associated with PRAVACHOL, BAYCOL, cortisone, intravenous contrast, and NIACIN. Her joint complaints were evaluated by a physician. No swollen or warm joints were noted on physical exam and no joint fluid was obtained. On 19 December 2000 the following lab work was performed: rheumatoid factor 10 (units and reference range were unspecified); anti-nuclear antibodies (ANA) 1:80 (homogeneous pattern). Please note that the event of uric acid crystals in the urine was not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's medical records. The reporting physician stated that the migrating arthralgias were moderate in severity and were possibly related to LYMERIX. As of 20 June 2001, the migrating arthralgias were ongoing. The adverse events of 'upper arm weakness' 'migrating arthralgias' and 'leg weakness' do not meet serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 200 letter. Additional information was received from the subject's lawyer, on 03 April 2006, in the form of a statement of injuries. The statement of injuries indicated that the subject experienced joint pain, flu-like symptoms, headaches, fatigue, rashes, possible memory loss, and decreased activities of daily life. The subject also experienced rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism. The statement of injuries claimed that all of these events were caused by vaccination with LYMERIX. Follow up information was received on 08 August 2008 via medical records. As early as 1993, the subject was diagnosed with osteoarthritis. In October 1994, she was evaluated for a history of migratory arthralgias and arthritis, possible seronegative rheumatoid arthritis. History also included leg cramps associated with LIPITOR and another unspecified cholesterol medication. On 19 October 2000, the subject complained of joint pain at the back of the left knee. Some uric acid crystals were noted on urinalysis, and she was diagnosed with a probable Baker's cyst. In early 2001, the subject started VIOXX for arthritis (unknown if this was an exacerbation of pre-existing osteoarthritis). On 29 March 2001, she underwent an arthroscopic procedure with medial and lateral meniscectomy and debridement of the patellofemoral joint. On 26 April 2001 she was evaluated by her orthopedist following acute right shoulder injury, and the physician expressed concern "that she may have a rotator cuff, acute or chronic". A rotator cuff tear was confirmed in June 2001, and she underwent "massive" rotator cuff repair on 02 July 2001. On 16 January 2002, she presented with increased left knee pain and achiness with some swelling, and diagnostic findings included some degenerative changes to the patellofemoral joint. Strengthening exercises, knee support, and anti-inflammatories were recommended. The events of shoulder injury/rotator cuff tear with surgical intervention and Baker's cyst were assessed to be incidental findings upon medical record review. Follow-up information in the form of medical records was received on 08 September 2008. An evaluation back in June of 2006 indicated that the subject was suffering from limb pain and tenosynovitis of the foot and ankle. Both incidental findings identified during review of medical records. The conditions reportedly existed for an extended duration. Other incidental findings were posterior tibial tendinitisi left noted on 07 February 2007 and again on 15 May 2007 with an added finding of dermatitis left. The dermatitis continued on 30 May 2007. A CT scan of the hip performed on 01 February 2007 diagnosed mild degenerative arthritis. There were no specific details regarding the claimed events. Follow up information was received on 06 October 2008 via medical records. In November 2005, the subject was evaluated for Lyme disease. On 06 December 2005, physician's notes indicated a history of Lyme disease, "likely lupus having caused aches and pains". On 13 February 2006 she was evaluated for low back pain that was "ongoing for at least two years" with radiculopathy. Treatment included ULTRAM. On 09 May 2006, low back pain was stable and she complained of a couple of headaches. On 28 September 2006, complaints included legs and back pain of several months duration, as well as fatigue and chest pain. In December 2006 the subject presented with fatigue and myalgias, in addition to gastroenteritis. On 11 January 2007, the subject experienced leg pain throughout the day, but reported that she "feels great". In August 2008, the subject was evaluated for joint pain (knee, ankle). Based upon the follow-up event of possible lupus, this case was assessed to be medically significant by GSK.