Age: 42.0
Sex: F
Vaccine: LYME
Symptoms: Rheumatoid factor, Rhinitis, Vertigo
Clinical narrative: Report 2001010763-1 describes tingling and joint swelling in a 42 year old female who received Lyme disease vaccine recombinant OspA (Lymerix). This report was received from the patient and has not been verified by a physician or other health care professional. The patient has no known drug allergies. There were no concurrent medications. She has no history of gout, psoriasis, or Crohn's disease. She has no family history of rheumatoid arthritis or systemic lupus erythematosus. The patient is an avid hiker. She reported that she removed three or four ticks from her legs in 1999. Within hours of removing the ticks, she developed two bull's eye rashes on her right leg, one bull's eye rash  on her left leg, and flu-like symptoms. She contacted her physician, who made a diagnosis of Lyme disease and prescribed "high doses of antibiotics." The patient was not seen by the physician, and no diagnostic evaluation was performed. The patient's symptoms resolved. Subsequently, the patient self-administered three doses of Lymerix on unspecified dates. In November 2000, she began to notice tingling of both arms and hands, which then became numb. She also developed "edema in all digits' and pain and swelling of both knees. She was referred to a rheumatologist in January 2001. The rheumatologist reportedly noted edema of the hands and fluid in the patient's right knee. No joint fluid was obtained. None of the patient's joint's were red or warm. The patient reported that erythrocyte sedimentation rate (ESR), antinuclear antibody (ANA) titer, and C-reactive protein (CRP) were measured on an unspecified date; results were not provided. Rheumatoid factor was reportedly measured on different occasions; the patient stated, 'Rheumatoid showed up low and sometimes did not show up at all". As of 04/26/01, the patient stated that she had swelling in both hips and both knees. She reported that her joint pain had worsened. Treatment of the joint pain and swelling was not specified. The treatment and outcome of the tingling, numbness, and edema of the digits were not specified. The adverse events of tingling, numbness, knee pain, and joint swelling do not meet ICM serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Additional info was received from the vaccine provider on 11/14/2001. The pt first presented to the vaccine provider on 12/29/2000 with chief complaints of numbness of both hands and arms and dizziness. The pt reported that the numbness began two weeks prior to the office visit, occurred while sleeping, and was aggravated by driving. She reported that the dizziness began on the morning of 12/28/2000. She characterized the dizziness as "mild." It was aggravated by movement and relieved by Antivert. At the time of the office visit, the pt was taking Celexa daily for an unspecified indication and Antivert four times daily as needed to relieve dizziness. On review of systems, the pt reported rhinits. On physical examination, her tympanic membranes were intact and there was no postnasal drip. The physical examination was normal. The physician's assessment was "vertigo, numbness." The physician prescribed Aleva and Claritin-D. The pt presented to the vaccine provider on 01/08/2001 with complaints of hand numbness and joint pain and stiffness. The affected joints were not specified. The pt reported that the joint pain and stiffness began two weeks prior to the office visit. She described the joint pain and stiffness as "moderate" and aggravated by changing position and standing. Under review of systems, the physician noted that the pt "denies joint or tingling." On physical examination, no abnormalities were noted. Specifically, no swelling or redness of joints or digits was noted. No tenderness was noted on palpation of any jont or digit. The physician's assessment was "arthralgia." He discontinued therapy with Aleva and dyazide, and prescribed Vioxx. The pt was seen by the vaccine provider on 05/02/2001. At that time, she complained of "severe" joint pain and was concerned about Lyme disease. She reported that Vioxx did not provide any relief for the joint pain. The physician's assessment was "arthralgia, unchanged." The vaccine provider referred the pt to an infectious disease specialist. The most recent info received from the vaccine provider on 11/14/2001, indicated that the arthralgia persisted as of 05/02/2001. Outcomes of the tingling, numbness, edema in the digits, joint swelling and stiffness, and vertigo were not provided. The adverse events of tingling, numbness, vertigo, arthralgia, joint swelling, and joint stiffness do not meet serious criteria, but are being submitted as an expedited report.