Age: 60.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Pain, Polyarthritis
Clinical narrative: This report describes the occurrence of inflammatory polyarthritis in a 60 year old female who was vaccinated with Lyme disease vaccine recombinant OspA (Lymerix). This report was received as part of litigation proceedings, with forwarding of medical of medical records. The subject's past medical history included Lyme Disease (1991,1998), a neuroma of right foot third web space(1998), lower leg phlebite (1970), cellulitis of the right calf (07/08/98), acute gastritis and acute esophagitis (1998) and tennis elbow. Surgical history included a lumbar laminectomy (01/12/98) and a left thyroid lobectomy (1975). Concurrent medications included lasonoprazole (Prevacid) and levothyroxine (Synthroid). The subject received Lymerix on 04/24/99 (Ly104A2) and 05/24/99 (Ly123A2). In a Statement of Injuries, her attorney alleged that the vaccines "suffers from an inflammatory polyarthritis secondary to vaccination with Lymerix, which manifests itself in pain and arthralgias in multiple joints." The following information was obtained from medical records. from 07/98 to at least 04/24/00, the subject was under the care of an internist. The subject reported that she experienced arthalgias rarely in her thumbs, wrists and occassionally in her knees and ankles. She also reported that she noticed she was dropping items. Laboratory analyses performed on 03/21/00 indicated abnormal results. Bilateral hand X-rays performed on 03/23/00 indicated normal results. Please see the Laboratory Data section. A letter dated 04/24/00 from this internist written to another internist stated," (The subject) was diagnosed with Lyme disease in 10/91 on the basis of a clinical syndrome of arthralgias and a bordedrline Lyme AB by ELISA with a negative IGM ELISA. She was treated with antibiotics with resolution of her complaints. Her next Lyme test was done in 01/95 for complaints of fatigue that ultimately was attributed to a mildly hypothyroid state and resolved with adjustment of Synthyroid dose. Her Lyme ELISA at that time was negative... (the subject) was next examined for a "boil" on her leg. On physical exam surrounding erythema chronica migranes were noted and she was started on Amoxicillin 500 tid (three times a day) for three weeks. Given history of previous positive Lyme test, no initial serology was done. (The subject) had worsening erythema concistent with cellulitis despite the dose of cefazolin (Ancef) 2 grams IVP (intravenou push)given in the office. There was prompt and complete resolution of her cellulitis of her cellulitis and the Augmentin and Probenicid was continued to complete a 3-week course. A follow-up Lyme by Western blot was obtained which was  strongly positive with multiple IgM and IgGbands. No ELISA was obtained at that time. (The subject) received two dosed (sic) of Lymrex (sic), specifically on 04/23/99 and 05/24/99 without significant reaction. (The subject again presented 03/21/00 with complaints of arthralgia of thumb and wrists bilaterally. There was intermittent knee and ankle pain.. (The subject) was screened for HLA-DR4 which was positive In review I have to question the initial diagnosis of Lyme in the absence of a high titer or follow up serology.  Her symptoms now raise the question active Lyme, reactivation of previously dormant Lyme or an unspecified autoimmune/immune complex disease. A post-Lyme and/or vaccine related autoimmune processmust be considered. Given her previous similar symptoms dating prior to a well documented Lyme infection or her vaccination, I feel this is less likely". From 04/23/01 to at least 05/02, the subject was under the care of a second internist. The subject reported that she was diagnosed with Lyme disease 12 years previously with some associated joint pain. She was treated with several weeks of antibiotics. She recalled another tick bite in 1998. It was noted that she had BCM with a superinfected staph infection and she was treated with Amoxicillin and Probencid. She was switched to amoxicillin/potassium clavulance (Augmentin) when she tested positive for Lyme disease. The subject reported that she experienced terrible hand pain,left greater than right, severe pain at base, knees and back pain shortly after receiving Lymerix. It was noted that she had neuropathy in her right foot. On physical examination, the physicians noted, "no joint swelling, no diffiulty concentrating, occassional left shoulder pain, easy bruising, toe numbness, but this was side effect from herniated disc. Symptoms started only 6 months. paresthesia, osteoporosis... hands very painful". The results of a bone scan and a left hand x-ray performed on 05/03/01 were abnormal (Please see Laboratory Data section.) A diagnosis of inflammatory arthritis questionably secondary related to Lyme vaccine was recorded. The physician prescribed hydrochlorquine (Plaquenil) and capsacin (Zostrix)and glucosamine with chondroitin. As or 05/02, the subject reported her left hand was very painful. from 10/70 to at least 04/24/02, the subject was under the care of her gynecologist. The subject reported that she experienced a sore right thumb with swelling (03/11/86), elbow and shoulder problems in 1995 for which she was treated with a muscle relaxant for and arthritis secondary to Lyme disease vaccine (date). The results of bone density scans performed on 06/17/96 and 09/14/99 indicated both normal and abnormal results.(Please see Laboratory Data section.) On 11/27/00, the subject was seen by a surgeon for ecchymosis and hematoma of the medical aspect of the right knee. He assessed this event as "unrelated to Evita-probably related to Vitamin E" and recommended. The most recent information received on 06/11/02 indicated the polyarthritis persisted as of 05/02. The adverse event "inflammatory polyarthritis" does not meet ICH serious criteria, but it being submitted as an expedited reportby special FDA request per the 06/28/00 letter.