Age: 63.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Arthralgia, Fatigue, Headache, Insomnia, Laboratory test abnormal
Clinical narrative: Three days post 3rd dose of vax, the vaccinee reported that every bone and muscle in her body ached, she had a headache, a stiff neck, fever, and was sleeping no more than three hours at a time. She was seen by physician and treated with ibuprofen. Patient records indicate that patient was seen on 22 May 2000 to have her arm checked. Afer the injection of LYMErix, her arm became swollen, tender and somewhat inflamed and red. She also reported feeling fatigued and "felt like she has her symptoms of Lyme disease coming back again." On examination, patient's arm had a little are of erythema at the injection site but "no true Lyme rash" was noted. Patient had an itchy rash on her shin but it was noted that it in no way resembled " a Lyme borreliosis type rash" . Patient was treated for Lyme (NOS) and treated with ibuprofen. Patient again had a doctor visit on 31 May 2000 complaining of arthralgias and myalgias. Her injection site was unremarkable. Her shoulder joints and upper extremitiy joints did not revela any acute inflammation but they were very tender and the muscles across her back and neck were tender to touch. Assessment was that patient had arthralgias and myalgias occurring within 3 to  days after the Lyme vaccine which were quite severe. Patient was very tearful and uncomfortable. Plan was to treat pain with hydrocodone/acetaminophen (Vicodin) and methylprednisolone (Medrol) 12 mg for one week. Laboratory work was performed for sedimentation rate. CBC, FANA (results not provided), C-reactive protein and rheumatoid factor. Physician noted that the reaction "could represent some type of allergice reaction or sensitivity to the vaccine itself." Assessment of events was to be re-evaluated after laboratory results were available. Patient reported that a "blood test for Lyme disease" was performed on 22 May 2000 and yielded "positive results for Lyme disease." Subsequently a culture for Lyme disease performed a week later was "false positive" which meant "she had a reaction to Lymerix". The physician provided the following laboratory test results: 22-May-2000 Lyme Western blot IgG (unable to get results due to staining). Lyme Western blot IgM was negative. Lyme HIA (eryme immunoassay) polyv impression positive: 31-May-200 ANA (antinuclear antibody) was negative, RA (Rhematoid arthritis factor) Quant <20 IU/ml (reference range: 0-20 IU/ml). C-reactive protein 0.5 mg/dl  03-Jul-2000 HLA (Human Leukocyte Antigen) Dr4 not present. DRB1*03, DRB1*15 present. Lyme Western blot, IgG impression positive. Diagnosis has not clearly been made. The patient continues to have arthralgias and weakness. Currently the treatment has been limited toward symptomatic managment. According to the physician, the patient has improved slightly in this time. On 03 September 2003, the patient's attorney alleged that the patient "suffered joint pain, fatigue, rashes, tingling, headache, migraine headaches. The onset of her symptoms is not clear at this time." Treatment of the alleged events was not reported. Arthralgia and weakness persisted as o 06 Septembe 2000. The outcome of the other adverse events was unknown. The most recent information, received on 03 September 2003, did not provide th outcome of the reported events.