18 days post vax, the subject reported generalized joint pain with swelling and slight redness in the joints. She had trouble sleeping, but no rash, respiratory or gastrointestinal symptoms. She was seen in an ER and treated with ibuprofen and Naprosyn. The follow up states the subject had a history of typical expanding erythema chronicum migrans lesion on 6/7/96 for which she was treated with doxycycline 100mg twice daily for three weeks, successfully. The subject's previously participated in study, receiving LYMErix on 7/1/98, 8/6/98 and 7/1/99. On 10/16/99, the subject complained of joint pains, fatigue, and of "not feeling well" for "weeks or months." Examination revealed tender joints including both elbows, both wrists, multiple interphalangeal and metacarpal-phalangeal joints and both knees. Her left wrist was particularly tender and warm to the touch, although not swollen or red. Laboratory tests included a nmal erythrocyte sedimentation rate (ESR) of 14; a negative rheumatoid facotr. Antinuclear antibody (ANA) titer of 1:150 in a diffuse pattern, and a positive Lyme ELISA with a western blot consistent with prior immunization. Immunoglobulin G 31 and 41kD bands were present. There were two immunoglobulin bands of doubtful significance. The subject was treated with sulindac for symptomatic relief. The subject was seen by another physician for consultation. Further tests showed mild anemia, minor elevations of liver function tests AST, ALT and parovirus B19 titers, which revealed a positive IgG and negative IgM consistent with her prior hisotry of fifth disease. The sbuject received a booster dose of LYMEri on 5/27/00. On 6/14/00, 18 days after receiving the booster dose of study vaccine, the subject reported generalized joint pain with swelling and slight redness joints. She had trouble sleeping, but no rash, respiratory or gastrointestinal symptoms. She was seen in an ER, and was treated with Advil and Naprosyn. Lab results included an elevated ESH of 34, AST 223, ALT 386, LDL 262, negative rheumatoid factor, and ANA of 1:640 again in the diffuse pattern. A rheumatologist was consulted. Additional lab tests included ESA and EES, ENA with negative resutls. DNA antibody, both single and double was positive. The latter titer was greater than or equal to 1:3120. Total complement was87. The subject was treated with oral prednisone. The event had not resolved on 7/31/00. The investigator regarded this event as serious (OMIC) as it suggested a significant hanard, contraindication, side effect or precaution that may be associated withe the sue of the study vaccine. Per discussions with the investigator and the consulting physicians, the subject's current diagnosis was possible vaccine-related or vaccine-exacerbated lupus. The investigatro reported the events as possibly related to study vaccine. Analysis of frozen blood specimens drawn on 5/27/00, before the booster dose of LYMErix, showed elevated aspartate transaminase, increased DNA antibodies and decreased complement component CD4, gamma glutamyl transferase, lactic dehydrogenase, alanine transaminase and complement component C3 values were within reference ranges. Tests for antinuclear antibody and histone dimer autoantibody levels were not provided. Per follow-up info received on 2/15/01, the subject was progression well. Her symptoms were diminishing with prednisone and Flaquinil treatment. She was on a tapered dose of prednisone. She had no recurrence of pericarditis. Bloodwork on 1/4/01 showed low inflammation much lower ANA titer and continued high titers of anti-double stranded DNA. The last info received on 1/7/03. The outcome of the event was unknown at the time of this report as the subject had been lost to follow up.