Age: 37.0
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Hallucination, auditory, Hallucination, visual, Infection, Laboratory test abnormal
Clinical narrative: Report A0359048A describes Lyme disease in a 37 year old female who received Lyme disease vaccine recombinant OspA. This report was received from the vaccinee and has not been verified by a physician or other healthcare professional. The medical history included allergy to Paxil and Lamictal, manisfested by a "severe" rash. The vaccinee had a "long history" of bipolar disorder requiring hospitalizations for periods from three days to two weeks, sometimes as frequently as every six months, since 1993. She also had anxiety and insomnia. As of 2/1/02, she was being tested for hypertension. She had arthritis with aching knees since age 20. The vaccinee stated that she had no history of gout, psoriasis, or Crohn's disease. There was no family history of lupus. Reportedly, her paternal grandfather and his seven sisters had an unspecified form of arthritis. Concurrent medications included lithium and phenilzine sulfate (Nardil) for treatment of bipolar disorder, Valium for treatment of anxiety, and Ambien for treatment of insomnia. In April 2000, the vaccinee reportedly received her first injection of LYMErix without adverse event. The vaccinee stated that in June 2000, she received her second injection of LYMErix. She reported that, on 7/5/00, she experienced auditory and visual hallucinations. She was hospitalzied on 7/5/00 or 7/6/00. It was reported that her hospitalization lasted three months. The vaccinee stated that by November 2000, she experienced exhaustion, blurred vision, muscle pains, irregular sleep patterns (she sometimes was only able to sleep one to two hours in a three-day period), irregular menses cycle (every two weeks), and unstable blood pressure (varied from "very low to very high.") She also reported that she developed "high" white blood cell counts. She stated that she was tested for Lyme disease by her psychiatrist in January 2001, and the test was "positive." She was seen by an infectious disease specialist in March 2001. On 3/14/01, Lyme total antibodies by ELISA were elevated. Lyme IgG Western blot reportedly demonstrated a 30kD band. A diagnosis of Lyme disease was reportedly made, and the vaccinee was treated with IV Rocephin for one month beginning in March 2001. On 4/3/01, Lyme IgG Western blot again reportedly demonstrated a 30 kD band. An unspecified test for syphilis was "mildly reactive." Rheumatoid factor and an unspecified anti-DNA test were "negative." On an unspecified date in 2001, Lyme IgG and IgM Western blots each demonstrated a 41KD band. She reported that she was tested for cat scratch fever on an unspecified date in 2001. B. henselae IgG was "256" and B. quintona IgG was "256." On 1/18/02, Lyme IgG Western blot demonstrated 30 and 41kD bands. At that time, she reportedly was told that she did not have Lyme disease. The vaccinee stated that it "has been impossible" for her to work since receiving LYMERix injections. As of 2/1/02, the outcomes of the events were unknown. She reportedly did not have Lyme disease, but was still unable to work. The vaccinee declined to grant authorization for manufacturer to contact her physicians. Therefore, no further info will be available.