Age: 38.0
Sex: F
Vaccine: LYME
Symptoms: Anorexia, Arthralgia, Balance disorder, Headache, Injection site erythema
Clinical narrative: On 5/28/00 or in June, 2000, the pt had her first dose of Lymerix. Within hours, post vax, she noted pain at injection site. The next day, she noted a 5cm X 10cm area of erythema, swelling, induration and tenderness around the injection site. There were a vague febrile sensation. The injection site symptoms persisted for about 7-10 days. During the last 1-2 days of this local site reaction, she had bilateral ankle pain and stiffness which resolved in a day or two. There may have been mild nausea during this period. On the day she returned to work, she reported nausea, anorexia, headache, photophobia and arthralgias. Joint swelling or erythema was not reported. These symptoms waxed and waned, but never completely disappeared. On 7/24/00, the pt presented to her PMD. He examined her (results unavailable). The pt was prescribed NSAIDS and instructed to return as needed. On 8/8/00, the symptoms were worse; headache had become more severe and persistent and a feeling of "unsteadiness" with fast movement. She was referred to reporting MD and his differential dx included a possible vax reaction and aseptic meningitis. He has prognosis for recovery to be excellent. He has advised against a 2nd dose of Lymerix. As of 8/18/00, the outcome of the event is improving.  Follow up on 03/15/2001: "The patient has no allergies and was taking no concurrent medications.  She was "basically healthy" per the physician.  The day of the vaccination, the patient reportedly experienced pain and a moderate rash at the injection site.  The physician reported that she also developed mild ankle pain, swelling, and stiffness that began on the day of immunization and resolved by 05/30/2000.  The injection site reaction persisted until 06/06/2000. The physician reported that on 06/15/2000, the patient developed sinusitis pain and a "syndrome typical of aseptic meningitis"; these were of moderate intensity.  On 07/24/2000, symptoms included intermittent nausea, anorexia, headache, photophobia, asthenia, tiredness, occasional fevers.  Cytomegalovirus IgM Titer was negative.  Epstein-Barr virus titer indicative of "past infection", and negative antinuclear antibody titer.  The vaccinee was prescribed doxycycline (07/28/2000-08/11/2000). Sinus x-rays were interpreted as normal.  The physician prescribed azithromycin on 08/11/2000.  The vaccinee's symptoms continued to wax and wane into 10/2000.  The vaccinee was referred to a neurologist on 10/31/2000.  The reporting physician did not have information regarding the outcome of this referral. However, on 03/07/2001, the physician indicated that the injection site rash was related to LYMErix administration, and the ankle pain and swelling, sinisitis pain, and "syndrome typical of aseptic meningitis" were possibly related to LYMErix administration.  The most recent information received on 03/07/2001, reported the outcome of the events as resolved..  Ankle swelling and "syndrome typical of sceptic meningitis" do not meet ICH serious criteria, but are being submitted as an expedited report by special request."