Age: 66.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Asthenia, Headache, Night sweats, Nightmare
Clinical narrative: This report described the occurrence of Lyme disease in a 65 year old female patient who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, and has been verified through medical treatment records received through the litigation process subsequently. The patient submitted a report directly to VAERS. According to the VAERS form completed by the patient, she had no pre-existing physician-diagnosed allergies, birth defects, or medical conditions. However, she indicated that concurrent medications included doxycyline, celecoxib, and valdecoxib. The patient reported that she had a tick bite at the time that one of the doses of Lymerix was administered. On a VAERS form completed by the patient on 11/15/02, she indicated that she received three injections of Lymerix on unspecified dates in 2001. The patient indicated that her adverse experience began in 2002. For the description of the event, she wrote, "Swollen wrist - arthritic like pain in entire wrist, arm, elbow, (right hand). Unable to use right hand and arm." She reported that unspecified blood tests were performed on 9/23/2 and 9/30/02; she did not provide the results of those tests. She indicated that the events were persisting. On 9/3/03, the patient's attorney alleged that the patient suffered right arm, hand and leg pain. The onset of her symptoms is not clear at this time. Treatment and outcome of the alleged events were not reported. Medical treatment records received documenting treatment that the patient received from a physician specializing in Infectious Disease provided the following additional information: Infectious Disease Specialist's note dated 3/12/03 indicated that the patient was being seen for further evaluation and management of possible Lyme disease. The following details were provided and noted to be inconsistent with information previously provided by the patient: The patient experienced a tick bite, from what she thought to be a dog tick, on her lower right back in the late 1990's. She experienced a circular rash which was not treated with any antibiotic at that time. The patient had received the Lyme disease vaccine series in 1999, in three doses over a six month period of time. She did experience some transient elbow achiness after the second and third doses, but remained well until July 2002, when she experienced another tick bite in the right side of her back that again developed a rash. She began to experience problems with weakness in her right hand and her wrist and her left hand became suddenly swollen without explanation. Blood count and sedimentation rate were normal. She was seen by Rheumatology and was treated with celecoxib, then steroid tablets, then meloxicam. Sedimentation rates, rheumatoid titers and ANA tests were negative. On 11/29/02, the patient had a positive Lyme titer and a Western Blot showed an IgM reaction to the 23-KD protein and IgG reactions to the 18 and 30 KD proteins. The patient was treated with tetracycline 500 mg three times daily for three months. Overall, the patient felt she had improved as of 3/12/03. Her energy was better. She still had some aches in her right leg and occasionally in her left knee. She had some residual swelling medially in her right knee, with some still present. She continued to have weakness in her right hand, some sweats and fevers, and occasional headaches. She had some blurriness of her eyes.  Neurologic, physiologic and brief mental exam, she had some difficulty spelling world backwards, missed one president, and made an error on serial 3 subtractions. The physician's impression was that the patient fit the complex of symptoms of chronic Lyme disease. He commented that the IgM reaction against the 23 KD protein is highly specific for the Lyme bacteria and the IgM reactivity reflects ongoing activity. The reaction against the 18 KD protein is also specific for Lyme. It is possible that the 30 KD protein is really a 31 KD reaction consistent with the Lyme vaccine, but it could be a separate protein again unique to the Lyme bacteria. Altogether, her symptoms and course are most consistent with chronic Lyme disease. She had begun responding to tetracycline and will probably need several additional months of treatment. It was decided to change her treatment to a combination of clarithromycin 500mg and hydroxychloroquine 200mg twice daily. It was also noted on 3/12/03 that the patient was taking the following medications: lisinopril and hydrochlorothiazide for high blood pressure, reloxifene, selenium, vitamin C and E, a multivitamin, calcium, and daily aspirin. Supplemental vitamin B and C were to be discontinued during the treatment period. Infectious Disease Specialist's note dated 6/11/03 indicated that the patient returned with a diagnosis of chronic Lyme disease probably dating back to the 1990's and reactivated by the Lyme disease vaccine series. The patient's medications on 6/11/03 continued to be Biaxin, Plaquenil, hydrochlorothiazide, lisinopril, reloxifene, aspirin, and vitamin E. The patient continued to show improvement. She was doing more. Occasionally, she experienced more post exertional fatigue and localized aches, especially in her right hand. She continued to experience some night sweats and was having some nightmares during sleep; however, she was sleeping well. She had experienced some stiffness in the morning and when she sat in one area. Some numbness and tingling was persisting in her right hand. Her right knee continued to show some swelling, but less than previously. She was walking better and no longer had a limp in her right leg. The physician's impression was that the patient was improving on the treatment regimen and he planned to continue it for another three months. He stated that she may well need another round of tetracycline in the fall, but planned to assess her progress in three to four months. He stated that he anticipated that it would take 12 to 18 months to get solid, sustained improvement. Infectious Disease Specialist's note dated 9/10/03 stated that the patient was continuing to make good progress. She continued to have some right knee and leg ache, some knee swelling, right second finger aches, and right hand numbness, but no other areas of aches or pains and no other areas of parathesias. Other medical information presented in the medical records includes the patient's experience of hypertension. This was not reported as an adverse event due to vaccine administration, but was found during the course of review of the patient's medical records; therefore, hypertension is not listed as an adverse event.