Report A0364941A describes confusion in a 47 year old female who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received as part of the litigation proceedings and medical records were provided. The patient is allergic to erythromycin (nausea and vomiting), codeine (lightheadedness and stomach upset), and bees. The medical history included fibroid uterus, ovarian cyst, endometrioma, menorrhagia, dysmenorrhea, monilial vaginitis, abortion/miscarriage, intersegmental dysfunction with lumbalgia and lumbar sprain (4/10/1986), pain, chronic low back pain, left shoulder pain with positive signs of impingement and rotator cuff tendonitis (since 2/24/1997), facial lesion with possible rosacea (4/21/1999), right ulnar collateral ligament sprain (11/29/1999), plantar warts, biliary disorder, chest pain, coughing, upper respiratory infection, viral syndrome, wheezing, epigastric pain and burning, fever, joint pain, lower and right upper quadrant pain, reflux symptoms, gastritis, nausea, nocturnal perspiration, polyarthritis, stiff joint, pulmonary lower lobe infiltrate, sinusitis, and swollen glands in neck. The surgical history included tonsillectomy, appendectomy, right partial ostectomy 5th met and right proximal interphalangeal joint (PIPJ) 5th partial ostectomy (8/18/93), and laparoscopic cholecystectomy. On 3/1/96, a CAT scan of the abdomen revealed an ill-defined discoid 8mm density in the posterior aspect of the left lower lobe. The patient consumed alcohol once to twice weekly. In 1992 the patient had Lyme disease test of antibodies IgM and IgG with negative results. Concurrent medications included ethinylestradiol with iron (Loestrin-Fe 1.5/30), calcium, and naproxen sodium (Anaprox-DS). On an unspecified date, the vaccinee received an injection of LYMErix; it was not known if the vaccinee had received previous injections of YMErix. In a statement of injuries, the vaccinee's attorney alleged that the vaccinee suffers from severe back pain and hip pain, knee pain, memory loss and confusion, extreme fatigue, rash, night sweats, burning and tingling in lower back, irregular heartbeat, and sinus infections. An office notes of 5/15/00 indicated that the patient complained of fatigue. Physician's impression at that time was to screen for coronary risk, check complete blood count and thyroid stimulating hormone. THe vaccinee was seen by a pulmonologist on 11/6/00 for sinus headache, chest pressure, chills, headache, scratch throat, and dry non-productive cough. Impression: 1. upper respiratory infection: mometasone furoate (NASONEX) 2 sprays each nostril daily, fexofenadine hydrochloride (Allegra) one twice daily; 2. electrocardiogram. A Lyme disease case report from (dated onset of first symptoms on 1/22/01) indicated that the patient had positive signs and symptoms of erythema migrans, arthritis, and sixth oranial nerve palsy. The patient also experienced unexplained fever, fatigue, and chronic sore throat. It was noted that the patient had exposed the lyme disease from the back yard. Lyme IgM/IgG Western Blot on 1/24/01 showed positive result by CDC criteria. Ceftin was prescribed. On 6/29/01, follow up office visit notes indicated that the vaccinee was diagnosed with Lyme disease sometime in 2001, and had received a Lyme vaccination. The vaccinee has been treated with Ceftinand doxycycline. Doxycycline was discontinued for two weeks due to sun poisoning at work. The patient became much sicker and doxycycline was resumed. It was also noted that the patient's fatigue was proved to be due to Lyme disease. The patient was to continue antibiotics chronically. The vaccinee was seen by a physician rehab consult on 10/9/01. The patient's chief complaint was low back pain. The patient described that she has had a chronic history of low back pain. She had sought chiropractic care and her condition did not improve even with treatment. In addition, she has had bilateral knee pain and bilateral shoulder pain. The patient also complained of transaxial lower back pain characterized as aching and burning. She has had no clear cut radicular, neurologic, bowel, bladder, or constitutional symptoms. However, both her lower back pain and bilateral knee pain were provoked by prolonged standing especially on hard surfaces as well as sitting. There was relative relief with lateral recumbency and she denied any locking, swelling or giving away. She indicated the left shoulder pain was greater than right especially in the morning; and the symptoms were intermittent. The patient stated that she was working with restrictions including avoiding prolonged standing, teacher's aid for fatigue and when bending to assist with combination locks, and no cafeteria duty. Physical examination showed BP at 126/74, heart rate 62 beats per minute, and respiratory rate at 10 per minute. Patient's mental status was appropriate and in no apparent distress at that time. The patient moved freely and easily throughout the evaluation without use of an assistive device. Spinal examination revealed some decrease in the lumbar lordosis. Lumbosacral spinal range of motion revealed mild limitations in flexion exacerbating transaxial back pain. Extension also exacerbating back pain. Tender bilateral L4-S1 paraspinals into the sciatic notches bilaterally. Negative sacroiliac joint provocative maneuvers. Neurological examination revealed deep tendon reflexes were symmetrical and intact in both lower extremities. No ankle clonus. Normal tone. Babinski sign absent. Cranial nerves 2 through 12 grossly intact. Sensation intact to light touch. Normal strength testing throughout all myotomes bilateral lower extremities. Extremities/musculoskeletal: negative sitting, supine and reverse straight leg raising. No atrophy, fascicculations or deformities noted. Positive left shoulder impingement sign with tender bicipital groove. Knee examinations were unremarkable. Normal hip evaluations. Medications at that time included Ceftin and Loestrin. Impressions: 1. lower back pain; 2. rule out degenerative disc disease lumbar spine; 3. left shoulder impingement syndrome; 4. bilateral patellofemoral knee pain. Recommendations: 1. bilateral knee, left shoulder, and lumbosacral spine x-rays; 2. physical therapy addressing left shoulder, bilateral knee, and lumbar spine; and unspecified prescription given; 3. chiropractic; 4. continue current work capacities. A second Lyme disease case report form (dated onset of first symptoms on 10/26/01) continued to report positive signs of erythema migrans and arthritis. Other symptoms included fatigue, joint pain, and headaches. Lyme IgM/IgG Western Blot (10/26/01) yielded a positive result as per CDC criteria. Mycoplasma subtyping by PCR revealed positive for M fermentans. On 11/07/01, the patient was first seen by a physical therapist for evaluation of lower back pain, left shoulder impingement, and left bicepital tendonitis (since 10/1/00). It was noted the progressive onset with Lyme disease was in 1/01, and the patient had an active lifestyle prior to 10/1/00. Patient's goal for treatment was pain relief. The patient received a total of ten therapy treatments. During her last visit on 12/5/01, the patient indicated that she was taking a new antibiotic (doxycycline), and her pain and achiness were gone. Physical therapist's comment: Patient was not progressing well with physical therapy and suddenly felt dramatically better after start of new antibiotic. On 12/13/01, the patient returned to the physical rehab consult for follow up. The patient had three physical therapy sessions without benefit except for shoulder pain. She continued to complain mostly of low back pain, right side bias and bilateral knee pain. There was no clear cut radicular symptoms. The patient experienced sudden and atraumatic onset of right lateral ankle pain two weeks ago. It was noted that the chiropractor gave her only short lived benefit. There was no progressive weakness, incontinence, or unexplained constitutional symptoms. Lumbar spine x-ray revealed mild degenerative disc changes. Shoulder and knee x-rays were unremarkable. The patient raised questions in regards to Lyme vaccination which was deferred to (a physician). Impressions: 1. chronic low back pain; 2. degenerative disc disease lumbar spine by x-ray; 3. Normal x-rays shoulder and bilateral knees; 4. new onset right ankle pain; 5. history of lyme disease. Recommendations: 1. MRI to rule out herniated nucleus pulposus (HNP); 2. continue home exercises. She has discontinued formal physical therapy. As of 5/15/02, the outcomes of the events were reported as unresolved. The adverse events arthralgia, memory loss, and confusion do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Following the reported onset of sinus infection and Lyme disease, the subject experienced decrease red blood cell count, increased mean corpuscular hemoglobin, vaginal candidiasis, and cervical pain priori to menses. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. Follow up on 02/26/04: "Information received on 01/29/04 indicated that, as of 09/22/03, the pt continued to experience myalgia, arthralgia, and Lyme disease."