Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Insomnia, Laboratory test abnormal, Muscle twitching, Myalgia, Palpitations
Clinical narrative: This report describes the occurrence of fibromyalgia in a 51 year old female who was vaccinated with Lyme disease vaccine recombinant OspA (LYMERix) for prophylaxis. This report was received as part of litigation proceedings, with forwarding of medical records. The subject's medical history included Lyme disease, Epstein-Barr virus infection, Candida infections, hemorrhoids, irritable bowel syndrome, chronic insomnia, depression since age 5, "severe" anxiety syndrome, chronic fatigue syndrome, temporomandibular joint syndrome, costochondritis (1990), myalgias (1996), uterine fibroids, and fibrocystic breasts. The subject presented to the vaccine provider on 7/22/99 with a one-day history of rash on her abdomen. The physician noted a rash consistent with erythema chronicum migrans. He prescribed a 30-day course of Ceftin. There were no known allergies. Surgical history included appendectomy and tubal ligation. Concurrent medications included Prilosec, Prevacid, Pepcid, nystatin, Diflucan, Flonase, Claritin, Clarinex, Allegra, amoxicillin, Motrin, and iron supplement, and aspirin. The subject received injections of LYMErix on 10/15/99 (130B9) and 11/29/99 (130A9). In a Statement of Injuries, her attorney alleged that the subject "suffers from joint and muscle pain throughout her body, in particular in her shoulders, hands and hips. In addition, she often experiences lower back pain with radiation down both legs. She also experiences fatigue as well as anxiety and depression." The following information was obtained from medical records. The subject returned to the vaccine provider on 12/7/99. She explained of gastrointestinal symptoms, general muscle aches, and headaches. The subject stated that she "feels sick all over-similar to when she had a flare-up of EBV. The gastrointestinal symptoms were later attributed to a hiatal hernia (non-event). The subject came under the care of a new physician on 3/28/00. She was taking no medicatios at that time. The subject reported the following symptoms; panic attacks with rapid heartbeats, sweaty clammy hands, dizziness and palpitations when in an open space; trouble sleeping, staying asleep, getting back to sleep; "severe" anxiety with depression with feelings of dread and doom, crying outbursts, perseveration over fears of dying; skin burning and itching, sometimes tingling, especially face and neck that sometimes felt like ants crawling; tongue burning; feeling jittery and jumpy; "extreme" muscle tension and twitches in muscles and joints, feeling achy all over; feeling cold often; appetite "falling off"; skin wrinkling and thinning, especially on hands and neck; and "terrible" memory. "The pt states that she continually ruminates over one disease over another and is sure that she is dying from one thing over another." The physician's impressions were "1. Probable depression. 2. Anxiety syndrome, severe. 3. Probable panic attacks. 4. The pt may in fact have hypothyroidism. I doubt this. Anemia must be kept in mind. 5. Menopause, possible." The physician prescribed Prozac and Xanax. The subject remained under the care of this physician until at least 3/20/03. During that time, she reported polyarthralgia, "unable to get through the day" due to "severe" anxiety, poor sleep, myalgia, fatigue, irregular menses, night sweats, and "pounding heart." However, on 8/23/00 and 3/8/01, she reported running five miles per day. On 3/8/01, she also reported that she was engaging in weight lifting. On 11/12/02, she reported "progressive symptoms of fibromyalgia." Tests for Lyme total antibodies, HLA-DR4 antigen, and Epstein-Barr virus were positive. Erythrocyte sedimentation rate was elevated. Other lab analyses were within the reference ranges. During this time, the physician made diagnoses of arthralgias 4/3/00, fibromyalgia 4/11/00, "probable post Lyme syndrome with fibromyalgia associated with nonrestorative sleep and perhaps mild secondary depression. Alternatively, she may be one of those rare patients who are HLA-DR4  positive who received LYMErix vaccine with vaccine related problems" 4/3/01, and possible chronic Lyme disease 4/3/01. On 3/12/01, the physician wrote a note to the pt stating, "Your Lyme 'Western Blot' test was negative. This make (sic) it less likely that you are chronically infected with the Lyme bacterium. It does not rule it out; however, nor does it rule out the possibility that you have a vaccine-related condition, though as we discussed, this is also unlikely. I suspect either a 'post-Lyme' phenomenon, or 'fibromyalgia' from some other cause." On 11/12/02, the physician noted that the subject "has become essentially disabled as a result other severe fibromyalgia." The physician prescribed Ambien, Elavil, magnesium, Celexa, BusPar, Effexor IL, Klonopin, "some herbal therapies and some simple supplements," and digestive enzymes. He referred the subject to a rheumatologist. The physician wrote a letter, dated 3/20/03. In the letter, he stated that, after receiving the second injection of LYMERix, "within a weeks time, she developed horrific pains in her joints and extremities, including dysesthesias involving tingling in her legs and arms, muscle spasticity and twitching. We advised that she obtain an HLA-DR4 typing because of reports associating the development of a rheumatoid-like arthritic syndrome in some patients who received the Lyme vaccine if they were seropositive for this HLA type. Her HLA-DR4 test indeed came back positive and she was advised not to receive the last dose of the LYMErix vaccine. Since that period, the pt has remained symptomatic with muscle pain, muscle spasms, fasciculations and twitching, dysesthesias and arthralgias. As a result of her fairly severe chronic pain, she has been unable to work. The pain also interferes with her sleep pattern and her sleep disorder has required the use of medications, including pain also interferes with her sleep pattern and her sleep disorder has required the use of medications, including clonazepam, Ambien and cyclohenzaprine. There is no evidence of a mood disorder. The pt's symptoms are complicated by chronic fatigue related to her sleep disorder, chronic pain syndrome and chronic anxiety because of the uncertainty of her pregnosis. She has numerous tender trigger nodules found in the anterolateral and lower intercostal muscles, the interscapular muscles, including the rhomboids, both levator scapulae, both trapezil muscles at their most cephalic margin, costochondral tenderness and sternal tenderness, trochanteric bursal tenderness, and numerous triggers in her gluteal muscles. The pt is unable to sit, bear weight on her lower extremities or walk for any extended period of time. She has arthralgias but no objective evidence of arthritis at this point in time. She requires a small dose of analgesics but has wanted to avoid strongest analgesics such as opiates. It is my impression that the subject suffers from fibromyalgia and possibly an early seronegative arthritis, which followed vaccinations with the LYMErix. At the current time, she remains totally disabled. Her prognosis is uncertain." Following the administration of LYMErix, the subject experienced allergies, serous otitis media, allergic rhinitis, sinusitis, vaginal candidiasis, upper respiratory infection, viral syndrome, hiatal hernia, diverticulosis, paravertebral sprain, and elevated partial thromboplastin time. 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. The most recent info was received on 6/02/03. The fibromyalgia and anxiety persisted as of 3/20/03. There was "no evidence of a mood disorder" at that time. One of the treating physicians considered the fibrmyalgia to be disabling. Therefore, this report has been reclassified as serious.  Follow up on 07/31/2003: "The most recent information, received on 07/25/2003, did not provide the outcome of the reported events; however, "Lyme symptoms" persisted as of 07/11/2003.  Information received on 06/02/2003 indicated that the fibromyalgia and anxiety persisted as of 03/20/2003.  There was "no evidence of a mood disorder" at that time.  One of the treating physicians considered the fibromyalgia to be disabling.  Therefore, this report has been reclassified as serious." A 15-day follow up report received 09/17/2003 adds no new info.  Follow up on 01/08/04: "The most recent information, received on 12/24/03, did not provide the outcome of the reported events."  Follow up on 06/17/04: "Information received on 05/05/04, revealed that the pt felt worse after "having a difficult winter. She continues to suffer from symptoms of severe fibromyalgia that have essentially caused her to be homebound this winter. She suffers from severe musculoskeletal pain and an associated sleep disorder. She has had little response to various interventions." The most recent information, received on 06/10/04, revealed that the pt saw a chiropractor in Jan and Feb 04 for neck, pelvis and hip adjustments." Follow up on 05/17/04 states: "The most recent information, received on 05/05/04, revealed that the pt felt worse after "having had a difficult winter. She suffers from severe musculoskeletal pain and an associated sleep disorder. She has had little response to various interventions."  Information received on 10JUN2004, revealed that hte patient saw a chiropractor in January and February 2004 for neck, pelvis, and hip adjustments. The most recent information received on 5NOV2004, indicated that a of 8SEPT2004, she continued to have anxiety and exacerbations of fibromyalgia. She was diagnosed with possible depression and premature ventricular contractions due to anxiety.