Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Myalgia
Clinical narrative: This report describes anxiety in a *51 y.o.* female who was vax'd w/Lyme disease vax 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 (90), myalgias (96), uterine fibroids, and fibrocystic breasts. The subject presented to the vaccine provider on 7/22/99 w/a one-day history of rash on her abdomen. The MD noted a rash consistent w/erythema chronicum migrans. He prescribed a 30-day course of cefuroxime (Ceftin). There were no known allergies. Surgical history included appendectomy and tubal ligation. Concurrent medications included omeprazole (Prilosec), lansoprazole (Prevacid), famotidine (Pepcid), nystatin, fluconazole (Diflucan), fluticasone (Flonase), loratadine (Claritin), an iron supplement, and aspirin.* The subject received injections of LYMErix *on 10/15/99 and 11/29/99*. In a statement of injuries her attorney alleged that the vaccinee "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." Time to onset following immunization, treatment, and outcomes of the alleged events were not reported. The adverse event "joint pain" does not meet serious criteria, but is being submitted as an expedited report by special FDA request. *F/UP report on 3/4/03: The following info was obtained from medical records. The subject returned to the vax provider on 12/7/99. She complained of gastrointestinal SXs, general muscle aches, and headaches. The subject stated that she "feels sick all over - similar to when she had a flare-up of EBC (Epstein-Barr virus). The gastrointestinal SXs were later attributed to a biatal hernia (non-event). The subject came under the care of a new MD on 3/28/00. She was taking no medications at that time. The subject reported the following SXs: panic attacks w/rapid heartbeat, sweaty clammy hands, dizziness and palpitations when in an open space; trouble sleeping, staying asleep, getting back to sleep; "severe" anxiety w/depression w/feelings of dread and doom, crying outbursts, perseveration over fears of drying; 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 1 disease over another and is sure that she is dying from 1 thing over another." The MD's impressions were "1) Probable depression. 2) Anxiety syndrome, sever. 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 MD prescribed fluxotine (Prozac) and alprazolam (Xanax). The subject remained under the care of this MD until at least 1/30/02. During that time, she reported arthralgias, "unable to get thru 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 5 miles/day. On 3/8/01, she also reported that she was engaging in weight lifting. Lyme total antibodies and HLA-DR4 antigen were positivel Other lab analyses were w/in the reference ranges. Please see Lab Data section. During this time, the MD made DXs of arthralgias (4/3/00), fibromyalgia (4/11/00), "Probable post Lyme syndrome w/fibromyalgia associated w/nonrestorative sleep and perhaps mild 2ndary depression. Alternatively, she may be one of those rare PTs who are HLA-DR4 positive who received LYMErix vax w/vax related prob's" (4/3/01), and possible chronic Lyme disease (4/3/01). The MD prescribed zolpidem (Ambien), and clonazepam (Klonopin). As of 1/30/02, the subject "feels good on Effexor XL... can't sleep". Medications at that time included venlafaxine, clonazepam, and amitriptyline. Following the admin of LYMErix, the subject experienced allergies, serous otitis media, vaginal candidiasis, URI, viral syndrome, and hiatal hernia. These events were not reported as adverse events due to vax admin 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, received on 8/13/02, did not provide the outcomes of the reported events.*