Age: 32.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Paraesthesia, Viral infection
Clinical narrative: This report describes joint pain in a 32 year old female who received Lyme disease vaccine recombinant OspA. This report was received as part of the litigation proceedings, with forwarding of medical record. The medical history included prematurity with"extreme low birth weight""long-standing"chest pain, "long-=standing" back pain, neuromas on bilateral sinusitis, recurrent streptpcoccal throat infections, recurrent tonsillitis infections mononucleosis at approximately 10 years of age, positive tuberculin skin test treated for six months with isoniazid (1996), occassional metallic taste, and rotoverted uterus. She reported drinking five to six alcoholic beverage two ot three times a week. There were no known drug allergies. Concurrent medications included mometasone fumarate (Flonase), phenylephrine/guaifencsin (Entex-LA), and clarithromycin (Biaxin; therapy completed seven days prior to receiving the second injections of Lymerix). The vaccine received injections of Lymerix on 03/16/99 (lot LY120D9; expiry, 01/20/00). 04/13/99 (lot LY10482, expiry, 10/29/1999) and 04/29/00 (lot LY144B9, 10/27/01). On 02/22/02, in a statement of Injuries, the vaccinee's attorney alleged that the vaccinee "suffers from joint pain. In addition, her feet hurt and her right toe tingles Also, (she) suffers from extreme and chronic fatigue. She has tested positive for Epstein-Barr.". The following information was obtained from medical records the vaccinee presented to her primary physician on 09/23/00 with a chief complaint of increased fatigue for two to three weeks. She reported that she had "infectious mono" at approximately 10 years of ago. On physical examination, the physician noted "slightly tender lower extremities, vaginal discharge". His assessment was R/O (rule out) chronic fatigue syndrome.". Laboratory analyses revealed anemia and the presence of Epstein-Barr viral capsid antigen IgG. Please see Laboratory Data Section. The vaccine remained under the care of this physician until at least 06/02/01. The vaccinee continued to complain of fatigue. The physician's assessment during this time period included premenstrual syndrome (10/13/000), "? adrenal insufficiency" 04/24/01), and R/O hypothyroidism, RA (rheumatoid arthritis)" 06/02/01. Laboratory analyses performed on 06/02/01 continued to demonstrate anemia;all other results were within the reference ranges. The physician referred the vaccinee to an infectious disease specialist and an endocrinologist. The vaccinee was evaluated by the infectious disease specialist on 05/01/01. At that time, she reported 'a two year history of fatigue. For the past few years, the patient has had frequent sore throats, was frequently treated with antibiotics and underwent a tonsillectomy, adenoidectomy, and septal repair. In 1996, the patient was found to have a positive PPD (purified protein derivative) of 25 mm and was treated with INH (isoniazid) for six months... She is complaining of night sweats. she maintains that she is exhausted and sleeps a lot. She has experienced a considerable weight gain. She tries to exercise although with little success. She had perimenstrual symptoms and is taking a preparation called Serafem which contains fluoxetine with modest benefits. She was noted... to have a positive Epstein- Barr virus serology and a normal thyroid stimulating hormone..She does complain of some occasional dizziness. She has some subjective shortness of breath on exertion.. no swelling of the fear, ankles or hands.''. The physician noted that the vaccinee had "pneumonia in the past, anemia and frequent colds" On physical examination, "The extremities and skin were negative... Joints were negative.". The physician's assessment was "this patient has fatigue of uncertain cause and probably multifactorial etiology. There is probably some component of a sleep disorder as well as componet of overweight and deconditioning." The physician discontinued fluoxetine therapy and prescribed amitriptyline hydrochloride (Elavil) 25 mg at bedtime. There is probably some component of a sleep disorder as well as components of overweight  and deconditioning." The physician discontinued fluoxentine therapy and prescribed amitriptyline hydrochloride (Elavil) 25 mg at bedtime. The vaccinee was evaluated by the endocrinologist on 06/18/01" for evaluation of weight gain and chronic fatigue. It is of some interest that the patient was a premature baby with an extremely low birth weight. She graduated college at a weight of 130 pounds and from that time began to slowly gain weight. She stopped smoking about 3.5 years ago with an acceleration of her weight loss (sic). She moved in with a friend who is a professional caterer about one year ago and her diet clearly increased dramatically in caloric content. Over the last year or so she has begun to snore loudly during her sleep and to wake up frequently. She tried a variety of over-the counter sleep modifications without benefit. She has become progressively fatigued and is tired from the time she awakens  in the morning. she has continued to function well  (in her job) with no change in her personality. On physical examination, she was 5 feet and 4 inches tall and weighed 203 pounds. Physical examination was remarkable only for "generalized obesity" The endocrinologist wrote, "In summary, this is a woman with progressive weight gain and profound fatigue, I see nothing on physical examination or in her routine laboratory studies to suggest Cushing syndrome. Progressive obesity in adulthood is extremely common in low birth weight children. In addition, the combination of her smoking cessation and changing eating habits is almost certainly a major cause of her progressive weight gain. I strongly suspect that much of her fatigue is a result of sleep apnea.". Following the administration of Lymerix, the vaccinee experienced pharyngitis, rhinitis, tonsillitis, hemorrhoids, allergies, allergic rhinitis, premenstrual syndrome, dysmenorrhea, anxiety,and hypercholesterolemia. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccine's medical records. Therefore, they are not listed as adverse events. The adverse events, 'joint pain' and 'tingling' do not meet serious criteria, but are being submitted as an expedited report by special FDA request  per the 06/28/00 letter.