Age: 39.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Feeling hot, Headache, Joint swelling
Clinical narrative: Multiple arthritic symptoms; joint pain and swelling (joint will get hot and red), both shoulders, neck, lower back pain, blurry vision in both eyes and headaches. The follow up received on 2/11/02 states joint pain in a 39 year old female who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the pt, who initially reported that she was a participant in a clinical trial. However, medical records confirmed that hse received the vaccine post-marketing. Additional info was received as part of litigation proceedings, with forwarding of medical records. Medical history included allergies to codeine and penicillin, tobacco use, bronchitis, emphysema, noninsulin dependent diabetes mellitus, "low blood sugar," "lazy right eye," blind spots, blurry vision, ocular migraines, hemorrhoids, fracture of the fourth right metatarsal, depression, anxiety, warts, and otitis media. THere was no personal or family history of gout, psoriasis, Crohn's disease, rhuematoid arthritis, or lupus erythematosus. The pt underwent x-ray of the right wrist with special attention to the scaphoid on 9/6/91, for an unspecified reason; the results were interpreted as "normal study." The pt underwent x-ray and three-phase bone scan of both hands and wrist, with special emphasis on the scaphoid, on 1/28/92 for an unspecified reason, the results were interpreted as "normal study." Family history was significant for diabetes mellitus and glaucoma in the pt's father; he was blind prior to his death. The pt had no history of Lyme disease. On 3/11/99, she presented to her primary physician "with multiple complaitns. Specifically she would like to get checked for Lyme's disease. She brings a three page letter describing her symptms. Essentially about four months ago she had a potential tick on her finger which she pulled off. She states that a few days after this she developed an itchy red rash on her turnk and her neck which looked like hives. She also had some associated swelling in the lips. She described off and on flu-like symptoms over the past three months. She's had various joint aches and pains most notable in the shoulders, the knees and the hops." Erythrocyte sed rate, ANA titer, and rheumatoid factor were measured on 3/11/99; the reuslts were negative. Total Lyme antibodies measured by ELA on 3/11/99 were reported as seronegative. The physician wrote, "I discussed with her briefly consideration of this being depression and considering a trial of an antidepressent." Antidepressent therapy was initiated on 3/25/99. Concurrent medications included Vioxx, Celebrex, Motrin, Zoloft and Lasix. The pt initially reported that hse received her first injection of LYMErix in the fall of 1998 and the second dose one month following the first. She reported to manufacturer that she had no adverse experiences following receipt of the first two injections. Review of medical records indicated that the first dose of LYMErix was injected into the right arm on 5/20/99, and the second dose of LYMErix was injected into the left arm on 6/28/99. The pt would later rpeort to a physician that joint pain began after the first injection of LYMErix. The pt received her third dose of LYMErix, injected into the left arm, on 7/28/99. The third dose was adminsitered two months, rather than the recommended interval of 12 months, following the administration of the first dose. The pt initially reported that approximately one month following the third injection, she developed right elbow edema, redness, pain and heat. She also reportedly developed bilateral ankle edema; no redness or heat was noted in the ankles. She stated that she experienced cervical pain at times. She reported that she experienced joint pain in both shoulders; the pain was worse in the right shoulder. The right shoulder pain continued to worsen over the next two years. The pt reported that she had not been seen by a physician at the time of "flare ups," but planned to be evaluated by an orthopedic surgeon. On 2/11/02, in a statement of injuries, the pt's attorney alleged that the pt "suffers from multiple joint pain, most prominently in the shoulder joints, as well as sensitivity to light and blurred vision." The following information was obtained from medical records. The pt's right shoulder was x-rayed on 8/18/99; the indication for the x-ray was "right shoulder pain." The radiologist's impression was "negative exam." The pt went to the local ER on 6/14/00, after falling and hitting her elbow on a concrete wall. She reported that her elbow was warm and swollen, and that she experienced pain in the elbow and a burning sensation in the arm. Medications at that time included sertraline and ibuprofen 800mg as needed; the pt did not report the indication for ibuprofen therapy. An x-ray of the elbow revealed that "chronic enthesopathy is present, but no acute fracture." A diagnosis of soft tissue injury was made. The elbow was wrapped in an bandage, and the arm was placed in a sling. The pt was sent home. The pt presented to a ophthalmologist on 10/26/00 with complaints of "Trouble with blurry vision, left eye seems to at times have blind spot in bottom of eye. Sometimes sees halo around light." She reported that she wore corrective eye lenses since the age of 2 years. She also reported that her father had diabetes mellitus and glaucoma, and that he was  blind prior to his death. She reported a history of ocular migraines that were relieved with ibuprofen. She reported seeing "blank spot" occasionally while driving and when having a migraine. Visual acuity with corrective lenses was 20/20 in each eye. discs-right 0.35, shallow cupping; left 0.2-0.25. Pressures were right 19, left 17. The ophthalmologist urged the pt to see a specialist "at her earliest time." On the referral slip, the ophthalmologist indicated a diagnosis of glaucoma. When seen again on 11/9/00, pressure were right 23, left 17. On 6/7/01, the pt returned to the ophthalmologist complaining of sore eyes. The ophthalmologist noted dry eyes and prescribed "Genteal gel." The opthalmologist again recommended that the pt see a specialist to "check optic nerve changes and autoimmune changes?" The pt did not make an appointment to see this specialist until 2/20/02. The pt came under the care of a new primary physician. She presented to this physician on 11/15/00 with a complaint of "right shoulder pain which she has been having for at least the past year. She says it is a heaviness which she feels only as she starts slowing down at night with limitations even adduction of the right shoulder without concomitant swelling or effusion. It usually responds to Motrin taken every eight hours. No active complaints." On physical examination, the physician noted "point tenderness on trapezius area of right shoulder but no limitation of movement of the shoulder. No effusion, crepitation, swelling or erythema of the shoulder." The physician's assessment was "right shoulder pain. Rule out degenerative process. She however says this is very responsive to Motrin taken as needed and she thinks that when she takes Motrin at night she doesn't wake up in the morning with any stiffness of the shoulder." She was advised to continue Motrin therapy and and to begin active exercieses of the right shoulder. The pt's now primary physician referred her to another ophthalmologist on 12/29/00 to rule out glaucoma.At that time, the pt reported burning, redness, epiphora, and foreign body sensation. She reported a history of migraines, moninsulin dependent diabetes mellitus for the past five to six years. "Blind spot when b.s. (blood sugar) is low," "lazy right eye," anxiety, and depression. She reported her occupation as "housewife." Medications included sertraline and ibuprofen. The ophthalmologist's impression was borderline glaucoma "with cupping" and blepharitis. The pt presented to her primary physician on 2/5/01, "complaining of multiple joint pains; mainly the neck, bilateral shoulder, low back, ankles and knees. She is trying to associate this after she was given LYMErix some time in May 1999. Since then she has been having symptoms of the above, especially right after the infection. Pt states she does quite a lot of lifting at home. She denies any recent trauma tto the affected areas that she mentioned. Denies ever complaining about it before the LYMErix injection. She denies any fever, chills. No hisotry of rheumatoid arthritis. No other associated problems." Physical examination revealed "Bilateral shoulder discomfort on palpation of bicipital tendon groove but no obvious swelling or erythema. Also has palpable complaints of tenderness on lumbosacral area. Gait normal. No obvious swellings in all joints in the lower extremities mainly the knees and nakles." The physician's assessment was "multiple sites of arthralgia." The physician continue Vioxx anti-inflammatory therapy. ESR, ANA titer and rheumatoid factor were negative. On 2/6/01, "The HLA DR region was typed and the following alleles were found: DRB1 1302 (DR6), DRB1 0101 (DR1)." The pt underwent MRI of the left shoulder on 3/29/01. The radiologist's impressions were "some increased signal identified in the supraspinetus tendon, compatible with partial tear or strain. Impingement of the supraspinstus at the level of the AC joint." The pt was referred to a specialist for evaluation of joint pain on 3/14/01. The pt presented to this physician "with many complaints. The pt's biggest complaint is her lower back pain and left shoulder pain and neck pain. The pt states approximately two years ago she had the Lyme disease vaccination. The pt's symptoms started approximately one week after her injection into her left shoulder of the vaccination. The pt states that she had severe left shoulder pain that progressively went into the right shoulder after she had her second injection. The pt states before this vaccination she had no pain at all. The pt denies any past injuries to her shoulder. The pt has significant complaints of multiple joint pains, redness, swelling and mentally irritable as well as rashes sporadically. There is an entire list of symptoms that the pt has had over the last two years; however, the pt comes today for her bone and joint pain that is excessively worse in the left shoulder. The pt states that she feels that it is a deep aching." Medications at the time of evaluation included sertraline and ibuprofen. On examination of the left shoulder, "Palpation of the anatomic landmark is tender. The AC joint and the SC joint are painful on stress. Palpation ofhte paravertebral muscles is slightly tender. ROM of the shoulder is limited actively by the pain, passively ROM is complete with exception of Yergason, Speed, Wright, and apprehension test are negative. Examination of hte cervical spine: The pt does not present any antalgic position of hte neck. THere is no scoliosis or kyphosis. Palpation of hte para-vertebral muscles elicite pain. Palpation of the spinous process is tender. Stimulation of the Greater Occpital nerve at the base of the skull is tender. Trapezius and Scalenius muscles are tender on palpation. The pain limits the ROM actively. On passive motion, flexion and extension are incomplete. The right and left rotation is possible at 100%. The right and left lateral flexion is possible also at 100%. Neurological examination of the upper extremities shows no abnormality and symmetrical reflexes without any sensory deficit. Spurling test is negative on both sides without pain radiating in the forearm. There is no sign of upper motor neuron lesion or sign of any particular nerve root compression in the cervical spine. There is no sign of thoracic outlet syndrome. Wright test is negative. Neurological evaluation of the lower extremities is also normal. Examination of the shoulder girdles is normal. Examination of hte elbows. The epicondyl is asymptomatic. Neurological examination is normal. There is no abnormal swelling. Palpation ofthe anatomic landmarks is pain free. The lateral ward is pain free. Muscle strength is normal around the elbow. The ROM is complete. No radial nerve entrapment syndrome. There is no motor or sensory ulna nerve anomaly. Resisted extension of the wrist and the extensors of the finger is not painful." The following was recorded as the diagnosis: "The subjective and objective evaluation of this pt is in favor of multiple joint pains, etiology unknown at this time." Under plan of treatment, the physician wrote, "There  is a possibility that she may have some sort of internal derangement of the left shoulder. The pt was given some samples of Mobic. The pt denied having physical therapy due to the expense of it. Her blood work that was perfomred was reviewed and was all within normal limits. I believe at this time that hte pt should be referred to a rheumatologist and the rheumatologist will be able to identify where her multiple joint pain is coming from, most likely a form of a rheumatoid like arthritis. There is a minimal chance that this could be associated with the Lyme disease vaccination." The pt was seen again by the specialist on 4/11/01 for "follow up of the complaint of a painful right shoulder that she claimed to be related to a Lyme vaccination. At close examination of this pt, this pain looks purely mechanic and not related to a systemic disease. It is coming from the AC joint of the right shoulder. A diagnosis of impingement syndrome has been made and an investigation has been done accordingly. The impingement test confirmed a diagnosis of impingement of syndrome." Upon examination of the right shoulder, "The clinical picture of this pt did not change since the last visit. The injection of the AC joint done confirmed the origin of the pain. There is no deterioration and no aggravation fo this arthritis. Palpation of the anatomic landmark is tender over the humeral head. The AC joint and the SC joint are not painful on stress. Palpation of hte paravertebral muscles is slightly tender. The painlimits ROM of the shoulder activity. Passive ROM is complete. Yargason, Speed, Wright and apprehension test are positive. There is a painful click at 70 degree of flexion and abduction. Injection test performed is positive for impingement syndrome of the AC joint." Diagnosis was recorded as "Mechanical impingement syndrome seconary to AC joint degeneration." Under plan of treatment, the physician wrote, "I do not see any relation to any vaccination problem. If there is a problem with Lyme disease, this painful shoulder is not related to it. I suggest acrominoplasty of the AC joint." X-ray of shoulders revealed "Degenerative changes of the left AC joint. Otherwise, unremarkable bilateral shoulders." The pt returned to the second ophthalmologist on 4/26/01. At that time, she reported "joint disease secondary to LYMErix vaccination." Medications at that time included ibuprofen. Blepharitis with lash crusting was observed. The ophthalmologist's impression was borderline glaucoma "with cupping." The pt saw the specialist on 5/21/01. "The subjective complaints are unchanged for the shoulder as well as for the orthopedic complaints." The diagnosis remained "Mechanical impingement syndrome secondary to AC joint degeneration." Following the reported onset of joint pain, the pt experienced chronic right otitis media, otitis externa, recurrent sinusitis, tooth abscess, enlarged lymph nodes in the breast, impacted cerumen, heartburn, temporomandibular joint dysfunction, allergic reaction to Augmentin, felon of hte third finger of the left hand, glaucoma, dry eyes, and blepharitis. These events were not reported as adverse events due to vaccine administration but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. The most recent info received 7/25/02,did not provide outcomes of the reported events.  Follow up on 03/26/2001: "1st correction: Dates of vaccine are 05/20/1999, 06/28/1999, 07/28/1999 all same Lot #: LY123A6; 2nd correction: My age at time of vaccination was 39; 3rd correction: 1st adverse event was after 1st shot 05/20/1999, right arm injection site and right shoulder pain.  Actually reported to RN administering 2nd shot (06/28/1999) of extreme pain in right shoulder and injection site."