Age: 44.0
Sex: M
Vaccine: LYME
Symptoms: Myasthenic syndrome, Skin burning sensation
Clinical narrative: Report A0357445A (formerly 2002000880-1) describes myasthenia gravis in a 44 year old male who received LYMErix. This report was received as part of litigation proceedings, with forwarding of medical records. Medical history included chronic low back pain treated with chiropractic, onychomycosis "for years," hypercholesterolemia, hypertension, right bundle branch block (1996), premature ventricular contractions, and nonsustained ventricular tachycardia. Concurrent medications included Zestril 20mg daily, acetylsalicylic acid 80mg daily, atenolol 20mg daily, Xcnical, and Sporanox. On 2/11/02, in a Statement of Injuries, the vaccinee's attorney alleged that the vaccinee "has been diagnosed with ocular myasthenia gravis, an autoimune condition which involving (sic) loss of muscular use in and around his left eye, resulting in a full-time "drooping" of that eye. In addition, the vaccinee suffers a painful burning sensation in the muscle of his thighs, whenever he stands for any length of time." Following the reported onset of myasthenia gravis, the vaccinee developed plagues on his knees and elbows that were "suggestive of psoriasis," and fatty infiltration of the liver. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. The vaccinee received his first and second injections of LYMErix on 4/23/99 and 5/19/99, respectively. Both injections were from lot LY120B9. An unspecified time post-immunization, he awoke with left eye ptosis. He placed a patch over his right eye in an unsuccessful attempt to strengthen his left eyelid. The ptosis persisted when he received his third injection of lYMErix on 4/20/00. He was referred to a neuro-ophthalmologist. The vaccinee was seen by the neuro-ophthalmologist on 8/23/00. The physician wrote that the vaccinee "states that one year ago he woke up and noted left eye ptosis. He notes that with fatigue the lid drooop is accentuated. He did try to place a patch over the right eye in order to strengthen his left eyelid but this was to no avail. He has had no generalized fatigue. However, he has had occasional burning sensation drown both legs with exercise. He has had no complaints of shortness of breath, dysphagia or double vision. He noticed that the left eyelid twitches at times. He received a Lyme vaccination in April 1999 and May 1999 just before the onset of his ptosis." On physical examination, "He did demonstrate mild curtaining and a positive lid twitch sign. There was dermatochalsis noted bilaterally. An ice pack test was carried out and also showed improvement of the ptosis." The physician's impression was "At this time we need to exclude myasthenia gravis." The vaccinee underwent nerve conduction studies and EMG on 9/11/00. "Repetitive nerve stimulation studies of the right median and spinal accessory nerves were normal. There was no decrement at rest or 90 seconds after exercise. The neurologist stated that the EMG "was a mildly abnormal single fiber EMG in the orbicularis oculi muscle. This would be consistent with ocular myasthenia gravis or other disorders." Acetylcholine receptor binding antibody (Ab) and Ach receptor blocking Ab were measured on 9/12/01 and were within the reported reference ranges. The vaccinee was seen by the neuro-ophthalmologist on 4/17/01. The physician wrote,"The vaccinee returns today for neuro-opthalmic follow-up of his myasthenia gravis. He was lost to follow up for several months. He ahs undergone a single fiber EMG which does suggest a presence of a neuromuscular defect. He ahs had no other now neurologic sings or symptoms including no dysarthria, dysphagia, weakness or shortness of breath. He is currently asymptomatic from a myasthenic point of view." On physical examination, "He continues to have a mild left ptosis and slight eyelid retraction on the right. Motility was full." The physician recommended a computed tomogram (CT) of the chest to rule out thymoms, and thyroid function testing. The vaccinee underwent CT of chest with contrast on 12/11/01. The radiologist's impression was "Normal chest CT with the exception of diffuse fatty infiltration of the liver." Results of thyroid function testing were not provided. The most recent info, received on 7/9/02, did not provide the outcome of the reported events. The adverse events "myasthenia gravis" and "burning sensation" do not meet serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00 letter.