Age: 35.0
Sex: M
Vaccine: LYME
Symptoms: Pain
Clinical narrative: The pt reportedly received Lymerix; the number of injections administered was not reported. In a statement of injuries, his attorney alleged that the vaccinee "suffers from joint pain, in particular in his knees, back, ribs, neck and jaw. He also experiences fatigue. In addition, he suffers from cardiomyopathy. Moreover, he has been dx'd with Lyme Disease. Time to onset following immunization, treatment and outcomes of the alleged events were not reported. Cardiomyopathy is considered "Medically Serious". **(Follow-up 7/1/02) The follow up states pt's medical history included tobacco use (1 pack of cigarettes/day), and alcohol use (12 beers/week), *ventricular actopy (inc'l premature ventricular contractions and bigeminy) since his teenage yrs, hypercholestrolemia, benign essential hypertension (March 99), Campylobacter jejuni infection (1997), recurrent strup throat. "Chronically infected tonsils", olobal hypokinesia (March 99), trace mitral regurgitation (March 99), pharyngitis (98). unspecified acquired hypothyroidism (March 99), and mild tricuspid regurgitation (98). Surgical history included cardiac catheterization (4/99). Family history included his grandfather had a myocardial infection in his 40's.* In addition, the vaccinee had a history of cardiomyopathy prior to immunization. On 2/19/99, he presented to vaccine provider for a physical examination. The physician noted cardiac enlargement. An electrocardiogram revealed sinus rhythm with premature ventricular contractions and bigeminy. The vaccinee was referred to a cardiologist. Echocardiograms and cardiac carbeterization revealed a dialated left ventricle withe left ventricular ejection fraction as low as 35 %. *The vaccinee was also noted to have positive Coxcackie virus titers and reduced platelet count. The cardiologist prescribed lisinopril 10 mg daily and one aspirain daily, these were the vaccinee's only medications at the time of immunization.* Following the onset of the reported adverse events, the vaccinee experienced elevated triglyceride concentration. This was not reported as an adverse event due to vaccine administration, but was found during the course of review of the vaccinee's medical records. Therefore, it is not listed as an adverse event. The vaccinee received his first injection of LYMErix at his request on 5/7/99. He "still notes PVCs" at the time of immunization. No adverse experience were recorded in the medical records following receipt of this injection. The vaccinee received his second injection of LYMErix on 6/8/99. *An echocardiogram performed on 7/19/99 revealed left artial and ventricular dilation and a leeft vantricular ejection fraction of 38%. The vaccinee was seen by his cardiologist on 7/26/99, who noted that the recent ochocardiogram results were "very similar to one had ... 6 months ago." An electrocardiogram revealed 1 ventricular actopic beat in every 6 to 7 beats. The cardiologist increased the lisinopril dosage to 40 mg daily. Cardiac stress test with Thallium exercise imaging was performed on 9/24/99 and demonstrated "abnormal exercise Thalliam planar acintigraphy with a dilated left ventricle but no myocardial parfusion abnormality." Equilibrium radionuclide angiocardiography and gaited first pass demonstrated "On these images were left ventricle is enlarged. The right ventricle is enlarged. The right atrium is enlarged. The left atrium is not well visualized. The well motion of the left ventricle was diffusely hypokinetic. The left ventricular ejection fraction is markedly depressed at 28%. The end disatolic volume is elevated at 214 ml. The peak filling rate is abnormal at 1.34 end diastolic volumes/second. The right ventricle is enlarged. However, the right ventricular ejection fraction is normal at 52."* The vaccinee presented to the vaccine provider on 10/1/99 with localized pain under both axillae. The vaccinee reported that he had goen to an ER, where he was told the pain was not heart pain. On physical examination, the vaccine provider noted "localized area of tenderness bilaterally-along anterior axillary line." Lyme IgG western blot demonstrated a 31 KD band; the lab reported this is an "equivocal" result. Lyme IgM western blot demonstrated 23 and 62 KD bands; the lab reported this is an "equivocal" result. *The vaccinee returned to his cardiologist on 10/11/99. The cardiologist noted that the vaccinee "was hospitalized in August because of ventricular actopy. He was studyed by [an electrophysiologist] who felt that he did not have a typical repetitive monomorphic ventricular tachycardia... He had a recent MUGA (multigated angiogram] showing a left ventricular ejection fraction of 28%, but it is possible that part of that drop is due to error since he has so much actopy during the examination. In any event, I am stating Carvedilol (Coreg) 3.125 mg hid (twice daily) and Aldectone [apironolactone] 25 mg bid today... In addition to the Coreg and Aldactone, he will continue with his medications of Liginopril 40 mg a day and aspirin. Also he will speak to [another MD] to have his Lyme disease Western blot exam explained to him. He was 2 bands that axe positive but I am not at all certain that this means that he has Lyme disease." In a letter to the cardiologist dated 10/29/99, the vaccinee's wife stated that the vaccinee "is being treated for Lyme disease w/antiobiotics at this time... We have learned that you may never, in fact, receive a definitive "positive" test as testing procedures are quite unreliable for Lyme. However, we feel it is necessary to research this possibility with [the vaccinee] further."* On 11/5/99, polymerase chain reaction (PCR) generated less tahn 2000 copies/mL hepatitis C, RNA, Lyme IgG western blot deomonstrated a 51kD band; the lab reported this is an "equivocal" result. Lyme IgM western blot demonstrated 23 and 62 KD bands; the lab reported this is an "equivocal" result. *An echocardiogram was performed on 11/10/99. The left ventricular ejection fraction was estimated to be 45%. The interpretine MD concluded, "In comparison to the report of echocardiogram dated 7/21/99, the left ventricular ejection fraction is marginally improved, otherwise no change." The vaccinee returned to his cardiologist on 11/15/99. As that time, he was being treated for Lyme disease with clarithromycin (Biaxin) and doxycycline. The vaccinee reported that he felt well. "On examination, he is looking very well." The cardibiologist increased the carvedilol dosage to 6.25 mg twice daily. The vaccinee underwent echocardiography on 2/9/00. The interpreting MD's impressions were "LVEF [left vantricular ejection fraction] estimated at 45% w/global hypokinesis. Dilated left ventricle. Measurements are only slightly larger than those noted 12/99. Left ventricular function unchanged. Flexible valves w/ou stenosis or significant regurgitation. Mild pulmonary hypertension." He returned to his cardiologist on 2/14/00, who noted that "He is feeling quite well... He has finished 14 weeks of Biaxin and Doxycyaline." The cardiologist increased the carvadilol dosage to 12.5 mg twice daily. Echocardiography performed 4/19/00 demonstrated an estimated left ventricular ejection fraction of 45%. The left ventricular and diastrolic dimension had decreased from 8.9 cm on 2/9/00 to 6.2 cm. In a letter dated 5/26/00, the MD who treated the vaccinee for Lyme disease wrote, "This PT, a dear hunter w/excessive tick exposure in a Lyme endemic area, has had a long history of ventricular ectopy. In March of 99, the PT had an ejection fraction of 35%. In April of 99, a heart cathetarisation was negative and the ejection fraction was 50%. The PT then received the LYMErix vaccine 5/99 and 6/99, and reports having had dramatically increased cardiac symptoms temporally related to the administration of the vax. In July of 99, the PT's ejection fraction dropped to 38% and by 9/99, it had dropped to 28%. In 10/99 and 11/99, Lyme Western blotting demonstrated reactivity to IgM 23 and 62, and as expected from the vaccine, reactivity to IgG 31. Reactivity to band 23, Osp C of 3. burgdorferi, is highly suggestive Lyme borraliosis. It suggests that this deer hunter from a Lyme endemic area may have had Lyme borroliosis as the cause of his cardiac disease. As such, I treated the PT with several months oral antibiotics. His ejection fraction and heart chamber size had improved. As of 4/00, his ejection fraction was now 43% and his left ventricle had become smaller. He still has abnormal heart function, but it is improved. It should be noted that the PT also received Coreg, Zestril (lisinopril), and spironolactone as part of his cardiac medical regimen. On 8/28/00, the vaccinee was seen by his cardiologist. "He had a gated blood pool study on 8/16/00. It showed a left ventricular ejection fraction of 45% which is exactly where his echocardiograms have been for the last year. The left ventricle is enlarged with an end diastrolic volume of 208 nillititers... His electrocardiogram is unchanged. He has sinus bradycardia w/a heart rate of 42 beats per minute. This is, undoubtedly, the effect of Carvedilol." An echocardiogram performed on 6/7/00 demonstrated an ejection fraction that was "marginal improved" to 45 to 50%. An echocardiogram performed on 2/14/01 demonstrated "no significant change" in comparison to the 6/7/00 echocardiogram. The vaccinee was seen by his cardiologist on 2/19/01. "He has had a very good six mts. He went skiing this winter with no ill effects and also went hunting and hiking this past fall." He returned to the cardiologist on 9/13/01. No change in his condition was noted. The vaccinee returned to his cardiologist on 3/21/02. "He is feeling quite well." It was noted that his cardiac examination was "totally w/in normal limits" and his electrocardiogram was "normal". His echocardiogram done on 3/15/02 was "virtually unchanged from previously. His left ventricular and diastrolic dimension was 6 60 cm and his left ventricular ejection fraction was estimated to be 40-45%." In a Statement of Injuries, his attorney alleged that the vaccinee "suffers from joint pain, in particular in his knees, back, ribs, neck and jaw. He also experiences fatigue. In addition, he suffers from cardiomyopathy. Moreover, [he] has been diagnosed with Lyme disease." Time to onset following immunization, treatment, and outcomes of the alleged events were not reported. The most recent info, received 6/13/02, did not specify the outcomes of the reported events. Info received 2/25/02 indicated that the cardiomyopathy persisted as of 9/13/01, and that the vaccinee was asymptomatic. The outcome of the Lyme disease was not provided.*  Reported on 02/27/2003: "The most recent information, received 02/14/2003, indicated that the cardiomyopathy had improved.  The outcome of the Lyme disease was not provided. A 15-day follow up report received 09/17/03 adds: The most recent info, received on 08/29/2003, indicated that the cardiomyopathy was "clearly quite stable". The outcome of the Lyme disease was not provided. A 15-day follow up report received 10/01/2003 adds: The most recent info received on 09/16/2003, did not provide the outcomes of the reported events. Info received on 08/29/2003 indicated that the cardiomyopathy was "clearly quite stable".    Follow up on 06/17/04: "no new information."