Following the second dose of Lymerix, the pt experienced a burning sensation of the stomach, esophagus, and tongue. An EGD was done. Stomach biopsy showed gastritis out 24 hour monitoring of gastric contents was normal. The MD felt that the pts condition was related to dysesthesia, neurologically caused. The pt was treated with Propulsid, Prevacid, and Carafate which did not alter his symptoms. Upon diagnosis it was found that the pt had a right sided facial droop. Cranial nerves were normal.   The most recent information received on 1/4/00, reported the condition of the pt is ongoing. A 15-day follow up report received 04/19/2002 adds: Report 2000000077-1 describes dysesthesia and burning mouth syndrome in a 72-year-old male who received Lyme disease vaccine recombinant (Lymerix). Additional info was received as part of litigation proceedings. Medical history included difficulty sleeping, bilateral heel spurs, osteoarthritis of the left knee (1986), degenerative changes of the dorsal spine (T5-T8, 1991), gout (1995), benign prostatic hypertrophy (1996), hypercholesterolemia (1996), elevated triglycerides (1996), hypertension (1997), glucose intolerance (1997), elevated lactic dehydrogenase (1995), elevated SGOT (1995), elevated creatine kinase (1996), elevated eosinophil counts (1997) and elevated SGPT (1999). The pt has no known allergies and no history of Lyme disease. Surgical history included tonsillectomy (1964) and unspecified nasal surgery(1965). Family history was significant for his father dying at age 34 and his sister dying at age 56: the pt reported the cause of their deaths as "Liver". The pt reported that he jogged 3 miles per day, six days per week. Concurrent medications included fosinoprel (Monopril) 20 mg daily, colchicine 0.6 mg daily, and tomazepam 30 mg daily at bedtime. Following the reported onset of the dysesthesia and burning mouth syndrome, the pt experienced increased serum creatinine concentration, suspected prostatitis, first-degree atrioventricular block, and ringing in the ears. There 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 pt received his first 0.5 mL intramuscular injection of Lymerix (lot LY12BD) on 02/11/1999. The pt was seen by his primary physician (the vaccine provider) on 02/23/1999. At that office visit, the pt reported that he "felt very tense, nervous" after receiving Lymerix, but "feels good now". The pt received his second 0.5 mL intramuscular injection of Lymerix (lot LY120BD) on 03/18/1999. No adverse experience was recorded in the vaccine provider's office records following the administration of this injection. The pt received his third 0.5 mL intramuscular injection of Lymerix (lot LY120BD) on 04/22/1999, two months after the first injection, rather than the recommended interval of 12 months. The reporting physician stated that the pt experienced a burning sensation of the stomach, esophagus and tongue. The pt was treated with cisapride (Propulsid), lansoprazole (Prevacid) and sucralfate (Carafate), which did not alter his symptoms. On physical examination, it was noted that the pt had a mild right-sided facial droop. Cranial nerves were normal. The physician attributed the burning sensation to a neurologically-caused dysesthesia. The following info was obtained through review of medical records. On 05/21/1999, 30 days after the administration of the third injection of Lymerix, the pt was seen by his primary physician with a chief complaint of "stomach burn, nausea, diarrhea, epigastric pain", the pt reported symptom onset on 05/20/1999 (25 days post-immunization). The physician made a diagnosis of peptic ulcer disease and prescribed Prevacid 30 mg daily. The pt was not seen again by the vaccine provider until 07/15/1999; reason for the visit was evaluation of hypertension and hypercholesterolemia. The pt reported that he still experienced "stomach burning sensation". The physician noted "He is having trouble with indigestion. He said that the Prevacid has helped before." The physician made a diagnosis of peptic ulcer disease and prescribed Prevacid. The pt was seen by the vaccine provider on 09/20/1999 with a chief complaint of epigastric pain. At that time, the pt reported that the burning sensation started following receipt of Lymerix in Feb 1999. The pt reported that the burning sensation now extended "into throat and mouth". The physician made a diagnosis of gastroesophageal reflux disease (GERD) and prescribed rabeprazole (Aciphax) 20 mg daily. Antibodies against Helicobacter pylori were measured on 09/25/1999: IgC and IgM antibodies were negative. The pt was referred to a gastroenterologist. The pt underwent esophagogastroduodenoscopy (EGD) and colonoscopy on 10/15/1999. Mild gastritis, mild duodenitis, and hypertrophy were observed. The gastroenterologist's impressions were "1. Mild gastritis, propyloric inflammation. 2. Hypertrophy." The pt then underwent colonoscopy. One to 3 diverticulums were identified and 3 polyps were removed. The gastroenterologist's impression was "Polyps of the right colon." The pathologist's diagnoses, based upon specimens obtained during EGD and colonoscopy, were "A. Stomach, antrum: Benign hypertrophic gastric mucosa. No H. pylori organisms identified. B Colon, proximal secum: Tubular adeonma. C. Colon, distal cecum: Mildly edematous colonic mucosa. D. Colon ascending: Hyperplastic polyp." The pt was seen by his primary physician on 11/4/1999. At that time, he reported that the gastroenterologist had prescribed Propulsid 10 mg daily, but it was "not helping". The pt stated that he had been experiencing "abdominal pain, burning feeling" since receiving Lymerix in April 1999. On physical examination, the physician observed a ventral hernia when the pt flexed his abdomen. The hernia was "about 3 to 4 inches up from xyphoid to above umbilicus." It was not tender. The physician's assessment was "Abdominal pain - secondary to ventral hernia?" An esophogram was performed on 11/08/1999. The radiologist's impression was "unremarkable esophogram." Ultrasound of the gallbladder was performed on 11/26/1999, which "shows a normal appearing gallbladder, which is free of stones. There is also no evidence of bile duct dilatation." The pt was seen by a gastroenteroloist on 11/12/1999 for "evaluation of chronic reflux symptoms." The pt reported that he "has been free of any digestive symptoms until April of this year after he received the Lyme disease vaccination and subsequently developed heartburn, burping and acid regurgitation, occurs day and night, not necessarily related to meals, for which he has been treated with antiacids, Prevacid and Prilosec in the past with no significant relief. He has been treated with Aciphex and Propulsid with marginal relief. His appetitie is well maintained. There is no recent history of dysphagia, odynophagia, significant abdominal pain, alteration of bowel movement or weight loss...Physical examination in the office is unremarkable including abdominal examination." In a letter to the vaccine provider, the gastroenterologist stated, "Per phone conversatio with (the pt) on 12/2/1999, his 'reflux symptoms' have been significantly improved while on Aciphex therapy lately." On 11/18/1999, the pt underwent an esophageal manometry study and 24-hour pH probe was inserted. The gastroenterologist's impression of the esophageal manometry study was "Normal esophageal manometry study". No gastroesophageal reflux was observed with the 24-hour pH probe. The pt was seen by the reporting physician on 01/03/2000. At that time, he reported his chief complain as "Acid Reflux". He indicated that the pain was a constant burning and was located in his abdomen. On a scale of zero to ten, he rated that pain as "7 to 8". At that time, he also reported ringing in his ears. In his review, the physician wrote, "Pt described sensations as dysesthesia. Pt is able to identify this symptom as dysesthesia." On 01/04/2000, total Lyme antibodies by RIA were 2.15 (seropositive >0.99). Lyme IgG by Western blot analysis was negative; only a 31 kDa band was present. Lyme IgM by Western blot analysis was negative; only a 31 kDa band was present. On 01/14/2000, serologies for hepatitis B and C were negative. Total hepatitis A antibody was reactive. The pt was seen by the reporting physician on 04/13/2000 "for increased sensation of burning to tongue and into throat. Pt denies GERD (gastroesophageal reflux disease), gas symptoms. Sense of smell is unaffected. No dysphagia with food/fluids. Pt admits to increased pain with numbness/tingling sensation to upper lip area and radiates to roof of mouth, bilateral nares, and chest area. Pt describes as furnace burning." On physical examinatino, the physician noted "right facial droop persists/unchanged". The physician's impression was "Dysensation to glossal/pharyngeal/nares area". The pt reported that a rapidly tapering course of methylprednisolone (medrol dosepak) "had helped in past". The physician prescribed another course. The reporting physician saw the pt on 07/11/2000 for a routine physical examination. The pt reported that his only complaint was "chronic burning pain to throat/chest". The physician's impression was "chronic complaint of dyspepsia/retrosternal pyrosis. Elevated concentrations of liver enzymes and creatinine were noted. On 07/21/2000, the physician's assessment was "rule out hepatitis". The pt was seen in a pain management clinic on 08/22/2000, with a chief complaint of "burning pain in his throat, mouth and chest". The pt told the pain management physician that "he was in his usual state of health until February of 1999 when...he received 3 Lyme disease vaccine intramuscular injections one month apart. He states that a few days after the first injection, he began to experience burning sensation in this stomach. After the second injection, the burning worsened. After the third injection, the burning progressed to his throat and mouth and nose...He describes his pain as burning, constant, not aggravated and not relieved by any medications or maneuvers...He denies having problems with sense of taste and smell." On physical examination, the physician "could not aggravate his pain by light palpation of his lips and face. I could not reproduce his anterior chest wall pain on percussion and palpation of his sternum and costochondral joints. Sensation to pinprick is within normal limits in his face, neck and anterior chest wall." The physician's impressions were "1. Chronic neuropathic pain. 2. Rule out burning mouth syndrom." The physician prescribed gabapentin (Neurontin) 100 mg three times daily. On 08/24/2000, folic acid and vitamin B12 concentrations were normal. The pt was seen by the gastroenterologist on 09/26/2000 for follow-up regarding the colonic polyps which had been removed on 10/15/1999. His medications at that time included Monopril 20 mg daily and colchoine 0.6 mg daily. The pt reported persistent burning in his chest. The physician's impression was "Atypical chest pain". The pt underwent EGG on 10/23/1999. The gastroenterologist's impressions were "1. Small gastric ulcer involving the antrum of the stomach. 2. Grade I reflux esophagitis." No Helicobacter-like organisms were seen in the biopsy specimen. The pt also underwent colonoscopy. The gastroenterologist's impressions were "1. Mild left-sided diverticulosis. 2. No polyps, masses or colitis." The gastroenterologist stated "Certainly the reflux changes can account for the pt's atypical chest pains. The pt should be on a proton pump inhibitor for a minimum of 2 months and I have given him a prescription for Prevacid 30 mg once a day...Lifestyle modification has been discussed with the individual. He also recommended a high-fiber diet. The pt was seen by the reporting physician on 01/22/2001 "for complaint of diffuse arthralgias since November". The pt reported that the burning and dysesthesia persisted. However, "Pt relates he feels fine." The physician's assessment was arthralgia and gout. He prescribed indomethacin 50 mg twice daily. Serologies for hepatitis had been repeatedd on 01/16/2001. Serologies for hepatitis B and C were negative. Hepatitis A IgM was non-reactive. On 02/27/2001, the pt saw the reporting physician "for complaint of increased burning mouth syndrome." On physical examination, the physician noted "right platysmal muscle deformity and right facial asymmetry. The physician's assessment was burning mouth syndrome and facial asymmetry. On 02/18/2001, total Lyme antibodies by RIA were <1.00 (negative, <1.00). The pt underwent computed tomograph (CT) of the brain, neck and chest, with and without contrast, on 03/03/2001. The results were "Unremarkable". On 03/18/2001, the pt was referred to a neurologist. On 04/02/2001, Erythrocyte sedimentation rate was 21 mm/hr. The pt was seen by the gastroenterologist on 05/01/2001 with a chief complaint of "trouble swallowing". At that time, the pt reported that he had "Lyme disease secondary to vaccination". The physician noted "recent onset of dysphagia over the past 2 months, mostly with solids but more of difficulty initiating swallow consistent with oropharyngeal dysfunctional process." His impression was "Dysphagia, most consistent with oropharyngeal process quite possibly related to Lyme disease from vaccine." A formal swallowing study was recommended. The pt stated that, following receipt of the third injection of Lymerix, he was told he had "acid reflux" which "was coincidental" to Lymerix administration. The pt alleged that he "developed a severe and permanent burning sensation along his entire oropharyngeal/esophageal tract". He also claimed that he sustained "severe and permanent injuries to his mouth, tongue, throat, esophagus, stomach and digestive tract". The pt claimed that he is also "suffering from osteoarthritis". The onset of this event, affected joint and treatment were not provided. Info received on 03/02/2001 did not specify treatment of the facial droop or osteoarthritis. The burning sensation along the pt's oropharyngeal/esophageal tract was reportedly worsening. The facial droop and osteoarthritis were ongoing. The most recent info received on 11/30/2001, did not provide the outcomes of the dysphagis, facial droop, osteoarthritis, or Lyme disease. The dysesthesia and burning mouth syndrome persisted as of 03/19/2001. The adverse events of dysesthesia, burning mouth syndrome, facial droop, and osteoarthritis do not meet ICM serious criteria, but are being submitted as an expedited report by special FDA request per the 06/28/2000 letter. Case number 2001004203-1 has been identified as a duplicate record to this case (2000000077-1) and all relevant info has been merged into this case. Case number 2001004203-1 will be logically deleted from the database and this case, number 1000000077-1, will stand as the case of record for this patient.