Age: 72.0
Sex: M
Vaccine: LYME
Symptoms: Medication error, Paraesthesia oral
Clinical narrative: Some time post vax, the pt developed osteoarthritis, burning sensation in esophageal tract. The outcome of these events was not provided. The follow up states this report describes dysesthesia and burning mouth syndrome in a 72 year old male who received Lyme disease vaccine recombinant OspA. Additional info was received as part of litigation proceedings. Medical history included difficulty sleeping, bilateral heel suprus, osteoarthritis of the left knee, degenerative changes of the dorsal spine, gout, benign prostatic hypertrophy, hypercholesterolemia, elevated triglycerides, hypertension, glucose intolerance, elevated lactic dehydrogenase, elevated SGOT, elevated creatine kinase, elevated eosinophil counts, and elevated SGPT. The pt had no known allergies and no history of Lyme disease. Surgical history included tonsillectomy and adenoidectomy and repair of a deviated nasal septum. Family history was significant for his father dying at age 38 and his sister dying at age 56; the pt reported the cause of their deaths as "liver." The pt reported that he jogged three miles per day, six days per week. Concurrent medications included Monopril, colchicine, temazepam at bedtime, Lopid, multivitamin, vitamin E, vitamin C, vitamin B complex, and garlic. Following the reported onset of dysesthesia and burning mouth syndrome, the pt experienced increased serum creainine concentration, suspected prostatitis, first-degree atrioventricular block, a urinary tract infection, ringing in the ears, and abscess and cellulitis around the left knee. These 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 0.5mL IM injection of LYMErix on 2/11/99. The pt was seen by his primary physician on 2/23/99. 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 0.5mL IM injection ofLYMErix on 3/18/99. No adverse experience was recorded in the vaccine provider's office records following the administration of this injection. The pt received his third 0.5mL IM injection of LYMErix on 4/22/99, 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 Propulsid, Prevacid, and 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 5/21/99, 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 5/20/99 (29 days post-immunization). The physician made a diagnosis of peptic ulcer disease and prescribed Prevacid 30mg daily. The pt was not seen again by the vaccine provider until 7/15/99; 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 indigenstion. 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 9/20/99 with a chief complaint of epigastric pain. At that time, the pt reported that the burning sensation started following receipt of LYMErix in February 1999. The pt reported that the burning sensation now extended "into throat and mouth." The physician made a diagnosis of gastroesophageal reflux disease and prescribed Aciphex 20mg daily. Antibodies against Helicobacter pylori were measured on 9/29/99: IgG and igM antibodies were negative. The pt was referred to a gastroenterologist. The pt underwent esophagogastroduodenoscopy and colonoscopy on 10/15/99. Mild gastritis, mild duodentiis, and hypertrophy were observed. The gastroenterologist's impressions were "mild gastritis, prepyloric inflammation, hypertrophy." The pt then underwent colonoscopy. One to three diverticulums were identified and three 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 "stomach, antrum: benign hypertrophic gastric mucosa. No H. pylori organisms identified. Colon, proximal cecum: tubular adenoma. Colon, distal cecum: mildly edematous colonic mucosa. Colon ascending: hyperplastic polyp." The pt was seen by his primary physician on 11/4/99. At that time, he reported that the gastroenterologist had prescribed Propulsid 10mg 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 esophagram was performed on 11/8/99. The radiologist's impression was "unremarkable esophagram." Ultrasound ofthe gallbladder was performed on 11/26/99, 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 gaastroenterologist on 11/12/99 for 'evaluation of chronic reflux symptoms." The pt reported that he "has been free of any digestive symptoms until April of  htis year after he received the Lyme disease vaccination and subsequently developed heartburn, burping and acid regurgitation, occurs dya and night, not necessarily related to meals, for which he has been treated with antacids, Prevacid and Priolosec in the past with no significant relief. He has been treated with Aciphex and propulsid with marginal relief. His appetite is well maintained. There is no recent histroy of dysphagia, odynophagia, significant abdominal pain, alteration of bowel movement or weight loss. Physical examination in the office is unremarkable including abdominal examiantion." In a letter to the vaccine provider, the gastroenterologist stated "Per phone conversation with the pt on 12/2/99, his reflux symtpoms have been significantly improved while on Aciphex therapy lately." On 11/18/99, the pt underwent an esophageal manometry study and 24 hr pH probe was inserted. THe gastroenterologist's impression of the study was "normal esophageal manometry study." No gastroesophageal reflux was observed with the 24 hr pH probe. The pt was seen by the reporting physician on 1/3/00. At that time, he reported his chief complaint 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 reated the pain as "seven to eight." At that time, he also reported ringing in his ears. In his rreview, the physician wrote, "Pt described sensations as dysesthesia. Pt is able to identify this symptoms as dysesthesia." On 1/4/00, total Lyme antibodies by EIA were 2.15. Lyme IgG Western blot analysis was negative; only a 31kDa band was present. Lyme IgM Western blot analysis was negative; only a 31 kDa band was present. On 1/14/00, serologies for hep B and C were negative. Total hep A antibody was reactive. The pt was seen by the reporting physician on 4/13/00 "for increased sensation of burning to tongue and into throat. Pt denies GERD, 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 examination, 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 Medro Dosepak "had helped in past." Tbe physician prescribed another course. The reporting physician saw the pt on 7/11/00 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 liber enzymes and creatinine were noted. On  7/21/00, the physician's assessment was "rule out hepatitis." The pt was seen in a pain management clinic on 8/22/00, 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 three Lyme disease vaccine IM injections one month apart. He states that a few days after the first injection, he began to experience burning sensation in his 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 sternuma nd costochondral joints. Sensation to pinprick is within normal limits in his face, neck and anterior chest wall." The physician's impression were "chronic neuropathic pain. Rule out burning mouth syndrome." The physician prescribed Neurontin 100mg three times daily. On 8/24/00, folic acid and vitamin B12 concentrations were normal. The pt was seen by the gastroenterologist on 9/26/00 for follow-up regarding the colonic polyps which had been removed on 10/15/99. His medications at that time included Monopril 20mg daily and colchicine 0.6mg daily. The pt reported persistent burning in his chest. The physician's impression was "atypical chest pain." The pt underwent EGD on 10/23/00. The gastroenterologist's impressions were "small gastric ulcer involving the antrum of the stomach. Grade I reflux esophagitis." NO helicobacter-like organisms were seen in the biopsy specimen. The pt also underwent colonoscopy. THe gastroenterologist's impressions were "mild left-sided diverticulosis. No polyps, masses or colitis." THe gastroenterologist stated, "certainly the reflux changes can account for the pt's atypical chest pain. The pt should be on a proton pump inhibitor for a minimum of two motnhs and I have given him a prescription for Prevacid 30mg 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 1/22/01 "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 50mg twice daily. Serologies for hepatitis had been repeated on 1/16/01. Serologies for hep B and C were negative. Hep A IgM was non-reactive. On 2/27/01, the pt saw the reporting physician "for complaint of increased burning mouth syndrome." On physical examination, the physiican noted "right platysmal muscle deformity and right facial asymmetry." The physician's assessment was burning mouth syndrome and facial asymmetry. On 2/28/01, total Lyme antibodies by EIA were <1.00. The pt underwent computed tomography of the brain, neck and chest, with and without contrast on 3/3/01. The results were "unremarkable." On 3/19/01, the pt was referred to a neurologist. On 4/2/01, rheumatoid factor and antinuclear antibody (ANA) titer were negative. Erythrocyte sedimentation rate was 11mm/hr. The pt was evaluated by a neurologist on 4/16/01. At that time, the pt reported that in addition to the "burning sensations" and dysesthesias previously described, he began having difficulty swallowing food in January 2001 and beginning in February 2001, he began to experience sensations of dryness and the subjective sensation that his eyes were "shrinking" as well as "burning" surrounding his eyes. Additionally, the pt reproted that on 3/25/01, without any warning, he lost all ability to see newsprint on a newspaper, which lasted a few hours before resolving. No abnormalities were noted on physical examination. The neurologist's impressions were "neurological examination today is 'normal' and fails to demonstate evidence of any significant focal or lateralized features. With the clinical history at hand it appears that the pt's complaints of 'sensory' distortion and 'burning' dysesthesias most likely reflect a postvaccinaiton neuropathic problem which is an unusual complication of the Lyme's prophylactic treatment. However, the rapid sequence of injections that he was given and the fact that they continued to be give despite his initial problems probably predisposed him to these persistent symptoms. Though this has not been recommended for patients over 70 I am uncertain as to what role this has actually played in his ongoing saga. The pt's recent problems with 'swallowing' that began in January 2001 remains a confusing issue. However, I suspect that it is probably another manifestation of the 'burning' dysesthesias and 'sensory' perversion that he is experiencing. Nevertheless, I feel that further 'GI' investigation is warranted. THe pt's most recent problem with transient 'visual' distortion which occurred on 3/25/01 remains a confusion issue if by nothing else by the vague and poor description. However, we cannot exclude that this might ahve reflected an unusual type of 'TIA.'" The physician prescribed Neurontin. Additional diagnostic evaluations were unrevealing, except for an abnormal barium swallow. The pt remained under the care of this neurologist until at least 7/16/01. During this time, the physician noted that the pt'sneck had "moderately decreased range of motion in all directions." It was noted by the physician that the pt remained clinically stable from a neurological standpoint. The neurologist suggested consideration of acupuncture. The pt wsa seen by the gastroenterologist on 5/1/01 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 two months, mostly with solids but more of difficulty initiating swallow consistent ith oropharyngeal dysfunctional process." His impression was "dysphagia, most consistent with oropharyngeal process quite possibly related to Lyme disease from vaccine." A formal swalowing study was recommended. The results of a modified barium swallow performed on 5/8/01 were interpreted as no abnormality with use of liquid consistency barium but mild retention of solid consistency barium. The pt was evaluated by an ophthalmologist on 4/14/201. At that time, the pt reported, "burning around both eyes. A feeling tha both eyes are swollen. An episode of gray vision in both eyes. He states that ever since he has had Lyme disease immunization injections there has been a burning feeling of the skin around both eyes and both eyes feel somewhat swollen. He also claims that on 3/25/01 he had one episode of gray vision in both eyes that lasted approximately 45 mintues. This occurred while he was indoors. It was moderate to severe. He could not read a newspaper or see anything clearly. After this episode he saw what he calls heat waves in front of his eyes. He states that this seemed to have occurred intermittently for a few days but then it disappeared, and he has not seen any since. His vision subsequently has returned to normal." On examination, visual acuity was 20/40 in the right eye and 20/30 in the left eye with his corrective lenses. "He had a mild amount of blepharochalasia in the inferior eyelids but no erythema. He has prominent muscle insertions on the sclera of each eye. Both corneas were clear; however, he does have a decrease in the tear meniscus with a small amount of mucus in the teat film. He has very early nuclar and cortical cataracts in both eyes. Dialated fundoscopic examination reveals some mild floaters in both eyes. The macular reflex was slightly reduced but the macules were dry with only a minimla amount of dark pigmentation. The nerve fiber layer appeared to be intact in both eyes. The vessels appeared to be of relatively normal size wihtout plaques." The physician's diagnoses were "asthenopia of both eyes of unknown etiology. Possible amaurosis fugax of both eyes. Cataracts of both eyes. Cupping of the optic nerves both eyes. Dry eyes." The physician noted the origin of the asthenopia to be unknown and stated that he had no suggestions on how to treat it. He felt that the possible amaurosis fugax was non-opthalmic in origin and that cardiovascular or neurological etiology "should be entertained." The physician prescribed artifical tears to be used as needed. Transcranial Doppler sonography and bilateral carotid duplex performed on 5/14/01 did not reveal any abnormalities. 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. Information received on 3/2/01 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 5/17/02, did not provide the outcomes of the dysphagia, facial droop, osteoarthritis, or Lyme disease. The dysesthesia and burning mouth syndrome persisted as of 7/16/01. The adverse events of dysesthesia, burning mouth syndrome, facial droop, and osteoarthritis do not meet serious criteria but being submitted as an expedited report by special FDA request per the 6/28/00 letter.