Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Hypertension, Hypotension, Hypoxia, Laboratory test abnormal, Neck pain
Clinical narrative: This report describes the occurrence of asthma in a 52 year old male who was vaccinated with Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, with forwarding of medical records. The subject's past medical history included asthma (October 1993), hypertention (June 1995), chronic neck pain following a motor vehicle accident, low back syndrome, low back pain (June 1997), right ulnar wrist pain (June 1997), right hand pain (June 1997), lateral ligament laxity of both ankles, grade II impingement syndrome (April 1991), left upper extremity pain (1991), paresthesia (1991), left shoulder bursitis (1991), left bicipetal tendonitis (1991 and September 1996), left rotator cuff tendonitis (May 1993 and September 1996), multiple bilateral ankle sprains, right shoulder pain and tightness (1996), myofascitis (April 1992), lumbar degenerative disc disease (1997), lumbar scoliosis, and recurrent left groin pain (1994). Of note, the subject was a barber and avid golfer. Concurrent medications included Rhinocort, Claritin, Proventil, Azmacort, AeroBid, Norvasc, Flomax, Prilosec, quinine sulfate, Relafen, Vioxx, levaquin, Ceftin, Cipro, Debrox, Nexium, Celebrex, Propusid, neomycin/polymyxin B sulfate/hydrocortisone, Veetids, acetaminophen/codeine, Cleocin, Roxicet, acetaminophen/hydrocodone, Nasonex, cephalexin, Fatanol, and lorazepam. The subject received LYMErix on 4/29/99 (lot number not provided), 5/27/99 (lot number not provided), and 5/8/00 (lot number not provided). On 2/11/02, in a Statement of Injuries, the subject's attorney alleged that the subject "suffers from joint pain. He also suffers from high blood pressure and asthma." The following information was obtained from medical records. The subject presented to the vaccine provider, who is also his primary care physician on 10/6/99 with complaints of coughing, wheezing, and shortness of breath. On physical examination, the physician noted that the subject had slight wheezes. The physician made a diagnosis of bronchial asthma and prescribed Azmacort. The subject remained under the care of this physician until at lest 12/17/01. Laboratory analyses performed on 5/16/00 demonstrated some abnormal results. On 11/7/00, the physician made a diagnosis of asthmatic bronchitis. The physician prescribed AeroBid, singulair, Flovent, Combivent, Cefzil, Advair, and Nasonex. The subject presented to the ER on 2/10/00 with complaints of shortness of breath, which began earlier that day. He had been using his inhalers as directed, but the shortness of breath persisted. He stated he had a fever, which broke on 2/9/00. He also had a productive cough and had been started on antibiotics. On physical examination, the physician noted the subject was in mild respiratory distress with bilateral expiratory wheezes. During this time, the physician noted his pulse oximetry was92% on room air, which indicated "some slight hypoxia." The subject was started on an asthma protocol (NOS). After two breathing treatments (NOS) he "cleared totally and was feeling much better." The physician made the diagnosis of asthma exacerbation and prescribed prednisone. The subject was to continue with his inhalers and antibiotics as directed. The physician referred the subject to follow up with his family physician. From 7/13/01 to at least 12/7/01, the subject was under the care of a chiropractor. The subject reported that he experienced lower back, neck and shoulder pain. The subject reported he had no recent trauma or illnesses "except arthritis, which he says is from Lymes (sic) disease which is being medically treated." The subject stated his pain increased with work and golf and was releived by CMT (certified message therapy) in the past. The chiropractor noted subluxation of C2/3, C6-T1, T4, including his rib on T5 right. He also noted "T/L junction and pelvic unleveling," swelling over bilateral sacroiliac joints, and multiple regions of myospasm and myofasical triggering in the upper thoracic and cervical spine. The chiropractor instructed the subject to apply ice to swollen joints and return as needed. The subject reportedly "Responded well to CMT." Following the administration of LYMErix, the subject experienced acute pharyngitis, acute sinusitis, symptomatic bladder outlet obstruction, left ankle sprain with soft tissue swelling and a small joint effusion, extensor carpi ulnaris tendinitis, right wrist tendonitis, benigh prostatic hypertrophy, decreased hearing secondary to right ear cerumen, syncope, and lumbosacral spain.. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. Information received 2/15/02 indicated that the subject required emergency room treatment for asthma. Therefore, the asthma in this report is considered medically serious and this report has been reclassified as serious, unexpected. The most recent information, received on 7/29/02, did not provide the outcomes of the reported events.