Age: 28.0
Sex: M
Vaccine: LYME
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Back pain, Bacterial infection
Clinical narrative: Report A0381929A describes joint pain in a 27 year old male who received Lyme disease vaccine recombinant OapA (Lymerix). This report was received as part of litigation proceedings, with forwarding of medical records. The patient's medical history included hypercholesterolemia, childhood asthma, allergic rhinitis, upper respiratory tract infection, right shoulder bursitis, right cubital tunnel syndrome, and acne. The subject had no known drug allergies. Family history was significant for unspecified arthritis, hypertension, and breast cancer in the patient's mother, stroke in the patient's father. Concurrent medications included loratadine (Claritin), Fosinopril (Monopril), simvastatin (Zocor), and topical tretinoin (Retin-A). The subject received injections of Lymerix on 4/6/99 (LY120D9) and 5/13/99 (LY120D2). In a Statement of Injuries, his attorney alleged that the subject "suffers from joint pain, loss of breath and fatigue. These symptoms required hospitalization. He also experienced a rash". The following information was obtained from medical records. The subject presented to the vaccine provider on 6/3/99. He reported a 2 day history of sore throat, head congestion, feeling "hot/cold", odynophagia, cough productive of white sputum and post-nasal drip. The subject reported that he had experienced fatigue, malaise, fever and chills the previous night. "Pt reports the same set of symptoms occurred in 12/98 when he had a viral URI. Pt denies chest pain, SOB, nausea/vomiting/diarrhea." The subject self-medicated with Advil Cold & Sinus. On exam, the physician noted bilateral nasal erythema and "mild" pharyngitis without exudate. His impression was "Pharyngitis/URI". An in-office test for streptococcus was negative. The physician prescribed Tylenol and Entex LA. The subject returned to the vaccine provider on 6/5/99 with worsening sore throat and fevers. On exam, the physician noted injected oropharynx, tonsillar exudate and bilateral swollen anterior cervical lymph nodes. An in-office test for streptococcus yielded a "weak positive" result. The physician's impression was "Acute follicular/streptococcal tonsillitis" and he prescribed Pen VK and Tylenol. The subject returned on 7/14/99 with a 1 day history of "pink spots" on his legs and face that were itchy and burning. He also reported sore throat, lower backache, myalgias and arthralgias. He had self-medicated with Benadryl. On exam, the physician noted "slight" erythema of the pharynx with no exudate. He observed "clustered vesicles on erythematous base" on the pt's nose, cheeks and legs "with crusting". His impression was "HSV" initial outbreak. He prescribed Valtrex. The pt returned on 7/15/99 with bilateral wrist and knee pain, stiff neck, continued sore throat and extension of the rash. The pt was "concerned about Lyme disease". On exam, the physician noted erythema of the throat and a red rash on the face and neck. An in-office test for streptococcus yielded a "weak positive" result. The physician's impression was "Strep pharyngitis". He continued Valtrex therapy and added Vantin. Lab analyses performed on 7/16/99 revealed a decreased lymphocyte count. Lyme total antibody screen was positive; IgG and IgM Western blots were negative. The pt presented to the local ER on 7/18/99 with complaints of "moderate and progressive general malaise, myalgias, arthritis and pleuritic chest pain for 2 days prior to arrival. Symptoms began while at rest; they have been increasing. The pt reported no improvement after beginning Vantin. He also reported that he had taken Relafen. On exam, the pt's temperature was 100.7F. The physician noted "initially tachycardia..The pt is in much distress initially with myalgias. It is difficult for pt to walk without assistance". The throat was "erythematous without abscess". The physician also noted "diffuse joint pains. The pt was hydrated with IV normal saline solution "with moderate objective improvement". The ER physician prescribed IV Toradol, Percocet, IV doxycycline and IV Rocephin. The pt was hospitalized with dx of "acute sepsis rule out acute Lyme disease". The pt was evaluated by an infectious disease specialist "for an acute febrile illness with rash". The pt told this physician that he had a rash on his palms and soles. On exam the specialist noted "an early confluent, morbilliform type of rash on the face which seem to be resolving. There are some papules present in the palms and the soles, more on the palms than the soles but in both places the papules are fairly sparse, particularly compared to the face. Pharynx shows enlarged tonsils, lymph nodes are palpable but small in the anterior cervical region." His impression was "Acute febrile illness with rash that involves face, palms and soles with what is exudative pharyngitis/tonsillitis".  He stated that "Lyme disease is unlikely cause of this acute illness". He ordered labs and continuation of doxycycline and ceftriaxone therapy. The pt was also evaluated by a cardiologist. Results of an ECG were consistent with acute pericarditis. His impressions were "Acute pericarditis in the setting of acute febrile illness likely related to acute strep infection, ? rheumatic fever, ? Lyme disease, ? viral, ? mononucleosis". The cardiologist discontinued ketorolac therapy and prescribed Indocin. On 7/19/99, the cardiologist noted myopericarditis and transferred the pt to a tertiary care center for further investigation. The cardiologist prescribed high-dose aspirin, Levaquin, Lasix, Capoten and digoxin. An infectious disease specialist Rx'd doxycycline. His symptoms improved and he was discharged from the hospital on 7/27/99. He remained under the care of the cardiologist at the tertiary care center until at least 8/14/01. On 8/6/99, the cardiologist wrote a letter to the pt's local cardiologist stating his was much better. He wrote, "I remain uncertain as to the exact etiology of the pt's 'syndrome'". On 8/27/99, he discontinued furosemide and captopril therapy and prescribed fosinopril (Monopril). On 8/14/01, the pt reported that he "fatigues easily...occasional SOB with extreme activity i.e. shoveling." The pt remained under the care of his local cardiologist until at least 10/17/01 when the pt reported that he feels fine and was asymptomatic. Following the reported onset of joint pain, the pt experienced idiopathic cardiomyopathy, sinus bradycardia, PVC's, right rotator cuff strain, ulnar impingement syndrome of the right wrist, cellulitis of the right foot, acute sinusitis, right otitis media, tinea cruris, gastroenteritis, and exudative tonsillitis. These events were not reported as adverse 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 most recent info, received on 9/24/02, did not provide the outcome of the reported events. Info received on 2/27/02 indicated that all events had resolved by 10/17/01. Follow up on 02/27/04: "Information, received on 07/31/03, indicated that the subject continued to experience fatigue as of 05/12/03; otherwise, he had "no symptoms".  Information received on 02/27/02 indicated that all events had resolved by 10/17/01." Information received on 27 July 2004 indicated that as of 08 July 2003, the patient was working full time. He complained of being easily fatigued, and of pain and dypsnea with excessive physical activity. The most recent information received on 30 September 2004 did not clarify outcome of the reported events.