Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Abdominal pain upper, Angioedema, Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody positive
Clinical narrative: Information has been received from a 45 year old male patient with no pertinent medical history who on 17-SEP-2010 was vaccinated IM with the first dose of RECOMBIVAX HB. On an unknown date the patient was vaccinated IM with the second dose of RECOMBIVAX HB. In May 2010 the patient was vaccinated IM with the third dose of RECOMBIVAX HB. Lot # is 662115/1104X (Thimerosal Free). Concomitant therapy included ZYRTEC and famotidine. After the first injection "approximately a year ago" approximately in 2009 the patient began experiencing stomach pain. After the second injection the patient experienced angioedema and hives. After the third injection in June 2010 the patient experienced stiffness of the hands. Unspecified medical attention had been sought. Blood work and X-rays of lungs and hands were performed (result not reported). The adverse events were not improved at the time of reporting. Follow up information received from a physician via office note stated that the patient was seen for rheumatology consultation, which was requested. He was a 45-year-old man with a chief complaint of a positive antinuclear antibody (ANA) and angioedema. His history of present illness was that he was well until September of 2009. At that time, he received his first hepatitis B vaccine. Subsequent to that, he developed abdominal and epigastric pain. A work-up including a CAT scan and ultrasound was unremarkable. In November of 2009 after receiving his second hepatitis B vaccine, he developed angioedema. In March 2010 he developed hives on his hands and his wrists, and occasionally on his feet. He was treated with antihistamines as well as famotidine and he had improvement in his symptoms. All of his gastrointestinal symptoms had resolved. In August of 2010 he developed bilateral hand pain which was worse with use and not associated with significant stiffness or swelling. As part of his work-up for his angioedema and hives, he had an allergy evaluation and an ANA was positive at 1:160 and hence, a rheumatology evaluation was recommended. He had no further angioedema or recurrent hives. He had no swelling of his joints and no further arthralgias. He had no history of photosensitive rashes. He had occasional oral ulcers which he describes as painful. He had no genital ulcers. He was never treated with steroids. He had no chest pain, shortness of breath, gastrointestinal symptoms, genitourinary symptoms, testicular pain, or Raynaud's phenomenon. He denied fevers, chills or night sweats and he had no further abdominal pain. Past medical history was unremarkable. He denied his blood pressure, diabetes, peptic ulcer disease. His medications were ZYRTEC, CLARITIN and famotidine. He had no known allergies. Social history - he was a pharmacist. He drinked alcohol socially. He denied tobacco use. His family history was negative for autoimmune rheumatologic diseases. His review of systems included occasional fatigue and difficulty sleeping but was otherwise non-contributory as outlined on his intake questionnaire. Exam revealed a pleasant, healthy appearing male in no distress. His blood pressure was 130/80. Skin exam showed no rashes, nodules or tophi. HEENT exam was within normal limits. Neck exam was supple with pathologic lymph nodes. The chest exam was clear to percussion and auscultation. Cardiac exam showed a regular rate and rhythm with a normal S1 and S2. Abdominal exam was soft and non-tender without organomegaly. Extremity exam showed no clubbing, cyanosis or edema. He had no livedo reticularis. His joints showed no active synovitis or effusions. His joints showed good range of motion without redness, warmth, swelling, tenderness, deformity or instability. His spine exam was non-tender. Straight leg raise was negative. Fibromyalgia points were non-tender. Neurologically he was alert and oriented x 3. He had no focal weakness. His reflexes were symmetric. His gait was normal. The physician reviewed his labs which included an ANA of 1 : 160 homogeneous, C4 was normal at 31, chemistry profile was unremarkable with a normal glomerular filtration rate (GFR), sed rate is 1, rheumatoid factor was negative and a CCP negative. A urinalysis was unremarkable. The patient had no further flare-ups. Clinically, he did not meet criteria for lupus, rheumatoid arthritis or systemic vasculitis. The physician suspected that his ANA was a false/positive but he will check a full battery of labs including all of the ANA subtypes, as well as a C1 esterase inhibitor, an ACE level, an ANCA and a Lyme titer. The patient was asked to have a chest x-ray, as well as hand and wrist x-rays to rule out any evidence of pulmonary disease or arthritic disease affecting his hands. At this point he appeared to be under good control with the therapy as described above. Should his symptoms recur, the physician would consider a skin biopsy with immunofluorescence to help look for the presence of an autoimmune disease although clinically, that seemed less likely. The physician also talked to him about considering treatment with a drug such as PLAQUENIL or Colchicine, should he have recurrent attacks but at this point, his symptoms were well controlled. The physician did remind him about the importance of sun precautions, given his positive ANA. Additional information has been requested.