Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site rash, Injection site warmth, International normalised ratio
Clinical narrative: Information has been received from a registered nurse and a physician concerning an 80 year old male non-diabetic with myelofibrosis, depression, "am immune disease", rosacea, hypertensive cardiovascular disease, hypercholesterolemia, gastritis, gout, osteoarthritis, benign prostatic hypertrophy, allergies to cetirizine hydrochloride (ZYRTEC) ("arthralgia"), timolol maleate (TIMOPTIC) and beta blockers ("pruritus"), large right iridectomy scar, rheumatoid arthritis, herpes zoster of the right upper extremity, left carpal tunnel syndrome, tinnitus, discoid atelectasis and a history of smoking (four packs per day for 40 years; quit in 1985), alcohol use (scotch daily; quit), pneumonia 91973), cardiac catherization, laparoscopic cholecystectomy, iridectomy, surgery for basal cell carcinome, diverticulosis, appendectomy, right cataract surgery, fracture of the left ankle, previous glaucome who on 25-Sep-2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# 651330/1048P) (0.5 ml), intramuscularly in the left deltoid area. Concomitant therapy included aspirin (ECOTRIN), alfuzosin hydrochloride (UROXATRAL) and hydroxyurea (HYDREA). Illness at time of vaccination included arteriosclerotic heart disease, osteoarthritis, edema, and hypertension. The patient subsequently developed swelling and redness, accompanied by tenderness in the left upper extremity. The patient had generalized weakness and weakness in the left arm. The patient was seen in the physician's office on 26-Sep-2006, at which time there was a 12 cm by 18cm erythematous warm macular rash in the mid left humeral area. It was suspected that the patient  had a local allergic reaction to pneumococcal 23v polysaccharide injection. Because of the erythema the patient was put on amoxicillin (+) clavulanate potassium (AUGMENTIN) (875 mg twice daily for 7 days). The area was demarcated with an ink marker /  demarcated with a blackening pen. The patient was called on the following day and stated that he felt much better with decreased left arm discomfort and no further malaise or leg weakness. He continued to use amoxicillin (+) clavulanate potassium (AUGMENTIN). The patient did present to the doctor's office on 29-Sep-2006 stating that he had been using amoxicillin (+) clavulanate potassium (AUGMENTIN), though examination of the left upper extremity revealed improvement in the proximal aspect of the area of erythema though there was progression distally. Because of this it was felt that the patient should be admitted and begun on intravenous antibiotic therapy until therapy until there was regression of the inflammation. The patient also complained of new onset of tenderness in the anterior aspect of his left mid tibial area in an area where there was a varicose vein which was tender to palpitation. The patient was in moderate distress secondary to left leg discomfort as well as some mild discomfort in the left upper extremity. There were varicose veins in the inferior extremities bilaterally, slightly more prominent on the left. The patient did not have some mild dyspnea on exertion. During the hospital course the patient was given a dose of vancomycin at the time of admission and a subsequent dose the following morning, followed by ampicillin sodium (+) sulbactam sodium (UNASYN) (3 g IV q6 hours) which was subsequently decreased to 1.5 g IV q6 hours with his daily improvement. There was marked resolution of the erythema and swelling and the patient had no further complaints. He was felt to be medically stable to be discharged on oral amoxicillin (+) clavulanate potassium (AUGMENTIN). Of note, the patient had a venous Doppler study done of his lower extremity which was negative for any deep venous thrombophletitis. He was advised warm soaks and elevation to the area of superficial phlebitis in the anterior tibial area. Also aspirin therapy. Of note, the patient did complain of pain in the coccygeal area, and became of this, an x-ray of the sacrum and coccyx was obtained which revealed no abnormalities. The patient was seen in consultation by a physician who felt that the patient was medically stable and the patient was advised to follow-up with another physician as an outpatient for his spinal discomfort.  It was noted that antihistamines were not prescribed because of the patient's known history of significant BPH and steroids were avoided because of the possibility of local infection. The patient had chemistry done which was reported as normal. At the time of discharge, "sodium 142, potassium 3.8, chloride 108, CO2 27, BUN 12, creatinine 0.9, glucose 122, INR 1.39, PTT 29.9, WBC count 5,000, Granulocytes 71, lymphs 18, mono 10, eos 1, basos 1, H and H 10.9/32, MCV 109 (patient is on HYDREA), MCHC 34, platelets 187,000".  A chest-x-ray revealed discoid atelectasis at the left base. The patient would be discharged on a 4g sodium RCCSF diet. Liver function test was normal except for a chronically elevated LDH of 354. Discharge medications included amoxicillin (+) clavulanate potassium (AUGMENTIN) (875 p.o. BID x 5 days), aspirin (ECOTRIN) (81 mg PO q AM), hydroxyurea (HYDREA) (500 mg 3 tablets q AM), alfuzosin hydrochloride (URIXATRAL) (10 mg daily at 6 PM). The condition on discharge was reported as improved and prognosis was good. The probable period of disability was reported as one week. Final diagnosis was allergic reaction/cellulitis of right upper extremity secondary to pneumococcal 23v polysaccharide vaccine and superficial phlebitis of the left leg. On 09-Oct-2006, the patient recovered. It was noted that the patient did not experience any adverse events following prior vaccinations. The reporter considered the patient's allergic reaction/ cellulitis of right upper extremity secondary to pneumococcal 23v polysaccharide vaccine and superficial phlebitis of the left leg to be an other medical event, disabling and life-threatening (OMIC). The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information is not expected. A medical record is attached as further documentation of the patient's experience.