Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Skin oedema, Skin warm
Clinical narrative: Information has been received from a register nurse concerning a 49 year old male patient with a history of myocardial infarction in 2010 and no drug reaction or allergies who on 08-OCT-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665924/0930Z Expiration date 17-JUL-2011) (Route not reported). Concomitant therapy included aspirin, PLAVIX and simvastatin (manufacturer unknown). The nurse reported that on 11-OCT-2010 the patient visited the doctor's office due to a reaction. The patient reported that while he was at home, he put ice on the area and took TYLENOL. Physician examined the area and noted that it was a little red around the elbow, area was warm and edematous. Physician determined it was a localized reaction. At the time of the report, the patient had not recovered. The patient sought medical attention. The nurse requested an investigation of the specific lot. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. Follow up information has been received from a registered nurse and a medical record concerning the 49 year old male patient with stable and asymptomatic coronary artery disease and no allergies who on 08-OCT-2010, at 10:45 AM, was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 into the right deltoid. The patient was in with swelling around his forearm and elbow since yesterday (10-OCT-2010). He did receive a PNEUMOVAX 23 in the right shoulder on Friday which should be three days ago. Then by Friday afternoon (08-OCT-2010) he had some soreness around his shoulder and had trouble raising his arm above shoulder height. By Saturday that had improved but then on Sunday which should be yesterday he developed the swelling and redness around the right elbow. Since then, he had used some ice and the swelling and redness had dropped considerably. There was no burning or itching around the area. No pain around the elbow. He denied ever having any cough, chest pain, shortness of breath, dizziness, wheezing, fevers, or chills. Physical examination: General: He was a well-developed, well-nourished gentleman in no acute distress. His age is 49. HEENT: Head normocephalic. Neck: Supple without adenopathy. Lungs: Entirely clear. Heart: Regular rate and rhythm. Abdomen: Soft and nontender without hepatosplenomegaly or mass. Musculoskeletal: He has excellent range of motion of shoulders. Normal strength and handgrip and upper arm strength bilaterally. Good range of motion to the right elbow. There is a little bit of redness, warmth, and edema around the volar aspect of the right proximal forearm and around the elbow but no tenderness there and no lymphangitic streaking and no tenderness at the deltoid of the shoulder where he received his injection. Neurologic: Neurovascular status is totally intact to the hand with good sensation and good dorsiflexion and plantar flexion strength of the wrist. Assessment: 1. Local reaction to PNEUMOVAX 23, which seemed to be subsiding and there was no evidence of any systemic allergic reaction nor of any infection. 2. Coronary artery disease, stable and asymptomatic. Plan: He had already worked all day today without difficulty and the physician advised that he apply ice packs off and on to the right forearm and should expect total resolution of this by the end of the week. Follow up as often as necessary if this was not the case. May use TYLENOL for a little discomfort if he needed to. Additional information is not expected. Available medical records will be provided upon request.