Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Granulocyte count increased, Hypertension, Hypoaesthesia, Injection site erythema
Clinical narrative: Initial and follow-up information has been received from a physician and a nurse concerning a 77 year old, male with no known drug allergies, who more than 5 years ago was vaccinated with a first dose of Pneumovax 23 and had no reaction to the first does who on 28-SEP-2006, at 10:00 a.m., was vaccinated intramuscularly, in the left deltoid muscle with a second dose of 0.5 ml of Pneumovax 23 (Lot # 651356/0089F). On approximately 28-SEP-2006 the patient developed redness and swelling of his left arm that traveled down his arm and he was placed on an oral antibiotic. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Medical Records received on 08-NOV-2006 from the physician indicated the following: The patient was seen by the physician on 28-SEP-2006 to establish care. The physician reported that the patient had an allergy to Iodine, history of abdominal aortic aneurysm repair (2000), "CEA" (2000), back surgery, ventral hernia repair (2001), history of frequent syncope events-eventually got pacemaker placed in January 2003, syncopal episode stopped, history of cataract surgery (2003) Coronary Artery Disease (CAD) with 3 cardiac stents placed, hypertension, history of status post right endarterectomy, history of colon cancer, history of abnormal TSH in past, borderline cholesterol, last flu shot (2005), ex-smoker (quit 50 years ago), no alcohol or drug use, who on 28-SEP-2006, at 10:00 a.m., was vaccinated intramuscularly, in the left deltoid muscle with a second dose of 0.5 ml of Pnemovax 23 (Lot # 651356/0089F). Concomitant therapy included ATENOLOL MSD, PRINIVIL, FLOMAX, VIAGRA, aspirin and vitamins (unspecified). The patient reported nocturia. Upon exam the physician noted enlarged prostate. In follow-up it was reported on 08-NOV-2006 by the nurse that on 29-SEP-2006, the patient had very severe swelling of the upper arm, elbow and forearm, very red and hot. The patient felt sick and very tired. The patient went to the Emergency Room (ER) for evaluation. At the time of this report, the patient had not recovered. Medical Records received on 08-NOV-2006 from a hospital concerning the patient. The patient was admitted to the hospital Emergency Room (ER) on 30-SEP-206 and was discharged on 30-SEP-2006. It was reported that twenty-four hours after receiving the Pneumovax 23 vaccine he began to note some redness and swelling extending distally. He was seen by physician on 29-SEP-2006 and prescribed KEFLEX, which he was advised to take if his symptoms worsened. The patient had noted increased swelling and some pain over the injection site. There was a moderate amount of redness extending distally into the left forearm. The patient reported having a fever of 102 degrees Fahrenheit last night which had resolved. Upon examination, the patient was positive for left arm redness and minimal warmth to touch, and positive for left arm pain. Ultrasound of the left upper extremity revealed to be negative with not evidence of deep vein thrombosis or clot. The physician in the ER felt that the patient had a hypersensitivity reaction to the Pneumovax 23. The physician recommended steroids and continue with BENADRYL. The patient received in the ER intravenous medications. The patient was advised to initiate the prescribed KEFLEX in the event that his arm became more swollen, red, with any new symptoms. The patient was discharged to home in good condition. He was given Prednisone 20 mg daily for five days. He was to continue with TAGAMET and BENADRYL. The patient had a follow-up appointment with his physician in two days. Medical Records received on 08-NOV-2006 from the physician indicated that the patient was seen in the physician's office on 10-OCT-2006. The patient's blood pressure was 178/104. The physician reported that the symptoms had totally resolved in the arm the patient had received the Pneumovax 23. The physician noted the patient was seen in the ER for these symptoms. The patient was placed on steroids. The patient reported he took FLOMAX and VIAGRA together the other night and had symptoms of numbness in legs. The symptoms were transient and resolved. The physician continued therapy with FLOMAX and discontinued therapy with VIAGRA. The physician advised the patient if any usual symptoms occurred the patient was to stop therapy with FLOMAX and to call the office. The patient was prescribed NORVASC for the treatment of hypertension. The physician stated that he would not wait before NORVASC was started to make sure FLOMAX was tolerated. Follow-up information received on 08-NOV-2006 contained the following adverse experiences: peripheral vascular disease (28-SEP-2006), cardiovascular disease (28-SEP-2006), benign prostatic hypertrophy with obstruction (28-SEP-2006), erectile dysfunction (28-SEP-2006) and thyroid stimulating hormone abnormal (28-SEP-2006), numbness in legs (approximately 10-OCT-2006), adverse drug effect (approximately 10-OCT-2006), hypertension (approximately 10-OCT-2006). Additional information has been requested.