Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Heart rate normal, Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 71 year old female who on 28-Mar-2008 was vaccinated IM with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot# 659147/1381U). On 28-MAR-2008, the patient experienced redness, swelling, pain, warmth and induration at the injection site several hours post vaccination. Unknown medical attention was sought by calling physician's office. The patient's symptoms continued. At the time of reporting the patient had not recovered. It was also reported that the patient might have had an injection site rash after a pneumococcal 23v polysaccharide vaccine (lot# not provided) given in the 1990's. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/30/2008. Information has been received from a nurse concerning a 71 year old female with asthma (since 1970), persistent cough, postnasal drip, gastrooesophageal reflux, breath shortness, bronchospasm and osteoarthritis and a history of endometriosis, discectomy, back surgery, colonoscopy, total abdominal hysterectomy and knee arthroplasty, maternal history of breast neoplasm, family history of diabetes mellitus and paternal grandmother with uterine cancer, who on 28-Mar-2008 at 9:10 AM was vaccinated intramuscularly into the left deltoid with a second 0.5 ml dose of PNEUMOVAX (lot# 659147/1381U). Concomitant therapy included AMITRIPTYLIN, LEVOXYL, pravastatin Na, PROTONIX, NEXIUM and albuterol. On 28-MAR-2008 the patient was evaluated in the office for a persistent cough. Her asthma was under good control without the need for maintenance medications. She did not even need to use albuterol in February 2008 she developed a respiratory infection after which she had been complaining of a pertinent cough associated with shortness of breath and tightness sensation in her chest. She has noticed occasional wheezing. She does not have hemoptysis. There is no fever or chills. There is no angina. The tightness is the chest does not radiate to her neck or left arm. The patient stated that she had a cardiac work up in the past including a stress test that was negative. She has a known history of gastric reflux disease with hiatal hernia for which is on NEXIUM. She also has a post nasal drip, but does not have chronic allergic rhinitis or sinus congestion. There are no other significant complaints. She has known osteoarthritis. Physical exam revealed that she was not observed to be obese. She was an alert, well developed, well nourished patient, in no acute distress. Pharynx was moist with no exudate. No adenopathy. Wheezing was hard. Heart rate and rhythm normal, no murmurs or jugular venous distention. Assessment revealed shortness of breath, cough, asthma, bronchospasm and esophageal reflux. The patient was given prescriptions for alprazolam, tamoxifen citrate, and TUSSIONEX PENNKINETIC ER for cough. On 28-MAR-2008 at 16:08, she called the office about her PNEUMOVAX injection site. She stated that the site was sore, hot to touch and has an area below the site that is reddened. She estimates the size to be 4x3. She stated that she received the pneumonia vaccine over ten years ago and had developed a red rash over half her arm. She had soreness at the site as well. She did not have any other adverse side effects at that time. She denies fever or trouble breathing. She was advised that the soreness and some swelling was normal and if the rash continued to increase in size or she developed a temperature >101.5, difficulty breathing she should call us back or go to the emergency room. The patient was advised to take BENADRYL 50 mgs, TYLENOL and ADVIL as needed throughout the weekend. The patient acknowledged understanding of the instructions provided. On 31-Mar-2008 the patient's symptoms continued and the patient had an office appointment for follow up of the adverse reaction to the pneumonia vaccine. The patient stated it was slightly tender and felt warm. She did not have fever or chills. She stated that the erythema has resolved. She still has swelling but it is improving. She does not have any shortness of breath, productive cough or any other complaints. The swelling has spread to below her elbow, but it is improving. There is no associated erythema. There is no stiffness in her joint. It was reported that the patient had an unusual intense local reaction to the vaccine. It was improving with BENADRYL50 mgs and ibuprofen. The physician did not think that she had cellulitis or an infection at this time. As she was improving she was advised to continue with BENADRYL50 mgs and ibuprofen and if it worsened or didn't resolve, prednisone at that time. The plan was to see the patient for follow up in three days or sooner if needed. On 31-MAR-2008 the patient was recovered. On 03-APR-2008 the patient was seen for an injection site check of the left deltoid. The left upper arm was negative for swelling, bruising, redness. It was very light pink on the ventral side of the arm, from inside of elbow to her shoulder. The patient stated she still has slight itching occasionally but that she is taking BENADRYL50 mgs once daily for this and the itching is relieved. The patient was instructed to call the office if she experiences any changes at the site or symptoms redevelop. No further information is available.