Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a 53 year old female who on 06-NOV-2009 was vaccinated with her first dose of PNEUMOVAX 23 (Lot number: 662747/1086X). The reporter mentioned that on 07-NOV-2009 the patient experienced a fever of 103.5 F, chills, headache, body aches, redness and 3 inch by 3 inch induration at the injection site after administration of PNEUMOVAX 23. At the time of reporting, the reporter was requesting a lot check be conducted. It was unknown if the patient sought medical attention. The patient recovered of the adverse experience on an unspecified date. Follow up information has been received from a licensed practical nurse and medical records concerning a 53 year old newly diagnosed type 2 diabetes mellitus-uncontrolled (diagnosed on 18-JUN-2009), female patient with obesity, obstructive sleep apnea, allergy to CECLOR who on 06-NOV-2009 was vaccinated at 4:51 PM with a first dose of PNEUMOVAX 23 (662747/1086X) in the left deltoid. Concomitant therapy included fish oil, aspirin, metformin HCl, calcium carbonate, vitamin D, BYETTA, lisinopril (manufacturer unknown), multivitamins with minerals, soy, and TYLENOL. On 13-OCT-2009, the patient received a dose of influenza virus split virion 3v vaccine inactivated (manufacturer unknown). The reporter stated that she saw the patient on Friday 06-NOV-2009 at which time she received her first PNEUMOVAX 23 as she is a new diabetic. Subsequently, the patient reported that she had a sore left upper arm that evening where she received the injection and it was red, warm and very tender by Saturday morning (07-NOV02009). She also had a 104 F fever which came down with TYLENOL. On 08-NOV-2009, it was noted that the patient had spiked up to 102 F in the past 24 hours. The patient reported that she felt better, but her arm was still very tender. It was reported that the patient's appetite was down and she was slightly nauseated so she did not take her BYETTA since Saturday morning (07-NOV-2009). The patient had no other symptoms such as myalgias (other than her left upper arm), vomiting, dyspnea, headache or sore throat. On 09-NOV-2009, at an office visit, the patient had a rash measuring 11 x 14 around the injection site. The patient stated that the muscles in her arm and shoulder hurt and she felt queasy. The patient also had fatigue. On physical exam, the patient appeared slightly pale and warm. The patient's skin had a 12x13 cm area of warm erythema with a 4 cm area of induration in the center that was very tender to touch. There was no bruising and her lymph nodes were tender and slightly enlarged on the left axilla x 2. The follow diagnostic tests were performed: temperature measurement 102.2 F, pulse oximetry 80, respiratory rate measurement 80, blood pressure measurement systolic 140/74 (sitting, left arm). The patient's temperature was rechecked and was now 101.7 F (PO). The patient was given ibuprofen 800 mg PO that afternoon in the office. The nurse practitioner and the physician felt that it was likely just a reaction to the PNEUMOVAX 23 rather than cellulitis. The patient was instructed to alternate with acetaminophen and ibuprofen for fever and pain. The patient was advised not to receive another PNEUMOVAX 23 in the future. On 10-NOV-2009, the patient called the office and reported that her red spot had moved down about 1 inch. The patient also reported that she had heart palpitations twice last night and her fever had gone down to 100. Later, that same day, the patient reported that she still was not 100%, and still had some heart palpitations and would call if it did not improve. At the time of the report, the patient's fever was resolving and the redness was lower (dependent) and not higher on arm. It was reported that the patient recovered from the other adverse events on an unspecified date. 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 for Biologics Evaluation and Research and was released. Follow up information has been received from the Licensed Practical Nurse who reported that the patient with diabetes type II at the time of vaccination recovered after 09-NOV-2009 appointment. The patient had not had any adverse event following prior vaccination. The patient's last office visit was on 25-FEB-2010. This is one of several reports received from the same source. No further information is available.