Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Product contamination, Pyrexia, Respiratory tract congestion, Skin lesion, Skin reaction
Clinical narrative: Information has been received from a medical assistant (also reported as registered nurse) concerning a 56 year old female patient with endometrial carcinoma and allergies to COMPAZINE and penicillin who on 27-SEP-2010 was vaccinated in her right deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 665708/0651Z) (Expiration date: 15-JUN-2011). Concomitant therapy included chemotherapy treatment. The medical assistant reported that on 30-SEP-2010, the patient had low grade fever, localized reaction of redness and swelling. The patient was given SEPTRA to be taken for 7 days on 30-SEP-2010. The patient still had some redness and swelling since the medical assistant spoke to her on 08-OCT-2010. The patient was told by 2 physicians that their opinion was the patient had these reactions because the vaccine itself was contaminated. The medical assistant mentioned that 20 other patients received PNEUMOVAX 23 with the same lot number as this patient and no reactions were reported. A complete blood cell count test (CBC) was performed recent and the results showed low white count, the test was repeated and the results back to normal. The patient sought medical attention by an office visit. Medical assistant was requested a lot check on Lot# 665708/0651Z to see if anyone else had reported reaction of this lot number. It was confirmed that not a PQC was involved. 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 a registered nurse who reported that the 56 year old female teacher patient who was undergoing chemotherapy for uterine cancer (also reported as endometrial carcinoma), on 27-SEP-2010 at 10:27 a.m was vaccinated IM into the right deltoid with the first dose of PNEUMOVAX 23 (Lot# 665708/0651Z). Concomitant therapy included antineoplastic (unspecified), albuterol sulfate, chlorpheniramine maleate, AMBIEN, aspirin, calcium (unspecified), COLACE, dexamethasone, lorazepam, NAPROX, omeprazole, REGLAN, FAM-LAX SENNA, SEPTRA DS, simvastatin (manufacturer unspecified), stool softener (unspecified) and ZYRTEC. By Tuesday 28-SEP-2010, the patient had a fever of 100.4. On 30-SEP-2010, the patient returned to the office with a reaction to PNEUMOVAX 23 in her right upper arm. She had a temperature of 100.0, pressure 126/76, lungs clear to auscultation. Head Ears Eyes Nose Throat (HEENT) unremarkable, heart sounds were normal. The localized skin reaction was hot to the touch and painful to touch with moderate free of induration in the center and with red streaking towards the right axilla. Her recent complete blood cell count (CBC) showed a low white count. On 30-SEP-2010, she repeated a CBC (results not reported, previously reported as back to normal). She was placed on KEFLEX on Monday 27-Sep-2010 for a cough and congestion and on 30-SEP-2010 was changed to SEPTRA, one twice a day for 7 days. The patient was advised to use warm compresses to the area to get more circulation to this area. On 01-OCT-2010, the patient came back to the office. That day she was afebrile and she stated she felt better. She was had mild nausea since this local skin reaction started. It was reported that BACTRIM could contribute to slight nausea. She was encouraged to take this with food. That day her blood pressure 126/76, temperature was 98.0 orally. Examination of the right elbow area showed less inflammation than last night. It was still slightly tender to touch, induration had gone down. The assessment in that office visit was cellulitis versus inflammatory reaction right deltoid, improving. That day the patient was advised to continue on SEPTRA twice a day with meals for a total of 7 days. She was also advised to continue using warm soaks to the area. On 18-OCT-2010, the patient was seen in the office again. This time was reported that the patient had an acute reaction to the vaccine with mild cellulitis. She was placed on BACTRIM for 7 days. She had not been using warm soaks to this area. She had an indurated open skin lesion that was not inflamed and minimal drainage. She had completed her BACTRIM antibiotic. There was no further erythema around the site. This time the patient was advice to use a warm soaks to this area 2 or 3 times a day, triple antibiotic ointment and coverage with a clean bandage daily. It was explained to patient that this was healing from the inside out and the warm soaks will continue to help this heal. Additional information is not expected.