Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Leukocytosis, Lymphocyte percentage decreased, Nausea, Neutrophil count increased
Clinical narrative: Information has been received from an investigator via Pfizer (Mfr#HQWYE418816JAN04) referring to a 70 year old female subject enrolled in a study. The subject's concurrent conditions included gastrooesophageal reflux disease, diverticulitis, lipids increased, muscle spasms, diffuse osteoarthritis, sinus operation. The subject was a non-tobacco user. The subject's medical history included benign breast neoplasm, cataract, cataract operation (right eye surgical repair), dysplasia, cryosurgery, uterine dilation and curettage. On 01-OCT-2003 the subject started the blinded therapy with bazedoxifene acetate (+) conjugated estrogens capsule or raloxifene tablet, one dosage form, daily orally for menopause. The blinded therapy was broken at the end of the study. The subject was receiving raloxifene, tablet, 60mg, once a day, orally. On 21-NOV-2003 the subject received PNEUMOVAX 23 (Lot# was reported as 2003P0012, which was invalid), intramuscularly, in left arm. Concomitant therapies included influenza virus vaccine (unspecified), PRILOSEC and VIOXX. The subject, who received PNEUMOVAX 23 and Influenza Virus Vaccine in her right arm on 21-NOV-2003, experienced an injection site reaction on the same day. One-day post immunization, the subject developed symptoms of fever, nausea, erythema and cellulitis to the left arm on 22-NOV-2003. The subject presented to the hospital emergency room (ER) with a large red raised area on her left arm, 6-8 inches in size, and associated shoulder pain. In the ER, she was treated with TYLENOL 650 mg and given a fluid load of 150-200 milliliter (CC) per hour. A complete blood count (CBC) analysis was taken on 23-NOV-2003, which indicated white blood cell (WBC) was 24.8, hemoglobin (HGB) was 13.8, hematocrit (HCT) was 41.0, red blood cell (RBC) was 4.39, Neutrophils was 91, lymphs was 4 (abnormal), absolute neutrophil count (neut) was 22.7 and platelet count was 251. On that day electrolytes were evaluated and considered to be within normal range, which included sodium 141, potassium 3.5mmol/L (also reported as 3.9 mmol/L), blood calcium was 9.2 mg/dL, chloride 10, bicarb 23, blood urea nitrogen (BUN) 19, creatinine 0.7 and glucose 91. On 23-NOV-2003, urine analysis was normal, blood culture showed no growth in 6 days, chest X-ray showed no infiltrates or effusion. On the same day, the subject also underwent a Computed Tomography (CT) scan due to abdominal pain, CT scan showed 2 cm gallstone, 5 mm kidney cyst, 6 cm calcified mass of the left adnexa most likely fibroid of the uterus and calcified ovarian lesion is difficult to exclude (essentially unremarkable, negative). She was subsequently hospitalized from 24-NOV-2003 through 25-NOV-2003 for left arm cellulitis with resulting leukocytosis, abdominal pain and fever. Treatment included IV antibiotic therapy of ANCEF 1 mg and ROCEPHIN and later she was transitioned to oral AUGMENTIN. On 24-NOV-2003, blood cultures included: blood sodium was 143 mmol/L, blood potassium was 3.7 mmol/L, RBC was 4.13, HGB was 13.0, HCT was 38.4, Platelets was 211, WBC was 20.9, Neut was 82, Lymph was 10 (abnormal), neut was 17 and blood calcium was 8.7 mg/dl. On 25-NOV-2003, culture urine showed 10-50000 multiple species probable contamination. The subject was recovered from cellulitis on 18-DEC-2003. The outcome of the event abdominal pain was unknown. Action taken with PNEUMOVAX 23 and raloxifene due to the events was not provided. The investigator considered the event cellulitis to be related to PNEUMOVAX 23 and raloxifene. The causality between the event abdominal pain and two suspect therapies was unknown. During the study protocol the subject was also placed on following therapies: TYLENOL PM, TYLENOL, MAALOX, VICODIN, ampicillin and intravenous hydration. Ampicillin therapy continued until 18-DEC-2003. Additional information is not expected.