Age: 31.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Myalgia, Myositis
Clinical narrative: Information has been received from a registered nurse concerning a female patient "in her 30's" who recently (approximately in October 2011) was vaccinated with a dose of PNEUMOVAX 23 (Lot number 667995/1150Z, Exp. Date: 04-MAR-2012) (dose and route not reported). Concomitant vaccine included FLUZONE. Both vaccines were administered on the same arm (recently, approximately in October 2011). The registered nurse reported that the patient developed cellulitis (approximately in October 2011). The patient was admitted to the hospital on either 22-OCT-2011 or 23-OCT-2011 for cellulitis of the arm. It was reported that the nurse did not have this chart and she was not sure what specific treatment the patient was receiving in the hospital. At the time of the report, the patient had not recovered. This is one of several reports from the same source. A lot check has been initiated. Additional Information has been received on 29-NOV-2011, from medical records and a nurse manager concerning a 31 year old female (216 pounds, 68 inches) with no known allergies or medical conditions with a history of cervical dysplasia with cone biopsy and family history of cardiovascular disorder. On 20-OCT-2011, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot number 667995/1150Z) (dose not reported) into her left deltoid at 1410. The patient was also vaccinated into her left deltoid on 20-OCT-2011 at 1410 with a dose of FLUZONE (SANOFI, lot number UH476AC). Concomitant medications included Vitamin D and VITAMIN C. On 21-OCT-2011, the patient experienced onset of pain in her left arm. On 22-OCT-2011 patient presented to Urgent Care Clinic with complaints of pain and redness of injection site of her left shoulder where she had received influenza and pneumonia vaccines two days prior. The patient reported that her muscle was sore at influenza vaccine site which she described as dull, aching, very painful to touch or move. The patient reported a fever (101.7, Fahrenheit), headache, body aches all over and sleep disturbance from the soreness. Patient stated she had been coming down with a virus and she had a cough of clear sputum for two weeks. On examination of her left deltoid, the skin color and pigmentation were reported as abnormal with approximately a 6x3 cm area of erythema, very tender to palpation, slightly tender with shoulder range of motion and area slightly warm. There was no induration, fluctuance or striae. Assessment reported was adverse effect of vaccines, myalgia and myositis. The patient was given a prescription given for acetaminophen-codeine #3 to take four times a day for five days for pain and was advised cold pack to the area for two to three days, ADVIL when necessary (prn) and to follow up with primary care physician no improvement. On 24-OCT-2011, the patient presented to the Emergency Room with two areas of erythema, swelling over her left shoulder and increased pain in the deltoid area. The patient also reported trouble eating and sleeping. It was noted that her history suggested an infectious process over left shoulder. On examination the patient was noted in moderate distress, febrile (39.7 Celsius) with two areas of erythema in her deltoid region that were measured as 8x4cm in the proximal area and the distal area measured 10x5 cm. The patient was admitted with diagnosis of cellulitis and she received morphine for pain, parenteral antibiotics (ceftriaxone and BACTRIM). The following laboratory results were reported: white blood cell count 21.7K/ul, neutrophils 86%, blood glucose 133 and blood cultures had no growth. On 27-OCT-2011, the patient was discharged with the following medications: AUGMENTIN twice a day for ten days, ibuprofen 600 milligram every six hours if needed and TYLENOL two tablets 325 milligrams each every four to six hours if needed for fever and pain. The patient was informed to resume usual activities as tolerated and ice to upper arm ten to fifteen minutes two to three times a day. On 03-NOV-2011, the patient returned to primary care physician for follow up on hospital stay. On examination, the physician reported that the patient's large areas of erythema and swelling in left upper arm had resolved and the patient continued to have some tender induration at the injection sites. The physician also reported the patient experienced Eustachian tube disorder, loose stools and vaginal itching. The physician's assessment was resolution of left upper arm cellulitis status post pneumonia and influenza vaccines. Patient advised to finish the antibiotics, ibuprofen for pain and four to six weeks for resolution of induration. At the time of this report, the patient had recovered. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. All available medical records will be provided upon request. Additional information has been requested.