Age: 45.0
Sex: F
Vaccine: FLU3, MMR, PPV
Symptoms: Tenderness, Tremor, Vomiting, White blood cell count increased
Clinical narrative: Information has been received from a healthcare worker concerning a patient who on approximately 15-NOV-2010 (earlier this week) was vaccinated with a dose of PNEUMOVAX 23 (Lot# 667271/0880Z) (Exp date 11-DEC-2011), SQ. The healthcare worker reported that the patient experienced infections at the injection site, "including cellulitis", which were treated with antibiotics and was received at emergency room but not admitted to the hospital. At the time of the report the patient had not recovered from these symptoms. A lot check has been initiated. Information has been received from a physician's office concerning a 45 year old female with a history of asthma, "thyroid" and migraine who on 10NOV2010 received PNEUMOVAX 23 (lot # 667271/0880Z) in left arm as subcutaneous injection. Also administered was MMR II (lot # 664888/0765Y) in left arm subcutaneously and a dose of FLUZONE (Sanofi-Pasteur) (lot # U3788AA) in the left arm intramuscularly. Concurrent medications included PROAIR HFA 108 MCC/ACT inhaler, DEPAKOTE ER 500 mg tablet, PROZAC, FLOVENT HFA 110 mcg/act inhaler, VICODIN 5-500 mg tablet, monolukast 10mg tablet, AMERGE 2.5 mg table, DELTAZONE 20 mg tablet and PHENERGAN w/o CODEINE 6.25-10mg/5 ml solution. On 11NOV2010 the patient's arm was bright red and swollen from elbow to shoulder. Patient sought treatment at a clinic and was told she had an infection and that the doctor thought it was in her bloodstream. Patient had lab test CBC which showed her WBC level was 12.4. Patient was shivering and unsure of temperature. Patient pain rated at a 15 out of 10. Patient requested treatment with IV antibiotics and to "become inpatient". Patient was prescribed BACTRIM, and diclofenac 50mg from walk-in clinic. Doctor was notified and prescribed VICODIN 5/500 mg and to go to ER if she had no relief. Patient recovered on an unspecified date. This is one of several reports from the same source. 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. Information has been received in the form of a medical record concerning a 45 year old female who on 10NOV2010 received a dose of PNEUMOVAX 23 (lot # 667271/0880Z) in left arm as subcutaneous injection. Also administered was MMR II (lot # 664888/0765Y) in left arm subcutaneously and a dose of FLUZONE (lot # U3788AA) in the left arm intramuscularly. The patient was seen by a physician on 11NOV2010 after she developed an area of redness and significant pain as well as L axillary pain and lymph node enlargement. The physician treated her with antibiotics, pain medicine and later on VICODIN was called in for pain control by her primary doctor. The patient presented into the urgent care clinic on the morning of 12NOV2010 to tell the physician that the lesion and pain were getting better. A few hours later the patient called the physician saying she was experiencing shaking, nausea, vomiting with no fevers. She had vomited about 3 times. The patient had no diarrhea, no vaginal symptoms, no sore throat or ear pain. Upon examination, the patient was found to have a 3 x 3 cm area of redness, swelling, exquisite tenderness and well demarcated lesion. No evidence of abscess or fluctuance. There was no streaking of cellulitis but there was a left-sided tenderness, less than 1 x 1 cm axillary lymph node that was exquisitely tender. The physician diagnosed the patient with myalgias and vaccine injection site local infection. The physician stated he was not sure if the myalgias were related to the local "left hand" vaccine injection site. A complete blood count revealed a white count of 12.4 thousand with a left shift. The patient was asked to follow up the following day for a recheck. The outcome at time of reporting was recovered. Additional information has been requested. All medical records will be provided upon request.