Age: 74.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Cellulitis, Erythema, Induration, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a doctor of pharmacy (Pharm.D.) concerning a 74 year old female patient with drug reaction / allergy to penicillin, "sulfa" and LEVAQUIN and with non-insulin dependent diabetes who on 16-MAR-2012, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 672556/1602AA, expiration date 13-JAN-2012) 0.65ml, SC. Concomitant therapy included metformin, PROTONIX, omega-3 marine triglycerides, ubiquinones (unspecified) and clindamycin. The reporter stated that an hour after the patient was administered ZOSTAVAX (Merck) on 16-MAR-2012, she experienced redness, itching and hardness in the back of the left arm. The patient was given BENADRYL and sent home. It was reported that the next day the patient went to the ER and was diagnosed with cellulitis in her left arm. Chem 7 panel, WBC and "Blood culture" were performed. Lot check requested by the pharmacist. At the time of the report, the patient's outcome was unknown. A lot check has been initiated. Follow-up information has been received from the doctor of pharmacy (Pharm.D.) who stated that on 16-MAR-2012, the patient was vaccinated with a dose of ZOSTAVAX (Merck) in the left arm and also with a dose of PNEUMOVAX 23 in the left arm (dose, route and lot number not reported). It was reported that on approximately 18-MAR-2012, (previously reported as 16-MAR-2012) the patient upon receiving both vaccines developed redness and itching in the left arm and hardening in back of arm. Later on (1-2 days) the patient was admitted to ER with cellulitis. At the time of the report, the patient's outcome was unknown. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot 672556/1602AA of ZOSTAVAX (Merck). Additional information will be provided upon finalization of this manufacturing investigation. Follow-up information has been received from the doctor of pharmacy concerning the retired patient with a history of rash after "Tiger-Balm", nausea and vomiting after LEVAQUIN, "microanaphylaxis" after sulfamethoxazole, anaphylaxis after SEPTRA and penicillin G benzathine and no illness at the time of vaccination, who on 16-MAR-2012, at 9:49 AM, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 672556/1602AA) SC, in the upper arm and a dose of PNEUMOVAX 23 SC, in the arm (lot number 671615/1170AA) (dose not reported). Past drug therapy included a dose of ADACEL. It was reported that the patient called office after immunization and complained of itchiness at back of the arm on 16-MAR-2012, at 12:16. The patient was advised to take BENADRYL 12.5mg for itchiness and ice pack to the arm. On 17-MAR-2012, the patient went to the emergency department due to redness, swelling and pain of the arm. She was prescribed vancomycin for cellulitis. On 18-MAR-2012, the patient went to the emergency department once more because of spreading cellulitis, vancomycin was changed to clindamycin. On 28-MAR-2012, the patient recovered from cellulitis. 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. Additional information is not expected.