Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced a severe local reaction at injection site.  The reaction was noticed about 16 hours after administration.  Her arm was swollen, warm, red, and itching.  She came to the pharmacy about 48 hours after administration because condition was worsening.  She had already began taking Benadryl.  I recommended that she go to the ER, which she did.  The physician there prescribed an antibiotic and advised her to follow up with her regular doctor if she continued to have problems.  The patient apparently followed up with her doctor, and I was told that she was given steroids and had improved.  I spoke to her husband on Thursday, January 31, 2008, and was told that it was almost cleared up. Information has been received from a pharmacist concerning a 64-year-old female with no pertinent medical history or alergies who on 25-JAN-2208 was vaccinated subcutaneously in the back of her arm above the elbow with one dose of 0.65 ml of ZOSTER vaccine live (Oka/Merck) (lot # 659325/1823U). Subsequently, the patient experienced an injection site reaction. The patient did not notice any symptoms until the day after the administration. 26-Jan-2008, when she pulled the band aid from the injection site. The area was red, swollen, warm, itchy and affected an area of 3 to 4 inches down to her elbow. An ice pack seemed to comformt the area. The patient showed the pharmacist her arm who directed her to the emergency room. At the E.R. the patient was given an antibiotic and was told to take BENADRYL. The pharmacist spoke to the patient on 28-Jan-2008 who said the swelling has now gone below the elbow and to the front side of her arm. The area was still itchy. The pharmacist also vaccinated the patient's husband that same day and he has not experienced any symptoms. No product quality complaint was involved. Follow up information was received from the pharmacist concerning a female who was vaccinated on 25-Jan-2008, at 3:45 Pm subcutaneously in the left arm with dose of ZOSTER vaccine live (Oka/Merck) (lot # 659325/1823U). On 26-Jan-2008 at 8:00 AM the patient experienced  a severe local reaction at the injection site. Her arm was swollen, warm, red and itching. BENADRYL did not alleviate her symptoms. She went to the ER and was told to follow up with her regular physician if her conditions worsened. The physician prescribed or administered steroids to clear up the condition. The patient recovered on 31-Jan-2008. The reporter considered severe injection site pruritis, injection site erythema, injection site warmth and injection site swelling to be other important medical events. Follow-up information hsa been received. The patient did not have any pre-existing allergies, birth defects or medical conditions. There was no illness at the time of vaccination. On 26-Jan-2008, the patient experienced a 20x15 cm area of erythema/induration and pain peripheral to the injection site on the left upper arm. The symptoms resovled within 5 days or oral prednisone. The pharmacist reported that she administered the vaccine to the patient and the patient came back a day alter with a "terribly swollen, itchy, warm arm". She advised the patient to go to the ER which she did and the patient was prescribed BACTRIM DS "just to make sure as a precautionary measure:" The ER advised the patient if she didn't get better to go for follow up to her internal medicine physician, which she did. The patient was prescribed steroids and the symptoms cleared up in a week or so. The patient call the pharmacist to inform her that she was all better. The pharmacist thought that "she may be allergic to one of the ingredients" in the vaccine. The patient was seen in the physicians office and the emergency room. The pharmacist reported that the patients symptoms did not require medical/surgical intervention to prevent death, life threatening illness, hospitalization, or disability. Therefore the adverse events are no longer considered to be other important medical events. Additional information is not expected.