Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pruritus, Skin test positive, Skin warm
Clinical narrative: 6/26/08 Swollen (softball sized) inflamed area near injection site with rash. Red inflamed rash on left and right arm, clustered on left thigh, some going up to groin area, left side hairline. Some appeared pustule like. Dr. prescribed Cephalexin and Cortaid topical. 6/27/08 Patient returned to pharmacy with increased redness and spreading of rash to other sites, the right eyelid, waistline,groin with some that appeared pustule like. Injection site swelling had improved but pain, rash, redness had spread all over body. Patient was distraught over the outcome of the vaccine and expressed this to the pharmacist on duty. Pharmacist on duty told patient to return immediately to her primary care doctor for treatment. Also, we spoke with the Zostavax (merck) rep. for our area and informed her of the incident and she will be contacting physician's office. This is in follow-up to report (s) previously submitted on 9/26/2008. Information has been received from a pharmacist concerning a 63 year old femlae who on 23-Jun-2008 was vaccinated subcutamously with a .65 ml dose of roster vaccine live (oka/Merck) (Lot # 659411/0293X). There were no concomitant medications reported. The pharmicist staed that a patient developed hives after receiveing roster vaccine live (Oka/Merck) (Lot # 659411/0293Y). The patient received the vaccine on 23-Jun-2008, and she came back to the pharmacy on 26-Jun-2008 with hives. The hives radiated to legs and waist. There were also some hives on her chest and one small blister on her eye lid. On 28-Jun-2008 she came back to the pharmacy and filled MEDROL dose pack. The patient told the pharmacist that she was referred to a dermatologist. Medical attention was sought, the pharmacist saw the patient. There were no product quality complaint. Follow up information was received concerning a 63 year old female patient with no medical history, no known allergies, who on 23-Jun-2008 at 4:30 pm was vaccinated with a first dose of ZOSTER vaccine live (Oka/Merck) (Lot # 659411/0293X) subcutaneously on the left arm. On 24-Jun-2008 at 8:00 am (also reported as 26-Jun 2008), the patient developed swollen (softball size) inflamed area near injectin site with rash. Red inflamed rash on left and right arm, clustered on left thigh, some going up to grain area, left side hairline. Some appeared pustule like doctor prescibed CEPHALAXIN and cortaid topical. On 27-Jun-2008 patient returned to pharmacy with inreased redness and spreading of rash to other sites, the right eye lid, waistline, gorin with some that appeared pustule like injection site swelling had improved but pain, rash, redness had spread all over body. Patient was distraught over the outcome of the vaccine and expressed this to the pharmacist. Pharmacist told patient to return immediatley to her primary care doctor for treatment. At the time of reporting the patient had not recovered. There was no illness at the time of vaccination. The events required ER/Dr visit. Follow up information was received froma the 63 year old patient who on 23-Jun-2008, between 4:30 and 4:45 pm, was vaccinated with a dose of ZOSTER vaccine live (Oka/Merk) (Lot # 659411/0293X, expiration date 29-Jul-2008). No concomitatnt medicatins reported. The patient reported as follows: "My husband and I were told by the pharmacist that we might expect some redness at the sight of the injection (LAVEK) OR TYLENOL would alleviate any possible pain. Initially there was some slight swelling and itching in both our arms. The next day, mine appeared to be more severe than my husband's. By Wednesday 25 Jun, my arm was very puff, hot, and red, and another red, itchy spot appeard on the inside of my left thigh. On Thursday, the spot on my left thigh became a full rash with blisters spreading up my leg into the groin area. It was also now developed on the inside of my right thigh, and there were red blotches on my abdomen, all of it painful and itching like crazy. There were also whelps or blisters on the right side of my neck, on the underside my right jawbone, and my left shoulder . Without an appointment I went to my family physician, who diagnosed a severe reaction to the vaccine, and prescribed KEFLEX (one capsule three time a daily) for the infection in my arm, and CORTAID for the rash elsewhere. Afterwards I went to the pharmacy, where the shot was administered, to determine if they had seen this kind of reaction before. The pharmacist did say she thought I had shigles. By Friday 27-Jun-2008, my right eyelid was affected, swollen, red and itching. The spot under my jawbones was worse, and now more blotches appeared on my chest and abdoemen. I called physician's office, who told me to see another physician. This physician's assistant said she believe it to be shingles. She took pictures of the infected areas, then scaping for cultures and studying than under a microscope, said it was shingles. She prescribed VALTREX (one tablet three time daily), and clobetaaol (applied topically twice a day except on face, armpits and groin area). On 11 Jul I was prescribed hydroxyzine and saran anti-itch lotion. On 16-Jul-2008, I was prescribed LOCOID lipocream. At the time of reporting the patient stated she was still working on the problem which got worse each day. The patient reported she was health at the time on vaccination. This is one of two reports from the same source. No further information is available.