Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Viral DNA test negative
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 72 year old male consumer with high blood pressure, high cholesterol, benign prostatic hyperplasia, CORICIDIN allergy and history of eczema and chickenpox (date unknown) who on 08-APR-2008 was vaccinated SQ in the left arm with 0.5mL zoster vaccine live (Oka/Merck) (lot # 659267/1836U). Concomitant therapy included lovastatin, NIASPAN and fish oil. Subsequently, the patient developed a bilateral rash 2-3 hours after vaccination. It was a diffuse rash that looked like chickenpox. It covered his trunk, arms and one leg. Medical attention was sought in the office. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information indicated that the patient developed more than 100 lesions all over on his legs, buttocks, and trunk. It was noted that there was no recent exposure to chickenpox or shingles. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. The sample of the lesions was collected and received in the laboratory on 30-APR-2008. The sample was taken from a vesicular lesion. The PCR results for the specimen from the vesicle lesion was an adequate specimen, no VZV identified-Negative. Additional information has been requested. This is in follow-up report(s) previously submitted on 6/24/2008.  Initial and follow-up information has been received from a registered nurse concerning a 72 year old male consumer with high blood pressure, high cholesterol, benign prostatic hyperplasia, CORICIDIN allergy and a history of eczema and chickenpox (date unknown) who on 08-APR-2008 was vaccinated SQ in the left arm with the first dose of 0.5ml ZOSTAVAX (lot # 659267/1836U).  Concomitant therapy included LOVASTATIN, NIASPAN and fish oil.  Subsequently, the patient developed chicken pox type rash on trunck and extremities 3-4 hours after vaccinations.  It was a diffuse rash that looked like chickenpox.  It covered his trunk, arms and one leg.  Medical attention was sought in the office.  There were no lab studies performed.  Subsequently the patient recovered.  There was no product quality complaint involved.  Follow-up information indicated that the patient developed more than 100 vesicular lesions all over on his legs, buttocks, and trunk.  It was noted that there was no recent exposure to chickenpox or shingles.  The patient was enrolled in the in a program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WTI VZV strain or with the OKA/Merck vaccine strain.  The sample of the lesions was collected and received in the laboratory on 30-APR-2008.  The sample was taken from a vesicular lesion.  The PCR results for the specimen from the vesicle lesion was an adequate specimen, no VZV identified-Negative.  Additional information is not expected.