Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Impaired healing, Injection site discharge, Injection site reaction, Injection site scab, Injection site scar
Clinical narrative: Information has been received from a pharmacist via a field representative concerning a male patient of unknown age. No concurrent condition, medical history and concomitant therapies were reported. On an unspecified date in February 2015, the patient was administered ZOSTAVAX (Lot#, dosage and route not provided) and developed a pock mark at the injection site shortly after the administration. The patient's pock mark at the injection site continually oozed, crusts over, then eventually the scab fell off and it started oozing again. It never healed. The patient visited several unspecified physicians regarding this issues but none of them were able to assist him. The pock mark had never completely healed. The patient was not recovered from the events at time of the reporting. The relationship between the events and ZOSTAVAX was not reported. Follow up information has been received on 15-JUN-2016 from a physician in the form of medical records and a 553A specimen form. According to medical records: The patient, now 83 years old, was seen by physician on 15-JUN-2016 for a wellness visit. The patient was noted to be a nonsmoker with no alcohol use with a medical history of left knee replacement (December 2008). The patient's family history included atrial fibrillation (mother), hypertension (mother and father), leukemia (father), basal cell carcinoma (father) and breast cancer (sister). The patient's current assessments included osteoarthritis, plantar fasciitis, essential hypertension benign, sick sinus syndrome, hyperlipidemia, vitamin D deficiency, obesity, basal cell carcinoma treated with Mohs surgery on forehead and back, and prostate cancer status post radiation. The patient also reported a fall within the last 3 months. Upon physical examination, the patient was noted to have a skin lesion on his right deltoid with no subcutaneous nodules or induration. The patient reported the skin lesion was following shingles vaccination about 1 and 1/2 years ago. The physician took a swab of the area and sent for evaluation upon the patient's request. The physician advised the patient to follow up with his dermatologist and possibly undergo a skin biopsy. The patient agreed to recommendation. According to the 553A specimen form: On 15-JUN-2016, a sample of the vesicle on the right deltoid was taken and sent for evaluation (VZVIP case number 1-14215671106). On 11-FEB-2015, an 82 year old male with a history of chicken pox in childhood was vaccinated with ZOSTAVAX, lot # K015308 in the left deltoid (in conflict, skin lesion noted on right deltoid and previously reported at injection site). A few days later, the patient experienced 2 itchy pimples (location not provided). The outcome of 2 itchy pimples was reported as recovered (date not provided). Upon internal review, sick sinus syndrome, basal cell carcinoma treated with Mohs surgery on forehead and back and prostate cancer status post radiation were considered to be medically significant. All available medical records will be provided upon request. Additional information has been requested.