Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a 55 year old female certified medical assistant with hypertension, esophageal acid reflux, and an allergy to epinephrine who on 18-MAY-2007 was vaccinated SC in the left upper arm with a dose of Zostavax (lot # 657559/0462U). Concomitant therapy included ACIPHEX and DIOVAN. On 18-MAY-2007, a few hours after receiving the vaccine, the patient experienced sneezing and "feeling chills." The symptoms resolved in three hours. On 19-MAY-2007, the patient developed soreness, erythema, warmth, and a firm nodule "larger than a quarter" at the injection site of the left upper arm. Unspecified medical attention was sought and ice application was recommended. The symptoms were resolving. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007. Information has been received from a 55 year old female certified medical assistant with hypertension, esophageal acid reflux, and an allergies to epinephrine and NOVOCAINE who on 18-MAY-2007 at 11:00 AM was vaccianted SC in the left upper arm with a first dose of ZOSTAVAX vaccine (Merck) (lot # 657559/0462U). Concomitant therapy included ACIPHEX and DIOVAN. There was no illness at the time of vaccination. On 18-MAY-2007, a few hours after receiving the vaccine, the patient experinced sneezing and "feeling chills." The symptoms resolved in three hours. On 19-MAY-2007, the patient developed soreness, erythema, warmth, and a firm nodule "larger than a quarter" at the injection site of the left upper arm. Unspecified medical attention was sought and ice application was recommended. The symptoms were resolving. No diagnostic laboratory tests were performed. A product quality complaint was nor involved. Additional information has been received from the reporter who indicated that on 18-MAY-2007 at 11:00 AM the adverse events began. She developed redness, itching, warmth, soreness, and a knot the size of a quarter at the site of injection. She had some chills and sneezing. The redness and soreness lasted five to seven days. Discoloration on the skin lasted for two weeks."The symptoms resolved in three hours. On 19-May-2007, the patient developed soreness, erythema, warmth, and a firm nodule "larger thatn a quarter" at the injection site of the left upper arm. Unspecified medical attention was sought and ice applicatin was recommended. The symptoms were resolving. No diagnostic laboratory tests were performed. A product quality complaint was not involved.  The patient subsequently recovered. A review of the release testing data revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards of the Center and was released. No further information is expected. This is in follow-up to report (s) previously submittedon 6/14/2007. Additional information has been received fromt he reporter who indicated that on 18-May-2007 at 11:00 AM the adverse events began. She developed redness, itching, warmth, soreness, and a know the site of a quarter at the site of injection. She had some chills and sneezing. The redness and soreness lasted five to seven days. Discoloration on the skin lasted for two weeks. The patient subsequently recovered. No further information is expected.