Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Peripheral swelling, Polymerase chain reaction positive
Clinical narrative: This spontaneous report was received from a 61 year old female patient. The patient's concurrent conditions included high blood pressure and allergy to latex and penicillin. The patient's medical history and concomitant medications were not provided. On 18-MAR-2016, the patient was vaccinated with ZOSTAVAX 1 shot (lot number, expiry date, route and dose not reported). On 18-MAR-2016, after vaccination, the patient experienced injection site swelling about the size of a quarter, that increased to the size of a silver dollar. On 19-MAR-2016 (reported as on the next day), it was reported that the injection site was itchy and had a rash. The patient sought medical attention on 20-MAR-2016, when the swelling reached her shoulder area. The area was hot. The patient received a treatment with BENADRYL and SARNA CREAM for the reported adverse events. No product quality complain (PQC) was involved. At the time of this report, the outcome of injection site swelling, peripheral swelling, feeling hot, rash pruritic and injection site pain was reported as not recovered. The reporter did not provide causality assessment between the reported events and the ZOSTAVAX. Follow up information has been received from the physician and registered nurse on 22-MAR-2016 referring to the patient who 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 patient's concurrent conditions included hypertension, hyperlipidemia, type 2 diabetes mellitus and obesity. Historical condition included high cholesterol, peripheral vascular disorder and depression. Allergies were noted as MEDROL DOSEPAK, penicillin, wasps, bees, latex, and "Shingles vaccine". The patient had chickenpox when she was child. On 18-MAR-2016 the patient was vaccinated with ZOSTAVAX (lot # L039096, 0.6 ml, subcutaneous in the left arm). Historical drugs included metformin, CHOLESTAGEL, venlafaxine hydrochloride, losartan (manufacturer unknown) and atorvastatin. Concomitant therapies included atorvastatin, aspirin (ASA), CHOLESTAGEL, metformin, losartan potassium (manufacturer unknown) and venlafaxine hydrochloride. On 18-MAR-2016, she developed a pustule on her left arm at the site of vaccination and redness. Rash was maculopapular. On 19-MAR-2016 the redness and pustule worsened. On 21-MAR-2016, the patient was seen by the physician in the office. The physician noted that there was 1 lesion at the injection site surrounded by a 2 cm x 4 cm area of redness with a 14cm x 16cm lighter pink area of erythema was noted around the 2cm x 4cm area. Scrapings from the pustule were taken and placed in viral media and sent for VZVIP Polymerase Chain Reaction (PCR) testing. VZVIP PCR was positive for VZV. The patient was placed on a MEDROL DOSEPAK and it was reported that she had a reaction to the MEDROL DOSEPAK. On 29-MAR-2016 the patient was seen again by the nurse and it was reported that the area was crusted and measured 1 mm. A second sample was obtained from the scabbed area at the vaccination area. The patient continued to only have 1 lesion. At this time, the patient was recovering but not fully recovered. On 29-MAR-2016, VZV strain identification PCR were positive for VZV and strain identification identified the OKA/Merck vaccine strain. On 30-MAR-2016, the patient was seen again in the office by another provider for an unrelated issue. It was noted that the area resolved and the patient fully recovered as of 30-MAR-2016. The outcome of redness and swelling at injection site was reported as slowly recovered. Follow up information has been received from a physician on 26-SEP-2016. It was reported that the patient's concurrent conditions also included a new allergy to shingles vaccine and on 21-MAR-2016 at 5:00 pm the patient experienced localized redness from elbow to shoulder. The physician informed that the patent recovered on 30-MAR-2016 after medical intervention to prevent serious criteria. The reporting physician considered the event localized erythema to be another important medical event. Additional information is not expected as all the information to complete the case was received. Patient information, events and narrative were updated.