Received Feb 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 74NC9 | — |
hard knot at injection site; Injection site hard knot; swelling at injection site; redness at injection site; mistakenly administered Shingrix adjuvant only; mistakenly administered Shingrix adjuvant only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site mass in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 74NC9, expiry date 13-NOV-2026) for prophylaxis. On 28-JAN-2025, the patient received the 1st dose of Shingrix. On 28-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: mistakenly administered Shingrix adjuvant only) and inappropriate preparation of medication (Verbatim: mistakenly administered Shingrix adjuvant only). On 30-JAN-2025, the patient experienced injection site mass (Verbatim: hard knot at injection site), injection site induration (Verbatim: Injection site hard knot), injection site swelling (Verbatim: swelling at injection site) and injection site erythema (Verbatim: redness at injection site). The outcome of the injection site mass, injection site induration and injection site swelling were not resolved and the outcome of the injection site erythema, inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown. It was unknown if the reporter considered the injection site mass, injection site induration, injection site swelling and injection site erythema to be related to Shingrix. It was unknown if the company considered the injection site mass, injection site induration, injection site swelling and injection site erythema to be related to Shingrix. Additional Information: GSK Receipt Date: 04-FEB-2025 The pharmacy technician mistakenly administered Shingrix adjuvant only, without reconstitution to the patient, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. The error was discovered two days later. The patient returned to the pharmacy on 30 January 2025 with injection site redness, swelling, and a hard knot. The vaccine administration facility was the same as primary reporter. Nothing else was reported. The case was linked with case US2019160501, reported by the same reporter.; Sender's Comments: US-GSK-US2019160501:same reporter