Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Redness at injection site; injection site with white dots; red skin/extension to arm and neck; rash that extended to the neck and back; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at injection site), injection site hypopigmentation (Verbatim: injection site with white dots), erythema (Verbatim: red skin/extension to arm and neck) and rash (Verbatim: rash that extended to the neck and back). The outcome of the injection site erythema, injection site hypopigmentation, erythema and rash were unknown. It was unknown if the reporter considered the injection site erythema, injection site hypopigmentation, erythema and rash to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site hypopigmentation, erythema and rash to be related to Shingrix. Additional Information: GSK Receipt Date: 10-FEB-2025 A pharmacist contacted GSK to request information about administering the second dose of Shingrix male patient mentioned that they previously suffered from adverse events which consisted in redness, with white dots present on the red skin and a rash that extended to the neck and back. They mentioned that they do not have information about when this first vaccine was given, the lot number or expiration date. The Health Care Professional enquired if GSK had any information about administering the second dose after a patient with such symptoms.