Received Jul 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | X5T42215ZK | — |
having a b urning sensation and discomfort at the injection site.; having a b urning sensation and discomfort at the injection site.; This non-serious case was reported by a physician via call center representative and described the occurrence of burning sensation skin in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number X5T42215ZK) for prophylaxis. On 18-APR-2025, the patient received the 1st dose of Shingrix. On 18-APR-2025, less than a day after receiving Shingrix, the patient experienced burning sensation skin (Verbatim: having a b urning sensation and discomfort at the injection site.) and injection site discomfort (Verbatim: having a b urning sensation and discomfort at the injection site.). The outcome of the burning sensation skin and injection site discomfort were unknown. It was unknown if the reporter considered the burning sensation skin and injection site discomfort to be related to Shingrix. It was unknown if the company considered the burning sensation skin and injection site discomfort to be related to Shingrix. Additional Information: GSK receipt date: 27-JUN-2025 The physician called in to request data about the administration of a second dose of Shingrix after a patient reported having a burning sensation and discomfort at the injection site.