Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
a bump (lump of tissue) that customer noticed at site of injection; Inflammation at site of injection; This non-serious case was reported by other health professional and described the occurrence of injection site inflammation in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 15-NOV-2025, the patient received Shingrix .5 ml. On 15-NOV-2025, less than a day after receiving Shingrix, the patient experienced injection site inflammation (Verbatim: Inflammation at site of injection). On an unknown date, the patient experienced injection site lump (Verbatim: a bump (lump of tissue) that customer noticed at site of injection). On 04-DEC-2025, the outcome of the injection site inflammation was not resolved (duration 19 days). The outcome of the injection site lump was not reported. It was unknown if the reporter considered the injection site inflammation and injection site lump to be related to Shingrix. It was unknown if the company considered the injection site inflammation and injection site lump to be related to Shingrix. Additional Information: GSK receipt date: 04-DEC-2025 The patient experienced a bump (lump of tissue) that was noticed at site of injection. The batch number was not provided and a request for this information has been made.