Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Redness/swelling around injection site/on upper arm that was injected; Redness/swelling around injection site/on upper arm that was injected; Fatigue; swelling on upper arm that was injected; This non-serious case was reported by a other health professional and described the occurrence of injection site swelling in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Redness/swelling around injection site/on upper arm that was injected), injection site erythema (Verbatim: Redness/swelling around injection site/on upper arm that was injected), fatigue (Verbatim: Fatigue) and swelling arm (Verbatim: swelling on upper arm that was injected). The outcome of the injection site swelling, injection site erythema, fatigue and swelling arm were resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema, fatigue and swelling arm to be related to Shingrix. It was unknown if the company considered the injection site swelling, injection site erythema, fatigue and swelling arm to be related to Shingrix. Additional Information: GSK Receipt Date: 23-OCT-2025 The reporter reported the AE that was disclosed in the course of a qualitative interview for a mixed-methods preference study among the general population sponsored, and therefore there are no additional details known about the patient or their medical history (e.g. treatment experience, comorbid conditions, etc). Patient was not treated for any of the symptoms. The batch number was not provided and a request for this information has been made.