Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 7523J | — |
Sore throat full of blisters like shingles; Sore throat; Fatigue; This serious case was reported by a consumer and described the occurrence of throat blister in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 7523J, expiry date 06-NOV-2026) for prophylaxis. On 06-NOV-2025, the patient received Shingrix. On 07-NOV-2025, 1 days after receiving Shingrix, the patient experienced throat blister (Verbatim: Sore throat full of blisters like shingles) (serious criteria GSK medically significant) and sore throat (Verbatim: Sore throat). In NOV-2025, the patient experienced fatigue (Verbatim: Fatigue). The outcome of the throat blister and sore throat were unknown and the outcome of the fatigue was not reported. It was unknown if the reporter considered the throat blister, sore throat and fatigue to be related to Shingrix. The company considered the throat blister to be unrelated to Shingrix. It was unknown if the company considered the sore throat and fatigue to be related to Shingrix. Additional Information: GSK Receipt Date: 08-NOV-2025 Patient had sore throat full of blisters like shingles. Fatigue and sores was just resting and took fluids.; Sender's Comments: A case of Oropharyngeal blistering, 1 days after receiving Shingrix, in a 61-year-old female patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.