Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Scleritis; This serious case was reported by a physician via sales rep and described the occurrence of scleritis in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included rosuvastatin. On 20-JUN-2025, the patient received the 1st dose of Shingrix. On 20-JUN-2025, less than a day after receiving Shingrix, the patient experienced scleritis (Verbatim: Scleritis) (serious criteria GSK medically significant and other: Serious as per reporter). In JUL-2025, the outcome of the scleritis was resolved. The reporter considered the scleritis to be related to Shingrix. The company considered the scleritis to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 23-JUL-2025 The physician reported that the patient received Shingrix and experienced scleritis; Sender's Comments: A case of Scleritis, less than a day after receiving Shingrix, in a 66-year-old female patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
ROSUVASTATIN