Received May 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | UNK | — |
Stem cell transplant after Shingrix series; Extra series prescribed; This serious case was reported by a pharmacist via call center representative and described the occurrence of stem cell transplant in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix and the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced stem cell transplant (Verbatim: Stem cell transplant after Shingrix series) (serious criteria clinically significant/intervention required) and drug schedule prescribing error (Verbatim: Extra series prescribed). The outcome of the stem cell transplant was unknown and the outcome of the drug schedule prescribing error was not applicable. It was unknown if the reporter considered the stem cell transplant to be related to Shingrix. The company considered the stem cell transplant to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 20-MAY-2025 The pharmacist explained that an adult patient had received two doses of Shingrix in 2019 (specific dates were unknown). Since the patient had undergone a stem cell transplant, their healthcare provider had recommended administering another series of Shingrix, which led to Drug schedule prescribing error.; Sender's Comments: Stem cell transplant is an unlisted event which is considered unrelated to GSK vaccine Shingrix.