Received May 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | PC65Y3 | — |
Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number PC65Y3) for prophylaxis. On 08-APR-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 19-MAY-2025 The health care professional reported that they got vaccines and did not know if they were familiar with that place or not but anyway. They got the Shingrix vaccine normally, it was supposed to be frozen however, they have an employee that did not know that so, she put it on the refrigerator. It have been refrigerated since we got it but it was not in frozen, so need to know if it was still be efficacy of it or they should get rid of it and order new and they have two people that were vaccinated with it, which led to incorrect storage of drug. Did they not, when it was not frozen, so need to you know if they need to be revaccinated. Besides the two patients reported, health care professional confirmed that no other patient was administered with Shingrix after being stored at non recommended temperatures. Medical information discussed with health care professional normal storage conditions for Shingrix. This case is linked with US2025062275, reported by same reporter.; Sender's Comments: US-GSK-US2025062275:same reporter,Different patient