Received Jun 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | — |
Vaccine stored outside recommended conditions and administered to patient.; Repeated dose of Shingrix was administered in less time than recommended.; Incorrect storage of drug; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis. On 08-OCT-2021, the patient received the 3rd dose of Shingrix. On 21-SEP-2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received FluLaval 2024-2025 season. On an unknown date, not applicable after receiving Shingrix and FluLaval 2024-2025 season and an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient.), extra dose administered (Verbatim: Repeated dose of Shingrix was administered in less time than recommended.) and incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug, extra dose administered and incorrect storage of drug were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-JUN-2025 and 05-JUN-2025 Registered Nurse called to report that she just have a general question. When a vaccine goes out of range. When a vaccine was stored and it was out of range in the refrigerator and if patient had to revaccinate the patient, how soon can we re-vaccinate them? What should be the time interval if it should be immediately or if patient have wait a certain period of time? The reporter asked these questions specifically for the Flu vaccine and the Shingrix. The reporter consented to follow up. The HCP did not specify the conditions of the temperature excursion since she said it happened a couple of years ago. The repeated dose of Shingrix vaccine was administered in less than 28 days. She did not know which number of dose was administered. Less than 20 patients were affected but she stated that they made the report. Patient stated that the flu vaccine was Flulaval however she stated that she did not have the information in front of her. The reporter mentioned that a patient received the second dose of Shingrix, however this dose was involved in a temperature excursion, which led to incorrect storage of drug. Therefore, they revaccinate the patient, which led to extra dose administered. The reporter wanted to confirm if the dose given on 08-OCT-2021 was considered valid since the the CDC recommended a 28-day interval from the invalid dose to reduce the risk for interference from interferon on the subsequent doses.