Received May 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | M7G39 | — |
administration after a below temperature excursion of 29.9 degree F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingrix) (batch number M7G39) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: administration after a below temperature excursion of 29.9 degree F as the minimum reached). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Shingrix, which led to incorrect storage of vaccine. The Vaccine Administration Facility was the same as Primary Reporter. No expiration date given for the vaccines nor date of administration. The reporter consented to follow up.; Sender's Comments: US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061547:Same patient,different suspect US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061545:Same reporter,Different patient