Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Rotarix was exposed to 5 excursions in 2024 and 2025; 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 patient who received Rotavirus vaccine for prophylaxis. On an unknown date, the patient received Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced incorrect storage of drug (Verbatim: Rotarix was exposed to 5 excursions in 2024 and 2025). The outcome of the incorrect storage of drug was 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: 06-JUN-2025 Medical assistant reported that Rotarix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was 9.76 Celsius and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions reported. The majority of all vaccines reported were administered to patients, which led to incorrect storage of drug. Caller transferred from vaccine reimbursement center, the reporter did not have patient, product, other adverse event details available during call. This is 1 of 8 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071799:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect US-GSK-US2025071803:Same reporter, Different suspect US-GSK-US2025071805:Same reporter, Different suspect US-GSK-US2025071802:Same reporter, Different suspect