Received Feb 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | M52GG | — |
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 2G273 | — |
| FLU3 | INFLUENZA (SEASONAL) (FLULAVAL) | GLAXOSMITHKLINE BIOLOGICALS | UNK | J5T9Z | — |
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | 9M2R7 | — |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | HP495 | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 3335K | — |
Vaccines administered after above and below temperature excursion; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) (batch number 3335K, expiry date 28-SEP-2025) for prophylaxis. Co-suspect products included DTPa (Infanrix) (batch number M52GG, expiry date 07-SEP-2026) for prophylaxis, Rota (Rotarix liquid formulation) (batch number HP495, expiry date 17-MAY-2026) for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 2G273, expiry date 15-APR-2027) for prophylaxis, Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number J5T9Z, expiry date 06-JUN-2025) for prophylaxis and Men ACWY-CRM NVS (Menveo) (batch number 9M2R7, expiry date 31-DEC-2025) for prophylaxis. On an unknown date, the patient received Boostrix, Infanrix, Rotarix liquid formulation, Pediarix, FluLaval 2024-2025 season and Menveo. On an unknown date, an unknown time after receiving Boostrix, Infanrix, Rotarix liquid formulation, Pediarix, FluLaval 2024-2025 season and Menveo, the patient experienced incorrect storage of drug (Verbatim: Vaccines administered after above and below temperature excursion). 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: 07-FEB-2025 The physician called to report a temperature excursion that happened during 22 hours 50 minutes with a maximum temperature of 10.22 degree Celsius for Bexsero, Boostrix, Engerix-B, FluLaval, Havrix, Infanrix, Kinrix, Menveo (1-vial), Pediarix and Rotarix (liquid). Those vaccines experienced two prior excursions, one of them during 32 hours 6 minutes with maximum temperature of 21.92 degree Celsius, and the other one during 9 hours 45 minutes with a minimum temperature of 1.53 degree Celsius. Physician mentioned that after those temperature excursions, some of the vaccines were administered to patients 1 dose of Menveo (1-vial presentation), 2 doses of FluLaval, 3 doses of Pediarix, 3 doses of Rotarix (liquid presentation), 2 doses of Infanrix, and 1 dose of Boostrix, which led incorrect storage of drug. The reporter did not have any patient demographics, but mentioned that vaccines were administered between February 3rd and 4th 2025. The reporter consented to follow up.