Received Aug 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| DTAPIPV | DTAP + IPV (KINRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | — | — |
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | — | — |
Maladministration of vaccines after a temperature excursion; 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 DTPa-HBV-IPV (Pediarix) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, HAV (Havrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Pediarix, Engerix B, Kinrix, Infanrix, Havrix, Menveo and Bexsero. On an unknown date, an unknown time after receiving Pediarix, Engerix B, Kinrix, Infanrix, Havrix, Menveo and Bexsero, the patient experienced incorrect storage of drug (Verbatim: Maladministration of vaccines after a 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: 30-JUL-2025 Medical Assistant reported that Pediarix, Rotarix pre filled version, Engerix-B, Kinrix, Infanrix, Havrix, Menveo one dose vial presentation and Bexsero vaccines were exposed to a minimum temperature of 31.53 degrees Fahrenheit and were below the recommended range for a maximum cumulative time of 2 hours and 45 minutes on 28-June-2025. In-house extended stability data does not supports the stability of Pediarix, Engerix-B, Kinrix, Infanrix, Havrix, Menveo one dose vial and Bexsero, which led incorrect storage of drug. In-house extended stability data supports the stability of Rotarix pre filled presentation and its listed expiration date still applies. The healthcare provider requires additional time to collect any relevant patient information related to the administration of these vaccines following exposure to freezing temperatures. The reporter consented to follow up.