Received Jun 30, 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 | — | — |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Administration after 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 an unspecified number of patients who received DTPa (Infanrix) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis. On an unknown date, the patients received Infanrix, Pediarix, Kinrix, Havrix, Engerix B, Bexsero, Menveo and Rotarix liquid formulation. On an unknown date, an unknown time after receiving Infanrix, Pediarix, Kinrix, Havrix, Engerix B, Bexsero, Menveo and Rotarix liquid formulation, the patient experienced incorrect storage of drug (Verbatim: Administration after 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: 18-JUN-2025 The reporter called and reported a temperature excursion for Infanrix, Pediarix, Kinrix, Havrix, Engerix-B, Bexsero, Menveo (1 vial) and Rotarix (liquid) vaccines. Medical assistant mentioned that the excursion happened on 16th May 2025, and since then, they had been using the vaccines. Due to the conditions of the excursion, they explained to the healthcare professional that the products (except Rotarix liquid version) should not be use and they should be discarded. At the end of the call, healthcare professional mentioned that she already reported this excursion in a prior call and mentioned that former agent informed that the vaccines were stable, Healthcare professional informed to be confused due to the below recommended temperature that they just provided. Due to the information from healthcare professional, it seemed that they had been using these vaccines after a temperature excursion which led to incorrect storage of drug.