Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 47Y5M | — |
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 5YB7L | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 95BJ9 | — |
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | A3X2K | — |
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | FH443 | — |
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | X7R4B | — |
Bexsero, Engerix-B, Havrix, Menveo, Infanrix and Pediarix were administered to patients; 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 Men B NVS (Bexsero) (batch number FH443, expiry date 30-SEP-2027) and (batch number A274J, expiry date 30-SEP-2027) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 95BJ9, expiry date 26-JUL-2026) for prophylaxis, HAV (Havrix) (batch number A3X2K, expiry date 07-SEP-2026) for prophylaxis, DTPa (Infanrix) (batch number 47Y5M, expiry date 26-JUN-2026) and (batch number 9KB9G, expiry date 07-JUL-2026) for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number X7R4B, expiry date 30-SEP-2025) and (batch number LN75D, expiry date 30-SEP-2025) for prophylaxis and DTPa-HBV-IPV (Pediarix) (batch number 5YB7L, expiry date 29-NOV-2026) and (batch number D252F, expiry date 10-APR-2027) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, the patient received Engerix B, Havrix and Infanrix. On an unknown date, the patient received Menveo. On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Bexsero, Engerix B, Havrix, Infanrix, Menveo and Pediarix, the patient experienced incorrect storage of drug (Verbatim: Bexsero, Engerix-B, Havrix, Menveo, Infanrix and Pediarix were administered to patients). 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 : 03-APR-2025 A medical assistant wanted to confirm the stability of Pediarix, Rotarix (1 vial), Havrix, Engerix-B, Kinrix, Infanrix, Menveo (1 vial) & Bexsero after a below temperature excursion of 18.98°F for 2 hours and 55 minutes that occurred on March 7, 2025 which led to incorrect storage of drug. During that period of time some of them (Bexsero, Engerix-B, Havrix, Menveo, Infanrix and Pediarix) were administered to patients without knowing that these vaccines had been through this temperature excursion, so the agent tried to collect the adverse event details (given that they were no longer viable according to the excursion data provided), but the healthcare professional only had their lot number and expiration date and mentioned she needed to review all the information that they had in order to know how many and which patients received the vaccines and, after gathering everything, she will be calling back medical information to provide all the left information needed, so case number was provided.