Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4L544 | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 42B22 | — |
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | J4K4X | — |
Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number 42B22, expiry date 07-MAR-2026), (batch number 79CX37, expiry date 12-DEC-2026), (batch number 47XP4, expiry date 16-JUL-2026), (batch number 39C29CD, expiry date 16-JAN-2027) and (batch number 42B22, expiry date 07-MAR-2022) for prophylaxis. Co-suspect products included HAV (Havrix) (batch number J4K4X, expiry date 20-DEC-2026), (batch number 22GP3, expiry date 11-SEP-2026) and (batch number H39C97, expiry date 01-JAN-2027) for prophylaxis and DTPa-HBV-IPV (Pediarix) (batch number 4L544, expiry date 10-OCT-2027) for prophylaxis. On an unknown date, the patient received Engerix B. On an unknown date, the patient received Havrix. On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Engerix B, Havrix and Pediarix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). 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: 09-JUN-2025 The nurse reported that she had an excursion on the 26th of the last month for 84 minutes and reporter just want to see if these vaccinations that were administered are viable. The nurse did not know the patients information, she only knew that the vaccines went through a temperature excursion on May 26th, 2025 and were administered to different patients, which led to incorrect storage of drug. Excursion information duration of 84 min with temperature is 13.4 degree Celsius no prior excursions.