Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Admin. after below 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 DTPa (Infanrix) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, Herpes zoster (Shingrix) for prophylaxis and RSVPreF3 adjuvanted (Arexvy) for prophylaxis. In APR-2025, the patient received Pediarix, Infanrix, Havrix, Engerix B, Menveo, Bexsero, Boostrix, Kinrix, Shingrix and Arexvy. In APR-2025, an unknown time after receiving Pediarix, Infanrix, Havrix, Engerix B, Menveo, Bexsero, Boostrix, Kinrix, Shingrix and Arexvy and an unknown time after receiving Pediarix, Infanrix, Havrix, Engerix B, Menveo, Bexsero, Boostrix, Kinrix, Shingrix and Arexvy, the patient experienced incorrect storage of drug (Verbatim: Admin. after 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: 12-MAY-2025 On 12th May 2025 a Clinic manager/AMAS called to report a temperature excursion for Pediarix, Infanrix, Havrix, Engerix-B, Menveo, Bexsero, Boostrix, Kinrix, Shingrix and Arexvy. Healthcare professional reported that since 07th April 2025 the vaccines were exposed to below recommended temperatures, and on 29th April 2025 the products were exposed to a minimum temperature of 29.9 °F which led to incorrect storage of drug. Healthcare professional asked that so patients that had been vaccinated during those excursions, during that time frame, do they need to be revaccinated? or what's the protocol for that? During the call, Healthcare professional did not share any patient information, she said that at the moment of the call, she did not have any information due to the situation, they add the list of all the vaccines, but they don't have the details of which patients received which vaccine.