Received Apr 18, 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 | — | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Inappropriate Storage Error; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a patient 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 and DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 16-JAN-2025, the patient received Infanrix, Pediarix, Kinrix, Havrix, Engerix B and Boostrix. On 16-JAN-2025, an unknown time after receiving Infanrix, Pediarix, Kinrix, Havrix, Engerix B and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Inappropriate Storage Error). 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-APR-2025 The physician reported that he had submitted his continuous thermometer readings for review by the VFC program, and was told had a temperature excursions at 0.91 degree Celcius and the total time out of range is 20 minutes. Reporter believed it was an error, as 20 min prior the temperature was 4.92 degree Celcius on 16 January 2025 at 11:42 am 20 minutes, the next temperature was taken at 12:02 pm where it registered 0.43 degree Celsius. There was a patient Involvement, which led to incorrect storage of drug.