Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (KINRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Unapproved age/ 2 months old received Kinrix; 2 months old received Kinrix instead of Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B). On an unknown date, the patient received Kinrix and did not receive Pediarix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved age/ 2 months old received Kinrix) and wrong vaccine administered (Verbatim: 2 months old received Kinrix instead of Pediarix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 28-AUG-2025 The reporter reported that they had a baby in their practice who was administered a Kinrix vaccine in 2025, and it looks like he, the vaccine that, he should have been administered was the Pediarix because his age at the time of the administration was three to two months old. The reporter had question for his following shot, it looked like the only difference between the two, was that the Kinrix have a Hepatitis component was that correct and so, if patient received the Hepatitis B and the Kinrix, separately, it affects the spacing of any of his following vaccines. Ther reporter asked that they need to change anything with his schedule.
ENGERIX B