Received Apr 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 4CA37C1 | IM / LL |
HCP stated that 0.5 mL from the DAPTACEL single-dose vial, which does not require a diluent, was nevertheless diluted with another 0.5 mL of sterile water and then the full 1.0 mL was administered to the patient with no ae; Initial information received on 16-Apr-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves a 9 months old female patient who was administered with full 1.0 ml dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] and it was stated that 0.5 mL from the DAPTACEL single-dose vial, which does not require a diluent, was nevertheless diluted with another 0.5 mL of sterile water no adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history, concomitant medications were not provided. No concomitant vaccines were administered. On 16-Apr-2026, the patient received (dose 3) 1.0 ml of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection, frequency: once, strength unknown (batch: 4CA37C1, expiry: 31-May-2027) via intramuscular in the left thigh for immunization and stated that 0.5 mL from the DAPTACEL single-dose vial, which does not require a diluent, was nevertheless diluted with another 0.5 mL of sterile water with no reported adverse event (Product preparation issue, onset: 16-Apr-2026, latency: same day). Action taken: Not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Comments: NONE