Received Sep 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | — | OT |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | 1 | 4CA28C1 | OT / LL |
adacel was given to the 3 months and 6 days old infant instead of daptacel with no reported adverse event; adacel was given to the 3 months and 6 days old infant instead of daptacel with no reported adverse event; Initial information received on 04-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (health care professional). This case involves a 3 months and 6 days old infant female patient who was administered diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] instead of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Sep-2025, 3 months and 6 days old patient received a dose 0.5 ml (dose 1) of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, Suspension for injection (lot 4CA28C1) (frequency: once and strength: standard) (expiry date 31-Mar-2027) via intramuscular route in the left thigh instead of diphtheria-15/tetanus/5 ac pertussis vaccine, Suspension for injection (unknown strength, lot and expiry date not reported) with no reported adverse event (product administered to patient of inappropriate age) (wrong product administered) (Latency: same day). Action taken was 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.