Received Aug 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 2CA77C1 | OT |
DAPTACEL was administered to an 11 years 11 months patient by accident with no reported adverse event; Initial information received on 13-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years and 11 months old female patient who received Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] by accident with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for Immunisation. On 07-Jan-2025, the patient received 0.5mL dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, Strength Standard, lot 2CA77C1 and expiry date 30-Apr-2025 via intramuscular route in Arm NOS (not otherwise specified) for immunization, by accident with no reported adverse event (product administered to patient of inappropriate age) (Latency Same day). Reportedly, Daptacel was administered to an 11 year old patient by accident on January and they wanted to know if the patient was still supposed to get a TDap booster or if there is a wait booster between the vaccines. HCP (Health care professional) mentioned that they were to use Adacel for the booster. 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.
Menquadfi