Received Aug 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 3CA25C1 | OT / LA |
daptacel used in unapproved age of 12 year adolescent pt with no reported adverse event; Initial information received on 21-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old male patient who received 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. Concomitant medications included Pneumococcal Vaccine Conj [Pneumococcal Conjugate Vaccine] for Immunisation. On 20-Aug-2025, the 12 year adolescent patient received 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, (Frequency Once) Suspension for injection, (unknown strength) lot 3CA25C1 and expiry date 30-Apr-2026 via intramuscular route in the left deltoid with no reported adverse event (product administered to patient of inappropriate age) (Latency Same day). Reportedly, Caller stated that when they gave the DTAP, it counted as an appropriate dose in their system also along with the State Registry. It did not mark as like a bad dose. 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.
PNEUMOCOCCAL CONJUGATE VACCINE