Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | — | OT |
administered a DTaP vaccine to a 14-month-old infant a full month earlier than scheduled with no reported adverse event; Initial information received on 22-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 14 months old female patient who received Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel], a full month earlier than scheduled with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for Prophylactic vaccination [immunisation], a full month earlier than scheduled with no reported adverse event (inappropriate schedule of product administration) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. Reportedly, The five dose immunization series consists of a 0.5 mL intramuscular injection administered at 2, 4, 6 and 15-20 months of age, and at 4-6 years of age. The Centers for Disease Control and Prevention (CDC) states that doses of any vaccine administered '>' 4 days earlier than the minimum interval or age should not be counted as valid doses and should be repeated as age appropriate. 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.