Received Jul 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | — | OT |
daptacel given to an 8 yr old with no reported ae; Initial information received on 18-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 8 years old and unknown gender 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. 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, with no reported ae (product administered to patient of inappropriate age) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence was requested. Reportedly, states that a child came in for a physical and they were delayed on their vaccinations, so they had to catch this child up. In May they were 7 years and 11 months, and she said that the patient's birthday is XXXX and they came in on 13MayxxXX. She states that she knows the recommendation is Tdap after 7 years of age on a delayed schedule. She states that the patient was just shy of being an 8-yearold in a week or 10 days. 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.