Received Aug 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
extra doses of ADACEL was administered with no reported adverse event; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked with US-SA-2025SA229198 (cluster case). This case involves a 11 years old male patient who received extra doses of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] 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 19-Feb-2025, the patient received an unknown dose of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for Immunization. On 23-Jul-2025 the patient also received an extra dose of the same vaccine (with an unknown batch number and expiry date) via unknown route in unknown administration site for Immunization with no reported adverse event (extra dose administered) (latency- same day). Information on the batch number could not be requested corresponding to the one at time of event occurrence. Reportedly, the patient was already up to date with the ADACEL. Caller refused to provide other information stating the she didn't have it and was not permitted to. She also advised not to be contacted because she didn't have the information regarding the vaccination. 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.; Sender's Comments: US-SA-2025SA229198:MENQUADFI
Menquadfi