Received Jun 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
two-day old patient was administered ADACEL last month, with no reported adverse event; Initial information received on 04-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 days old male patient who was administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] last month, 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 in May 2025, the 2 days old patient last month received a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (strength: standard and frequency: once) (lot number and expiry date not reported) via intramuscular route in unknown administration site for immunization with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence Reportedly, They wanted to know what the possible adverse events are and what the monitoring requirements would be. Treatment: Patient was monitored for reactions. 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.