Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8115AA | OT / LA |
administration of ADACEL to an elderly patient (72-year-old patient ) with no adverse event; Initial information received on 21-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 72 years old elderly male patient who had administration of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no 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 20v (CRM197) (Prevnar 20) for Immunisation. On 21-Apr-2025, the 72-year-old patient received a standard dose of 0.5 ml once of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot U8115AA, expiry date- 31-MAR-2026) via intramuscular route in the left deltoid for Immunization; with no adverse event (product administered to patient of inappropriate age) (latency- same day). Action taken was not applicable. Reportedly, Reporter asked if it would be accounted for the patient because the information only says it is up to 64 years of age. She asked if we have recommendations on how they should proceed from here. No Treatment was received. 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.
Prevnar 20