Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | OT |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8122AA | OT / RA |
administration of ADACEL outside of the recommended interval with no reported adverse event; Initial information received on 02-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 52 years old and unknown gender patient for whom diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], administration of adacel outside of the recommended interval with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Apr-2025, the patient received an unknown dose (0.5ml) of diphtheria-2/tetanus/5 AC pertussis vaccine; Suspension for injection with unknown strength (lot U8122AA with expiry date 30-APR-2026) via intramuscular route in the right arm for Immunization and On 06-Mar-2025, the patient received an unknown dose of suspect diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) On 29-APR-2025 the patient developed administration of adacel outside of the recommended interval with no reported adverse event (extra dose administered). (latency: same day). 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.