Received Jun 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8906AA | — |
4 doses of unsuitable adacel were administered with no ae; Initial information received on 22-May-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves an unknown age female patient who had 4 doses of unsuitable diphtheria, tetanus and acellular pertussis vaccine (Adacel) administered with no adverse event The patient's past medical history, past drugs, vaccination(s), family history, concomitant medications were not provided. On an unknown date, The patient received diphtheria, tetanus and acellular pertussis vaccine (Adacel) Suspension for injection (dose, route, site, strength, route: unknown) for immunization. The patient had 4 doses of unsuitable Adacel administered with no adverse event [(Poor quality product administered, onset date: unknown, latency: unknown) (batch: U8906AA, expiry: 31-May-2028)]. Action taken: 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.
Comments: NONE