Received Jul 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | — |
medication error due to patient received ADACEL as a primary catch up immunization on 31 JUL 2023 and the 2nd and last dose was given on 22 APR 2024 with no AE; Initial information received on 02-Jul-2026 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 14-year-old patient of unknown gender who received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] as a primary catch up immunization on 31 Jul 2023 and the 2nd and last dose was given on 22 Apr 2024 with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. On 31-Jul-2023, the patient received a 0.5 mL once of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] suspension for injection (batch: unknown, expiry: unknown) (strength: unknown) via unknown route in an unknown administration site for immunization [Immunisation]. On 22-Apr-2024, the dose was administered again at 0.5 mL once (1X) as the second dose via unknown route in an unknown administration site for immunization [Immunisation], with no adverse event (Extra dose administered) (Latency same day) 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 medication 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