Received May 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | 2CA56C1 | OT / LA |
11-year-old patient received an expired ADACEL, with no reported adverse event; Initial information received on 14-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 11 years old male patient who received an expired diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included meningococcal vaccine a/c/y/w conj (tet tox) (menquadfi); and hpv vaccine vlp rl1 4v (yeast) (gardasil) for Immunisation. On 13-May-2025, the patient received an expired 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (Strength- standard and frequency- once) lot 2CA56C1 and expiry date- 12-MAY-2025 via intramuscular route in the left deltoid for Immunisation with no reported adverse event (expired product 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 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.
MENQUADFI; GARDASIL