Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | 1 | U7927AA | OT / RA |
patient was vaccinated on 20Oct2025 using the product that had expired on 13Oct2025 with no adverse event; Initial information received on 20-Oct-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 78 years old patient of unknown gender who was vaccinated on 20-Oct-2025 using the DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] that had expired on 13-Oct-2025 with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza vaccine inact split 3v (Fluzone high dose) for Immunisation. On 20-Oct-2025, the patient received a dose 1 of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (Suspension for injection) (lot: U7927AA; strength: standard; frequency: once) that had expired on 13-Oct-2025 with no adverse event (expired product administered) (latency: same day) via intramuscular route in the right arm for Immunisation. 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.
Fluzone high dose