Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | U8491AA | OT / LA |
Product was administered after the excursion with no adverse event; Initial information received on 21-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to other case US-SA-2025SA117087 This case involves an unknown age female patient who received diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult [tenivac] after the excursion with no adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On 27-Mar-2025, the patient received 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult Suspension for injection of standard strength with lot U8491AA and expiry date 27-Mar-2027 once via intramuscular route in the left deltoid for immunisation after the excursion with no adverse event (poor quality product administered) (Latency same day) Reportedly, Duration of temperature excursion: 55 days, Maximum/minimum temperature reached: 11 °C. Extended stability data did not cover the excursion. Human error not involved. Fridge malfunction 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.; Sender's Comments: US-SA-2025SA117087: