Received Jun 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | — | — |
was administered with the vaccine to 0.5 ml that had been exposed to minus 0.8 degree Celsius for less than 10 minutes with no reported adverse event; was administered with the vaccine to 0.5 ml that had been exposed to minus 0.8 degree Celsius for less than 10 minutes with no reported adverse event; Initial information received on 29-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age female patient who was administered with Diphtheria-2/Tetanus-5 Adsorbed Toxoids no Preservative Adult [Tenivac] to 0.5 ml that had been exposed to minus 0.8 degree celsius for less than 10 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2024, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids no Preservative Adult suspension for injection that had been exposed to minus 0.8 degree celsius for less than 10 minutes (poor quality product administered) (product storage error) (latency: same day) (strength, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. No adverse event was reported. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. 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.; Sender's Comments: 2025SA155495: