Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | C5281AA | OT |
deteriorated vaccine administered with no reported adverse event; Initial information received on 06-Apr-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional This case involves an unknown age female patient who had deteriorated DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] administered 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, the patient received a deteriorated dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5281AA, Expiry: 05-Oct-2019) via unknown route in unknown administration site for prophylactic vaccination as white particles were noticed to be floating in the vials when administering (poor quality product administered) (latency: same day). It was reported, before this issue was identified 5 vials was already administered to 5 patients. Reporter also asked, I would like to have the following Lot's checked. Concerning as my daughter received the same lot. Can a few batches be contaminated, while others are ok and the Lot's: C5281AA, C5307AA & C5367AA. 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.