Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
TDAP to a 6-month old baby. They were suppose to administer DTAP with no reported adverse event; Initial information received on 09-Sep-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 6 month old and unknown gender patient who recieved Diphtheria, Tetanus And Acellular Pertussis Vaccine instead of DTAP 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 an unknown dose of suspect Diphtheria, Tetanus And Acellular Pertussis Vaccine produced by unknown manufacturer lot number, strength and expiry date-unknown) via unknown route in unknown administration site instead of DTAP for prophylactic vaccination (Immunisation) and TB skin test (Skin test) (wrong product administered) (latency-same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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.