Received Jul 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | U8209CB | OT |
Inappropriate use due to administration of a QUADRACEL dose to a 3 years old patient, intended to grab the Dtap vaccine, as indicated on the box, but mistakenly grabbed quadracel and administered it to patient with no adverse event; Inappropriate use due to administration of a QUADRACEL dose to a 3 years old patient, intended to grab the Dtap vaccine, as indicated on the box, but mistakenly grabbed quadracel and administered it to patient with no adverse event; Initial information received on 16-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 years old female patient who received diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel (vero)], reporter intended to grab the diphtheria, tetanus and acellular pertussis vaccine, as indicated on the box, but mistakenly grabbed quadracel and administered it to the patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB vaccine CONJ (TET TOX) (ACTHIB); varicella zoster vaccine (varicella vaccine) and hepatitis A vaccine (hepatitis A), all for Immunisation. On 11-Jul-2025, the patient received 0.5 ml of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine Solution for injection of standard strength, frequency once with lot U8209CB and expiry date 31-May-2026 via intramuscular route in unknown administration site for Immunization, reporter intended to grab the diphtheria, tetanus and acellular pertussis vaccine, as indicated on the box, but mistakenly grabbed quadracel and administered it to the patient with no reported adverse event (product administered to patient of inappropriate age) (Wrong product administered) (Latency same day). Reportedly, reporter stated that the patient is new to them. 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.
ACTHIB; VARICELLA VACCINE; HEPATITIS A