Received Apr 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | U8209CB | LL |
received only the powder HIB portion that was mixed incorrectly with a separate sterile diluent,with no reported adverse event; Initial information received on 02-Apr-2026 regarding an unsolicited valid non-serious case received from other or unknown health care professional (HCP). This case involves a 15-month-old female patient who received only the powder Haemophilus influenzae type b (HIB) portion that was mixed incorrectly with a separate sterile diluent, with no reported adverse event of acellular pertussis vaccine, diphtheria toxoid, poliomyelitis vaccine (inactivated), and tetanus toxoid (QUADRACEL). The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 04-Dec-2025, the patient started taking acellular pertussis vaccine, diphtheria toxoid, poliomyelitis vaccine (inactivated), and tetanus toxoid Suspension for injection as 0.5 mL (route: unknown) for immunization. The patient received only the powder HIB portion that was mixed incorrectly with a separate sterile diluent, with no reported adverse event (Product preparation error), onset: 04-Dec-2025 and latency: same day) (batch: U8209CB, expiry date: unknown)]. 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.
Comments: NONE