Received Apr 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | U8383AB | IM / RL |
inappropriate use due to administering QUADRACEL to a 22-month-old patient/out of the recommended age group with no Adverse Event; Initial information received on 09-Mar-2026 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 22-month-old female patient who had inappropriate use due to administering diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (Quadracel) out of the recommended age group with no adverse event. The patient's past medical history, past drugs, family history were not provided. Concomitant medication(s) included pneumococcal vaccine conjugate 20-valent (Prevnar20). The patients past vaccination includes Diphtheria vaccine toxoid, HIB vaccine conj (menigococcal protein), Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Vaxelis). On 05-Mar-2026, the patient received dose 2 of diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine suspension for injection (strength: standard) (batch: U8383AB, expiry: 31-Jan-2027) as 0.5 mL once intramuscular in right thigh for immunization, out of the recommended age group with no adverse event (Product administered to patient of inappropriate age) (latency: same day) Quality assurance health coordinator from the provider's office stated that a patient had been administered with Quadracel, with the patient's age being out of the recommended range. The caller wanted to know if the dose should be repeated, and when it should be given. 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
Prevnar 20