Received Apr 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | U8623AA | IM / LL |
pre-assessed as a medication error (unintentional)/an inappropriate use (unknown intention) due to the administration of QUADRACEL to a patient under 4 years of age with no reported adverse event; Initial information received on 07-Apr-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 year male patient who was administered with Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine (at the age of 17 months) which was pre-assessed as a medication error (unintentional)/an inappropriate use (unknown intention) due to the under 4 years of age with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s), family history, were not provided. Concomitant medications included PNEUMOCCOCAL 15 (pneumococcal vaccine conj 15v), hepatitis b vaccine and haemophilus b conjugate vaccine. On 07-Apr-2026, the patient received dose 2 (0.5 ml) of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine suspension for injection, frequency: once (Strength = standard), batch: U8623AA, expiry: 31-Aug-2027 via intramuscular route in left vastus lateralis for immunization which was pre-assessed as a medication error (unintentional)/an inappropriate use (unknown intention) under 4 years of age (Product administered to patient of inappropriate age) (latency: same day). It was reported "Nurse practitioner reported that a 17 month old patient received a dose of QUADRACEL. Caller stated that the patient is very behind in vaccinations and this could have led to the incorrect product being administered. Nurse practitioner was not aware of any adverse reactions at the time of the call". 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
Pneumococcal vaccine conj 15v (CRM197); Hepatitis b vaccine; Haemophilus b conjugate vaccine