Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | U8383AB | IM / RL |
received QUADRACEL when it was not indicated for the patient's age with no reported adverse event; Initial information regarding this unsolicited valid non-serious case was received on 28-Apr-2026 from Healthcare Professional (HCP). This case involves a 6-month-old patient of unknown gender who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO) VACCINE (vQUADRACEL) when it was not indicated for the patient's age with no reported adverse event The patient's past medical history, past drugs, vaccination(s), family history, were not provided. Concomitant medication(s) included pneumococcal vaccine conjugate (pneumococcal conjugate 20) for immunization. On 11-Mar-2026, the patient received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO) VACCINE (Strength = standard) Suspension for injection dose 0.5 ml 1x(once) intramuscular in Right Thigh for immunization, when it was not indicated for the patient's age with no reported adverse event [(Product administered to patient of inappropriate age, latency: same day) (batch: U8383AB, expiry date: 31-Jan-2027)]. 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 conjugate vaccine