Received May 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK352AA | — |
patient received only the liquid component of PENTACEL by accident, with no reported adverse event; Initial information received on 13-May-2026 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a 3-year-old male patient who received only the liquid component of Diphtheria/Tetanus/5 Hybrid Ac (Pentacel) with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. Concomitant medication(s) included pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance) for Prophylactic vaccination (immunization). On 27-Apr-2026, the patient started received dose 3 of suspect Diphtheria/Tetanus/5 Hybrid Ac, powder and suspension for suspension for injection, Strength = standard, frequency: once (batch: UK352AA, expiry date: 28-Feb-2027) (route unknown) for immunization and received only the liquid component of PENTACEL by accident, with no reported adverse event (Single component of a two-component product administered) (latency: same day). 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
Vaxneuvance