Received Apr 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK367AA | IM / LL |
administered the Hib component from the PENTACEL vaccine, and it was reconstituted with sterile water rather than with the DTaP-IVP liquid component/DTaP-IPV component of the vaccine was not administered with no AE; Initial information regarding this unsolicited valid non-serious case was received on 13-Apr-2026 via Health Care Professional (HCP). This case involves a 2-month-old male patient who had the Hib component from the DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) vaccine administered, and it was reconstituted with sterile water rather than with the DTaP-IPV liquid component, and the DTaP-IPV component of the vaccine was not administered with no AE (adverse event). The patient's past medical history, past drugs, and family history were not provided. Concomitant medication(s) included rotavirus vaccine live reassort oral 5v (RotaTeq) and pneumococcal vaccine conj 20v (CRM197) (Prevnar 20). On 09-Apr-2026, the patient received a 0.5 mL single dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO)/HIB(PRP/T) VACCINE520 [PENTACEL (VERO)] (batch: UK367AA, expiration date: 31-Mar-2027) (strength: unknown) via intramuscular route in the left thigh for immunization [Immunisation]. The Hib component from the PENTACEL vaccine was reconstituted with sterile water rather than with the DTaP-IPV liquid component of the PENTACEL vaccine. The sterile water was from a supply used to reconstitute Varicella vaccines. It was to have been the first dose in the series. The DTaP-IPV component of the PENTACEL vaccine was not administered. The healthcare professional (HCP) requested information regarding the Hib component of the PENTACEL vaccine being reconstituted with sterile water and administered to the patient and asked if the Hib component is valid or needs to be repeated. [(Single component of a two-component product administered, onset: 09-Apr-2026, 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
Rotateq; Prevnar 20