Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK346AA | IM / RL |
administered the HIB portion of PENTACEL to 2 separate patients, however it was reconstituted with diluent made for Merck's live vaccine with no reported adverse event; Initial information received on 28-Apr-2026 regarding an unsolicited valid non-serious case received from other or unknown healthcare professional. This case involves a 4-month-old male patient reporter reported administered the HIB portion of PENTACEL to 2 separate patients, however it was reconstituted with diluent made for Merck's live vaccine with no reported adverse event while being treated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (PENTACEL Vero). The patient's past medical history, past drugs, vaccination(s), family history,were not provided. Concomitant medication(s) included pneumococcal vaccine conj 20v CRM197 (Prevnar 20) and rotavirus vaccine live reassort oral 5v (RotaTeq) for immunization. On 16-Apr-2026, the patient received dose 1 DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE powder and suspension for suspension for injection (strength: standard) Dose 0.5 ml 1x(once) intramuscularly in right thigh, for immunization. The healthcare professional (HCP) administered the HIB portion of PENTACEL to 2 separate patients; however, it was reconstituted with diluent made for Merck's live vaccine with no reported adverse event (product preparation issue, onset date: 16-Apr-2026 and latency: same day) (batch: UK346AA, 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
Prevnar 20; Rotateq