Received Mar 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 2 | UK330AA | IM / RL |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 2 | MH1449 | IM / LL |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 2 | Y014320 | PO / MO |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK330AA | IM / LL |
said one of their nurses accidentally reconstituted Pentacel with 0.7mL sterile diluent instead of using the liquid component in the other vial with no adverse event; Initial information received on 02-Mar-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves a 4-month-old female patient to whom one of their nurses accidentally reconstituted DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO)/HIB(PRP/T) VACCINE (PENTACEL VERO) with 0.7mL sterile diluent instead of using the liquid component in the other vial with no adverse event The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Concomitant medication(s) included RotaTeq (Rotavirus vaccine live reassort oral 5v) and Prevnar 20 (Pneumococcal vaccine conj 20v (CRM197)) both as prophylactic vaccination. On 23-Feb-2026, the patient accidentally received a 0.5 mL dose 1 of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO)/HIB(PRP/T) VACCINE powder and suspension for suspension for injection (batch: UK330AA, expiry: 31-Jul-2026) (strength: Standard) via intramuscular route in Left thigh for immunization, with 0.7mL sterile diluent instead of using the liquid component in the other vial with no adverse event (Product preparation error) (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.
Rotateq; Prevnar 20