Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | U7931AB | OT / LL |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
she gave the wrong medication to a 4-month old patient/patient received QUADRACEL and a HIB vaccine, but the patient was supposed to receive PENTACEL, with no reported adverse event; Initial information received on 11-Apr-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 4 months old female patient to whom received Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel] and a hib vaccine, instead of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB vaccine (Hib) Rotavirus vaccine and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 09-Apr-2025, the patient received a 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 09-Nov-2025 and lot U7931AB) via intramuscular route in the left vastus lateralis as immunization instead of Pentacel with no reported adverse event (wrong product administered) (same day latency). 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.
Hib; Rotavirus vaccine; Prevnar 20