Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK344AA | OT / LL |
pentacel was reconstituted with a sterile diluent used w/ mmr and proquad (sterile water) with no reported ae; Initial information received on 28-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 month old female patient who was administered with Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (VERO)] was reconstituted with a sterile diluent used w/ MMR and Proquad (sterile water) with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Immunoglobulin Antihepatitis B (Hepatitis B [Immunoglobulin Antihepatitis B]) For Immunisation; Pneumococcal Vaccine Conj 20v (Crm197) (Pneumococcal Vaccine Conj 20v (Crm197)) For Immunisation; And Rotavirus Vaccine (Rotavirus Vaccine) for Immunisation. On 27-Oct-2025, the patient received a 07ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (lot UK344AA, standard strength, frequency once and expiry date-31-Jan-2027) via intramuscular route in the left thigh for Immunization was reconstituted with a sterile diluent used w/ MMR and proquad (sterile water) with no reported ae (product preparation error) (latency-same day). Action taken was 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.
HEPATITIS B [IMMUNOGLOBULIN ANTIHEPATITIS B]; PNEUMOCOCCAL VACCINE CONJ 20V (CRM197); ROTAVIRUS VACCINE