Received Dec 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 1 | UK193AA | OT / LL |
concomitant administration of pentacel and acthib with no reported adverse event; Initial information received on 25-Nov-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 7 months old male patient who had concomitant administration of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] And Hib (Prp/T) Vaccine [Act-Hib], 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 Elasomeran (Moderna COVID-19 vaccine), Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) and Rotavirus vaccine live reassort oral 5v (Rotateq). On 24-Nov-2025, the patient received an unknown dose (dose 1) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK193AA, expiry date and strength not reported) via intramuscular route in the left thigh for prophylactic vaccination (Immunisation) and concomitant administration of pentacel and acthib with no reported adverse event (extra dose administered) (latency same day). On an unknown date in 2025, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). 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.
Moderna COVID-19 vaccine; Prevnar 20; Rotateq