Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK017AA | OT / LL |
| DTP | DTP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
inappropriate use due to administration of the wrong vaccine with no reported adverse event; giving the next dose of Hib too early with no reported adverse event; an extra dose of IPV was given with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 years old female patient who was inappropriately administered with wrong vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] instead of Diphtheria, Tetanus And Nos Pertussis Vaccine with no reported adverse event and The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Polio Vaccine Inact 3v (Vero) (Ipol Polio Vaccine) for Immunisation. On 02-Jun-2025, the patient was inappropriate administered with wrong vaccine of 0.5mL Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot UK017AA, expiry date 30-Jun-2025; strength standard and frequency once) via intramuscular route in the left thigh for Immunization (wrong product administered) instead of Diphtheria, Tetanus And Nos Pertussis Vaccine and the Hib vaccine was given earlier than scheduled with (inappropriate schedule of product administration) (latency same day) and (extra dose administered). Reportedly, the reporter called to report that Pentacel and Ipol were incorrectly administered to a patient. She explained that the vaccines to be given was suppose to be a Dtap and Polio. She also asked for any information or guidance in this event that an extra dose of IPV was given and that the Hib vaccine was given earlier than scheduled. She added that the patient's Hib vaccine was scheduled in October 2025 since it was given last April 2025. 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.; Sender's Comments: US-SA-2025SA158247:
IPOL POLIO VACCINE