Received Jun 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UJ807AA | OT |
inappropriate use due to administering Pentacel when the same patient was 7 and 9 years old with no reported adverse event; Initial information received on 30-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 years old female patient who was inappropriately use administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] when the patient was 7 and 9 years old 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 Hepatitis a vaccine (Hepatitis a vaccine) and Varicella zoster vaccine live (Oka/Merck) (Varivax) for Immunisation. On 24-Feb-2025, the patient received 0.5mL (dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection ((lot UK168AA, expiry date 31-Oct-2025) via intramuscular route in the deltoid NOS (not other specified) and on 11-Apr-2023 she also received 0.5mL (dose 2) of vaccine (lot UJ807AA, expiry date 01-Oct-2023) (frequency once and strength standard) via intramuscular route in the deltoid NOS for Immunisation. On 24-Feb-2025, the patient was inappropriately administered with pentacel when the same patient was 7 and 9 years old with no reported adverse event (product administered to patient of inappropriate age) (latency same day). Reportedly, the reporter called to ask a question regarding the administration of Pentacel. She mentioned that the patient came from another country and she was behind her routine vaccines. Patient needed DTAP, IPV, and HIB. Pentacel was first given when the patient was 7 years old and now that she's 9 years old. Reporter asked if it was okay or if the patient needs to be re-vaccinated. 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 a vaccine; Varivax