Received Jul 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK167AA | OT / LL |
administered a pentacel and a pediarix to a 6 month old patient, when they should have administered the act hib along with the pediarix with no reported ae; Initial information received on 02-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient who was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] and pediarix when they should have administered the act hib along with the pediarix 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 Diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid(Pediarix) ,Pneumococcal vaccine conj 20v (CRM197) (Pneumococcal vaccine conj 20v (CRM197) and Rotavirus vaccine (Rotavirus vaccine) for Immunisation. On 01-Jul-2025, the patient received 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection, lot UK167AA,expiry date: 31-Oct-2025,strength: standard, frequency: once via intramuscular route in the left thigh for immunisation and a pediarix to a 6 month old patient, when they should have administered the act hib along with the pediarix with no reported adverse event (wrong product administered) (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.
PEDIARIX; Pneumococcal vaccine conj 20v (CRM197); Rotavirus vaccine