Received Jul 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | OT |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK040AA | OT / LL |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 1 | UK166AA | OT / RL |
extra dose of Hib caused by administration of both PENTACEL and ACT-HIB (with no reported adverse event); inappropriate use due to administration of PENTACEL, instead of the prescribed medication, Pediarix (with no reported adverse event); Initial information received on 10-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA-2025SA197998 This case involves a 9 weeks old female patient who received an extra dose of hib caused by administration of both Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] and Hib (Prp/T) Vaccine [Act-Hib and inappropriate use due to administration of Pentacel, instead of the prescribed medication, Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid [Pediarix] with no reported adverse events. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal Vaccine Conj 20v (Crm197) [Prevnar 20] and Rotavirus Vaccine Live Oral 1v [Rotarix)] both for Immunisation. On 10-Jul-2025, the patient received an extra dose of Hib due to administration of 0.5 ml (dose 1) of suspect HIB (PRP/T) Vaccine (Frequency once), Powder and solvent for solution for injection, Strength standard, lot UK166AA and expiry date 30-Sep-2025 via intramuscular route in the right thigh and an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site both for prophylactic vaccination (immunization) (extra dose administered) (Latency Same day) and inappropriate use due to administration of Pentacel, instead of the prescribed, unknown dose of Pediarix, not produced by Sanofi Pasteur (unknown formulation, strength and expiry date) lot number not reported for prophylactic vaccination (immunization) 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.; Sender's Comments: US-SA-2025SA197998:
PREVNAR 20; ROTARIX