Received Feb 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT / RL |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT / LL |
received 2-doses of HIB in the same day with no reported adverse event; received PENTACEL and ACTHIB at their appointment and they should have gotten DTAP and ACTHIB with no reported adverse event; Initial information received on 06-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who received 2-doses of hib in the same day with no reported adverse event and received diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero) and hib (prp/t) vaccine [ACT-HIB] at their appointment and they should have gotten diphtheria, tetanus and acellular pertussis vaccine 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 (Pneumococcal Vaccine Conj 20V (CRM197). On 30-Jan-2025, the patient received 0.5 mL 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 the right thigh, received 0.5mL dose of suspect hib (prp/t) vaccine, powder and solvent for solution for injection via unknown route in the left thigh,both for Prophylactic vaccination (Immunisation) and received 2-doses of hib in the same day with no reported adverse event (extra dose administered) and received pentacel and acthib at their appointment and they should have gotten diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer, unknown formulation and acthib with no reported adverse event (wrong product administered) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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.
PNEUMOCOCCAL VACCINE CONJ 20V (CRM197)