Received Feb 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK022AA | OT / RL |
she administered the pentacel to a patient, but when she administered it, she only gave the diluent with no reported adverse event; Initial information received on 30-Jan-2025 regarding an unsolicited valid non-serious case received from a Other health professional. This case involves, a 3 months old female patient who was administered the Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel], but when she administered it, she only gave the diluent 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 B Vaccine (HEP B VAX); Pneumococcal Vaccine and Rotavirus Vaccine for Immunization. On 17-Jan-2025, the patient was administered 0.5 ml dose of the (Standard) Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (once) (lot UK022AA, expiry date: 30-Apr-2025) (unknown route) in the right thigh for immunization, but when she administered it, she only gave the diluent with no reported adverse event (single component of a two-component product administered) (latency-same day). Reportedly, The MA (Medical Assistant) did not mix it with the compound. The patient didn't get that part of the vaccine. 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.
HEP B VAX; PNEUMOCOCCAL VACCINE; ROTAVIRUS VACCINE