Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK199AA | OT |
administered PENTACEL that was reconstituted with a different diluent - a diluent produced by Merck.with no adverse event; inappropriate use due to the patient only receiving the HIb part of pentacel with no reported adverse event; Initial information received on 08-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who was administered only hib part of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] that was reconstituted with a different diluent - a diluent produced by merck 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 Concomitant medications included hepatitis b vaccine, pneumococcal vaccine and polio vaccine (polio) for prophylactic vaccination (Immunisation). On 14-Aug-2025, the patient received only hib part of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, suspension for injection (dose 0.5 ml) (lot UK199AA and expiry date 30-Apr-2026) (strength: standard and frequency: once) via intramuscular route in the thigh NOS (not otherwise specified) for immunization and was reconstituted with a different diluent - a diluent produced by merck with no adverse event (product preparation error) (single component of a two-component product administered) (Latency: same day). Reportedly, HCP reported that the powder part of PENTACEL was administered with Merck Sharp '& Dohme Live Virus Sterile Diluent. No adverse reaction was reported at the time of call. 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 B VACCINE; PNEUMOCOCCAL VACCINE; POLIO