Received May 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 3 | UKO15AA | OT / LL |
pentacel was administered twice (in one day),the first vaccination, only the diluent was administered,in the second vaccination, the fully reconstituted pentacel was administered with no reported adverse event; Initial information received on 13-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who was administered an extra dose of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] twice (in one day),during the first vaccination, only the diluent was administered, in the second vaccination, the fully reconstituted pentacel was administered 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 15v (CRM197) for Immunisation. On 07-May-2025, the patient received an extra (dose 3) of 0.5 ml of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, Powder and suspension for suspension for injection, lot UKO15AA,expiry date: 31-May2025, Frequency = once, Strength:Standard, via intramuscular route in the left thigh for prophylactic vaccination (immunization) which was administered twice (in one day),during the first vaccination, only the diluent was administered, in the second vaccination, the fully reconstituted pentacel was administered with no reported adverse event (extra dose administered) (latency:same day). Reportedly,patient was reported waking up crying and was holding his head and no treatment given. 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 15V (CRM197)