Received Jun 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | K1098A | OT |
PENTACEL was administered without the ActHib portion with no reported adverse event; Initial information received on 20-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who received diphtheria/tetanus/5 hybrid AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] without the ACT-HIB portion 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) (Prevnar 20); and Rotavirus vaccine live oral 1v (Rotarix) as both for Immunisation. On 16-Jun-2025, the patient received 0.5 ml of diphtheria/tetanus/5 hybrid AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection with strength- standard (expiry date- 30-SEP-2025 and lot K1098A) once via unknown route in unknown administration site for Immunization, without the ACT-HIB portion with no reported adverse event (single component of a two-component product administered) (latency- same day). Reportedly, Caller inquiring if the DTaP-IPV portion would be valid and then if the Act-Hib portion could be administered separately. 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.
Prevnar 20; Rotarix