Received Mar 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 4 | UK038AA | OT / LL |
only PENTACEL's DTap-IPV component was administered with no reported AE; Initial information received on 24-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age / gender patient who received only DTAP-IPV component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] 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 a vaccine (Hepa); and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) both for Immunisation. On 14-Mar-2025, the patient received 0.5 ml of dose 4 of DTAP-IPV component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (strength- standard, expiry date- 30-JUN-2025 and lot UK038AA) via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (single component of a two-component product administered) (latency- same day). 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.
Hepa; Prevnar 20