Received Jun 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 4 | UK043AA | OT |
administering only the liquid component of Pentacel, with no reported adverse event; Initial information received on 18-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient for whom diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)] administering only the liquid component of pentacel, 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 7v (CRM197) (Prevnar). On 16-Jun-2025, the patient received the liquid component of dose 4 (0.5ml) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine; Suspension for injection with Strength = standard (lot UK043AA with expiry date 31-AUG-2025) via intramuscular route in the thigh nos 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.
Prevnar