Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK332AA | IM / RL |
administration of only the acthib component of pentacel, with no reported adverse event; Initial information received on 04-Mar-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 years old male patient who was administration of only the ActHIB 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 medication(s) included proquad (Measles vaccine live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3), Varicella zoster vaccine live (Oka/Merck)), prevnar 20 (Pneumococcal vaccine conj 20v (CRM197)), and havrix (Hepatitis a vaccine inact). On 05-Feb-2026, the patient received a dose 1 of 0.5 milliliter (mL) once dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE powder and suspension for suspension for injection (batch number: UK332AA, expiry date: unkown) (strength: Standard) via intramuscular route in right thigh for immunization (immunisation) and only only the ActHIB component was administered with no adverse event (Single component of a two-component product administered) (Latency: same day). It was reported, "Licensed practical nurse (LPN) sought guidance following the administration of only the ACTHIB component of PENTACEL. LPN explained that the DTaP-IPV component was present in the packaging but only ACTHIB, reconstituted with sterile water, was administered." Action taken: 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.
Proquad; Prevnar 20; Havrix