Received Apr 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK174AB | IM / RL |
expired PENTACEL vaccine was administered with no AE; Initial information received on 08-Apr-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4-month-old male patient who was administered with an expired dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (Pentacel) with no Adverse Event (AE). The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. Patient had past vaccination history Vaxelis (Diphtheria vaccine toxoid, HIB vaccine conj (menigococcal protein), Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid) on 05-Feb-2026. Concomitant medication(s) included rotavirus vaccine and pneumococcal vaccine. On 08-Apr-2026, the patient received an expired dose 1 (0.5 ml dose) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (Pentacel) powder and suspension for suspension for injection, Strength: standard, Frequency = once via intramuscular route in the right thigh for Immunization no Adverse event (Expired product administered) (same day). 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.
Comments: NONE
Rotavirus vaccine; Pneumococcal vaccine