Received May 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK434AA | IM / LL |
lyophilized ACTHIB portion of PENTACEL that was reconstituted with a sterile diluent, with no reported adverse event; Initial information received on 05-May-2026 regarding an unsolicited valid non-serious case received from an other or unknown healthcare professional (HCP). This case involves a 1-year-old male patient who received lyophilized ACTHIB portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine-520 [Pentacel (Vero)] that was reconstituted with a sterile diluent, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. The patient received a dose 4 of 0.5 mL 1X dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine-520 powder and suspension for suspension for injection (batch number: UK434AA, expiry date: 30-Jun-2027) (strength: standard) via intramuscular route in an Left Thigh for immunization [Immunisation] with no adverse event (product preparation issue) (Latency same day). Action taken: Not applicable. Disclaimer: 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
Hepatitis A