Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK356AA | OT / RL |
only the powder part of PENTACEL was given to the patient and the powder was mixed with 0.7% Sterile Water with no reported adverse event; Initial information received on 29-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient to whom only the powder part of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] was given and the powder was mixed with 0.7% sterile water 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 NIRSEVIMAB (BEYFORTUS [NIRSEVIMAB]). On 27-Oct-2025, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Powder and suspension for suspension for injection (lot UK356AA, Expiry: 28-Feb-2027, Strength: Standard, Frequency: once) via intramuscular route in the right thigh as Immunization, from which only the powder part was given and the powder was mixed with 0.7% sterile water with no reported adverse event (product preparation error) (Latency: 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.
BEYFORTUS [NIRSEVIMAB]