Received Feb 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK193AA | OT / LA |
administering of act-hib vaccine to 16-year-old patient patient with no reported adverse event; Initial information received on 04-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 years old male patient who was administered to HIB (PRP/T) Vaccine [ACT-HIB], 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 Varicella zoster vaccine (Varicella vaccine) for Immunisation; Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for Immunisation; and Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero) for Immunisation. On 29-Jan-2026, the patient received 0.5mL of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK193AA, frequency once, strength standard and expiry date not reported) via intramuscular route in the left arm for Immunization, with no reported adverse event (product administered to patient of inappropriate age) (latency same day). It was reported "it was an extra dose. He had it already before but date was unknown to them since patient just moved to the country. He was due for a different vaccine instead of the ACT-HIB." 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.
Varicella vaccine; Menquadfi; Bexsero