Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | U8558BA | OT / LA |
patient did not get 0.5 mL, which was the full recommended dose of MENQUADFI, with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old male patient who did not get 0.5 ml, which was the full recommended dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] 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 Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero) for Immunisation. On 16-Sep-2025, the patient received Dose 1 of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine 1x(once) Solution for injection (strength standard) expiry date-30-Sep-2028 lot U8558BA via intramuscular route in the left deltoid for Immunization did not get 0.5 ml, which was the full recommended dose of menquadfi, with no reported adverse event (incorrect dose administered) (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.
Bexsero