Received Aug 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8558BA | OT / LA |
| MENB | MENINGOCOCCAL B (TRUMENBA) | PFIZER\WYETH | UNK | — | OT / LA |
menquadfi and trumenba were administered together (combined) in one syringe with no reported adverse event; menquadfi and trumenba were administered together (combined) in one syringe with no reported adverse event; Initial information received on 19-Aug-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 16 years old female patient who was administered with Meningococcal vaccine B rfHbpA/fHbpB [Trumenba] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] together (combined) in one syringe with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Aug-2025, the patient received 0.5 ml of Trumenba not produced by Sanofi Pasteur with strength- standard (formulation, expiry date and lot number not reported) once and 0.5 ml of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection with strength- standard (expiry date- 30-SEP-2028 and lot U8558BA) once were together (combined) in one syringe and given via intramuscular route in the left deltoid for Immunization with no reported adverse event (product use issue) (extra dose administered) (latency- same day). Reportedly, the patient did not report any adverse reaction. 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.