Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U7852AB | OT / LA |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | — | OT / LA |
had a "vaccine mix-up" and that the MENQUADFI was beside the diluent for MMR-II/mistakenly combined the MENQUADFI with the MMR-II administered this mixture to patient, with no reported adverse event; had a "vaccine mix-up" and that the MENQUADFI was beside the diluent for MMR-II/mistakenly combined the MENQUADFI with the MMR-II administered this mixture to patient, with no reported adverse event; Initial information received on 10-Apr-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to US-SA-2025SA105763 (Cluster case). This case involves a 19 years old female patient who experienced a vaccine mix-up" and that the Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] was beside the diluent for MMR-II/mistakenly combined the menquadfi with the MMR-II and the patient was administered this mixture, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Apr-2025, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot U7852AB , Expiry: 31-Oct-2025) (Strength: Standard) via intramuscular route in the left arm as immunization which was mistakenly mixed with MMR-II as diluent, the menquadfi was beside the diluent for MMR-II with no reported adverse event (product preparation error) (poor quality product administered) (Latency: same day). Reportedly, they said that these patients did not need MENQUADFI. Pharmacist said that patients did not report any adverse events. 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.; Sender's Comments: US-SA-2025SA105763:patient 2