Received Aug 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
MENQUADFI was given at an earlier than recommended interval to a patient with no reported adverse events; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to US-SA-2025SA229437 (cluster case) This case involves a 11 years old male patient who received Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] earlier than recommended interval with no reported adverse events. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Tetanus vaccine toxoid (AdaCel) for Immunisation. On 19-Feb-2025, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (once), Solution for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunisation. On 23-Jul-2025, the patient received an extra, unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, (once), Solution for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunization, earlier than recommended interval with no reported adverse events (extra dose administered) (Latency Same day). Information regarding batch number corresponding to the one at time of event occurrence will not be available. Reportedly, The patient was already up to date with the ADACEL while the MENQUADFI was given at an earlier than recommended interval. She explained that the patient has already received both vaccines last 19-Feb-2025 and was given again last 23-Jul-2025. 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-2025SA229437:
Adacel