Received Dec 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
product was administered post excursion with no reported adverse event; Initial information received on 05-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases-US-SA-2025SA367207 and US-SA-2025SA367108 This case involves an unknown age and unknown gender patient to whom product (MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]) was administered post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Dec-2025, the patient received MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Immunization post excursion with no reported adverse event (poor quality product administered) (latency same day). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. It was reported "Reason: Unknown, because it happened over the holiday weekend while the office was closed on 28Nov2025.Max/low temperature reached: negative 0.1CDuration: 30 minutesPrevious Excursion- No Human error- Unknown Administered post-excursion- Yes, 3 patients were administered with MENQUADFI after. No one was administered with the other two vaccines.Does extended stability data cover the excursion? No. Description of eventAdverse events :No patient information was provided as she needs to check with her superior if she can give the patient information" 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.; Sender's Comments: US-SA-2025SA367108: US-SA-2025SA367207: