Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UA493AA | OT |
ship date on shipping label is more than two days prior to receiving the vaccine and one dose was administered with no reported adverse event; Initial information received on 28-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 16 years old male patient who received one dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [menquadfi] and ship date on your shipping label is more than two days prior to receiving the vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Apr-2025, the patient received an unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (lot UA493AA) (strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and ship date on shipping label is more than two days prior to receiving the vaccine with no reported adverse event (poor quality product administered) (Latency: same day). Reportedly, The medical assistant reported that they received a shipment of 10 vials of MENQUADFI today, 28 April 2025, at 9:00 AM. The medical assistant noted that the vaccines were still cold upon arrival, and the doctor and the nurse stated that the vaccine looks fine. 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.