Received Apr 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8558BA | — |
staff prepared menquadfi 30 minutes ahead of time, it was left on the counter, out of refrigeration, during that time (30 minutes) before it was administered with no reported adverse event; Initial information received on 13-Mar-2026 regarding an unsolicited valid non-serious case received from other or unknown healthcare professional (HCP). This case involves a patient of unknown age and unknown gender, and reporter reported that MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] was left on the counter, out of refrigeration, 30 minutes before it was administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. On 12-Mar-2026, the patient received unknown dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] solution for injection (batch number: U8558BA, expiry date: 30-Sep-2028) (strength: unknown) via unknown route in an unknown administration site for immunization (Immunisation). Reporter reported that yesterday one of her staff prepared MENQUADFI 30 minutes ahead of time. She stated that it was left on the counter, out of refrigeration, during that time (30 minutes) before it was administered with no reported adverse event (Product storage error, onset: 12-Mar-2026, latency: same day). Medical Information Specialist (MIS) did not assert whether the MENQUADFI vaccination was viable or not. No further information was gathered at the time of the call. 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.
Comments: NONE