Received Aug 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8493AA | OT / LA |
reconstituted MENQUADFI with sterile diluent for vaccines, with no reported adverse event; Initial information received on 30-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA-2025SA222935 (cluster case). This case involves a 16-year-old male patient who was administered with Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] which was reconstituted with sterile diluent for vaccines, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV Vaccine for Immunisation. On 29-Jul-2025, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine solution for injection standard strength (lot U8493AA and expiry date- 31-Aug-2025) (frequency-once) via intramuscular route in the left deltoid for Immunization, which was reconstituted with sterile diluent for vaccines with no reported adverse event (product preparation error) (latency-same day). 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-2025SA222935:
HPV VACCINE