Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | U8493AA | OT / LA |
used sterile water as a diluent for menquadfi with no reported adverse event; Initial information received on 10-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 years old male patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] and sterile water was used as a diluent 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 Tetanus vaccine (Tetanus vaccine) for Immunisation. On 08-Sep-2025, the patient received 0.5 ml of dose 1 of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection with standard strength (expiry date- 31-MAY-2028 and lot U8493AA) once via intramuscular route in the left arm for Immunization and sterile water was used as a diluent for Menquadfi 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.
Tetanus vaccine