Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8573AA | OT |
did not get his full dose of MENQUADFI/it was only 0.03 mL that remained and which the patient did not receive, with no reported adverse event; Initial information received on 11-Sep-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 12 years old male patient who did not get his full dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]/it was only 0.03 ml that remained and which the patient did not receive, 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 Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) for Immunisation; HPV vaccine VLP rL1 4v (yeast) (Gardasil) for Immunisation; and Influenza vaccine (Fluzone) for Immunisation. On 11-Sep-2025, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (lot U8573AA, with unknown strength and expiry) via intramuscular route in the arm nos (not otherwise specified) as immunization, the patient drew back or flinched at the last second and did not get the full 0.5 mL dose. Physician stated that the patient received most of the dose, it was only 0.03 mL that remained and which the patient did not receive, with no reported adverse event (incorrect dose administered) (Latency: same day). 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.
Tdap; Gardasil; Fluzone