Received Jul 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8370AA | OT / LA |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | 3CA30C1 | OT / RA |
temperature excursion: negative disposition, administered menquadfi with no reported adverse event; Initial information received on 23-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional (Live follow up processed together on the same day). This case involves a 12 years old female patient who had received Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] And Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] after temperature excursion: negative disposition with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Jul-2025, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection (expiry date: 30-APR-2028 and lot U8370AA) (strength: standard and frequency: once) via intramuscular route in the left deltoid; On the same day, also received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection (expiry date: 30-APR-2026 and lot 3CA30C1) via intramuscular route in the right deltoid as immunization and temperature excursion: negative disposition, administered menquadfi with no reported adverse event (poor quality product administered) (latency: smae 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.