Received Sep 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8361AA | OT / RA |
| MNQ | MENINGOCOCCAL CONJUGATE (MENACTRA) | SANOFI PASTEUR | 2 | — | OT |
patient's vaccination history indicated receiving 1 dose of MENACTRA in 2018 and another dose in 2023 was given MENQUADFI yesterday, 26-Aug-2025 with no reported adverse event; Initial information received on 27-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 18 years old female patient with vaccination history indicated receiving 1 dose of Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra] in 2018 and another dose in 2023, was given Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] yesterday, 26-aug-2025 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2018, the patient received dose 1 of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine Solution for injection via unknown route in unknown administration site and on an unknown date in 2023 she again received dose 2 of Menactra via unknown route in unknown administration site for immunization (strength, dose, batch and expiry date unknown for both the doses). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On 26-AUG-2025, the patient received a Booster dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine dose 0.5 ml 1x(once) Solution for injection (strength standard) lot U8361AA expiry date-31-Mar-2028 via intramuscular route in the right deltoid for immunization with no reported adverse event (Extra dose administered) (same day latency) for Menquadfi. Reportedly, since the patient was going to college this weekend, a booster of MENQUADFI was provided. Then, they found out that the patient had a booster in 2023 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.