Received Aug 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8361AA | OT |
menquadfi was administered but was given did intradermally instead of intramuscularly with no reported adverse event; about 0.2 ml of menquadfi was given in the error/after the error was discovered a proper dose of menquadfi was administered intramuscularly with no reported adverse event; When the tb test was placed by a medical assistant (MA), the patient complained that it was hurting; Initial information received on 12-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 years old female patient who was administered to Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] but was given did intradermally instead of intramuscularly with no reported adverse event, about 0.2 ml of menquadfi was given in the error/after the error was discovered a proper dose of menquadfi was administered intramuscularly and when the Tuberculin Test [Tubersol] was placed by a medical assistant (ma), the patient complained that it was hurting. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV vaccine VLP rL1 9v (yeast) (Gardasil 9) for Product used for unknown indication. On 11-Aug-2025, the patient received 0.2mL of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (lot U8361AA, expiry date 31-Mar-2028) via intradermal route in the left forearm, also received an unknown dose of vaccine (lot U8361AA, expiry date 31-Mar-2028) via intramuscular route in unknown administration site and Tubersol (Tuberculin Test) Solution for injection, (lot 4CA02C1 and expiry date on 31-Jan-2028) dosage unknown for prophylactic vaccination (Immunisation). On 11-Aug-2025, the patient was administered to menquadfi but was given intradermally instead of intramuscularly with no reported adverse event (incorrect route of product administration), 0.2 ml of menquadfi was given in the error/after the error was discovered a proper dose of menquadfi was administered intramuscularly with no reported adverse event (extra dose administered) and when the tb test was placed by a medical assistant (ma), the patient complained that it was hurting (vaccination site pain) following Tuberculin Test and Meningococcal A-C-Y-W135 (T Conj) Vaccine. Reportedly, After the the mistake, the patient was fine. The caller planned to continue to check with the patient about her status. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (vaccination site pain). At time of reporting, the outcome was Unknown for the event (vaccination site pain). 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.
Gardasil 9; TUBERSOL