Received Mar 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8369BA | OT / RA |
Menquadfi was administered post temperature excursion with no reported adverse event; Initial information received on 24-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 years old male patient who was administered MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] post temperature excursion 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 HPV VACCINE (HPV VACCINE) for Immunisation; and MENINGOCOCCAL VACCINE B (MENB) for Immunisation. On 19-Mar-2025, the patient received 0.5 ml dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection (strength- standard) (lot U8369BA and expiry date- 31-MAR-2028) via intramuscular route in the right arm for Immunisation post temperature excursion with no reported adverse event (poor quality product administered) (latency- same day). Reportedly, Max/low temperature reached: lowest temp of negative 0.6°C and max temp of 6.3°CDuration: 25 hrs Previous Excursion- NONE, Human error- Unknown, Administered- YES, Does extended stability data cover the excursion- NO. Action taken- not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown for both the events. 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.; Sender's Comments: US-SA-2025SA086554:02460337 US-SA-2025SA087172:02460523
HPV VACCINE; MENB