Received Mar 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8369BA | OT / RA |
Administered MENQUADFI post temperature excursion with no reported AE; Max/low temperature reached at lowest temp of negative 0.6°C and max temp of 6.3°C for 25 hrs with no adverse event; Initial information received on 24-Mar-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case was linked with US-SA-2025SA086720 and US-SA-2025SA086554. This case involves a 16 years old male patient where for the Meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] reporter reported max/low temperature reached at lowest temp of negative 0.6°c and max temp of 6.3°c for 25 hrs with no adverse event and vaccine was administered 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. 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 ae (poor quality product administered) (latency- same day). On an unknown date in 2025 the reporter reported max/low temperature reached at lowest temp of negative 0.6°c and max temp of 6.3°c for 25 hrs with no adverse event (product storage error) (unknown latency). Reportedly, 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-2025SA086720:02460523 US-SA-2025SA086554:02460337