Received Feb 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8370AA | OT |
temperature excursion of menquadfi; max/low temperature reached: 46.7F Duration out of labelled range: 8 days with no reported adverse event; temperature excursion of menquadfi vaccine administered with no reported adverse event; Initial information received on 03-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA-2025SA035119, US-SA-2025SA035116, US-SA-2025SA035136, US-SA-2025SA035137 and US-SA-2025SA035178. This case involves a 15 years old male patient who was administered with Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] after excursion, with no reported adverse event and the vaccine were exposed to temperature excursion of; max/low temperature reached: 46.7f duration out of labelled range: 8 days, 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, the patient received (0.5 ml, once) dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine, Solution for injection (strength: not reported) (lot: U8370AA, Expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization). On an unknown date the vaccine was exposed to temperature excursion of Meningococcal A-C-Y-W135 (T Conj) Vaccine, max/low temperature reached: 46.7 f duration out of labelled range: 8 days with no reported adverse event (product storage error) and was administered to a patient with no reported adverse event (poor quality product administered) (latency: same day) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine. Human error: yes 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.; Sender's Comments: US-SA-2025SA035119: US-SA-2025SA035116: