Received Dec 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 2 | U8818CAE | OT |
patient was administration of a second dose of influenza vaccine within the same season with no reported adverse event; Initial information received on 24-Nov-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 administration of a second dose of Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] within the same season 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 Meningococcal vaccine B rfHbpA/fHbpB (Trumenba). On 24-Nov-2025, the patient received dose 2 of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine suspension for injection at the dose of 0.5 ml (once) (strength: unknown) ( lot U8818CAE, expiry date: 30-Jun-2026) via intramuscular route in unknown administration site for immunization within the same season (extra dose administered) (latency: same day). 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.
Trumenba