Received Feb 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8820DA | OT / LA |
a patient that is 55 years old received the FLUZONE HD with no reported adverse event; Initial information received on 13-Feb-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 55 years old female patient who received the influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] 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 ELASOMERAN (MODERNA COVID-19 VACCINE) for Immunisation. On 30-Jan-2026, the patient received 0.5 ml of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength- unknown, expiry date- 30-JUN-2026 and lot UT8820DA) via intramuscular route in the left deltoid for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency- same day). Action taken was 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.
MODERNA COVID-19 VACCINE