Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8852NA | OT |
The vaccine appears transparent; however, upon shaking it, observed some particulates suspended within it with no reported adverse event; Initial information received on 13-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional This case involves an unknown age and unknown gender patient who received influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] and the vaccine appears transparent; however, upon shaking it, observed some particulates suspended within it 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 an unknown dose of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- unknown, expiry date- 30-SEP-2026 and lot UT8852NA) via unknown route in unknown administration site fo r Immunization and the vaccine appears transparent; however, upon shaking it, observed some particulates suspended within it with no reported adverse event (poor quality product administered) (same day latency). It was reported that, During the call, HCP (healthcare professional) checked the other FLUZONE NP they have with the same Lot and stated that they are clear and "cloudy" with tiny particulates but the particulates were not the same as the one that was administered, HCP stated that the "tiny particulates" may be air bubbles but he was not sure. 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.