Received Dec 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | TFAA2545 | OT / RA |
products had been in transit too long and inadvertently administered one dose to a patient with no reported adverse event; products had been in transit too long and inadvertently administered one dose to a patient with no reported adverse event; Initial information along with live-follow-up was received on 02-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 years old male patient who had experienced an event product (Influenza USP Trival A-B Subvirion NO Preservative Vaccine [Fluzone]) had been in transit too long and inadvertently administered one dose with no reported adverse The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Nov-2025, the patient received a 0.5 ml (1x) dose of suspect Influenza USP Trival A-B Subvirion NO Preservative Vaccine suspension for injection (strength: unknown) (lot TFAA2545, expiry date: 30-Jun-2026) via intramuscular route in the right arm for Influenza immunisation It was reported, the products had been in transit too long and inadvertently administered one dose to a patient with no reported adverse event (product storage error) (onset and latency: unknown) (poor quality product administered) (onset: 29-Nov-2025, latency: same day). It was reported "Caller received an order on 28NOV2025. However, the product was supposed to be received by 26-NOV-2025. Caller confirmed that VAXSERVE deemed the products not suitable for use due to time in transit and are sending them a replacement order. One of the pharmacists was not aware that the products had been in transit too long and inadvertently administered one dose to a patient. Temperature excursion: negative disposition and product used." 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.