Received Feb 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 2 | UT8878KA | OT / LL |
patient received a dose of fluzone np after being declared not good for use, with no reported adverse event; Initial information received on 06-Feb-2026 regarding an unsolicited valid non-serious case received from a nurse along with live follow up received on 09-Feb-2026 both documents were processed together. This case involves a 2 years old male patient who received a dose of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] after being declared not good for use, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Feb-2026, the patient received dose 2 Booster dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection dose 0.5 ml 1x(once) Strength = standard lot UT8878KA expiry date-30-Jun-2026 via intramuscular route in the left thigh for Influenza (Influenza immunisation) after being declared not good for use, with no reported adverse event (poor quality product administered) (same day latency). It was reported "Nurse explains that with the snow that everyone was having, there were delays in shipment. When they got the shipment of FLUZONE NP, nothing seemed out of range. She hadn't even thought about it because she assumed that they got it when they were supposed to. The following day, the office manager told her that they had received a message stating that the shipment was in transit for too long." 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.