Received May 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 6 | UT8861KA | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8861KA | IM |
Patient received Fluzone post excursion with the first excursion occurred on 04FEB2026: reached a high of 47.4F for 30 mins '&' low of 28.9F for 45 mins with no reported adverse event; Initial information received on 01-May-2026 regarding an unsolicited valid non-serious case received from other or unknown health care professional. This case involves a 9-year-old male patient who received influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] post excursion with the first excursion occurred on 04-Feb-2026: reached a high of 47.4F for 30 mins '&' low of 28.9F for 45 mins with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, concomitant medications were not provided. On 02-Mar-2026, the patient received a 0.5 mL of influenza USP TRIVAL A-B subvirion no preservative vaccine suspension for injection (batch number: UT8861KA, expiry date: 30-Jun-2026) (strength: unknown) via intramuscular route in an unknown vaccination site for prophylactic vaccination [Immunisation] post excursion with the first excursion occurred on 04-Feb-2026: reached a high of 47.4F for 30 mins '&' low of 28.9F for 45 mins with no reported adverse event (Product storage error and latency: unknown). It was reported, "The second excursion occurred on 13-MAR-2026: reached a high of 47.3F for 30 mins and low of 35.4F for 30 mins. Both excursions were due to inventory. The third excursion occurred on 14-MAR-2026: reached a high of 49.6F for 1 hour and 30 mins due to an unknown reason. Was it related to a human error: YES. Does the extended stability data cover the excursion: NO " 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.