Received May 21, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 7+ | — | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8861KA | IM |
temperature excursion of vaccines; reached a high of 47.4F for 30 mins '&' low of 28.9 F for 45 mins with no reported adverse event; Initial information received on 01-May-2026 regarding an unsolicited valid non-serious case received from an other or other health care professional. This case involves 19-year-old female patient and it was reported temperature excursion of vaccines after receiving Influenza Usp Trival A-B Subvirion No Preservative Vaccine (Fluzone) 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, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml of Influenza Usp Trival A-B Subvirion No Preservative Vaccine suspension for injection in pre-filled syringe (batch number: UT8861KA; expiry date: 30-Jun-2026) via Intramuscular route in an unknown administration site for immunization and the products had 3 temperature excursions; the first excursion occurred on 04-FEB-2026: reached a high of 47.4F for 30 mins and low of 28.9F for 45 mins (Product storage error, onset: unknown, latency: unknown). 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.
Comments: NONE