Received Jan 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8854AA | OT |
refrigerator was frequently being opened max/low temperature reached: 25.9? duration out of labelled range: 2 hours 29 minutes/ product administered, with no reported adverse event; Initial information received on 09-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional via call center. This case involves an unknown gender Adolescent patient who experienced an event refrigerator was frequently being opened Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] max/low temperature reached: 25.9? duration out of labelled range: 2 hours 29 minutes and the product was administered, 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 a unknown dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine suspension for injection (strength: unknown) (lot: U8854AA, expiry date: 30-Jun-2026) via unknown route in unknown administration site for Influenza immunization was reached max/low temperature reached: 25.9? duration out of labelled range: 2 hours 29 minutes as the refrigerator was frequently being opened (Poor quality product administered) (latency: unknown). It was reported "Supervisor reported a temperature excursion for FLUZONE NP that was exposed to 25.9? for 13 minutes. The vaccines were also exposed to previous excursions on 11Oct2025 at 31.5°F for 15 minutes and 50.5°F for 10 minutes and another one on 23Oct2025 at 32.2°F for around 15 minutes or less. Preventative supervisor stated that the excursions were due to probe misplacement and they are confident that it did not actually reach that temperature. MIS attempted to collect consent instead, but they said that their vaccines did not freeze, so they're trying to make sure that they gave the correct information. Preventative Supervisor added that this refrigerator is not one of their regular units and though it is on all the time, vaccines are not always in it. They wanted to make sure that they have the right timeframes because this cannot be right as the vaccines were not frozen and that they would call back within the day. MIS informed that the vaccines would still be unsuitable for use since the temperature reported to us was below 0? already but if they are confident that the vaccines did not reach that temperature then it would be up to their discretion if they would continue using the vaccines. Suitable for use after the excursion: No Human Error: Yes" 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.