Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8823DA | IM / RA |
excursion happened on 8APR2026, and 1 dose was administered on 12APR2026, with no reported adverse event; Initial information received on 27-Apr-2026 regarding an unsolicited valid non-serious case received from other or unknown health care professional (HCP). This case involves a 48-year-old male patient who received Influenza Trivalent Recombinant Vaccine [Flublok] which was exposed to an excursion due to new fridge was not regulating the temperature very well and it got too cold where Highest/lowest temperature reached 30.9 Fahrenheit for 15 minutes, with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 12-Apr-2026, the patient received 0.5 mL dose (once) of Influenza Trivalent Recombinant Vaccine, Solution for injection of unknown strength (batch: U8823DA, expiration date: 31-May-2026) via intramuscular route in the right arm for Influenza [Influenza Immunisation], which was exposed to an excursion due to new fridge was not regulating the temperature very well and it got too cold where Highest/lowest temperature reached 30.9 Fahrenheit for 15 minutes, with no reported adverse event. [Poor quality product administered] [latency: same day]. It was reported that, "this excursion did not occur due to a human error, extended stability data did not cover the excursion. Previous excursion: at 50.70F for 9 Hours." 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.