Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUN3 | INFLUENZA (SEASONAL) (FLUMIST) | MEDIMMUNE VACCINES, INC. | UNK | — | — |
temp tag (scanning app) showed it had exceeded safe temp. Tried to report through the app, was malfunctioning and was unable to either request a new unit or to report temp failure; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided). No medical history was reported. No concomitant products were reported. The patient received Flumist (expiration date(s) 08-DEC-2025), via unspecified route, on an unknown date. The patient received 1 dose(s). A Patient administered Flumist. The report contains a Potential SAE associated with the Accuspray Single Dose device. A malfunction has been reported for the Accuspray Single Dose device as a result of Adverse Event Without Identified Device or Use Problem. On an unknown date, the patient experienced temp tag (scanning app) showed it had exceeded safe temp. tried to report through the app, was malfunctioning and was unable to either request a new unit or to report temp failure (preferred term: Product storage error). It is unknown if any action was taken with Flumist (flumist, influenza virus vaccine polyvalent, q/laiv). The outcome of the event(s) of temp tag (scanning app) showed it had exceeded safe temp. tried to report through the app, was malfunctioning and was unable to either request a new unit or to report temp failure was unknown. The event was considered non-serious. This case was marked as suppressed due to Medication Error with no AE. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUMIST Product Role:Suspect Device Problem code:Adverse Event Without Identified Device or Use Problem Manufacturer Name:ASTRAZENECA Labeled for single use:No Sample was available. Investigation by AstraZeneca/MedImmune Quality Assurance provided no indication that the complaint resulted from the manufacturing or packaging of the concerned batches Non-Significant correction on 16-Oct-2025: Null flavor for the reporter and patient details were added. Narrative amended.