Received Dec 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUN3 | INFLUENZA (SEASONAL) (FLUMIST) | MEDIMMUNE VACCINES, INC. | UNK | 15291857 | IN / NS |
DIZZINESS; SEVERE SWEATING; BLACK SPOTS; NAUSEA; A spontaneous report has been received from a consumer. The report concerns a male child patient of [withheld] ethnic origin born in 2014 (age 11 years, height 144 cm, weight 29.483 kg). No medical history was reported. No concomitant products were reported. The patient received Flumist (batch number(s) 15291857) (expiration date(s) 06-SEP-2026) 1 dosage form, via nasal use for flu vaccine on 18-OCT-2025. The patient received 1 dose(s). No malfunction has been reported for the Accuspray Single Dose device. On 18-OCT-25, the patient experienced severe sweating (preferred term: Hyperhidrosis), dizziness (preferred term: Dizziness), nausea (preferred term: Nausea) and black spots (preferred term: Skin disorder). The patient recovered from the event(s) black spots, dizziness, nausea and severe sweating after 1 day on 18-OCT-2025. The events were considered non-serious. 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
Medical History/Concurrent Conditions: Flu vaccination