Sex: M
Vaccine: FLUN3
Symptoms: Road traffic accident, Syncope
Clinical narrative: SYNCOPE VASOVAGAL; MOTOR VEHICLE ACCIDENT; FIVE MINUTES AFTER LAIV, A MAN EXPERIENCED SYNCOPE WHILE HE WAS DRIVING HOME FROM THE VACCINATION APPOINTMENT; A literature report has been received. The article was published. The report concerns a male patient of Unknown ethnic origin (age 28 years).    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza vaccine live reassort 4v), via nasal route, for influenza prophylaxis on an unknown date.     No malfunction has been reported for FLUMIST.    On an unknown date, the patient experienced syncope vasovagal (preferred term: Syncope). On an unknown date, the patient experienced motor vehicle accident (preferred term: Road traffic accident). On an unknown date, the patient experienced five minutes after laiv, a man experienced syncope while he was driving home from the vaccination appointment (preferred term: Treatment noncompliance).     The outcome of the event(s) of syncope vasovagal, motor vehicle accident and five minutes after laiv, a man experienced syncope while he was driving home from the vaccination appointment was unknown.     The events were considered serious (important medical event).     The reporter considered that there was a reasonable possibility of a causal relationship between Flumist (influenza vaccine live reassort 4v) and the following event(s): syncope vasovagal, motor vehicle accident and five minutes after laiv, a man experienced syncope while he was driving home from the vaccination appointment. The company physician considered that there was a reasonable possibility of a causal relationship between Flumist (influenza vaccine live reassort 4v) and the following event(s): syncope vasovagal. The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist (influenza vaccine live reassort 4v) and the following event(s): motor vehicle accident and five minutes after laiv, a man experienced syncope while he was driving home from the vaccination appointment.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect  Manufacturer Name: AstraZeneca AB  Manufacturer address:   Manufacturer city:   Manufacturer Country:      Minor correction on 18-Sep-2024: Vaccine reproter added. Narrative updated.; Sender's Comments: Syncope and road traffic accident are not listed in the company core data sheet of Q/LAIV. Serious event of Treatment noncompliance is also reported. Underlying  could be a possible confounding contributory risk factor for the occurrence of event. Due to limited information on circumstances leading to events, start date of suspect drug, onset date and outcome of events, clinical course, treatment provided, risk factors, relevant medical history, concurrent conditions, concomitant medications, detailed diagnostic and etiologic workup, the evaluation did not find the evidence to exclude a causal relationship between the event (syncope) and suspect drug; the evaluation did not find the evidence to suggest a causal relationship between the event (road traffic accident) and suspect drug.