Age: 33.0
Sex: F
Vaccine: FLUN4
Symptoms: Eye pruritus, Fatigue, Nasal congestion, Nasal discomfort, Rhinorrhoea
Clinical narrative: ITCHY EYES; RUNNY NOSE; SLIGHT NASAL CONGESTION; I ALSO FELT TIRED IN THE AFTERNOON; SEASONAL ALLERGIES; OCCASIONAL LOUD SNEEZING; TICKLE IN NOSE; A solicited report from a non-interventional study/data collection program has been received from a consumer. The report concerns a female patient (age 30 years, height 63 in, weight 135 lb).    The patient's past and current medical history included cold urticaria (ongoing).     Concomitant medication included loratadine (since 09-Oct-2021) and ascorbic acid, herbal Nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (since 10-Oct-2021).     The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) once/single administration, via nasal route, for flu vaccine on 04-Oct-2021.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On 06-Oct-2021, the patient experienced occasional loud sneezing (preferred term: Sneezing), tickle in nose (preferred term: Nasal discomfort), seasonal allergies (preferred term: Seasonal allergy), runny nose (preferred term: Rhinorrhoea), slight nasal congestion (preferred term: Nasal congestion) and i also felt tired in the afternoon (preferred term: Fatigue). On 07-Oct-2021, the patient experienced itchy eyes (preferred term: Eye pruritus).     The patient recovered from the event of i also felt tired in the afternoon after 5 days on 10-Oct-2021. The patient recovered from the event of itchy eyes after 4 days on 10-Oct-2021. The patient recovered from the event of occasional loud sneezing, tickle in nose and runny nose after 1 week on 12-Oct-2021. At the time of reporting, the event of slight nasal congestion was ongoing. The outcome of the event of seasonal allergies was unknown.     The events were considered non-serious.     The reporter considered that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following events: occasional loud sneezing, i also felt tired in the afternoon, itchy eyes, tickle in nose, runny nose and slight nasal congestion. The company physician considered that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following events: occasional loud sneezing, i also felt tired in the afternoon, itchy eyes and tickle in nose. The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following events: runny nose, seasonal allergies and slight nasal congestion.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Summary of follow up information received by AstraZeneca/MedImmune on 13-Oct-2021 from consumer via solicited source: Source of the report was updated to Non-interventional / Post-marketing study from spontaneous. New non-serious event of itchy eyes was added. Outcome for the events of occasional loud sneezing, tickle in nose, runny nose and i also felt tired in the afternoon was updated from not recovered to recovered. Stop date was added for the same. Suspect indication was added and start date and stop date was added. Patient demographics updated. Narrative updated.