Sex: M
Vaccine: FLUX
Symptoms: Blood cholesterol abnormal, Decreased immune responsiveness, Inappropriate schedule of product administration, Medication error, Nasal congestion
Clinical narrative: DECREASED IMMUNE RESPONSIVENESS; BLOOD CHOLESTEROL ABNORMAL; NASAL CONGESTION; PERITONSILLAR ABSCESS; PHARYNGITIS STREPTOCOCCAL; POSTOPERATIVE ABSCESS; PSORIASIS; SNORING; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION; A solicited report from a non-interventional study has been received from the regulatory authority. The report concerns a male patient of Unknown ethnic origin (age 34 years).    The patient's past and current medical history included psoralen with long wavelength ultraviolet light (dates not reported), treatment noncompliance (dates not reported), uv light therapy (dates not reported), vasectomy (dates not reported) and covid-19 vaccination (dates not reported). The following demography was reported for the patient's parent:   Sex: Unknown    Concomitant medication included acitretin for product used for unknown indication (from APR-2016 to AUG-2016).     The patient received Influenza (influenza vaccine), via unknown route, for product used for unknown indication during NOV-2017.     The patient started treatment with Cosentyx (secukinumab) 300 mg, subcutaneous, on an unknown date for psoriasis and with Methotrexate (methotrexate) 15 mg on an unknown date for product used for unknown indication.     No malfunction has been reported for INFLUENZA.    The report described a medication error for Influenza. The reported term was inappropriate schedule of product administration (Preferred term: Inappropriate schedule of product administration).     On an unknown date, the patient experienced decreased immune responsiveness (preferred term: Decreased immune responsiveness). On an unknown date, the patient experienced blood cholesterol abnormal (preferred term: Blood cholesterol abnormal). On an unknown date, the patient experienced nasal congestion (preferred term: Nasal congestion). On an unknown date, the patient experienced peritonsillar abscess (preferred term: Peritonsillar abscess). On an unknown date, the patient experienced pharyngitis streptococcal (preferred term: Pharyngitis streptococcal). On an unknown date, the patient experienced postoperative abscess (preferred term: Postoperative abscess). On an unknown date, the patient experienced psoriasis (preferred term: Psoriasis). On an unknown date, the patient experienced snoring (preferred term: Snoring).     It is unknown if any action was taken with Influenza (influenza vaccine), Cosentyx (secukinumab) and Methotrexate (methotrexate).     At the time of reporting, the event of peritonsillar abscess was improving. The outcome of the event(s) of decreased immune responsiveness, blood cholesterol abnormal, nasal congestion, pharyngitis streptococcal, postoperative abscess, psoriasis, snoring and inappropriate schedule of product administration was unknown.     The events were considered serious (important medical event).     The company physician considered that there was a reasonable possibility of a causal relationship between Influenza and the following event(s): pharyngitis streptococcal.     The company physician did not consider that there was a reasonable possibility of a causal relationship between Influenza and the following event(s): peritonsillar abscess, decreased immune responsiveness, nasal congestion, psoriasis, snoring, blood cholesterol abnormal, inappropriate schedule of product administration and postoperative abscess.     Laboratory values are available.    Device Information:     Combination Product Report: Yes    Product As Reported: INFLUENZA  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Summary of follow-up information received by AstraZeneca/Medimmune on 31-Oct-2022 from physician via solicited report: Outcome of event Peritonsillar abscess updated to Recovering from Unknown. New reporter physician added. Case became medically confirmed. New concomitant product Acitretin added. Other company causality of suspect products Influenza, Cosentyx and Methotrexate added. Indication of concomitant product added. Dosing regimen updated. Relevant history added. Lab data added. Narrative updated.