Sex: F
Vaccine: FLUN3
Symptoms: Blood creatine phosphokinase increased, Eosinophil count decreased, Muscle spasms, Myalgia, Neutrophil count increased
Clinical narrative: ELEVATED CK; Elevated Ck, muscle spasms, muscle pain, elevated RBCs, Platelets, Neutrophils. Decreased eosinophils. Low vitamin d; MUSCLE SPASMS; ELEVATED RBCS; ELEVATED PLATELETS; ELEVATED NEUTROPHILS; DECREASED EOSINOPHILS; LOW VITAMIN D; MUSCLE PAIN; A spontaneous report has been received from a consumer concerning a female patient with height of 58 inches and with weight of 80 pounds.    No medical history was reported. The following demography was reported for the patient's parent: Sex: ASKU. Concomitant medication included influenza vaccine live reassort 3v.     On an unknown date, the patient was administered with Flumist (influenza vaccine live reassort 3v) (batch number ASKU), via nasal route. No malfunction has been reported for Flumist.    On an unknown date, the patient experienced elevated ck (preferred term: Blood creatine phosphokinase increased), muscle spasms (preferred term: Muscle spasms), elevated rbcs (preferred term: Red blood cell count increased), elevated platelets (preferred term: Platelet count increased), elevated neutrophils (preferred term: Neutrophil count increased), decreased eosinophils (preferred term: Eosinophil count decreased), low vitamin d (preferred term: Vitamin D decreased) and muscle pain (preferred term: Myalgia).     Treatment with Flumist was not changed.   The outcome of the events of elevated ck, muscle spasms, elevated rbcs, elevated platelets, elevated neutrophils, decreased eosinophils, low vitamin d and muscle pain was unknown.     The events were considered serious (important medical event) by the company physician.     The reporter considered that there was a reasonable possibility of a causal relationship between Flumist and the following event: elevated ck.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    All required follow-up attempts have been completed to obtain the Lot / Batch number for Flumist, however the Lot / Batch number was not received.    Summary of follow-up information received by AstraZeneca/MedImmune on22-Dec-2023 via marketing company: Summary of unsuccessful Lot/Batch number attempts added. Narrative updated.    Minor correction on 03-Jan-2024: Added valid null flavors to All fields for Reporter. Added valid null flavors to State field for Reporters 3  and 4.  Populated applicable null flavors for All events. Temporarily removed causality for event Elevated CK. Narrative updated.; Sender's Comments: Blood creatine phosphokinase increased, muscle spasms, red blood cell count increased, platelet count increased, neutrophil count increased, eosinophil count decreased and vitamin D decreased are not listed in the company data sheet of Q/LAIV. Events of red blood cell count increased, platelet count increased, neutrophil count increased and eosinophil count decreased may possibly be in association. Blood creatine phosphokinase increased may further be contributory to muscle spasms. However, due to limited information on start date and indication of the suspect drug, onset date and outcome of the events, patient's complete demographics, relevant medical history, circumstances surrounding the events, aetiological and diagnostic workup with baseline values if available (complete blood panel, imaging studies, physical examination), concurrent diseases, concomitant medications, risk factors, family history, the evaluation did not find evidence to suggest a causal relationship between the events and the suspect drug.