Sex: U
Vaccine: FLUN4, FLUN4
Symptoms: Atrioventricular block, Cardiac pacemaker insertion, Mechanical ventilation, Pericardial effusion, Pyrexia
Clinical narrative: WITHIN 2 WEEKS WENT INTO HEART BLOCK/WITHIN 24 HOUR WAS FILLING WITH FLUID/WENT INTO HEART BLOCK WAS ON VENTILATOR FOR A WEEK, FURTHER CLARIFIED PATIENT WAS ON VENTILATOR IN THE HOSPITAL/FLUMIST ATTACKED THE AV NODE THE ELECTRICAL COMPONENT OF THE HE; WITHIN 12 HOURS WAS RUNNING A HIGH FEVER; A spontaneous report has been received from a consumer concerning a patient of unknown gender of Unknown ethnic origin born in 1979.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    On an unknown date, the patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown) once/single administration, via nasal route. On an unknown date, the patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) once/single administration, via nasal route.    A unknown administered Flumist quadrivalent. No malfunction has been reported for this combination product.     On an unknown date, the patient experienced within 2 weeks went into heart block/within 24 hour was filling with fluid/went into heart block was on ventilator for a week, further clarified patient was on ventilator in the hospital/flumist attacked the av node the electrical component of the heart and killed it, neither worked, further atrial and ventricle did not work/heart does not work (preferred term: Atrioventricular block). On an unknown date, the patient experienced within 12 hours was running a high fever (preferred term: Pyrexia).     Action taken with Flumist Quadrivalent #1 and Flumist Quadrivalent #2 was not applicable.    At the time of reporting, the event of within 2 weeks went into heart block/within 24 hour was filling with fluid/went into heart block was on ventilator for a week, further clarified patient was on ventilator in the hospital/flumist attacked the av node the electrical component of the heart and killed it, neither worked, further atrial and ventricle did not work/heart does not work was ongoing. The outcome of the event(s) of within 12 hours was running a high fever was unknown.     The company physician suggested to club the reported event within 2 weeks went into heart block & within 24 hour was filling with fluid and went into heart block was on ventilator for a week, further clarified patient was on ventilator in the hospital and flumist attacked the av node the electrical component of the heart and killed it, neither worked, further atrial and ventricle did not work and heart does not work to within 2 weeks went into heart block/within 24 hour was filling with fluid/went into heart block was on ventilator for a week, further clarified patient was on ventilator in the hospital/flumist attacked the av node the electrical component of the heart and killed it, neither worked, further atrial and ventricle did not work/heart does not work and upgraded the seriousness from non-serious to serious and assessed it as serious due to the seriousness criteria of Life-threatening and Hospitalization.    The event of within 12 hours was running a high fever was upgraded by company physician from non-serious to serious due to seriousness criteria of hospitalization.    The company physician suggested not to capture the ended up with pacemaker, has pacemaker that pushes bottom heart of heart so that blood flows though, in and out of hospital a lot, in hospital for 2 weeks and then back in hospital for and 3 weeks, reason for hospitalization not further clarified, without pace maker he cannot live, heart does not beat, maybe 30 times and i have talked to several people that have had problems with flumist as an events.    The reporter considered that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (Dose-1) and the following event(s): within 12 hours was running a high fever and within 2 weeks went into heart block/within 24 hour was filling with fluid/went into heart block was on ventilator for a week, further clarified patient was on ventilator in the hospital/flumist attacked the av node the electrical component of the heart and killed it, neither worked, further atrial and ventricle did not work/heart does not work.     The reporter considered that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (Dose-2) and the following event(s): within 12 hours was running a high fever and within 2 weeks went into heart block/within 24 hour was filling with fluid/went into heart block was on ventilator for a week, further clarified patient was on ventilator in the hospital/flumist attacked the av node the electrical component of the heart and killed it, neither worked, further atrial and ventricle did not work/heart does not work.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect; Sender's Comments: Atrioventricular block and pyrexia are not listed in the company core data sheet (CCDS) of Q/LAIV. Due to limited information on baseline health condition of vaccinee before vaccine administration, circumstances leading to the events, start date of Q/LAIV, onset date and outcome of events, clinical course, treatment details, relevant medical history, concomitant medications, concurrent conditions, risk factors leading to the events, allergic history or previous history of anaphylaxis, detailed etiological and diagnostic workup; the evaluation did not find evidence to suggest a causal relationship between the events and Q/LAIV.