Age: 43.0
Sex: M
Vaccine: FLUR4
Symptoms: Autopsy, Cardiomegaly, Death, Hepatic steatosis, Hypertension
Clinical narrative: patient died 810 hours after vaccination; cardiomegaly; hepatic steatosis; hypertension; obesity (body mass index 35.9 kg/m2); Initial information received on 13-Mar-2021 regarding an unsolicited valid serious case from a other health professional.   This case is linked to cases 2021SA091271, 2021SA091252, 2021SA091286, 2021SA091303, 2021SA091334, 2021SA091349, 2021SA091366, 2021SA091398, 2021SA091448, 2021SA091468, 2021SA091489, 2021SA091516, 2021SA091556, 2021SA091604, 2021SA091690, 2021SA091745, 2021SA091782, 2021SA091798, 2021SA091833, 2021SA091855 and 2021SA091879. (Same Literature article)  Abstract: On October 7, 2016, the Food and Drug Administration approved recombinant hemagglutinin quadrivalent influenza vaccine (RIV4) (Spodoptera frugiperda cell line; Flublok Quadrivalent) for active immunization for the prevention of influenza disease in individuals 18 years of age and older. Clinical trials did not reveal any major differences in adverse events or serious adverse events following Flublok Quadrivalent versus standard dose quadrivalent inactivated influenza vaccine. To improve our understanding of the safety profile of this vaccine, we reviewed and summarized adverse event reports after Flublok Quadrivalent administration to the vaccine adverse event reporting system (VAERS). Through June 30, 2020, VAERS received 849 reports after RIV4 vaccination. The vast majority (810; 95%) were nonserious. Among serious events, there were 10 cases of Guillain-Barre syndrome, including 5 people who required mechanical ventilation and 2 people who died. Many allergic reactions were reported as non-serious, but required interventions to treat a life-threatening event, example: epinephrine, nebulizers, albuterol, glucocorticoids, and supplemental oxygen. Two people experienced a positive rechallenge (which are allergic reactions after repeated vaccination with RIV4), including a person who despite premedication with antihistamines developed respiratory difficulties, required epinephrine, and was transported to the emergency department. The occurrence of anaphylaxis and other allergic reactions in some individuals may reflect an underlying predisposition to atopy that may manifest itself after an exposure to any drug or vaccine and does not necessarily suggest that Flublok Quadrivalent is particularly allergenic. Post marketing safety surveillance will continue to be vital for understanding the benefits and risks of quadrivalent recombinant influenza vaccine.  This case involves a 43-year-old male patient who presented with cardiomegaly, hypertension, obesity (body mass index 35.9 kg/m2), hepatic steatosis and patient died (death) 8-10 hours, after he received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment, vaccination family history and concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number, expiry date and other dosing details were not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious cardiomegaly, hypertension, obesity (body mass index 35.9 kg/m2) (obesity) and hepatic steatosis (unknown latency) and the patient died (death), 8-10 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Other relevant tests were not reported.  The medical examiner noted the intensity for hepatic steatosis as moderate.  It was not reported if the patient received any corrective treatment before death.  An autopsy was done. The autopsy report states that the cause of death was cardiomegaly (heart weighed 544 g) associated with hypertension and obesity (body mass index 35.9 kg/m2).   There will be no information available on the batch number for this case.; Sender's Comments: This case involves a 43-year-old male patient who presented cardiomegaly, hypertension, obesity and hepatic steatosis and the patient died (death), 8-10 hours after the administration of FLUBLOK QIV. Time of onset is compatible for death and unknown for other reported events. An autopsy was done. The autopsy report states that the cause of death was cardiomegaly (heart weighed 544 g) associated with hypertension and obesity (body mass index 35.9 kg/m2). Further information regarding previous vaccination/medical treatment and tolerance, concomitant medication, other underlying risk factors if any and their etiological factors, other laboratory investigations results, would be needed for further assessment of the case. Based on reported information role of suspect vaccine cannot be assessed.; Reported Cause(s) of Death: cardiomegaly; hypertension; hepatic steatosis; obesity