Sex: M
Vaccine: FLUR4
Symptoms: Death, Guillain-Barre syndrome, Influenza like illness
Clinical narrative: Guillain Barre syndrome; flu-like symptoms; patient died approximately two-three weeks later; Initial information was received on 13-Mar-2021 regarding an unsolicited valid serious case from other health care professional, issued from a literature article.    This case is linked to cases 2021SA091226, 2021SA091252, 2021SA091286, 2021SA091303, 2021SA091334, 2021SA091349, 2021SA091366, 2021SA091398, 2021SA091448, 2021SA091468, 2021SA091489, 2021SA091516, 2021SA091556, 2021SA091604, 2021SA091690, 2021SA091745, 2021SA091782, 2021SA091798, 2021SA091833, 2021SA091855 and 2021SA091879 (same article).  This case involves a 66 years-old male patient who experienced Guillain-Barre syndrome, flu-like symptoms (influenza like illness) and died (death), while he received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  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 percent) 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.  The patient's medical history included Coronary artery surgery in 2016 and recent dental abscess [Tooth abscess] (time course not specified).  The patient's past medical treatments, concomitant therapy, vaccinations and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious Guillain-Barre syndrome 49 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed serious flu-like symptoms (influenza like illness) 2-3 weeks following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Patient was hospitalized for both events and improved [recovering] with intravenous immunoglobulin treatment and physical therapy.  On an unknown date, the patient was discharged to rehabilitation and died approximately two weeks later (death) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant.  Details of laboratory data were not reported.  Cause of death was not reported and it was unknown if autopsy was done.  Information on batch number was requested for this case.; Sender's Comments: This case involves a 66 year-old male patient who presented with Guillain-Barre syndrome (49 days) and influenza like illness (2 to 3 weeks) after the administration of FLUBLOK QIV, he was hospitalized for these events and his condition improved after intravenous immunoglobulin treatment. He was discharged to rehabilitation and died (death) approximately two weeks later. Time of onset is compatible. No electrophysiologic findings, clinical details regarding bilateral ophthalmoparesis/ reduced reflexes or cytoalbuminologic dissociation (elevation of CSF protein level above laboratory normal value AND CSF total white cell count < 50 cells/ microliter) was provided for the patient in this specific case. GBS is considered as a potential risk for all influenza vaccines. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, autopsy result, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: death