Sex: F
Vaccine: FLUR4
Symptoms: Angioedema, Hypersensitivity, Joint swelling, Paraesthesia, Serum sickness-like reaction
Clinical narrative: angioedema; Serum sickness type reaction; hand tingling; generallized joint swelling; Allergic reaction to flu vaccine; Initial information received on 13-Mar-2021 regarding an unsolicited valid serious case from a other health professional.  This case is linked to cases 2021SA091226, 2021SA091252, 2021SA091271, 2021SA091286, 2021SA091303, 2021SA091334, 2021SA091349, 2021SA091366, 2021SA091398, 2021SA091448, 2021SA091468, 2021SA091489, 2021SA091556, 2021SA091604, 2021SA091690, 2021SA091745, 2021SA091782, 2021SA091798, 2021SA091833, 2021SA091855 and 2021SA091879 (Same Literature article).  Abstract: On October 7, 2016, the FDA 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-Barré 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, e.g., epinephrine, nebulizers, albuterol, glucocorticoids, and supplemental oxygen. Two people experienced a positive rechallenge (i.e., 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. Postmarketing safety surveillance will continue to be vital for understanding the benefits and risks of quadrivalent recombinant influenza vaccine.  This case involves a 43-years-old female patient who had serum sickness type reaction, angioedema and allergic reaction to flu vaccine (hypersensitivity), hand tingling (paraesthesia) and generallized joint swelling (joint swelling), while she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications 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 in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious serum sickness type reaction, angioedema and allergic reaction to flu vaccine (hypersensitivity) (unknown latency), hand tingling (paraesthesia) and generallized joint swelling (joint swelling) 1 day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. The patient was hospitalized for these events and the event angioedema was assessed as medically significant.  The details of laboratory data were not reported.  It was not reported that patient was discharged with a corrective treatment of steroid taper and was asked to be followed up with Hematology and rheumatology on an outpatient basis.  At the time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a 43-years-old female patient who had serum sickness type reaction, angioedema, hypersensitivity, paraesthesia and joint swelling after vaccination with FLUBLOK QIV. The time to onset is compatible with the role of the vaccine. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.