Sex: F
Vaccine: FLUR4
Symptoms: Bradycardia, Exposure during pregnancy, Headache, Hypertension, Neuropathy peripheral
Clinical narrative: Initial information was received on 13-Mar-2021 regarding an unsolicited valid serious case from other healthcare professional.   A literature article:  This case is linked to cases 2021SA091226, 2021SA091252, 2021SA091271, 2021SA091286, 2021SA091303, 2021SA091334, 2021SA091349, 2021SA091366, 2021SA091398, 2021SA091448, 2021SA091468, 2021SA091489, 2021SA091516, 2021SA091556, 2021SA091604, 2021SA091690, 2021SA091745, 2021SA091782, 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. 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. Post marketing safety surveillance will continue to be vital for understanding the benefits and risks of quadrivalent recombinant influenza vaccine. This case involves a female patient (age not reported) who had swelling neuropathy, bradycardia, hypertension and headache, while she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and she was pregnant (vaccine exposure during pregnancy) at the time of vaccination. The date of last menstrual period was not reported. The estimated due date was not reported. 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 swelling neuropathy (neuropathy peripheral, bradycardia, hypertension and headache (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. The patient was hospitalized for these events. Events swelling neuropathy (neuropathy peripheral) and bradycardia were assessed as medically significant. The details of laboratory data were not reported. It was not reported if the patient received a corrective treatment. It was a case of vaccine exposure during pregnancy. Pregnancy outcome was unknown at the time of report. At the time of reporting, the outcome was unknown for all the events. Sender's Comments: This case concerns a female patient (age not reported) who had neuropathy peripheral, bradycardia, hypertension and headache after vaccination with FLUBLOK QIV and she was pregnant at the time of vaccination. 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 predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.