Sex: F
Vaccine: FLUR4
Symptoms: Blindness unilateral, Blood alkaline phosphatase increased, Blood glucose increased, Headache, Lymphocyte count
Clinical narrative: Optic papillitis; 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, 2021SA091271, 2021SA091286, 2021SA091303, 2021SA091334, 2021SA091349, 2021SA091366, 2021SA091398, 2021SA091468, 2021SA091489, 2021SA091516, 2021SA091556, 2021SA091604, 2021SA091690, 2021SA091745, 2021SA091782, 2021SA091798, 2021SA091833, 2021SA091855 and 2021SA091879 (same 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-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 27 years old female patient who experienced optic papillitis (optic neuritis), after she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient ongoing medical history included ocular migraine (retinal migraine), Polycystic ovarian syndrome (Polycystic ovaries), paroxysmal supraventricular tachycardia and active tobacco user (one-half pack of cigarettes per day).  Medical treatment, vaccination, concomitant medication 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 a serious optic papillitis (optic neuritis), five days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  It was also reported that there was no evidence of a tumor or demyelination. The physician planned to follow her as an outpatient and to evaluate her for neuromyelitis optica and multiple sclerosis.  Details of laboratory data not reported.   Corrective treatment: corticosteroid.  At the time of reporting, the patient was recovering from the optic neuritis (also reported that her symptoms improved).  Conclusion: Vaccination remains the single best defense against influenza and its complications. Post marketing safety surveillance will continue to be vital for understanding the benefits and risks of Quadrivalent recombinant influenza vaccine.; Sender's Comments: This case involves a 27 years old female patient who had optic neuritis, after receiving FLUBLOK QIV. The time to onset compatible. Medical history included Retinal migraine, Polycystic ovaries, Supraventricular tachycardia and Tobacco user. Additional information regarding patient's 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.