Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Chest discomfort, Syncope
Clinical narrative: Syncope; Anaphylaxis; This literature case was received on 08-Aug-2022 and concerned a female patient of unspecified age. At the time of initial report, the patient was a 62-year-old.  This case report investigated if patients who are considered high risk for hypersensitivity reactions to coronavirus disease vaccines may still receive vaccination under a graded-dose protocol.  The patient's past medical history included rhinitis, asthma, pituitary tumor and numerous serious allergic reactions to over 40 medications with symptoms ranging from hives, lip angioedema and lightheadedness to sensations of impending doom, presyncope and dyspnea. It was not specified which of the previous conditions occurred prior to influenza vaccine administration. The patient's concomitant medications were not reported.    On an unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location and indication: not reported) The batch number was not reported.   Reportedly, her first influenza vaccine caused anaphylaxis with syncope requiring epinephrine injection.  The outcome of events was not reported.   On an unspecified date, the patient presented to the outpatient Allergy clinic to address concerns regarding receiving vaccination against SARS-CoV-2. After deliberating about options, the patient decided to pursue vaccination in a graded-dose fashion with Johnson & Johnson's vaccine. The patient was administered five step graded challenge which she tolerated with some mild chest tightness which was successfully treated with a short-acting beta-agonist.  Updated guidelines now suggest that instead of deferring the second dose if the first dose caused allergic symptoms, Allergy consultation should be pursued, and the second dose administered through a graded dosing protocol under observation. The advantages of this protocol over a full vaccination challenge include early detection for anaphylaxis in high-risk individuals as well as improved patient satisfaction.  The reporter assessed the events of anaphylaxis and syncope as related to influenza vaccine, as it caused the events.   The events of 'anaphylaxis' and 'syncope' were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.   Company comment: This case report investigated if patients who are considered high risk for hypersensitivity reactions to coronavirus disease vaccines may still receive vaccination under a graded-dose protocol. A 62-year-old patient experienced anaphylaxis and syncope after receiving the suspect product influenza vaccine. The patient's past medical history included numerous serious allergic reactions to over 40 medications with symptoms ranging from hives, lip angioedema and lightheadedness to sensations of impending doom, presyncope and dyspnea. Based on the information provided, causality of the suspect vaccine is assessed as possibly related. Brighton collaboration criteria for anaphylaxis could not be assessed due to insufficient information provided.; Reporter's Comments: The reporter assessed the events of anaphylaxis and syncope as related to influenza vaccine, as it caused the events.; Sender's Comments: This case report investigated if patients who are considered high risk for hypersensitivity reactions to coronavirus disease vaccines may still receive vaccination under a graded-dose protocol. A 62-year-old patient experienced anaphylaxis and syncope after receiving the suspect product influenza vaccine. The patient's past medical history included numerous serious allergic reactions to over 40 medications with symptoms ranging from hives, lip angioedema and lightheadedness to sensations of impending doom, presyncope and dyspnea. Based on the information provided, causality of the suspect vaccine is assessed as possibly related. Agency criteria for anaphylaxis could not be assessed due to insufficient information provided.