Sex: U
Vaccine: FLUC3
Symptoms: Aphasia, Arthralgia, Derealisation, Diarrhoea, Dizziness
Clinical narrative: Anaphylactic reaction; Shortness of breath; Dizziness; Tachycardia; Palpitations; Abdominal pain; Nausea; Diarrhea; Pruritus; Vertigo; Dry heaving; Weird feeling; This spontaneous case was received on 15-Dec-2022 from other healthcare professional (reference number: 2022BHV003212) and concerned a patient of unreported age and gender.   The patient's medical history and concomitant medications were not reported. The patient's historical drug included Aimovig (erenumab aooe) taken between 15-Jun-2018 and 13-Jul-2018, after which the patient experienced shortness of breath, dizziness, vertigo, pre-syncope, impending doom/derealization, paraesthesia, aphasia, fatigue, migraine, tachycardia, palpitations, nausea, dry heaving, vomiting, diarrhea, angioedema, pruritus, flushing, hives, and arthralgia. The patient had anaphylaxis to many chemicals, mostly ethoxylated chemicals (including polysorbate 60), the higher the molecular weight, the larger the risk of anaphylaxis, as reported.  On 27-Oct-2018, the patient was vaccinated with Flucelvax Quadrivalent (reported as ' Flucelvax Quad') (influenza vaccine inact sag 4v; dose, route of administration, anatomical location, and indication: not reported). The batch number reported was 252674 and expiry date was 30-Jun-2019.   On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced possible anaphylactic reaction, shortness of breath, dizziness, vertigo, weird feeling, tachycardia, palpitations, nausea, dry heaving, diarrhea, abdominal pain and pruritus.   As reported, the patient has anaphylaxis to many chemicals, mostly ethoxylated chemicals.   The outcome of all events was not reported.   The reporter did not provide causality assessment.  The events of anaphylactic reaction, shortness of breath, dizziness, tachycardia, palpitations, nausea, diarrhea, abdominal pain and pruritus were considered to be medically significant by Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A patient of unreported age and gender was vaccinated with Flucelvax Quadrivalent. An unknown amount of time after vaccination, the patient experienced anaphylactic reaction, shortness of breath, dizziness, vertigo, weird feeling, tachycardia, palpitations, nausea, dry heaving, diarrhea, abdominal pain and pruritus. The patient's medical history and concomitant medications were not reported. The patient's historical drug included Aimovig, after which the patient experienced shortness of breath, dizziness, vertigo, pre-syncope, impending doom/derealization, paraesthesia, aphasia, fatigue, migraine, tachycardia, palpitations, nausea, dry heaving, vomiting, diarrhea, angioedema, pruritus, flushing, hives, and arthralgia. As reported, the patient has anaphylaxis to many chemicals, mostly ethoxylated chemicals. Information regarding relevant laboratory findings and diagnostic data was not provided.  Causal role of the suspect vaccine is unassessable for the events anaphylactic reaction, dyspnoea, dizziness, vertigo, feeling abnormal, tachycardia, palpitations, nausea, retching, diarrhea, abdominal pain and pruritus, due to lack of information provided and unclear chronology.; Sender's Comments: A patient of unreported age and gender was vaccinated with Flucelvax Quadrivalent. An unknown amount of time after vaccination, the patient experienced anaphylactic reaction, shortness of breath, dizziness, vertigo, weird feeling, tachycardia, palpitations, nausea, dry heaving, diarrhea, abdominal pain and pruritus. The patient's medical history and concomitant medications were not reported. The patient's historical drug included Aimovig, after which the patient experienced shortness of breath, dizziness, vertigo, pre-syncope, impending doom/derealization, paraesthesia, aphasia, fatigue, migraine, tachycardia, palpitations, nausea, dry heaving, vomiting, diarrhea, angioedema, pruritus, flushing, hives, and arthralgia. As reported, the patient has anaphylaxis to many chemicals, mostly ethoxylated chemicals. Information regarding relevant laboratory findings and diagnostic data was not provided.  Causal role of the suspect vaccine is unassessable for the events anaphylactic reaction, dyspnoea, dizziness, vertigo, feeling abnormal, tachycardia, palpitations, nausea, retching, diarrhea, abdominal pain and pruritus, due to lack of information provided and unclear chronology.