Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Vertigo, Vomiting
Clinical narrative: Vertigo; Couldn't see; Couldn't walk; Low potassium; Dizziness; Vomiting; Diarrhea; This spontaneous case was received on 11-Jan-2024 from other non-healthcare professional (consumer) (reference number: SEQW24-00187) and concerned a 70-year-old, male patient.  The patient's concurrent conditions included hypertension. The patient's concomitant medications included amlodipine, losartan, vitamin B12, vitamin C, vitamin D3, and zinc, all used for unreported indication.  On 16-Dec-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization against influenza disease. The batch number reported was 371623 and expiry date was 30-Jun-2024.  On 23-Dec-2023, seven days after receiving Fluad Quadrivalent, the patient experienced bad reaction of vertigo with vomiting, diarrhea, dizziness, and he could not see and walk. The patient had to call 911. Ambulance took him to hospital where he stayed in emergency room for six hours. The patient took blood exams which were ok, as reported, except for low potassium. The patient was treated with diazepam for dizziness and with medication reported as 'Zolphem or something similar' for vomiting. The patient was prescribed meclizine upon discharge, but pharmacist told him not to take it and to continue with diazepam.  At the time of initial reporting, the patient had not recovered from the events of vertigo, 'vision decreased', 'unable to walk', dizziness, vomiting, and diarrhea.  The outcome of the event of potassium low was not reported.  The reporter did not provide a causality assessment. The patient stated that he was not sure if reactions were from the vaccine or an interaction with concomitant medications.   All events were considered to be serious due to seriousness criteria of medical significance.  Company comment: On 23-Dec-2023, seven days after receiving Fluad Quadrivalent, the patient experienced bad reaction of vertigo with vomiting, diarrhea, dizziness, and he could not see and walk. The patient had to call EMS. Ambulance took him to hospital where he stayed in emergency room for six hours. Blood exams was fine, except for low potassium. The patient's concurrent conditions included hypertension. The patient's concomitant medications included amlodipine, losartan. Based on unsuggestive temporal relationship with the vaccine, confounding factors such as patient's advanced age (70) and underlying medical history and concomitant medications, causality is assessed as not related for all events.; Sender's Comments: On 23-Dec-2023, seven days after receiving Fluad Quadrivalent, the patient experienced bad reaction of vertigo with vomiting, diarrhea, dizziness, and he could not see and walk. The patient had to call EMS. Ambulance took him to hospital where he stayed in emergency room for six hours. Blood exams was fine, except for low potassium. The patient's concurrent conditions included hypertension. The patient's concomitant medications included amlodipine, losartan. Based on unsuggestive temporal relationship with the vaccine, confounding factors such as patient's advanced age (70) and underlying medical history and concomitant medications, causality is assessed as not related for all events.