Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Cerebrovascular accident, Coma
Clinical narrative: Stroke; Coma; This spontaneous case was received on 19-Nov-2021 from other non-healthcare professional (the patient's daughter) via The Regulatory Authority (reference number: SEQW21-05531) and concerned a 73-year-old, female patient.  The patient's concurrent conditions included allergy to statins, derivatives of penicillin, gabapentin, morphine, sulfa and lisinopril, allergy to red cabbage and high blood pressure which was maintained with medication. The patient's concomitant medications included multivitamin (vitamins NOS), D3 (colecalciferol), melatonin, Colace (docusate sodium), Miralax (macrogol 3350), atenolol, pantoprazole, Zoloft (sertraline hydrochloride), doxazosin, potassium chloride and Zetia (ezetimibe), all used for unreported indications. The patient's historical vaccines included Covid-19 vaccine (brand not specified) in February and March.  On 22-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 312836 and expiry date was 06-May-2022.  On 25-Oct-2021, three days after receiving Fluad Quadrivalent, the patient experienced stroke.  On an unknown date in 2021, the patient ended up with coma and was admitted to hospital for five days.  On an unknown date in 2021, the patient was discharged from the hospital.  The outcome of the events was not reported.  The reporter assessed the events as related to Fluad Quadrivalent. The reporter was inclined to the influenza vaccine as the reason for the stroke because it was the only uncommon thing the patient had got in the days before the stroke.  The events of stroke and coma were considered to be serious due to criteria of hospitalization and medical significance by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 73-year-old, female patient, experienced stroke, three days following vaccination with Fluad Quadrivalent. An unknown amount of time following vaccination, the patient ended up with coma as reported. Patient's concurrent condition included high blood pressure which may have contributed to the development of the events. More information regarding medical history and relevant diagnostic findings is needed. With the information currently available causality is unassessable.; Reporter's Comments: The reporter was inclined to the influenza vaccine as the reason for the stroke because it was the only uncommon thing the patient had got in the days before the stroke.; Sender's Comments: A 73-year-old, female patient, experienced stroke, three days following vaccination with Fluad Quadrivalent. An unknown amount of time following vaccination, the patient ended up with coma as reported. Patient's concurrent condition included high blood pressure which may have contributed to the development of the events. More information regarding medical history and relevant diagnostic findings is needed. With the information currently available causality is unassessable.