Age: 65.0
Sex: F
Vaccine: FLUA3, FLUA4
Symptoms: Feeling hot, Immediate post-injection reaction, Retching, Unresponsive to stimuli
Clinical narrative: Unresponsive; Looked to be having a partial seizure; Had fainted with her eyes partially opened/come back to consciousness; Acted as if she was going to vomit, but only produced dry heaves; Feeling hot; This spontaneous case was retrieved on 04-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1685813-1), reported by other health professional and concerned a 65-year-old, female patient.  The patient's medical history included vasovagal fainting more than five years prior. The patient had no known allergies. The patient's concomitant medications were unknown.  On 09-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: reported as 'one', route of administration: intramuscular, anatomical location: right arm and indication: not reported). The batch number reported was 312842.  On the same day, immediately after receiving Fluad Quadrivalent, the patient started feeling hot and became unresponsive. The patient was still breathing, however, she looked to be having a partial seizure or had fainted with her eyes partially opened. 911 was contacted and just prior to the Emergency Management Service (EMS) arrival, the patient started to come back to consciousness and acted as if she was going to vomit, but only produced dry heaves. EMS arrived on the scene within several minutes and took the patient to the hospital. No laboratory analyses were performed.  On the same day, the patient recovered from the event of 'faint'.  The outcome of the events of 'unresponsive to stimuli', partial seizures, dry heaves and feeling hot was unknown.  The reporter did not provide a causality assessment.  The events of 'faint', 'unresponsive to stimuli' and partial seizures were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 65-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent. Immediately after vaccination the patient started feeling hot and became unresponsive. As reported the patient looked like she would have a partial seizure or had fainted. After she regained consciousness she was retching. The patient's medical history was significant for vasovagal fainting more than five years prior. The Information regarding the related diagnostic findings has not been provided. Limited information precludes causality assessment for the event partial seizure. Based on provided information causality for the remaining events is assessed as possibly related.; Sender's Comments: A 65-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent. Immediately after vaccination the patient started feeling hot and became unresponsive. As reported the patient looked like she would have a partial seizure or had fainted. After she regained consciousness she was retching. The patient's medical history was significant for vasovagal fainting more than five years prior. The Information regarding the related diagnostic findings has not been provided. Limited information precludes causality assessment for the event partial seizure. Based on provided information causality for the remaining events is assessed as possibly related.