Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Fatigue, Feeling abnormal, Injection site pain, Injection site reaction
Clinical narrative: Injection site was constantly pulsing; Dizzy; Felt that her body was fighting a battle, or something very serious; Still feels pain at the injection site; Feeling tired; She thought that she was going to die; The back of her throat was ticklish; This spontaneous case received on 13-Nov-2020 from pharmacist via The Agency (reference number: SEQW20-05113) and concerned a 71-year-old female patient.  The patient's medical history was not reported. The patient was not taking any concomitant medications, not even Aspirin (as reported).  On 07-Mar-2020, 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 and anatomical location: not reported) for flu prophylaxis. The batch number was not reported, 2019-2020 season.  On 21-Mar-2020, exactly two weeks after receiving Fluad Quadrivalent, the patient said that the injection site was constantly pulsing, but it was not painful.  On an unknown date in 2020, unknown time after receiving Fluad Quadrivalent, the patient was feeling tired, dizzy and the back of her throat was ticklish. She felt that her body was fighting a battle, or something very serious. She thought that she was going to die. The patient also said that she still feels pain at the injection site. The patient also reported that it was sever reaction.  At the time of initial reporting on 13-Nov-2020, the patient had not recovered from the event 'vaccination site pain'.  The outcome of all other events was not reported.  The reporter did not provide a causality assessment.  The event of 'near death experience' was considered to be medically significant by a Physician within The Company's Risk Management Department.  Company comment: The patient experienced  vaccination site discomfort two weeks after administration of Fluad Quadrivalent while other reported events: near death experience, throat irritation, dizziness, feeling abnormal (reported as 'felt that her body was fighting a battle, or something very serious'), vaccination site pain and fatigue occurred on an unknown date. The patient was not taking any concomitant medications, not even Aspirin (as reported) while medical history was not reported. Causality is assessed as possibly related for vaccination site reactions (discomfort and pain) and unassessable for all other events. (unclarified chronology); Sender's Comments: The patient experienced  vaccination site discomfort two weeks after administration of Fluad Quadrivalent while other reported events: near death experience, throat irritation, dizziness, feeling abnormal (reported as 'felt that her body was fighting a battle, or something very serious'), vaccination site pain and fatigue occurred on an unknown date. The patient was not taking any concomitant medications, not even Aspirin (as reported) while medical history was not reported. Causality is assessed as possibly related for vaccination site reactions (discomfort and pain) and unassessable for all other events. (unclarified chronology)