Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Malaise, Pyrexia
Clinical narrative: She is very upset she took this vaccine; Malaise; Fatigue; Fever; Rapid heart rate/racing heart; Irregular blood pressure; Facial flushing; Confusion; This spontaneous case was received on 04-Feb-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-00405) and concerned a 70-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 01-Oct-2020, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279735 and expiry date was 04-May-2021.  On an unspecified date in Oct-2020, reported as that night, after receiving Fluad (TIV), the patient had an adverse reaction: she experienced facial flushing, irregular blood pressure, rapid heart rate, malaise, fatigue, confusion and fever.   On an unspecified date in Oct-2020, after a week, the patient recovered from fever.   On an unspecified date, the patient saw a dermatologist for the flushing. The patient was very upset she took this vaccine.   At the time of initial reporting on 04-Feb-2021, the patient did not recover from the events of 'heart rate increased', 'blood pressure abnormal', malaise, fatigue, confusion, facial flushing and 'emotional distress'. She still had irregular blood pressure and racing heart and was seeing a cardiologist. The patient was having the two weeks heart monitor.  The reporter considered the events as related to Fluad (TIV). The reporter stated she had an adverse reaction and was told this had happened with the senior flu vaccine and the blood pressure and heart had been affect by this.  Company Comment: A 70-year-old, female patient developed heart rate increased, blood pressure abnormal, flushing, confusional state, emotional distress, malaise, fatigue and pyrexia after vaccination with the suspect product, Fluad (TIV). Chronology needs more clarification. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Advanced age confounds causality. Based on plausible time relationship, causality for all events is assessed as possibly related. The provided information is not sufficient to assess Brighton Collaboration criteria for anaphylaxis.; Reporter's Comments: The reporter stated she had an adverse reaction and was told this had happened with the senior flu vaccine and the blood pressure and heart had been affect by this.; Sender's Comments: A 70-year-old, female patient developed heart rate increased, blood pressure abnormal, flushing, confusional state, emotional distress, malaise, fatigue and pyrexia after vaccination with the suspect product, Fluad (TIV). Chronology needs more clarification. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Advanced age confounds causality. Based on plausible time relationship, causality for all events is assessed as possibly related. The provided information is not sufficient to assess Brighton Collaboration criteria for anaphylaxis.