Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Flushing, Headache, Loss of consciousness, Malaise
Clinical narrative: head felt flushed; back pain; trouble breathing; seeing black spots; headache; weakness; fatigue; temperature of 100.6; Initial information received on 10-Oct-2022 (with live follow-up processed together) regarding an unsolicited valid serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 80 years old female patient who reported head felt flushed, back pain, trouble breathing, seeing black spots, headache, weakness, fatigue and temperature of 100.6 while receiving vaccine influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Contrast media allergy, Lung cancer, Heart disorder and Macular degeneration.  Concomitant medications included paracetamol (Tylenol) for Headache and Body temperature abnormal; and aflibercept (Eylea) for Macular degeneration.  On 07-Oct-2022, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine (with an unknown dosage, formulation, route, expiry date, batch number) in unknown administration site for Immunization.  Caller reporting she received Fluzone high dose quadrivalent last Friday, on 07-Oct-2022. Caller reporting within 2 or 3 minutes she experienced a reaction and the paramedics came and transported her to the emergency room where she was kept overnight. Caller reporting symptoms including seeing black spots (loss of consciousness), head felt flushed (flushing), had trouble breathing (dyspnoea), back pain. Patient reporting while in the emergency room her treatment included fluids and bloodwork. She is currently experiencing weakness (asthenia), fatigue, headache, and temperature of 100.6 (body temperature abnormal). Currently she is taking Tylenol. The patient was hospitalized on the same day. The patient was discharged on 08-Oct-2022 (hospitalization during 1 days).  Caller again called back and stated that she also has Macular Degeneration and receives eye injections for her eye called Eylea. Patient was supposed to receive an injection tomorrow. However, the patient still doesn't feel well and is exhausted. She cancelled the appointment and is rescheduled for 21-OCT-2022.  Relevant laboratory test results included: Body temperature - On an unknown date: [100.6]  Action taken - not applicable.  A corrective treatment with fluids and bloodwork was received for the events. Currently she is taking Tylenol.  Outcome -Unknown; Sender's Comments: Sanofi company comment dated 16-OCT-2022: This case involves a 80 years old female patient who reported head felt flushed, back pain, trouble breathing, seeing black spots, headache, weakness, fatigue and temperature of 100.6 while receiving vaccine influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent]. Although the role of suspect cannot be denied for the events, however lack of information regarding details surrounding the events, clinical course precludes the comprehensive assessment of this case. Furthermore, medical history of patient is also a confounding factor.