Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Malaise, Nonspecific reaction
Clinical narrative: macular degeneration; terrible reaction to fluzone qiv hd; doesn't feel well; exhausted; Initial information received on 10-Oct-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case is linked to case 2022SA418432.  This case involves a 80 years old female patient who experienced doesn't feel well, macular degeneration, exhausted and terrible reaction to fluzone qiv hd 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.  Concomitant medications included aflibercept (eylea) for Macular degeneration.  On an unknown date, the patient received a  dose of suspect influenza quadrival a-b high dose hv vaccine  lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious macular degeneration (unknown latency) following the administration of influenza quadrival a-b high dose hv vaccine. This event was assessed as medically significant.  On an unknown date the patient developed a non-serious doesn't feel well (malaise), exhausted (fatigue) and terrible reaction to fluzone qiv hd (nonspecific reaction) (unknown latency) following the administration of influenza quadrival a-b high dose hv vaccine.  It was reported "Patient had a terrible reaction to FLUZONE QIV HD and was sent to the hospital within 2 minutes of getting the flu vaccine. She previously reported this incident a few minutes ago to another agent and it was reported to PV. Caller 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 21OCT2022. Caller would like to know if it is okay to put EYLEA into her body at that time or if that time frame is too soon? Caller stated that she will never receive this vaccine again and is telling all of her friends to stay away. Agent recommended for patient to discuss her concerns with her HCP/retinal specialist to determine when it would be appropriate to administer EYLEA".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (doesn't feel well, macular degeneration, exhausted, terrible reaction to fluzone qiv hd).  At time of reporting, the outcome was Unknown for the events doesn't feel well, macular degeneration, exhausted and  event terrible reaction to fluzone qiv hd.; Sender's Comments: Sanofi company comment dated 17-Oct-2022: This case concerns a involves a 80 years old female patient who experienced doesn't feel well, macular degeneration, exhausted and terrible reaction to fluzone qiv hd while receiving vaccine influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  Based on information provided, the causal role of company suspect cannot excluded. Case will be re-evaluated post further update on information regarding underlying disease, risk precipitating factor, past medical history and patient lifestyle which will preclude a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.