Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Fatigue, Nervousness, Nocturia, Pain
Clinical narrative: she can't raise her arm up and she can't shampoo her hair; midnight and every hour on the hour she had to get up to go to the bathroom:; scared; joint pain and two or three inches from where the vaccine was given; uncomfortable; radiating shooting pain in right shoulder; right shoulder was completely swollen and the skin was swollen; very tired; Initial information was regarding an unsolicited valid non serious case was received from a consumer/non-healthcare professional via Medical Information (Reference number- 00781262) and transmitted to Sanofi on 22-Sep-2021.  This case involves a 79- year-old female patient who experienced uncomfortable (discomfort), midnight and every hour on the hour she had to get up to go to the bathroom (nocturia), scared (nervousness), joint pain and two or three inches from where the vaccine was given (vaccination site joint pain), she can't raise her arm up and she can't shampoo her hair (vaccination site movement impairment), radiating shooting pain in right shoulder (pain), right shoulder was completely swollen and the skin was swollen (vaccination site swelling) and very tired (fatigue), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing Degenerative arthritis peripheral joint.  On 21-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route in the right deltoid for prophylactic vaccination.  On 21-Sep-2021, the patient developed non-serious uncomfortable (discomfort), scared (nervousness), joint pain and two or three inches from where the vaccine was given (vaccination site joint pain), radiating shooting pain in right shoulder (pain), right shoulder was completely swollen, the skin was swollen (vaccination site swelling) and very tired (fatigue) (on the same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date, the patient developed non-serious midnight and every hour on the hour she had to get up to go to the bathroom (nocturia) and she can't raise her arm up and she can't shampoo her hair (vaccination site movement impairment) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  It was reported She is reporting potential AE (adverse event) information and she would like to know if what she is reporting as been reported with Fluzone High-Dose Quadrivalent. she is reporting adverse reactions to a flu vaccine administered to her on 21-Sep-2021, a potential adverse event that happened and has made her very uncomfortable for almost 24 hours. she received the vaccine at 3:30 pm in her right deltoid area and within 30 minutes she had a radiating shooting pain in her right shoulder and it really scared her. Her right shoulder was completely swollen and the skin was swollen and it was painful and she couldn't move her arm toward the medial or center of her body. She states that it is "so serious" and "really terrible" and she is in "excruciating pain" and she can't move it. She states that it is a joint pain and two or three inches from where the vaccine was given. She states that she does have a little degenerative arthritis. Vaccine increases the cytokine activity and there is a foreign protein in the flu shot. She states that she can't raise her arm up and she can't shampoo her hair. About midnight and every hour on the hour she had to get up to go to the bathroom.  At time of reporting, the outcome was Unknown for the events.  There will be no information available on the batch number for this case.