Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Joint swelling, Pruritus, Urticaria, Vaccination site discolouration, Vaccination site swelling
Clinical narrative: the site where the vaccine was given is swollen; site where the vaccine was given is swollen and discolored/describe a purple mark 2 to 3 inches long; That night, when she was getting undressed, she began to feel itchy; took off her clothes, she was covered in hives horrible hives on the front and back of her arms and legs; worried because her ankles were also swollen; Initial information was received on 08-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (Medical Information (GMI) Inquiry Number 00759870).  This case involves a 84 years old female patient who experienced non serious events that night, when she was getting undressed, she began to feel itchy(pruritus), took off her clothes, she was covered in hives horrible hives on the front and back of her arms and legs(urticaria), worried because her ankles were also swollen(Joint swelling), the site where the vaccine was given is swollen  (Vaccination site swelling) and discolored/describe a purple mark 2 to 3 inches long (vaccination site discoloration) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  On 05-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number and expiry date not provided via unknown route in unknown administration site for prophylactic vaccination.  On 05-Sep-2021 the patient developed non-serious events that night, when she was getting undressed, she began to feel itchy (pruritus), took off her clothes, she was covered in hives horrible hives on the front and back of her arms and legs (urticaria), worried because her ankles were also swollen (joint swelling) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 06-Sep-2021 the patient developed non-serious events the site where the vaccine was given is swollen (vaccination site swelling) and discolored/describe a purple mark 2 to 3 inches long (vaccination site discolouration) one day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "Patient had FLUZONE HIGH DOSE vaccine on Sunday. She had a reaction for the first time with the vaccine, even though she gets it yearly. Had vaccine at 11am and that evening had onset of side effects including itching. Patient was trying to go to her doctor today in hopes of getting prednisone or something. Wanted to know more about what was in it that could make her have this reaction. She also wanted to report this adverse event. She did not notice anything wrong for the rest of the day. She stated that she shopped, then sat on a chair and watched the gardener because she doesn't get around that well. She did not have trouble breathing. She self-medicated with four benadryll and went to sleep. They also stated that the area is swollen "like a huge cyst" daughter stated that the swollen area is the size of a baseball. Daughter stateed that she looks as if she was beaten."  No lab data was provided.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome of events was reported as unknown.  Dosage interval - once.