Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: her cheeks became red; the patient felt itching in injection site and that at the site started to swell, noticed that 2 areas of redness and swelling the size of 50 cent pieces at injection site, they were hot and painful; the patient felt itching in injection site and that at the site started to swell, noticed that 2 areas of redness and swelling the size of 50 cent pieces at injection site, they were hot and painful; the patient felt itching in injection site and that at the site started to swell, noticed that 2 areas of redness and swelling the size of 50 cent pieces at injection site, they were hot and painful; the patient felt itching in injection site and that at the site started to swell, noticed that 2 areas of redness and swelling the size of 50 cent pieces at injection site, they were hot and painful; the patient felt itching in injection site and that at the site started to swell, noticed that 2 areas of redness and swelling the size of 50 cent pieces at injection site, they were hot and painful; the patient felt itching in injection site and that at the site started to swell, noticed that 2 areas of redness and swelling the size of 50 cent pieces at injection site, they were hot and painful; Initial information regarding this unsolicited valid non-serious case was received from other health professional on behalf of a patient and transmitted to Sanofi on 16-Oct-2020.  This case involved a 87 years old female patient for whom reported that her cheeks became red (Erythema) the patient felt itching in injection site (Injection site pruritus) and that at the site started to swell, noticed that 2 areas of redness and swelling the size of 50 cent pieces at injection site, they were hot and painful (Vaccination site inflammation associated with Vaccination site erythema, Vaccination site swelling, Vaccination site pain and Vaccination site warmth), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On 14-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ476AA, expiry date: 30-Jun-2021) via unknown route in the left deltoid for prophylactic vaccination.  On 14-Oct-2020, she felt itching in injection site (Injection site pruritus) and when she got home it was stated that at the site started to swell she noticed that 2 areas of redness (Vaccination site erythema) and swelling the size of 50 cent pieces at injection sight (Vaccination site swelling) immediately following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. They were hot (Vaccination site warmth) and painful (Vaccination site pain) and the inching continued all night her cheeks became red (Erythema) and lasted 2 days and subsided today. The area is still swollen and hot to touch and still painful today.  Final diagnosis was the patient felt itching in injection site and that at the site started to swell, noticed that 2 areas of redness and swelling the size of 50 cent pieces at injection site, they were hot and painful and her cheeks became red.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient had not recovered from the reported event/events.   At the time of reporting, the patient was recovering from the events, erythema and injection site pruritus and had not recovered from the other reported events.