Age: 73.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: INJECTION SITE MASS; INJECTION SITE WARMTH; HEADACHE; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE SWELLING; LYMPHADENOPATHY; Initial information received on 20-Dec-2024 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-hcp (health care professional).  This case involves a 73 years old female patient who experienced headache, injection site erythema, injection site induration, injection site mass, injection site swelling, injection site warmth and lymphadenopathy after receiving RSV vaccine prot. subunit PreF3 (Arexvy) and COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) and Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Oct-2024, the patient received a unknown dose of suspect Arexvy not produced by Sanofi Pasteur (lot 2FP37) via intramuscular route in unknown administration site as prophylactic vaccination; On the same day, the patient received a unknown dose of suspect Novavax COVID-19 Vaccine not produced by Sanofi Pasteur (lot 6024MF016) via intramuscular route in unknown administration site as prophylactic vaccination; On the same day, the patient received a unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot U8515CA) (strength and expiry date: unknown) via intramuscular route in unknown administration site as immunization.  On 25-OCT-2024 the patient developed headache, injection site erythema (vaccination site erythema), injection site induration (vaccination site induration), injection site mass (vaccination site mass), injection site swelling (vaccination site swelling), injection site warmth (vaccination site warmth) and lymphadenopathy (latency: same day)   Relevant laboratory test results included: Mammogram - On an unknown date:  [Lymph nodes on right side are swollen]  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all events.  Sender's Comment: This 73-year-old Female experienced Headache, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth, Lymphadenopathy and Mammogram abnormal after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Headache, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth, Lymphadenopathy and Mammogram abnormal were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and the events Headache, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth, Lymphadenopathy and Mammogram abnormal was considered Possible.