Age: 73.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Lymph nodes on right side are swollen; Headache; Injection site erythema /redness on whole upper right arm; Injection site induration; Injection site mass; Injection site swelling/swollen, hard bump; Injection site warmth/injection site hot to touch; This non-serious case was reported by a consumer via regulatory authority and described the occurrence of lymphadenopathy in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2FP37) for prophylaxis.   Co-suspect products included COVID-19 VACCINE PROT. SUBUNIT (NVX COV 2373) (NOVAVAX COVID-19 VACCINE) (batch number 6024MF016) for covid-19 immunization and INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) (batch number U8515CA) for prophylaxis.   On 25-OCT-2024, the patient received Arexvy (intramuscular), NOVAVAX COVID-19 VACCINE (intramuscular) and FLUZONE HIGH DOSE (intramuscular). On 25-OCT-2024, less than a day after receiving Arexvy, the patient experienced lymphadenopathy (Verbatim: Lymph nodes on right side are swollen), headache (Verbatim: Headache), injection site erythema (Verbatim: Injection site erythema /redness on whole upper right arm), injection site induration (Verbatim: Injection site induration), injection site mass (Verbatim: Injection site mass), injection site swelling (Verbatim: Injection site swelling/swollen, hard bump) and injection site warmth (Verbatim: Injection site warmth/injection site hot to touch). On 27-OCT-2024, the outcome of the headache was resolved (duration 2 days). The outcome of the lymphadenopathy, injection site erythema, injection site induration, injection site mass, injection site swelling and injection site warmth were not resolved.   It was unknown if the reporter considered the lymphadenopathy, headache, injection site erythema, injection site induration, injection site mass, injection site swelling and injection site warmth to be related to Arexvy.     It was unknown if the company considered the lymphadenopathy, headache, injection site erythema, injection site induration, injection site mass, injection site swelling and injection site warmth to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-DEC-2024 A 73 year old female patient received Arexvy vaccine, Fluzone high dose vaccine and Novavax Covid-19 Vaccine and experienced headache, injection site erythema, injection site induration, injection site mass, injection site swelling, injection site warmth, lymphadenopathy and mammogram abnormal. The patient reported redness on whole upper right arm, swollen, hard bump, injection site was also hot to touch, and headache for 2 days. The patient stated the symptoms were improving such as injection site was not as red but blotchy, still present bump but not as hard, injection site was not as hot but still warm and no headache.  The patient had a routine mammogram and was informed about lymph nodes on right side were swollen. The reporter considered the adverse events to be possibly related to Novavax Covid-19 Vaccine. It was unknown if the reporter considered the adverse events to be related to Fluzone high dose vaccine. No concomitants were used/reported. This report was one of several cases received as part of a line-listing, each containing minimal information. No further information was expected.