Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Pain at injection site; Swollen at injection site; Solid red patch on arm /Skin red; Itching red patches; Joint pain; Muscle pain/muscle aches in her back and legs; Fatigue; Area hot to touch; painful upper arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included diabetes.   On 29-SEP-2023, the patient received Arexvy (intramuscular, left arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain at injection site), injection site swelling (Verbatim: Swollen at injection site), erythema (Verbatim: Solid red patch on arm /Skin red), pruritus (Verbatim: Itching red patches), joint pain (Verbatim: Joint pain), muscle pain (Verbatim: Muscle pain/muscle aches in her back and legs), fatigue (Verbatim: Fatigue), feeling hot (Verbatim: Area hot to touch) and pain in arm (Verbatim: painful upper arm).The outcome of the injection site pain, injection site swelling, erythema and pruritus were not resolved and the outcome of the joint pain, muscle pain, fatigue and feeling hot were unknown and the outcome of the pain in arm was resolving.   It was unknown if the reporter considered the injection site pain, injection site swelling, erythema, pruritus, joint pain, muscle pain, fatigue, feeling hot and pain in arm to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site swelling, erythema, pruritus, joint pain, muscle pain, fatigue, feeling hot and pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 04-OCT-2023 The reporter was the patient.  The Lot and expiration date were not available but patient provided the NDC number for the vaccine. The patient reported that she was administered the Arexvy vaccine on Friday at a local pharmacy. The patient reported that she was a diabetic and took medications for this.  She had taken many vaccines in the past 5 years and had mild common reactions but not as with the Arexvy vaccine.  The patient reported that the vaccine was injected in the left arm.  The patient reported that one (1) inch below the injection site it there were red patches that had been expanding and growing from ½ a dollar size and now was to a huge red 3X4 inches patch that it itching. The patient reported that feeling very fatigue, muscle aches in her back and legs and joint pain.  The patient reported that swelling at the injection site, painful injection site and hot to touch and solid red patch on the arm that had expanded and she had pain in the upper arm.  The patient reported that she took pictures and shared with her health care provider (HCP). The patient reported that at the time of reporting it was still red, itches, and sore and swollen but the pain was diminishing.  It had not been resolved. The reporter consented to follow up.