Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: injection site red ring; injection site pain; injection site warm to touch; injection iste coloration; Injection site raised; Injection site induration; Injection site bruise; This non-serious case was reported by a consumer and described the occurrence of injection site bruising in a 63-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2C9Y2) for prophylaxis.   The patient's past medical history included immunization reaction. Previously administered products included Covid 19 vaccine.   On 04-JUN-2024, the patient received Arexvy (intramuscular, left deltoid). In JUN-2024, less than 2 weeks after receiving Arexvy, the patient experienced injection site bruising (Verbatim: Injection site bruise), injection site pain (Verbatim: injection site pain), injection site warmth (Verbatim: injection site warm to touch), injection site coloration (Verbatim: injection iste coloration), injection site swelling (Verbatim: Injection site raised) and injection site induration (Verbatim: Injection site induration). On 18-JUN-2024, the patient experienced injection site erythema (Verbatim: injection site red ring). The outcome of the injection site bruising, injection site erythema, injection site pain, injection site warmth, injection site coloration, injection site swelling and injection site induration were not resolved.   It was unknown if the reporter considered the injection site bruising, injection site erythema, injection site pain, injection site warmth, injection site coloration, injection site swelling and injection site induration to be related to Arexvy.     It was unknown if the company considered the injection site bruising, injection site erythema, injection site pain, injection site warmth, injection site coloration, injection site swelling and injection site induration to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-JUN-2024 The patient called for concern about left upper arm rash and said that she got the RSV shot about three weeks ago and about a week ago the injection site started to bruise and form and red ring around the injection site. She also stated that the injection site is warm to touch and very painful. She was wanting to schedule an appointment. According to medical documentation the patient received Arexvy on 4th June 2024 at a local pharmacy. She told that about 1 week after the injection she developed soreness in her upper arm. She then started to notice a coloration that looks like a bruise. Then on the 18th she developed a red ring around the area and reported that the arm was tender at this  location and feels slightly hot. She denied other injury, bite. Recalled having some type of pediatric reaction to an immunization but does not recall which vaccine or what the reaction was. She had received Covid vaccines without difficulty. She did not contact her pharmacy or the vaccine company yet regarding this reaction. She denied fever, chills, malaise, numbness or tingling, swelling within the armpit or localized lymph node involvement. Patient was advised to apply cold compress to the affected area and closely monitor for any progressive symptoms, She was advised to contact both the pharmacy and manufacturer to relay information.  Patient signed medical release of information to submit the Arvexy vaccine reaction to GlaxoSmithKline.