Age: 63.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Bacterial infection, Headache, Injection site infection, Malaise, Pain
Clinical narrative: infection from the patient's arm/bacterial infection at injection site; Dead tissue; Black spot on arm; wound; headache; malaise; Product Complaint; Arm soreness; hurt to lift it up; This serious case was reported by a pharmacist via call center representative and described the occurrence of injection site infection in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5S27E, expiry date 06-JUL-2025) for prophylaxis. This case was associated with a product complaint.   On 10-JAN-2024, the patient received Arexvy (intramuscular, right deltoid). On 10-JAN-2024, less than a day after receiving Arexvy, the patient experienced pain in arm (Verbatim: Arm soreness) (serious criteria clinically significant/intervention required). In JAN-2024, the patient experienced mobility decreased (Verbatim: hurt to lift it up) (serious criteria clinically significant/intervention required). On an unknown date, the patient experienced injection site infection (Verbatim: infection from the patient's arm/bacterial infection at injection site) (serious criteria clinically significant/intervention required), necrosis (Verbatim: Dead tissue) (serious criteria GSK medically significant and clinically significant/intervention required), skin discoloration (Verbatim: Black spot on arm) (serious criteria clinically significant/intervention required), wound (Verbatim: wound) (serious criteria clinically significant/intervention required), headache (Verbatim: headache), malaise (Verbatim: malaise) and pharmaceutical product complaint (Verbatim: Product Complaint). The patient was treated with neomycin sulfate, polymyxin b sulfate (Antibiotic). The outcome of the injection site infection, necrosis, pain in arm, mobility decreased, skin discoloration, wound, headache and malaise were not resolved and the outcome of the pharmaceutical product complaint was unknown.   It was unknown if the reporter considered the injection site infection, necrosis, pain in arm, mobility decreased, skin discoloration, wound, headache and malaise to be related to Arexvy.   It was unknown if the company considered the injection site infection, necrosis, pain in arm, mobility decreased, skin discoloration, wound, headache and malaise to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-FEB-2024 The reporter reported that patient was administered a dose of Arexvy in the right deltoid muscle.  The patient reported arm soreness that lasted for a couple days, then got better over the next couple days and then started getting worse.  The patient came back to the pharmacy on 19th January 2024, stating her arm was very sore and hurt to lift it up.  The reporter looked at arm, stated there was no redness.  The reporter advised patient to see her doctor.  The patient saw doctor on 22nd January 2024 and was prescribed a round of antibiotics.  The reporter stated that patient came back to pharmacy again on 1st February 2024 complaining of a black spot on her arm.  The patient went back to her doctor on 2nd February 2024, who told her the black spot was dead tissue. The patient was given another round of antibiotics and was referred to a dermatologist.  A procedure with the dermatologist was planned for next Wednesday to go in and clean out infection from the patient's arm. The patient had a bacterial infection at injection site. She had to be treated with antibiotics and had a scheduled appointment with healthcare professional to debride the wound. The reporter also stated that the patient had ongoing headache and malaise. The reporter had a bacterial infection at injection site.  She had to be treated with antibiotics and has a scheduled appointment with healthcare professional to debride the wound. The reporter did not want to use any of the remaining 8 doses (16 vials) left in that box of lot 5S27E. She asked for credit, pharmacy would return the remaining 8 doses and asked to send shipping label to pharmacy. The adverse event was determined to be related to PQC (Pharmaceutical product complaint). The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.