Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Pain in extremity, Pyrexia, Stomatitis
Clinical narrative: cold; freezing; real bad headche; Morning woke up with blister on lip and in mouth; Morning woke up with blister on lip and in mouth; Unable to eat or drink; Lip sore; sore in mouth; Weakness; chills; body pain/bodyache; arm pain; pain at injection site; fever; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included fibromyalgia (in 2008) and rheumatoid arthritis (in 2007). Concurrent medical conditions included wheezing, drowsiness and pain. Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix), Influenza vaccine (Fluzone), salbutamol sulfate (Albuterol Sulfate), alendronate sodium (Alendronate), clonazepam, cyclobenzaprine, ergocalciferol (Ergocalciferol D2), folic acid, gabapentin, hydrochlorothiazide, linaclotide (Linzess), metformin, methotrexate sodium, naloxone, pantoprazole (Pantoprazol), ropinirole, budesonide;formoterol fumarate (Symbicort), tramadol, sucralfate and tofacitinib citrate (Xeljanz). Family history included rheumatoid arthritis (patient's mother had a RA (Rheumatoid arthritis) and patient's father had Rheumatoid arthritis and patient's grandparent had a Rheumatoid arthritis and osteoarthritis (OA)) and osteoarthritis (patient's grandparent had a osteoarthritis).   On 22-JAN-2024, the patient received the 1st dose of Arexvy (intramuscular, unknown deltoid). On 22-JAN-2024 23:00, less than a day after receiving Arexvy and 20 days after receiving Boostrix, the patient experienced injection site pain (Verbatim: pain at injection site), fever (Verbatim: fever), weakness (Verbatim: Weakness), chills (Verbatim: chills), general body pain (Verbatim: body pain/bodyache) and pain in arm (Verbatim: arm pain). On an unknown date, the patient experienced cold (Verbatim: cold), feeling cold (Verbatim: freezing), headache (Verbatim: real bad headche), lip blister (Verbatim: Morning woke up with blister on lip and in mouth), blistering of mouth (Verbatim: Morning woke up with blister on lip and in mouth), unable to eat (Verbatim: Unable to eat or drink), lip soreness (Verbatim: Lip sore) and mouth ulcer (Verbatim: sore in mouth). The patient was treated with paracetamol (Tylenol). The outcome of the injection site pain was not resolved and the outcome of the fever was resolved (duration 3 days) and the outcome of the weakness, chills and general body pain were resolved and the outcome of the pain in arm was resolving and the outcome of the cold, feeling cold, headache, lip blister, blistering of mouth, unable to eat, lip soreness and mouth ulcer were not reported.   The reporter considered the injection site pain, fever, weakness, chills, general body pain and pain in arm to be possibly related to Arexvy. It was unknown if the reporter considered the cold, feeling cold, headache, lip blister, blistering of mouth, unable to eat, lip soreness and mouth ulcer to be related to Arexvy.     The company considered the injection site pain, fever, weakness, chills, general body pain and pain in arm to be possibly related to Arexvy. It was unknown if the company considered the cold, feeling cold, headache, lip blister, blistering of mouth, unable to eat, lip soreness and mouth ulcer to be related to Arexvy.   Additional Information: GSK receipt date: 24-FEB-2024 The reporter reported that the patient had received 1st dose of Arexvy vaccine. The reporter reported that he/she contacted for this report.  The reporter was not aware of the additional vaccine administered. The reporter reported that the patient was not visited to the hospital or emergency room visit. The reporter reported that the patient took immunosuppressant. The patient reported that she had a fever for 3 days and then weakness for 4 days along with the body pain after the injection. The reporter reported that patient took the flu and TDAP vaccine a few weeks earlier. The follow-up could not be possible as no contact details were available.