Age: 85.0
Sex: F
Vaccine: PNC20, RSV, PNC, RSV
Symptoms: Arthralgia, Injection site pruritus, Injection site swelling, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: swelling behind the left calf; petechiae on left calf/petechiae about the size of a handprint on her left calf; joints started hurting mostly in the bilateral knees; swelling behind the left calf and petechiae about the size of a handprint on her left calf; weight bearing on either leg; itching at the injection site; itching at the injection site also swelling; stiffness and as the day went by the stiffness became worse; Hard to move; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 85-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2C9y2, expiry date 21-AUG-2025) for prophylaxis.   Co-suspect products included Pneumococcal vaccine conj 7v (CRM197) (Prevenar) for prophylaxis.   On 24-OCT-2024, the patient received Arexvy (intramuscular, left deltoid) and Prevenar. On 28-OCT-2024, 4 days after receiving Arexvy, the patient experienced stiffness (Verbatim: stiffness and as the day went by the stiffness became worse) and mobility decreased (Verbatim: Hard to move). On 29-OCT-2024, the patient experienced injection site itching (Verbatim: itching at the injection site) and injection site swelling (Verbatim: itching at the injection site also swelling). On 30-OCT-2024, the patient experienced joint pain (Verbatim: joints started hurting mostly in the bilateral knees), swelling of knees (Verbatim: swelling behind the left calf and petechiae about the size of a handprint on her left calf) and weight bearing difficulty (Verbatim: weight bearing on either leg). On 31-OCT-2024, the patient experienced calf swelling (Verbatim: swelling behind the left calf) and petechia (Verbatim: petechiae on left calf/petechiae about the size of a handprint on her left calf). On 04-NOV-2024, the outcome of the injection site itching and injection site swelling were resolved (duration 6 days) and the outcome of the stiffness and mobility decreased were resolved (duration 7 days) and the outcome of the joint pain was resolved and the outcome of the swelling of knees and weight bearing difficulty were resolved (duration 5 days) and the outcome of the petechia was resolved (duration 4 days). The outcome of the calf swelling was not resolved.   It was unknown if the reporter considered the injection site itching, injection site swelling, stiffness, mobility decreased, joint pain, swelling of knees, weight bearing difficulty, calf swelling and petechia to be related to Arexvy.     It was unknown if the company considered the injection site itching, injection site swelling, stiffness, mobility decreased, joint pain, swelling of knees, weight bearing difficulty, calf swelling and petechia to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-NOV-2024 The patient reported she received Arexvy and also received Prevnar at the same time. The patient stated that everything went according to how it was supposed to go until she woke up Monday morning, (28-OCT-2024), woke up with stiffness and as the day went by the stiffness became worse and it was hard to move.  On Tuesday, (29-OCT-2024), the stiffness continued, however, there were more symptoms that appeared, itching at the injection site also swelling.  On Wednesday morning, (30-OCT-2024), joints started hurting mostly in the bilateral knees. The patient stated that she could not do much weight bearing on either leg due to swelling from the back of the knee on left side to the ankle on the left side. On Thursday, (31-OCT-2024), the patient noticed a lot more swelling behind the left calf and petechiae about the size of a handprint on her left calf.  On Friday, (01-NOV-2024), the patient was advised to go to the emergency room at her local hospital. Several tests were run but everything came up negative. The patient stated that at the time of reporting, the patient had recovered for almost all of her symptoms.  On the day of reporting, the patient was going to see her health care professional. It was unknown if the reporter considered the injection site itching, injection site swelling, stiffness, mobility decreased, joint pain, swelling of knees, weight bearing difficulty, calf swelling and petechia to be related to Prevnar.