Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection area was swelling; injection area was red/red streak going down from the injection site about 4 inches; iItching; sometimes hot; joint pain; achy/soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included diverticulitis, renal disease (had 3rd stage kidney disease in 2016), intestinal resection and peridiverticular abscess. Previously administered products included Proton Pump Inhibitors (for years), Shingrix with an associated reaction of pain (received 1st dose in July 2018 had hit her like a ton of bricks, refer case US2023AMR153165) and Shingrix with an associated reaction of pain (received 2nd dose (date not provided) had hit her like a ton of bricks, refer case US2023AMR149797). Concurrent medical conditions included hypothyroidism. Concomitant products included famotidine (Pepcid).   On 20-OCT-2023, the patient received Arexvy (left arm). In OCT-2023, an unknown time after receiving Arexvy, the patient experienced joint pain (Verbatim: joint pain) and pain (Verbatim: achy/soreness). On 23-OCT-2023, the patient experienced injection site swelling (Verbatim: Injection area was swelling), erythema (Verbatim: injection area was red/red streak going down from the injection site about 4 inches), pruritus (Verbatim: iItching) and feeling hot (Verbatim: sometimes hot). The outcome of the injection site swelling was unknown and the outcome of the erythema, pruritus, joint pain and pain were not resolved and the outcome of the feeling hot was resolved.   It was unknown if the reporter considered the injection site swelling, erythema, pruritus, feeling hot, joint pain and pain to be related to Arexvy.     It was unknown if the company considered the injection site swelling, erythema, pruritus, feeling hot, joint pain and pain to be related to Arexvy.   Linked case(s) involving the same patient:  US2023AMR149797, US2023AMR153165   Additional Information: GSK receipt date: 27-Oct-2023 The patient received the Arexvy vaccine and reported starting on Monday (23rd October 2023), she was itching really bad at the injection site and the injection area was red, swelling, sore, and sometimes hot (more when itching). The patient also reported that starting Wednesday 25th October 2023, she noticed a red streak going down from the injection site about 4 inches, that is hot. The red area started about the size of a dime or quarter and is now the size of a 50 cent piece on the day of reporting.  The patient reported that her arm was still sore, itchy and red. The patient also reported that she had joint pain and achy, but that was common for her and she cannot say it was worse since receiving Arexvy. The patient did not had any lot/expiry information with her. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2023AMR149797:Shingrix Dose 2 US-GSK-US2023AMR153165:Shingrix Dose 1