Received Jun 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | LA |
Injection site rash; Injection site redness; Injection site swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included gastric bypass (Gastric Bypass 20 years ago) and breast cancer (history of Breast cancer). Concomitant products included anastrozole, folic acid, escitalopram oxalate (Lexapro), ubidecarenone (Co Q-10), vitamin c and vitamin b12. On 11-JUN-2025, the patient received Arexvy (left arm). On 12-JUN-2025, 1 days after receiving Arexvy, the patient experienced injection site rash (Verbatim: Injection site rash), injection site erythema (Verbatim: Injection site redness) and injection site swelling (Verbatim: Injection site swelling). The outcome of the injection site rash, injection site erythema and injection site swelling were not resolved. It was unknown if the reporter considered the injection site rash, injection site erythema and injection site swelling to be related to Arexvy. It was unknown if the company considered the injection site rash, injection site erythema and injection site swelling to be related to Arexvy. Additional Information: GSK receipt date: The reporter was the husband of the patient. The patient received Arexvy on Wednesday 11 June 2025 in the left arm. The next day, the patient noticed a rash, redness and swelling at the injection site. The reporter had very limited contact information for the HCP.
Medical History/Concurrent Conditions: Breast cancer (history of Breast cancer); Gastric bypass (Gastric Bypass 20 years ago)
Anastrozole; Folic acid; Lexapro; Co q-10; Vitamin C; Vitamin b12