Received Jun 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | RA |
Rash became cellulitis/Cellulitis near Arexvy injection site; This non-serious case was reported by a consumer and described the occurrence of injection site cellulitis in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included asthma. Concurrent medical conditions included egg allergy (egg white and egg yolk allergy), grass allergy, spice allergy, allergy to plants (Mold and Ragweed) and drug allergy (Allergic to ampicillin, erythromycin, Avelox, Lincocin, Seconal, atropine, fillers used in Doxycycline tablets, NSAIDS). On 07-JUN-2025, the patient received Arexvy (right deltoid). On 08-JUN-2025, 1 days after receiving Arexvy, the patient experienced injection site cellulitis (Verbatim: Rash became cellulitis/Cellulitis near Arexvy injection site). The patient was treated with doxycycline (Doxycycline Monohydrate). The outcome of the injection site cellulitis was not resolved. It was unknown if the reporter considered the injection site cellulitis to be related to Arexvy. It was unknown if the company considered the injection site cellulitis to be related to Arexvy. Additional Information: GSK Receipt Date: 15-JUN-2025 This report was submitted via the online direct entry reporting system. The patient had vaccine, and rash became cellulitis and cellulitis occurred near Arexvy injection site.
Medical History/Concurrent Conditions: Allergy to plants (Mold and Ragweed); Asthma; Drug allergy (Allergic to ampicillin, erythromycin, Avelox, Lincocin, Seconal, atropine, fillers used in Doxycycline tablets, NSAIDS); Egg allergy (egg white and egg yolk allergy); Grass allergy; Spice allergy