Received Feb 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | IM / LA |
painful lump in her left deltoid; painful lump in her left deltoid; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site lump in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 06-DEC-2024, the patient received Arexvy (intramuscular, left deltoid). On 06-DEC-2024, less than a day after receiving Arexvy, the patient experienced injection site lump (Verbatim: painful lump in her left deltoid) and injection site pain (Verbatim: painful lump in her left deltoid). The outcome of the injection site lump and injection site pain were not resolved. It was unknown if the reporter considered the injection site lump and injection site pain to be related to Arexvy. It was unknown if the company considered the injection site lump and injection site pain to be related to Arexvy. Additional Information: GSK Receipt Date: 08-JAN-2025 The patient self-reported this case for herself. Patient reported that she received her Arexvy vaccine and has had a painful lump in her left deltoid that has not resolved.