Received Apr 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | IM / LA |
Muscle ache; Chills; Fever; Diarrhea NOS; Headache; Nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 05-APR-2025, the patient received Arexvy (intramuscular, left deltoid). On 05-APR-2025, several minutes after receiving Arexvy, the patient experienced headache (Verbatim: Headache) and nausea (Verbatim: Nausea). On 06-APR-2025, the patient experienced muscle pain (Verbatim: Muscle ache), chills (Verbatim: Chills), fever (Verbatim: Fever) and diarrhea (Verbatim: Diarrhea NOS). The outcome of the headache, nausea, muscle pain, chills, fever and diarrhea were resolving. It was unknown if the reporter considered the headache, nausea, muscle pain, chills, fever and diarrhea to be related to Arexvy. It was unknown if the company considered the headache, nausea, muscle pain, chills, fever and diarrhea to be related to Arexvy. Additional Information: GSK Receipt Date: 07-APR-2025 The patient self-reported this case. The patient received Arexvy vaccine and within a few minutes she had headache and nausea. On the next day of vaccination she started having chills, fever, muscle aches and diarrhea and stated that the symptoms have all improved, however they are all ongoing.