Received May 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | E75E5 | — |
severe headache; nasal congestion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of headache in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number E75E5, expiry date 05-NOV-2025) for prophylaxis. On 30-APR-2025, the patient received Arexvy. On 01-MAY-2025, 1 days after receiving Arexvy, the patient experienced headache (Verbatim: severe headache) and nasal congestion (Verbatim: nasal congestion). The outcome of the headache and nasal congestion were not resolved. It was unknown if the reporter considered the headache and nasal congestion to be related to Arexvy. It was unknown if the company considered the headache and nasal congestion to be related to Arexvy. Additional Information: GSK Receipt Date: 01-MAY-2025 A pharmacy manager called to report that a patient who received Arexvy yesterday (day before reporting) was experiencing severe headache and nasal congestion one day after getting vaccine. Patient had to go to urgent care to check out this. Reporter wanted to know do GlaxoSmithKline have any information of this adverse reactions in their database.