Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
CHF; COPD; This serious case was reported by a consumer via interactive digital media and described the occurrence of congestive heart failure in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced congestive heart failure (Verbatim: CHF) (serious criteria GSK medically significant) and chronic obstructive pulmonary disease (Verbatim: COPD). The outcome of the congestive heart failure and chronic obstructive pulmonary disease were not reported. It was unknown if the reporter considered the congestive heart failure and chronic obstructive pulmonary disease to be related to Arexvy. The company considered the congestive heart failure to be unrelated to Arexvy. It was unknown if the company considered the chronic obstructive pulmonary disease to be related to Arexvy. Additional Information: GSK Receipt Date: 05-SEP-2025 This case was reported by a patient via interactive digital media. Patient had two conditions, chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF).; Sender's Comments: A case of Cardiac failure congestive, unknown time after receiving Arexvy in a patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (concurrent chronic obstrutive pulmonary disease).