Received Jun 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 772LC | — |
I have stage 5 PKD; This serious case was reported by a consumer and described the occurrence of polycystic kidney, unspecified type in a 68-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) suspension for injection (batch number 772LC) for prophylaxis. Concurrent medical conditions included hypoalphalipoproteinemia, hypothyroidism, peripheral neuropathy, depression, benign prostatic hypertrophy, obesity and polycystic kidney, autosomal dominant. Concomitant products included amlodipine, calcitriol, febuxostat, fenofibrate, furosemide, eicosapentaenoic acid ethyl ester (Icosapent Ethyl), levothyroxine, pregabalin, sertraline, tamsulosin and tirzepatide. On 25-SEP-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced polycystic kidney, unspecified type (Verbatim: I have stage 5 PKD) (serious criteria GSK medically significant). The outcome of the polycystic kidney, unspecified type was resolved. It was unknown if the reporter considered the polycystic kidney, unspecified type to be related to Arexvy. The company considered the polycystic kidney, unspecified type to be unrelated to Arexvy. Additional Information: GSK Receipt Date:26-MAY-2026 The patient has stage five polycystic kidney disease, and he was getting ready for transplant workup and need vaccination details.; Sender's Comments: A case of Congenital cystic kidney disease, on an unknown time after vaccination with unknown dose of Arexvy, in a 68-year-old male patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.
Benign prostatic hypertrophy; Depression; Hypoalphalipoproteinemia; Hypothyroidism; Obesity; Peripheral neuropathy; Polycystic kidney, autosomal dominant
AMLODIPINE; CALCITRIOL; FEBUXOSTAT; FENOFIBRATE; FUROSEMIDE; ICOSAPENT ETHYL; LEVOTHYROXINE; PREGABALIN; SERTRALINE; TAMSULOSIN; TIRZEPATIDE