Received Aug 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
retina tear; loss my center vision; Rheumatoid arthritis; sjogrens; lupus; adrenal deficiency; Raynauds; This serious case was reported by a consumer via interactive digital media and described the occurrence of retinal tear in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced retinal tear (Verbatim: retina tear) (serious criteria GSK medically significant and clinically significant/intervention required), central vision loss (Verbatim: loss my center vision) (serious criteria GSK medically significant), rheumatoid arthritis (Verbatim: Rheumatoid arthritis) (serious criteria GSK medically significant), sjogren's (Verbatim: sjogrens) (serious criteria GSK medically significant), systemic lupus erythematosus (Verbatim: lupus) (serious criteria GSK medically significant), adrenal insufficiency (Verbatim: adrenal deficiency) (serious criteria GSK medically significant) and raynauds (Verbatim: Raynauds). The patient was treated with Steroids. The outcome of the retinal tear, central vision loss, rheumatoid arthritis, sjogren's, systemic lupus erythematosus and raynauds were not reported and the outcome of the adrenal insufficiency was not resolved. It was unknown if the reporter considered the retinal tear, central vision loss and adrenal insufficiency to be related to Shingrix. The reporter considered the rheumatoid arthritis, sjogren's, systemic lupus erythematosus and raynauds to be related to Shingrix. The company considered the retinal tear, central vision loss, rheumatoid arthritis, sjogren's, systemic lupus erythematosus and adrenal insufficiency to be unrelated to Shingrix. The company considered the raynauds to be related to Shingrix. Linked case(s) involving the same patient: US2021AMR198955 Additional Information: GSK Receipt Date: 06-AUG-2025 This case was reported by a patient via interactive digital media. The patient received shingrix vaccine a few years ago (from reporting date) that triggered rheumatoid arthritis, sjogrens, raynauds, lupus and at the time of reporting also had adrenal deficiency that he/she steroid dependent on to live. The patient also developed a retina tear that had three surgeries on and loss his/her center vision. The patient would never tell anyone not to get a vaccine but dang sure would say to do some deep research beforehand.; Sender's Comments: A case of Retinal tear, Central vision loss, Rheumatoid arthritis, Sjogren's syndrome, Systemic Lupus erythematosus and Adrenal insufficiency, unknown time after receiving Shingrix in a patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. US-GLAXOSMITHKLINE-US2021AMR198955:same patient