Received Jul 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Rheumatoid arthritis; Crying; Cannot sleep/Insomnia; This serious case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis in a 51-year-old female patient who received Herpes zoster (Shingrix) solution for injection for prophylaxis. On 21-FEB-2026, the patient received the 2nd dose of Shingrix. On 23-FEB-2026, 2 days after receiving Shingrix and 100 days after receiving Shingrix, the patient experienced rheumatoid arthritis (Verbatim: Rheumatoid arthritis) (serious criteria GSK medically significant), crying (Verbatim: Crying) and insomnia (Verbatim: Cannot sleep/Insomnia). The patient was treated with nsaids and steroids. The outcome of the rheumatoid arthritis, crying and insomnia were not resolved. It was unknown if the reporter considered the rheumatoid arthritis, crying and insomnia to be related to Shingrix. It was unknown if the reporter considered the rheumatoid arthritis to be related to Shingrix. The company considered the rheumatoid arthritis to be unrelated to Shingrix. Additional Information: GSK receipt date 06-JUL-2026 The reporter was the husband of a patient. The reporter stated that the patient received their first dose of shingrix and had no adverse reactions. The reporter stated the patient had their second dose in the afternoon, and the following Monday the patient could not get out of bed and was immobile. The patient had pain that started at her right hip and traveled down to the patient's leg and foot. The patient also had pain that started the following Monday in both wrists' arms and hands. The reporter stated that sometimes the pain was on one side and sometimes the pain was on both sides of the patient's upper body. The patient was crying from the pain and cannot sleep, sit or stand for long periods of time. The reporter stated that the symptoms were intermittent. The patient went to her physician to address the symptoms. The patient took NSAIDS and steroids for the pain. The patient had an antibody test and was diagnosed with RA. The specialist gave the patient a steroid injection for pain at an unknown location. The specialist prescribed the patient oral steroids and some kind of cancer drug. The batch number was not provided upon follow- up with the reporter.; Sender's Comments: Rheumatoid arthritis, 2 days and 100 days after vaccination with 1st dose and 2nd dose of Shingrix in a 51-year-old female patient. Case lacks further information on medical history, concurrent conditions and laboratory data. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Test Date: 2026; Test Name: antibody test; Result Unstructured Data: (Test Result:Rheumatoid arthritis,Unit:unknown,Normal Low:,Normal High:); Test Date: 2026; Test Name: CCP; Result Unstructured Data: (Test Result:314,Unit:unknown,Normal Low:,Normal High:)