Received Apr 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Injection site pain; swelling at injection site; bruising; uncomfortable; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. In NOV-2025, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain), injection site swelling (Verbatim: swelling at injection site), injection site bruising (Verbatim: bruising) and injection site discomfort (Verbatim: uncomfortable). The outcome of the injection site pain, injection site swelling, injection site bruising and injection site discomfort were resolved (duration 3 days). It was unknown if the reporter considered the injection site pain, injection site swelling, injection site bruising and injection site discomfort to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site swelling, injection site bruising and injection site discomfort to be related to Shingrix. Linked case(s) involving the same patient: US2026AMR046680 Additional Information: GSK receipt date: 31-MAR-2026 A member of the public called to report adverse reactions to the first and second doses of the Shingrix vaccine. The member of the public did not know the exact dates of when the vaccines were administered but mentioned the first Shingrix vaccine was administered four months ago, and the second Shingrix vaccine early February 2026. The first Shingrix dose felt like a painful tetanus shot, swollen, bruising, pretty uncomfortable for 3 days if the patient touched it. The patient mentioned the pharmacist injected the first dose of Shingrix fast. The patient has a history of Rheumatoid Arthritis. The Shingrix vaccines were administered at a local pharmacy and not the patient and physician office. The patient consented to follow up with her physician and provided the contact information. The patient mentioned they had not told their physician about the adverse reactions to Shingrix yet as they have not had a recent appointment. The patient did not know their physician and first name or email address to provide. For tolerance of 2nd dose refer case US2026042682.; Sender's Comments: GSK-US2026AMR046680:
Rheumatoid arthritis