Received Jul 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
Injection site pain; Injection site swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) (expiry date 10-MAR-2027) for prophylaxis. Concurrent medical conditions included sciatica. On 30-APR-2025, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain) and injection site swelling (Verbatim: Injection site swelling). The outcome of the injection site pain and injection site swelling were not resolved. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix. It was unknown if the company considered the injection site pain and injection site swelling to be related to Shingrix. Linked case(s) involving the same patient: US2025081876 Additional Information: GSK Receipt Date: 30-JUN-2025 The patient self-reported this case. The patient received her first dose of Shingrix vaccine on 30th April 2025 and reported that she had pain and swollen of the injection site and she did not experience the sciatic pain with the 1st dose. The patient had sciatic nerve issues and got treatment with a chiropractor and her condition was under control and had just left the chiropractor office when she went to get the 2nd dose of Shingrix. This case is linked with US2025081876, reported by same reporter.; Sender's Comments: US-GSK-US2025081876:Same patient/Dose 2
Sciatica