Received Jul 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / RA |
soreness of injected arm; Sinus infection; flu-like symptoms; Unexpected therapeutic benefit; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On 27-JAN-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness of injected arm), sinus infection (Verbatim: Sinus infection), influenza-like symptoms (Verbatim: flu-like symptoms) and unexpected therapeutic effect (Verbatim: Unexpected therapeutic benefit). The outcome of the injection site pain, sinus infection and influenza-like symptoms were resolved and the outcome of the unexpected therapeutic effect was not applicable. It was unknown if the reporter considered the injection site pain, sinus infection and influenza-like symptoms to be related to Shingrix. It was unknown if the company considered the injection site pain, sinus infection and influenza-like symptoms to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR089300 Additional Information: GSK Receipt Date: 03-JUL-2025 The reporter was the patient. He had an unexpected benefit. He did not want to disclose, at this time, what the specific condition was that he had in his background that the Shingrix had a positive effect on it. He said this condition is a condition that occurs world-wide. Shingrix shot 1 on 27 Jan 2025, he experienced a typical headache, soreness of injected arm, general weakness, flu-like symptoms, light cough, runny nose. These events were more intense than he expected. All of these events resolved/came to an end but then he developed a sinus infection. He had never had a sinus infection before. He was prescribed an antibiotic and it resolved.; Sender's Comments: US-GSK-US2025AMR089300:2nd dose