Received Oct 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Muscle pain; Tiredness; Something more unusual than I felt with a vaccine; Injection site redness; Frequent bowel movements/ more frequent bathroom trips; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. On 02-SEP-2025, the patient received the 1st dose of Shingrix. On 02-SEP-2025, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Injection site redness) and frequent bowel movements (Verbatim: Frequent bowel movements/ more frequent bathroom trips). On an unknown date, the patient experienced muscle pain (Verbatim: Muscle pain), tiredness (Verbatim: Tiredness) and feeling abnormal (Verbatim: Something more unusual than I felt with a vaccine). The outcome of the injection site erythema and frequent bowel movements were not resolved and the outcome of the muscle pain, tiredness and feeling abnormal were not reported. It was unknown if the reporter considered the injection site erythema, frequent bowel movements, muscle pain, tiredness and feeling abnormal to be related to Shingrix. It was unknown if the company considered the injection site erythema, frequent bowel movements, muscle pain, tiredness and feeling abnormal to be related to Shingrix. Additional Information: GSK Receipt Date: 04-SEP-2025 The reporter stated that the patient experienced redness at injection site and frequent bowel movements. The reporter also stated that the patient had the common side effects of Shingrix vaccine and experienced muscle pain, tiredness, more frequent bathroom trips, something more unusual the patient felt with vaccine.