Received May 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
large bump around on the side of anus and inflamed anus; large bump around on the side of anus and inflamed anus; This non-serious case was reported by a consumer and described the occurrence of anal inflammation in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis. Concomitant products included semaglutide (Ozempic), amlodipine besilate, valsartan (Exforge), atorvastatin calcium propylene glycol solvate (Atorvastatin) and metformin hydrochloride (Metformin). On 16-APR-2026, the patient received Shingrix .5 ml and Flu vaccine. On 17-APR-2026, 1 days after receiving Shingrix and Flu vaccine, the patient experienced anal inflammation (Verbatim: large bump around on the side of anus and inflamed anus) and mass (Verbatim: large bump around on the side of anus and inflamed anus). The outcome of the anal inflammation and mass were resolved with sequelae. It was unknown if the reporter considered the anal inflammation and mass to be related to Shingrix, Shingrix Pre-Filled Syringe Device and Flu vaccine. It was unknown if the company considered the anal inflammation and mass to be related to Shingrix, Shingrix Pre-Filled Syringe Device and Flu vaccine. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-MAY-2026 Patient took both the flu shot and Shingrix shot at the same time and had large bump around on the side of anus and inflamed anus. The batch number was not provided upon follow- up with the reporter.
Ozempic; Exforge; Atorvastatin; Metformin