Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Gout; This non-serious case was reported by a consumer via call center representative and described the occurrence of gout in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included hyperthyroidism. Additional patient notes included The patient stated that he was not a meat eater and does not eat bread or pasta. He also states that he does not drink alcoholic drinks. Concomitant products included amoxicillin, prednisone and levothyroxine sodium (Levothyroxin). In JUN-2025, the patient received the 1st dose of Shingrix .5 ml. In JUN-2025, 1 week after receiving Shingrix, the patient experienced gout (Verbatim: Gout). The outcome of the gout was not resolved. It was unknown if the reporter considered the gout to be related to Shingrix. It was unknown if the company considered the gout to be related to Shingrix. Additional Information: GSK Receipt Date: 29-SEP-2025 The reporter was the patient. He stated that he had received both Shingrix vaccines on time. He reported experiencing edema with bumps on the right foot and ankle, as well as on the right side of his stomach under the arm, one week after the first vaccination. The bumps were diagnosed as gout and were accompanied by a fever. He also mentioned that he had recently experienced a gout episode after eating mussels and salmon. He stated that he had never had gout prior to receiving the Shingrix vaccine. Patient had 2nd dose of Shingrix in August 2025. The batch number was not provided and a request for this information has been made.
Hyperthyroidism
Comments: The patient stated that he was not a meat eater and does not eat bread or pasta. He also states that he does not drink alcoholic drinks
AMOXICILLIN; PREDNISONE; LEVOTHYROXIN