Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Painful arm; large red; hot; swollen; weakness; Ehlers-Danlos syndrome; This non-serious case was reported by a consumer and described the occurrence of Ehlers Danlos syndrome in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on an unknown date). On 06-JUN-2025, the patient received the 2nd dose of Shingrix. On 07-JUN-2025, 1 days after receiving Shingrix, the patient experienced pain in arm (Verbatim: Painful arm), erythema (Verbatim: large red), feeling hot (Verbatim: hot), swelling (Verbatim: swollen) and weakness (Verbatim: weakness). In JUN-2025, the patient experienced Ehlers Danlos syndrome (Verbatim: Ehlers-Danlos syndrome). The outcome of the Ehlers Danlos syndrome was not reported and the outcome of the pain in arm, erythema, feeling hot, swelling and weakness were not resolved. It was unknown if the reporter considered the Ehlers Danlos syndrome, pain in arm, erythema, feeling hot, swelling and weakness to be related to Shingrix. It was unknown if the company considered the Ehlers Danlos syndrome, pain in arm, erythema, feeling hot, swelling and weakness to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JUN-2025 Reporter stated that patient received second dose of Shingrix and had painful arm. Also stated patient had large red, hot, swollen and weakness. Patient had Ehlers-Danlos syndrome.