Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
injection site was becoming red; the injection site was swollen; the injection site was hot; fever; Fatigue; Nausea; headach; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 09-APR-2025, the patient received the 1st dose of Shingrix. In APR-2025, less than a week after receiving Shingrix, the patient experienced injection site erythema (Verbatim: injection site was becoming red), injection site swelling (Verbatim: the injection site was swollen), injection site warmth (Verbatim: the injection site was hot), fever (Verbatim: fever), fatigue (Verbatim: Fatigue), nausea (Verbatim: Nausea) and headache (Verbatim: headach). The outcome of the injection site erythema, injection site swelling, injection site warmth, fever, fatigue, nausea and headache were not reported. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, fever, fatigue, nausea and headache to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site swelling, injection site warmth, fever, fatigue, nausea and headache to be related to Shingrix. Additional Information: GSK Receipt Date: 11-APR-2025 The patient had Shingrix vaccine on 09 Apr 2025 and the injection site was becoming red and hot and swollen. Also running 100.4 fever, fatigue, nausea and headache. They questions was this ok and how likely would patient have such severe symptoms at second shot.