Received Feb 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
She still has not received Shingrix dose 2; red injection site; and swollen injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient did not receive the 2nd dose of Shingrix. In MAY-2024, the patient received the 1st dose of Shingrix. In MAY-2024, not applicable after receiving Shingrix and less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: red injection site) and injection site swelling (Verbatim: and swollen injection site). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: She still has not received Shingrix dose 2). The outcome of the injection site erythema and injection site swelling were resolved (duration 10 days) and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix and Shingrix. It was unknown if the company considered the injection site erythema and injection site swelling to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 05-FEB-2025 The reporter stated that she received dose 1 Shingrix in May 2024. She stated that within 24 hours her arm was red and swollen. That lasted 10 days and then resolved. The reporter stated that as per her PCP and her neurologist had different ideas on getting dose 2. The patient still had not received Shingrix dose 2 and will speak to her HCP again. Information provided per content. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination.