Received Dec 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Injection site discoloration; Inappropriate Schedule of Vaccine - did not receive second dose within 2-6 months; Incorrect vaccine administration technique - given below deltoid; Injection site redness; Injection site swelling/ and swollen (AE) to the size of a softball.; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In MAY-2025, the patient received the 1st dose of Shingrix (left arm).The patient did not received the 2nd dose of Shingrix. In MAY-2025, less than a month after receiving Shingrix the patient experienced injection site erythema (Verbatim: Injection site redness), injection site swelling (Verbatim: Injection site swelling/ and swollen (AE) to the size of a softball.) and vaccine administered at inappropriate site (Verbatim: Incorrect vaccine administration technique - given below deltoid). On an unknown date, the patient experienced injection site discoloration (Verbatim: Injection site discoloration) and incomplete course of vaccination (Verbatim: Inappropriate Schedule of Vaccine - did not receive second dose within 2-6 months). The outcome of the injection site erythema and injection site swelling were resolved and the outcome of the injection site discoloration was not resolved and the outcome of the vaccine administered at inappropriate site and incomplete course of vaccination were not applicable. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site discoloration to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site swelling and injection site discoloration to be related to Shingrix. Additional Information: GSK receipt date:23-DEC-2025 The patient received Shingrix dose in the left arm below (lower than) the deltoid. As of 23-Dec-2025, she had not received the second Shingrix dose. After the injection, the injection site was red and swollen to the size of a softball. The redness and swelling resolved after about three to four months in 2025. An outline of discoloration persisted in a softball-size area around the injection site. The discoloration was described as a different shade of her skin tone and nothing else was reported. The batch number was not provided upon follow- up with the reporter.