Received Aug 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 99d52 | SC / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | LA |
HCP advised her Shingrix should not be injected into her deltoid muscle but instead in the tissue on the back of the arm; injection site turned red and the redness spread about four fingers in length/After a few days the site turned pink; Weakness; dose administered in the back in the arm, not in the muscle; After a few days the site turned pink and spread to the size of a palm and was itchy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 13-JUL-2025, the patient received Shingrix (left arm). On 13-JUL-2025, an unknown time after receiving Shingrix, the patient experienced wrong route of administration (Verbatim: dose administered in the back in the arm, not in the muscle). On 14-JUL-2025, the patient experienced injection site erythema (Verbatim: injection site turned red and the redness spread about four fingers in length/After a few days the site turned pink) and weakness (Verbatim: Weakness). In JUL-2025, the patient experienced injection site itching (Verbatim: After a few days the site turned pink and spread to the size of a palm and was itchy). On an unknown date, the patient experienced drug prescribing error (Verbatim: HCP advised her Shingrix should not be injected into her deltoid muscle but instead in the tissue on the back of the arm). The outcome of the injection site erythema and injection site itching were unknown and the outcome of the weakness was not resolved and the outcome of the drug prescribing error and wrong route of administration were not applicable. It was unknown if the reporter considered the injection site erythema, injection site itching and weakness to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site itching and weakness to be related to Shingrix. Additional Information: GSK Receipt Date: 18-JUL-2025 The patient had her second dose of Shingrix administered on 13th July 2025 and stated the vaccinating healthcare professional (HCP) advised her Shingrix should not be injected into her deltoid muscle but instead in the tissue on the back of the arm, which led to drug prescribing error. It was unknown if the vaccine was administered intramuscularly or subcutaneously. On the following day, the injection site turned red and the redness spread about four fingers in length and after a few days the site turned pink and spread to the size of a palm and was itchy.