Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
redness near injection site; slight swelling at/near injections site; herpes breakout on leg; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included herpes virus infection (She has had this happen before in the past and it is always on her leg only). On 26-SEP-2025, the patient received the 1st dose of Shingrix. In SEP-2025, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness near injection site), injection site swelling (Verbatim: slight swelling at/near injections site) and herpes virus infection (Verbatim: herpes breakout on leg). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the injection site erythema and injection site swelling were unknown and the outcome of the herpes virus infection was not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and herpes virus infection to be related to Shingrix. It was unknown if the company considered the injection site erythema, injection site swelling and herpes virus infection to be related to Shingrix. Additional Information: GSK Receipt Date: 29-SEP-2025 The patient was the reporter. She did not want to provide her email address. She had received Shingrix shot 1 on Friday, 26th September 2025. She did not have the lot number or the expiration date. She had reported experiencing a little reaction. She stated that south of the injection site, she had a 2 inch by 1 inch red area that was slightly raised. She had also mentioned a slight herpes breakout on her leg, which was very small. She had experienced this before, always on her leg, and used valtrex to manage it. She was not planning to receive the second dose, as her doctor had advised against it. The batch number was not provided and a request for this information has been made.
Medical History/Concurrent Conditions: Herpes virus infection (She has had this happen before in the past and it is always on her leg only)