Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | — | — |
topical reaction at the site of the injection; A 64 years old female patient received an extra dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on 30th April 2019) and Shingrix (received 2nd dose of vaccine on 20th July 2019). On 13-FEB-2025, the patient received the 3rd dose of Shingrix. On 13-FEB-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: A 64 years old female patient received an extra dose of Shingrix). On an unknown date, the patient experienced injection site reaction (Verbatim: topical reaction at the site of the injection). The outcome of the injection site reaction was resolved and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the injection site reaction to be related to Shingrix. It was unknown if the company considered the injection site reaction to be related to Shingrix. Additional Information: GSK Receipt Date: 06-MAY-2025 On 6th May 2025, a pharmacist called to report that a 64 year old female patient had received an extra dose of Shingrix by mistake. The first dose had been administered on 30th April 2019, followed by the second dose on 20th July 2019. On 13th February 2025, a third dose had mistakenly been given, which led to Extra dose administered. The patient had experienced a reaction and had visited her medical provider, who had pulled some titers tests and reviewed her medical records. A medical professional had identified a topical reaction at the injection site. The patient was not immunocompromised. The pharmacist stated that the patient was fine.