Received Jun 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | k2bb7 | — |
spot in arm which was visibly lumpy and harder; spot in arm which was visibly lumpy and harder; suspected tendinitis; The pharmacist thought that the vaccine was administered lower than it should have been; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a female patient who received Herpes zoster (Shingrix) (batch number k2bb7, expiry date 30-JAN-2027) for prophylaxis. In FEB-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site lump (Verbatim: spot in arm which was visibly lumpy and harder), injection site induration (Verbatim: spot in arm which was visibly lumpy and harder), tendonitis (Verbatim: suspected tendinitis) and vaccine administered at inappropriate site (Verbatim: The pharmacist thought that the vaccine was administered lower than it should have been). The outcome of the injection site lump and tendonitis were unknown and the outcome of the injection site induration was not reported and the outcome of the vaccine administered at inappropriate site was not applicable. It was unknown if the reporter considered the injection site lump, injection site induration and tendonitis to be related to Shingrix. It was unknown if the company considered the injection site lump, injection site induration and tendonitis to be related to Shingrix. Additional Information: GSK receipt date: 27-MAY-2025 The pharmacist stated that a patient received her first dose of Shingrix in February 2025. After her dose, she developed a spot in her arm which was visibly lumpy and harder than normal. The pharmacist thought that the vaccine was administered lower than it should have been which led to vaccine administered at inappropriate site. It may be tendinitis.