Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
swollen injection site; injection site lump; injection site edema; arm began hurting/ forearm was painful; injection site tenderness/injection site became painful; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. In JAN-2025, the patient received the 1st dose of Shingrix (left deltoid). In JAN-2025, immediately after receiving Shingrix, the patient experienced injection site tenderness (Verbatim: injection site tenderness/injection site became painful), injection site swelling (Verbatim: swollen injection site), injection site lump (Verbatim: injection site lump), injection site edema (Verbatim: injection site edema) and pain in arm (Verbatim: arm began hurting/ forearm was painful). In JAN-2025, the outcome of the injection site swelling was resolved. In FEB-2025, the outcome of the injection site lump and injection site edema were resolved. The outcome of the injection site tenderness and pain in arm were not resolved. It was unknown if the reporter considered the injection site tenderness, injection site swelling, injection site lump, injection site edema and pain in arm to be related to Shingrix. It was unknown if the company considered the injection site tenderness, injection site swelling, injection site lump, injection site edema and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 13-MAR-2025 The patient reported that she received her first Shingrix vaccine in January of 2025. The injection was painful, and her arm began hurting immediately, not to resolve for a few weeks. She reported that in the days immediately following the injection the injection site (Left Deltoid) became swollen and painful, with a hard lump. These symptoms persisted for a few weeks and the injection site was still painful to the touch. She also reported that her forearm was painful at the same time, and it was still painful. She stated that she wears a brace at times due to the pain. She denied any medications or conditions that could have contributed to the issue.