Received Apr 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
swelling at injection site; red at injection site; hard lump at injection site; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes. On 25-MAR-2025, the patient received the 1st dose of Shingrix (left arm). On 26-MAR-2025, 1 days after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling at injection site), injection site erythema (Verbatim: red at injection site) and injection site lump (Verbatim: hard lump at injection site). The outcome of the injection site swelling, injection site erythema and injection site lump were resolving. The reporter considered the injection site swelling, injection site erythema and injection site lump to be related to Shingrix. The company considered the injection site swelling, injection site erythema and injection site lump to be related to Shingrix. Additional Information: GSK Receipt Date: 03-APR-2025 The patient received concomitant product wygovey. The reporter reported injection was further down arm than typically done, roughly midway between shoulder and elbow.
Diabetes