Received Jul 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
After dose 1 she had a hard, swollen area around the injection site about 3 inches in diameter; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: After dose 1 she had a hard, swollen area around the injection site about 3 inches in diameter). Rechallenge with Shingrix was positive. The outcome of the injection site swelling was not reported. It was unknown if the reporter considered the injection site swelling to be related to Shingrix. It was unknown if the company considered the injection site swelling to be related to Shingrix. Additional Information: GSK Receipt Date:23-JUN-2025 Patient has had both doses of Shingrix. The area did swell after dose 2, but it nearly as much.