Received May 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
swelling around the injection site /made a motion of about a 6 inch circle on her arm; Fever; Fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: swelling around the injection site /made a motion of about a 6 inch circle on her arm), fever (Verbatim: Fever) and fatigue (Verbatim: Fatigue). The outcome of the injection site swelling was not reported and the outcome of the fever and fatigue were resolved (duration 1 day). It was unknown if the reporter considered the injection site swelling, fever and fatigue to be related to Shingrix. It was unknown if the company considered the injection site swelling, fever and fatigue to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR061338 Additional Information: GSK Receipt Date: 09-MAY-2025 A female patient, approximately 55 years old, received both doses of the Shingrix vaccine. After each dose the patient experienced swelling around the injections site and made a motion of about a 6 inch circle on her arm. She also experienced fever, fatigue that lasted about a day each time. For tolerance to second dose, refer case US2025AMR061338.