Received May 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
swelling around the injection siteand mad a motion of about a 6 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 adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site swelling (received first dose on an unknown date for tolerance of first dose refer case US2025AMR059471). 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: swelling around the injection siteand mad a motion of about a 6 circle on her arm), fever (Verbatim: fever) and fatigue (Verbatim: fatigue). Rechallenge with Shingrix was positive. 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: US2025AMR059471 Additional Information: GSK Receipt Date: 09-MAY-2025 The patient of approximately 55 age took the 2 dose series of Shingrix vaccine. The reporter stated that after each dose the patient experienced swelling around the injections site and mad a motion of about a 6 inch circle on her arm. She also experienced fever, fatigue that lasted about a day each time.