Received Oct 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | IM / LA |
injection site was raised, red, uncomfortable, and sore; injection site was raised, red, uncomfortable, and sore; injection site was raised, red, uncomfortable, and sore; injection site was raised, red, uncomfortable, and sore; left arm ached and was painful to lift or move for a week; left arm ached and was painful to lift or move for a week; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included iodine allergy. Concomitant products included metformin hydrochloride (Metformin), hydrochlorothiazide, lisinopril dihydrate (Lisinopril) and atorvastatin calcium propylene glycol solvate (Atorvastatin). On 16-APR-2025, the patient received Shingrix (intramuscular, left arm). On 16-APR-2025, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: left arm ached and was painful to lift or move for a week) and mobility decreased (Verbatim: left arm ached and was painful to lift or move for a week). On an unknown date, the patient experienced injection site swelling (Verbatim: injection site was raised, red, uncomfortable, and sore), injection site erythema (Verbatim: injection site was raised, red, uncomfortable, and sore), injection site discomfort (Verbatim: injection site was raised, red, uncomfortable, and sore) and injection site pain (Verbatim: injection site was raised, red, uncomfortable, and sore). The outcome of the injection site swelling, injection site erythema, injection site discomfort, injection site pain, pain in arm and mobility decreased were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site discomfort, injection site pain, pain in arm and mobility decreased to be related to Shingrix. It was unknown if the company considered the injection site swelling, injection site erythema, injection site discomfort, injection site pain, pain in arm and mobility decreased to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR127373 Additional Information: GSK Receipt Date: 02-OCT-2025 The reporter/patient is a female that received her first dose of Shingrix and experienced that her left arm ached and was painful to lift or move for a week. This started the same day as receiving the vaccine on 16 APR 2025. The patient reported that the injection site was raised, red, uncomfortable, and sore but did not prevent her from doing anything. The patient stated she was allergic to Povidone (pre-existing Shingrix) and her first reaction to Povidone was in her early 20 years of age.; Sender's Comments: US-GSK-US2025AMR127373:Same patient/Dose 2
Medical History/Concurrent Conditions: Iodine allergy
METFORMIN; HYDROCHLOROTHIAZIDE; LISINOPRIL; ATORVASTATIN