Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Swelling at injection site; extreme hives; rash; malaise; This serious case was reported by a pharmacist via sales rep and described the occurrence of injection site swelling in a adult 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 at injection site) (serious criteria other: Serious as per reporter), hives (Verbatim: extreme hives) (serious criteria other: Serious as per reporter), rash (Verbatim: rash) (serious criteria other: Serious as per reporter) and malaise (Verbatim: malaise) (serious criteria other: Serious as per reporter). The outcome of the injection site swelling, hives, rash and malaise were unknown. The reporter considered the injection site swelling, hives, rash and malaise to be related to Shingrix. The company considered the injection site swelling, hives, rash and malaise to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 13-MAR-2025 The pharmacist reported that one of their employees of the pharmacy (patient) was around 55 years old who experienced an extreme reaction to the first dose of vaccine. The patient missed multiple days of work and had to go to urgent care.; Sender's Comments: Injection site swelling, Urticaria, Rash and Malaise are listed events which, due to the following criteria (insufficient information on medical history, concurrent conditions, concomitant medications and time to onset) are considered unrelated to GSK vaccine Shingrix.