Received Jun 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
swelling in feet and ankles; feet swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of ankle swelling in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included minimal change disease (diagnosed 10 years ago). Concomitant products included prednisone and lisinopril. On 28-MAY-2025, the patient received the 1st dose of Shingrix. On 29-MAY-2025, 1 days after receiving Shingrix, the patient experienced ankle swelling (Verbatim: swelling in feet and ankles) and swelling of feet (Verbatim: feet swelling). The outcome of the ankle swelling and swelling of feet were not resolved. It was unknown if the reporter considered the ankle swelling to be related to Shingrix. The reporter considered the swelling of feet to be related to Shingrix. It was unknown if the company considered the ankle swelling to be related to Shingrix. The company considered the swelling of feet to be related to Shingrix. Additional Information: GSK Receipt Date: 11-JUN-2025 The reporter was the patient. The patient received Shingrix vaccine and had major swelling in feet and ankles. The patient was diagnosed with Minimal Change Disease (MCD) 10 years ago. The patient believes she had the disease for 30 years before she was diagnosed. The patient's Minimal Change Disease presents with swollen feet and ankles, which has been under control with current medication. When she becomes ill with a cold, or infection, she experiences swelling in feet and ankles and bottom torso. When this happens, she would took an increased dose of prednisone which will resolve the swelling. The patient takes Prednisone 15 microgram daily and Lisinopril 5 microgram daily to treat MCD. The patient sees a nephrologist who treats and monitors her MCD. On 28 May 2025, the patient received the first dose of Shingrix. Within 24 hours, the patient began to experience major swelling in her feet and ankles. Subsequently, the patient increased the Prednisone dose to 30 microgram daily to treat the swelling at the time of the call she was taking 25 microgram daily of Prednisone. The swelling of her feet and ankles has not resolved. The patient was confident that the swollen feet was related to the Shingrix vaccine. The patient did not plan to get the second dose of Shingrix vaccine. The patient has lab work done every 3 months to monitor MCD. Her next lab work is due in July 2025.
Minimal change disease (diagnosed 10 years ago)
PREDNISONE; LISINOPRIL