Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
diagnosed with coronary artery disease; Suspected Carpal tunnel; This serious case was reported by a consumer via call center representative and described the occurrence of coronary artery disease in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of paraesthesia, Flu vaccine, RSV vaccine and COVID-19 vaccine. Concurrent medical conditions included non-hodgkin's lymphoma (patient who was diagnosed in Non-Hodgkin's Lymphoma in 2020). Concomitant products included rituximab (Rituxan). On 20-MAR-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced coronary artery disease (Verbatim: diagnosed with coronary artery disease) (serious criteria hospitalization and clinically significant/intervention required) and carpal tunnel syndrome (Verbatim: Suspected Carpal tunnel). The outcome of the coronary artery disease and carpal tunnel syndrome were unknown. It was unknown if the reporter considered the coronary artery disease and carpal tunnel syndrome to be related to Shingrix. The company considered the coronary artery disease to be unrelated to Shingrix. It was unknown if the company considered the carpal tunnel syndrome to be related to Shingrix. Linked case(s) involving the same patient: US2025131746 Additional Information: GSK receipt date: 13-OCT-2025 At her doctor appointment in February, she was told that she had drug induced polyneuropathy. Her cardiologist had her do a CAT scan and she was diagnosed with coronary artery disease. She got a catheterization and stent done on 26-JUN-2025 and was hospitalized. Her neurologist did an EMG and nerve conduction testing and told her she may have carpal tunnel. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of coronary artery disease, unknown time after receiving Shingrix, in a elderly female patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Non-Hodgkin's lymphoma (patient who was diagnosed in Non-Hodgkin's Lymphoma in 2020)
RITUXAN
Test Date: 20250626; Test Name: CAT scan; Result Unstructured Data: (Test Result:diagnosed with coronary artery disease,Unit:unknown,Normal Low:,Normal High:); Test Date: 20250626; Test Name: EMG; Result Unstructured Data: (Test Result:carpal tunnel,Unit:unknown,Normal Low:,Normal High:); Test Date: 20250626; Test Name: nerve conduction test; Result Unstructured Data: (Test Result:carpal tunnel,Unit:unknown,Normal Low:,Normal High:)