Received Mar 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | RA |
stroke; Cerebral thrombosis; Weakness of the left side; This serious case was reported by a consumer via patient support programs and described the occurrence of stroke in a 62-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included dolutegravir sodium, lamivudine (Dovato) film-coated tablet (batch number) for hiv positive. The patient's past medical history included heart attack (Patient experienced heart attack on 2017), left ventricular assist device insertion and stroke. Concurrent medical conditions included chronic kidney disease stage 3 (Chronic kidney disease stage 3 Not currently taking any medication for this.). Concomitant products included warfarin and acetylsalicylic acid (Aspirin). On 23-MAR-2024, the patient received Shingles vaccine (right arm). On 23-MAR-2019, the patient started Dovato daily. On 29-MAR-2024, 6 days after receiving Shingles vaccine and 1833 days after starting Dovato, the patient experienced stroke (Verbatim: stroke) (serious criteria hospitalization and GSK medically significant) and weakness left or right side (Verbatim: Weakness of the left side) (serious criteria GSK medically significant). On an unknown date, the patient experienced cerebral thrombosis (Verbatim: Cerebral thrombosis) (serious criteria GSK medically significant). Dovato was continued with no change. On 29-MAR-2024, the outcome of the stroke was unknown. In APR-2024, the outcome of the cerebral thrombosis was resolved. The outcome of the weakness left or right side was not resolved. The reporter considered the stroke to be possibly related to Shingles vaccine. It was unknown if the reporter considered the weakness left or right side and cerebral thrombosis to be related to Shingles vaccine and Dovato. It was unknown if the reporter considered the stroke to be related to Dovato. The company considered the stroke, weakness left or right side and cerebral thrombosis to be unrelated to Shingles vaccine and Dovato. Additional Information: GSK Receipt Date: 07-MAR-2025 Consumer reported that he had a heart attack in 2017, and his sister took to her house and last year had a stroke in 2024 and patient was in hospital for Stroke from 29 Mar 2024 to 3 May 2024. Patient said on speaker and the left side was weaker because of the stroke. His stroke and heart attack were before starting the Dovato. Patient thought stroke came from taking the shingles vaccine. Patient got Left Ventricular Assist Device (LVAD) in 2018. 7 days after he had the vaccine and had the stroke. She changed to Dovato and gave him a shingles shot on Mar. 23, 2024. He was admitted in the regular hospital from March 29th and discharged to the on April 3rd. When patient went into that was when they diagnosed with the blood clot. Patient was wheeled into and went right into surgery; they went into side and cleared the blood clot.; Sender's Comments: Cerebrovascular accident, Hemiparesis and Cerebral thrombosis are unlisted events which are considered unrelated to GSK Shingles vaccine and Dovato.
Chronic kidney disease stage 3 (Chronic kidney disease stage 3 Not currently taking any medication for this.)
Medical History/Concurrent Conditions: Heart attack (Patient experienced heart attack on 2017); Left ventricular assist device insertion; Stroke
WARFARIN; ASPIRIN; DOVATO