Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Shingles; This serious case was reported by a consumer via other manufacturer and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included ruxolitinib phosphate (Jakafi) tablet for product used for unknown indication. On an unknown date, the patient received the 1st dose of Shingrix and Jakafi (oral) 20 mg twice a day (40 mg daily). On 25-FEB-2025, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles) (serious criteria clinically significant/intervention required). The patient was treated with valaciclovir. The action taken with Jakafi was unknown. The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingrix. The company considered the shingles to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 11-MAR-2025 A 66-year-old female patient initiated the use of oral Jakafi (ruxolitinib) 20 mg tablets BID on an unknown date for an unknown indication. The batch/lot number and expiration date were not reported On 25-FEB-2025, at the time of the report, the patient was diagnosed with shingles and was prescribed with valacyclovir to treat it. She was in between her first injection of Shingrix and her second injection of Shingrix when she developed signs of shingles. The outcome of the events was not reported. Concomitant medications were not reported. The Jakafi drug was ongoing. Medical history was not reported. No additional information was provided. Serious spontaneous report Shingles intervention required assessed as listed per the regulatory authority.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
JAKAFI