Received Mar 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Transverse Myelitis; This serious case was reported by a physician via sales rep and described the occurrence of myelitis transverse in a adult male 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 myelitis transverse (Verbatim: Transverse Myelitis) (serious criteria GSK medically significant). The outcome of the myelitis transverse was resolved. The reporter considered the myelitis transverse to be possibly related to Shingrix. The company considered the myelitis transverse to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 07-MAR-2025 Patient had been vaccinated with Shingrix dose 1. A few days after the vaccination the patient went to the emergency room and had developed Transverse Myelitis. The patient was treated and managed by neurology and with physical therapy the patient recovered. The hospital physicians had no other causes and believed the vaccine might have caused the issue. The patient later refused to get the 2nd dose but has fully recovered.; Sender's Comments: Myelitis transverse is an unlisted event which is considered unrelated to GSK vaccine Shingrix.