Received Jun 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Peripheral facial palsy; This serious case was reported by a consumer and described the occurrence of facial palsy in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included No prior history, No diabetes. Concomitant products included atorvastatin, ramipril, ezetimibe and omeprazole. On 18-MAY-2025, the patient received the 2nd dose of Shingrix. On 09-MAR-2025, the patient received the 1st dose of Shingrix. On 20-JUN-2025, 33 days after receiving Shingrix and 103 days after receiving Shingrix, the patient experienced facial palsy (Verbatim: Peripheral facial palsy) (serious criteria GSK medically significant). The patient was treated with prednisone. The outcome of the facial palsy was not resolved. It was unknown if the reporter considered the facial palsy to be related to Shingrix and Shingrix. The company considered the facial palsy to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 23-JUN-2025 The patient self-reported this case for himself. The patient was treating with high dose oral prednisone for 6 days plus a 4-day taper. Patient had taken concomitants include atorvastatin for many years, Ramipril, Ezetimibe, Vit D, Omeprazole and Multivitamin. Peripheral facial palsy symptoms were treated.; Sender's Comments: Facial paralysis is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Comments: No prior history, No diabetes
ATORVASTATIN; RAMIPRIL; EZETIMIBE; OMEPRAZOLE