Received May 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Bell-palsy; I thought I went through a stoke; Suspected vaccination failure; shingles included, the only thing I needed was to have the clusters; That weird feeling of the shingles; Fever; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In MAR-2025, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: Bell-palsy) (serious criteria GSK medically significant), stroke (Verbatim: I thought I went through a stoke) (serious criteria GSK medically significant), vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles included, the only thing I needed was to have the clusters), weird feeling (Verbatim: That weird feeling of the shingles) and fever (Verbatim: Fever). The outcome of the bell's palsy, stroke, vaccination failure, shingles, weird feeling and fever were not reported. The reporter considered the bell's palsy to be related to Shingles vaccine. It was unknown if the reporter considered the stroke, vaccination failure, shingles, weird feeling and fever to be related to Shingles vaccine. The company considered the bell's palsy, stroke and vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, weird feeling and fever to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-MAY-2025 The case was received from the patient via interactive digital media. The reporter had taken the shingles vaccine. The reporter thought he/she went through a stoke. His/her right side of face dropped completely, my eye closed, the pain throughout my right side of my face, and behind my ear it was so painful. The reporter thought the stroke took place behind the ear. That weird feeling of the shingles included, the only thing he/she needed was to have the clusters, oh also with fever. The reporter reported, never again would take a vaccine. His/her mouth went to the left side of face. The reporter reported that you need 2 vaccines to get protected for 7 years, he/she was protected for 31/2 years. It was called Bell-palsy from the shingles vaccine. This symptoms can last upto 8 months. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Cerebrovascular accident and Bell's palsy is an unlisted event which is considered unrelated to GSK Shingles vaccine.