Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
Facial drooping; Ear pain; dizziness; nausea; This serious case was reported by a consumer and described the occurrence of facial droop in a 64-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included shingles and ramsay-hunt syndrome. Concomitant products included VARICELLA ZOSTER VACCINE, aciclovir (Acyclovir) and prednisone. On 01-JAN-2020, the patient received the 2nd dose of Shingles vaccine. On 25-FEB-2026, 2247 days after receiving Shingles vaccine, the patient experienced facial droop (Verbatim: Facial drooping) (serious criteria GSK medically significant), ear pain (Verbatim: Ear pain), dizziness (Verbatim: dizziness) and nausea (Verbatim: nausea). The outcome of the facial droop, ear pain, dizziness and nausea were not resolved. It was unknown if the reporter considered the facial droop, ear pain, dizziness and nausea to be related to Shingles vaccine. The company considered the facial droop to be unrelated to Shingles vaccine. It was unknown if the company considered the ear pain, dizziness and nausea to be related to Shingles vaccine. Additional Information: GSK receipt date: 12-MAR-2026 The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Facial paralysis (BCWG Category 4), 2247 days after vaccination with 2nd dose of Shingles vaccine, in a 64-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology (Concurrent medical conditions included shingles and ramsay-hunt syndrome) based on medical history.
Ramsay-Hunt syndrome; Shingles
VARICELLA ZOSTER VACCINE; ACYCLOVIR; PREDNISONE