Received Jun 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 2M7GR | IM / LA |
major eye-lid infection/ side of eye affected; spread to face and under cheek close to ear/ Viral infection in face; facial nerves have been affected; mouth drooping; Flu like symptoms; achy/ feeling achy; This serious case was reported by a consumer via call center representative and described the occurrence of facial droop in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 2M7GR, expiry date 31-JAN-2027) for prophylaxis. On 16-MAY-2025, the patient received the 2nd dose of Shingrix (intramuscular use, left arm). On 16-MAY-2025, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms) and pain (Verbatim: achy/ feeling achy). In JUN-2025, the patient experienced facial droop (Verbatim: mouth drooping) (serious criteria GSK medically significant). On an unknown date, the patient experienced eye infection viral (Verbatim: major eye-lid infection/ side of eye affected), viral infection (Verbatim: spread to face and under cheek close to ear/ Viral infection in face) and facial nerve disorder (Verbatim: facial nerves have been affected). The patient was treated with valaciclovir (Valacyclovir) and prednisone. On 19-MAY-2025, the outcome of the influenza-like symptoms was resolved (duration 3 days). The outcome of the facial droop and facial nerve disorder were not resolved and the outcome of the pain was resolved (duration 3 days) and the outcome of the eye infection viral was resolving and the outcome of the viral infection was resolved. It was unknown if the reporter considered the facial droop, influenza-like symptoms, pain, eye infection viral, viral infection and facial nerve disorder to be related to Shingrix. The company considered the facial droop to be unrelated to Shingrix. It was unknown if the company considered the influenza-like symptoms, pain, eye infection viral, viral infection and facial nerve disorder to be related to Shingrix. Additional Information: GSK Receipt Date: 11-JUN-2025 The patient self-reported this case for herself. She stated that she had received her second dose of Shingrix in her left arm on 16th May 2025. She reported experiencing symptoms that evening, including body aches and flu-like symptoms, which lasted for three days. A few days later, she developed a major infection on her eyelid and the side of her eye. Eight days after that, the infection had spread to her face, beneath her cheek, and near her ear, affecting a wide area. She noted that the condition lasted for a while. She reported that three days ago, her mouth had begun to droop. She had seen three physicians for examination and treatment and had an appointment with a neurologist on 10th June 2025. She stated that she had been prescribed Valacyclovir 1 gram to take every 12 hours for 7 days, and Prednisone 10 milligram, 5 tablets daily for 7 days, with the dosage decreased by one tablet every 7 days until gone (a total of 42 tablets prescribed). The name of the prescribing physician and the date of prescription were not provided. She stated that the achy, flu-like symptoms had resolved, the eyelid area was nearly healed, and although her face remained tender, no infection seem to be present now. She mentioned that the neurologist believed her facial nerves had been affected. She also stated that her husband, an attorney, intended to pursue legal action against GlaxoSmithKline due to the adverse events she experienced following the Shingrix vaccination.; Sender's Comments: Facial paralysis is an unlisted event which is considered unrelated to GSK vaccine Shingrix.