Received Nov 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | UNK | — |
she got shingles in her right eye/the right eye is red and itchy.; increased eye pressure; This serious case was reported by a nurse via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received mepolizumab (Nucala) solution for injection in pre-filled pen for nasal polyp. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Caller reports she had one dose of Shingrix about 3 years ago but never received the second dose.). On an unknown date, the patient started Nucala (subcutaneous) 100 mg and the 3rd dose of Shingrix. On an unknown date, an unknown time after starting Nucala and an unknown time after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: she got shingles in her right eye/the right eye is red and itchy.) (serious criteria GSK medically significant) and increased intraocular pressure (Verbatim: increased eye pressure). The action taken with Nucala was unknown. The outcome of the ophthalmic herpes zoster was not resolved and the outcome of the increased intraocular pressure was unknown. It was unknown if the reporter considered the ophthalmic herpes zoster and increased intraocular pressure to be related to Nucala, Nucala Autoinjector Device and Shingrix. The company considered the ophthalmic herpes zoster to be unrelated to Nucala, Nucala Autoinjector Device and Shingrix. It was unknown if the company considered the increased intraocular pressure to be related to Nucala, Nucala Autoinjector Device and Shingrix. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date 23-OCT-2025 The patient, a retired nurse, reported that she received one injection of Nucala Autoinjector for nasal polyps a few months ago, although she could not recall the exact date or month. Approximately two weeks following the injection, she developed shingles in her right eye. The patient mentioned that she had received one dose of the Shingrix vaccine about three years ago but did not complete the second dose, indicating an inappropriate schedule of vaccination. The caller states she kept going on and off the steroid eye drops because they was raising the pressure in her right eye. The shingles was still not resolved, and the right eye was red and itchy. Caller states she only took the one dose of Nucala and her HCP decided it. Steroid consider as co-suspect.; Sender's Comments: The company has assessed that it is unlikely that Ophthalmic herpes zoster was caused by the Nucala drug, Nucala AUTOINJECTOR DEVICE .Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought. A case of Ophthalmic herpes zoster, an unknown time after receiving Shingrix, in a female patient. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Nucala