Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 94J5E | — |
inflammation of optic nerve on their right eye; asthma exacerbation ,asthma flare, asthma was worse, with chest pain, shortness of breath; pain at the injection site; This serious case was reported by a nurse via call center representative and described the occurrence of optic neuritis in a female patient who received Herpes zoster (Shingrix) (batch number 94J5E, expiry date 02-MAY-2027) for prophylaxis. Concurrent medical conditions included asthma. On 09-FEB-2026, the patient received the 1st dose of Shingrix. In FEB-2026, 1 week after receiving Shingrix, the patient experienced optic neuritis (Verbatim: inflammation of optic nerve on their right eye) (serious criteria GSK medically significant), asthma aggravated (Verbatim: asthma exacerbation ,asthma flare, asthma was worse, with chest pain, shortness of breath) and injection site pain (Verbatim: pain at the injection site). The outcome of the optic neuritis, asthma aggravated and injection site pain were unknown. It was unknown if the reporter considered the optic neuritis, asthma aggravated and injection site pain to be related to Shingrix. The company considered the optic neuritis to be unrelated to Shingrix. It was unknown if the company considered the asthma aggravated and injection site pain to be related to Shingrix. Additional Information: GSK Receipt Date:11-MAR-2026 The patient received the first dose of Shingrix and a week after immunization, she experienced an asthma exacerbation. She developed inflammation of the optic nerve in her right eye and had another asthma flare. Her asthma symptoms worsened, with chest pain and shortness of breath, and she continued to have pain at the injection site.; Sender's Comments: A case of Optic neuritis, 1 week after receiving Shingrix, in a female patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Asthma