Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
permenant hearing loss; she experienced an immense amount of sinus pressure; This serious case was reported by a physician via sales rep and described the occurrence of sinus pressure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 01-OCT-2024, the patient received Shingrix. On 01-OCT-2024, immediately after receiving Shingrix, the patient experienced sinus pressure (Verbatim: she experienced an immense amount of sinus pressure) (serious criteria other: Serious as per reporter). On an unknown date, the patient experienced hearing loss (Verbatim: permenant hearing loss) (serious criteria GSK medically significant). On 04-OCT-2024, the outcome of the sinus pressure was resolved. The outcome of the hearing loss was not resolved. The reporter considered the sinus pressure to be related to Shingrix. It was unknown if the reporter considered the hearing loss to be related to Shingrix. The company considered the sinus pressure and hearing loss to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 26-JAN-2026 The sinus pressure persisted for approximately three days. On the third day, the patient contacted her primary care provider and was advised to monitor the symptoms and follow up as needed. The sinus pressure resolved the following day. Several months after the vaccination was received, the patient visited her audiologist, who advised that permanent hearing loss had been noted. The batch number was not provided upon follow up with the reporter.; Sender's Comments: A case of Paranasal sinus discomfort and Deafness, Immediately after vaccination with unknown dose of Shingrix, in a 68-year-old female patient. Causal association is indeterminate. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Further follow up information has been sought