Received Feb 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
4 days in a coma; and got SHINGLES 4 years later.; Symptomatic - Did Not Receive the 2nd vaccination; This serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 31-JAN-2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not received the 2nd dose of Shingrix. On 08-JAN-2025, 1438 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: and got SHINGLES 4 years later.) (serious criteria hospitalization). On an unknown date, the patient experienced coma (Verbatim: 4 days in a coma) (serious criteria hospitalization and GSK medically significant) and incomplete course of vaccination (Verbatim: Symptomatic - Did Not Receive the 2nd vaccination). The outcome of the shingles and incomplete course of vaccination were unknown and the outcome of the coma was resolved (duration 4 days). It was unknown if the reporter considered the shingles and coma to be related to Shingrix. The company considered the shingles and coma to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 30-JAN-2025 Consumer stated no one told him he needed a 2nd dose of Shingrix. The patient was proceeded to get SHINGLES 4 years after first dose and was hospitalized for 16 days, 4 days in a coma. Patient would like to be contacted and would like to send pictures and be a spokesperson. Consumer stated he doesn't believe commercial presents itself as to how serious shingles can be and the commercial needs to stated 2 shots are to be given. The reporter Consented to follow up. Till the time of reporting, the patients did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.; Sender's Comments: Herpes zoster and Coma are unlisted events which are considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).