Received Mar 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | RA |
Encephalitis NOS; aggressive; loss of memory; cant walk; Hallucinations; body was slow; inability to talk/ not talking much; Sodium low; calm; This serious case was reported by a consumer via call center representative and described the occurrence of encephalitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes, hypertension and hypercholesterolemia. In NOV-2024, the patient received the 1st dose of Shingrix (right arm). On an unknown date, 2 weeks after receiving Shingrix, the patient experienced encephalitis (Verbatim: Encephalitis NOS) (serious criteria hospitalization and GSK medically significant), aggression (Verbatim: aggressive) (serious criteria hospitalization), memory loss (Verbatim: loss of memory) (serious criteria hospitalization), unable to walk (Verbatim: cant walk) (serious criteria hospitalization), hallucination (Verbatim: Hallucinations) (serious criteria GSK medically significant), movements reduced (Verbatim: body was slow), aphasia (Verbatim: inability to talk/ not talking much), sodium decreased (Verbatim: Sodium low) and relaxed (Verbatim: calm). The outcome of the encephalitis, aggression, memory loss, unable to walk and aphasia were not resolved and the outcome of the hallucination, movements reduced, sodium decreased and relaxed were unknown. It was unknown if the reporter considered the encephalitis, aggression, memory loss, unable to walk, hallucination, movements reduced, aphasia, sodium decreased and relaxed to be related to Shingrix. The company considered the encephalitis, aggression, memory loss, unable to walk, hallucination, movements reduced, aphasia, sodium decreased and relaxed to be unrelated to Shingrix. Additional Information: GSK Receipt Date : 18-MAR-2025 and 19-MAR-2025 Reporter reported that her husband was vaccinated with Shingrix in November 2024 (exact date unknown). Received first dose of Shingrix in his right arm. The consumer received the vaccination at approximately two weeks after vaccination with Shingrix the consumer started hallucinated. The reporter stated the consumer's body was slow, he was calm and not talked much which was abnormal for the consumer. The consumer was taken to the emergency department for evaluation. The consumer was diagnosed as having low sodium and released to home with instructions for high sodium diet. Approximately one month later the consumer became aggressive and he was admitted to the hospital. Date of hospital admission 29 DEC 2024. The reporter stated many tests were performed by the hospital. The consumer remained in the hospital and on 11 February 2025 the consumer was given a diagnosis of Encephalitis. The consumer was released from the hospital on 23rd January 2025 and due to aggression the consumer was readmitted to the hospital on 25 January 2025. The consumer remained hospitalized at the time of the call from the reporter. The reporter stated she was unsure if consumer received any other vaccinations/medication at the time of vaccination with Shingrix.; Sender's Comments: Encephalitis, Aggression, Amnesia, Gait inability, Hallucination , Hypokinesia, Aphasia, Blood sodium decreased and Feeling of relaxation are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Diabetes; Hypercholesterolemia; Hypertension