Received Apr 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 93KK4 | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
needed assistance to get to the restroom due to balance and weakness; needed assistance to get to the restroom due to balance and weakness; He is diabetic and sugars spiked with inability to regulate; fever; lethargy; Non-traumatic rhabdomyolysis- acute; Acute renal failure; transaminitis acute; altered mental status; Pneumonitis acute; UTI without hematuria; delirium.; severe sepsis; Organ failure; This serious case was reported by a consumer and described the occurrence of diabetes mellitus aggravated in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included type ii diabetes mellitus and hyponatremia. Concomitant products included insulin nos, tamsulosin hydrochloride (Tamulosin) and gabapentin. On 01-MAR-2025, the patient received Shingrix. On 01-MAR-2025, less than a day after receiving Shingrix, the patient experienced diabetes mellitus aggravated (Verbatim: He is diabetic and sugars spiked with inability to regulate) (serious criteria death, hospitalization and GSK medically significant), fever (Verbatim: fever) (serious criteria death and hospitalization) and lethargy (Verbatim: lethargy) (serious criteria death and hospitalization). On 02-MAR-2025, the patient experienced loss of balance (Verbatim: needed assistance to get to the restroom due to balance and weakness) (serious criteria death and hospitalization) and weakness (Verbatim: needed assistance to get to the restroom due to balance and weakness) (serious criteria death and hospitalization). In MAR-2025, the patient experienced rhabdomyolysis (Verbatim: Non-traumatic rhabdomyolysis- acute) (serious criteria death, hospitalization and GSK medically significant), acute renal failure (Verbatim: Acute renal failure) (serious criteria death, hospitalization and GSK medically significant), transaminitis (Verbatim: transaminitis acute) (serious criteria death and hospitalization), mental status changes (Verbatim: altered mental status) (serious criteria death and hospitalization), pneumonitis (Verbatim: Pneumonitis acute) (serious criteria death, hospitalization and GSK medically significant), urinary tract infection (Verbatim: UTI without hematuria) (serious criteria death and hospitalization), delirium (Verbatim: delirium.) (serious criteria death, hospitalization and GSK medically significant), sepsis (Verbatim: severe sepsis) (serious criteria GSK medically significant) and organ failure (Verbatim: Organ failure). The outcome of the sepsis and organ failure were not reported. The patient died on 09-MAR-2025. The reported cause of death was rhabdomyolysis, acute renal failure, transaminitis, mental status changes, pneumonitis, urinary tract infection and delirium. It was unknown if the reporter considered the diabetes mellitus aggravated, fever, lethargy, loss of balance, weakness, rhabdomyolysis, acute renal failure, transaminitis, mental status changes, pneumonitis, urinary tract infection, delirium, sepsis and organ failure to be related to Shingrix. The company considered the diabetes mellitus aggravated, fever, lethargy, loss of balance, weakness, rhabdomyolysis, acute renal failure, transaminitis, mental status changes, pneumonitis, urinary tract infection, delirium and sepsis to be unrelated to Shingrix. It was unknown if the company considered the organ failure to be related to Shingrix. Additional Information: GSK Receipt Date: 22-APR-2025 This report was submitted by a caregiver. The patient was in hospital for on 01 March 2025, he had fever, lethargy. On 02 March 2025, he needed assistance to get to the restroom due to balance and weakness. He was diabetic and sugars spiked with inability to regulate. The symptoms got worse. Other Products were reported as yes The patient was an active, individual. He took good care of himself. The reporter checked with his primary care physician and she indicated there were no significant health concerns in the previous year. He got severe sepsis and all of his organs failed. The patient died on 09 March 2025.; Sender's Comments: A case of a 70-year-old male patient, with multiple events for Shingrix vaccine. There is insufficient evidence to establish a conclusive causal relationship. The case is confounded by polypharmacy and comorbidities; Reported Cause(s) of Death: Non-traumatic rhabdomyolysis- acute; Acute renal failure; transaminitis; altered mental status; Pneumonitis acute; UTI without hematuria; delirium
Hyponatremia; Type II diabetes mellitus
INSULIN NOS; TAMULOSIN; GABAPENTIN