Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Shingrix potential off-label early administration due to uncertainty in the immunocompromised status in a diabetic patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Shingrix potential off-label early administration due to uncertainty in the immunocompromised status in a diabetic patient). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 23-JUL-2025 The health care provider wanted to know if it was okey to give Shingrix to a 48-year-old patient with diabetes which led to inappropriate age at vaccine administration. The reporter mentioned that the patient had already received the first dose. The agent tried to collect adverse event details for the uncertainty of the immunodeficient state of the patient at the beginning of the call, but the health care provider only provided gender and date of birth and refused to give the rest. Transfer to second line was made for further assistance, after this, the health care provider mentioned to not consider the patient diabetes as a cause of an immunodeficient state. The healthcare professional refused to provide more details than patient gender and date of birth and MI agent understood this as a denial of consent for follow up, as she did not want to delve further into the matter and provide more details.
Diabetes