Received Sep 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | FT95N | — |
Fever; Fatigue; Shingrix first dose administration during an episode of Shingles; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of fever in an adult female patient who received Herpes zoster (Shingrix) (batch number FT95N, expiry date 25-APR-2027) for prophylaxis. Concurrent medical conditions included shingles. 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 fever (Verbatim: Fever), fatigue (Verbatim: Fatigue) and product use in unapproved indication (Verbatim: Shingrix first dose administration during an episode of Shingles). The outcome of the fever and fatigue were resolved and the outcome of the product use in unapproved indication was not applicable. It was unknown if the reporter considered the fever and fatigue to be related to Shingrix. It was unknown if the company considered the fever and fatigue to be related to Shingrix. Additional Information: GSK Receipt Date: 12-AUG-2025 A pharmacist wanted to get safety information related to the administration of the first dose of Shingrix during an episode of Herpes Zoster. The patient alerted the health care provider of this, 45 days after the vaccination and mentioned to have had fever and fatigue after its administration, claiming that she shouldn't have received the first dose.
Shingles