Received Aug 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
skin lesions in face and back; This serious case was reported by a pharmacist via sales rep and described the occurrence of skin lesion in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included recurrent urinary tract infection. On 26-MAY-2025, the patient received the 1st dose of Shingrix. On 30-JUN-2025, 35 days after receiving Shingrix, the patient experienced skin lesion (Verbatim: skin lesions in face and back) (serious criteria other: Other medically imp. condition). The outcome of the skin lesion was not resolved. The reporter considered the skin lesion to be related to Shingrix. The company considered the skin lesion to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 05-AUG-2025 Patient reported skin lesions in face and back was reported as worsened. Patient with skin lesions (similar to shingles lesion) need to consult specialist dermatologist. The patient was taking antibiotics for Recurrent urinary tract infections.; Sender's Comments: A case of Skin lesion, 35 days after receiving Shingrix, in a 66-year-old male patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Recurrent urinary tract infection