Received Oct 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Shingles, shingles outbreak to her face, mouth, throat and lips; Burning skin; Numbness; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included atrial fibrillation (Atrial fibrillation), heart rate irregular (Irregular heart beat), non-insulin-dependent diabetes mellitus (NIDDM) and arthritis (Arthritis). Concurrent medical conditions included hypertension (Hypertension) and breast cancer (Breast cancer Currently in remission). On 02-APR-2025, the patient received the 1st dose of Shingrix. In APR-2025, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles, shingles outbreak to her face, mouth, throat and lips), burning skin (Verbatim: Burning skin) and numbness (Verbatim: Numbness). In MAY-2025, the outcome of the shingles was resolved with sequelae. The outcome of the burning skin and numbness were unknown. It was unknown if the reporter considered the shingles, burning skin and numbness to be related to Shingrix. It was unknown if the company considered the shingles, burning skin and numbness to be related to Shingrix. Additional Information: GSK Receipt Date: 13-OCT-2025 Patient stated that it was a bad case and lasted about one month. The batch number was not provided and a request for this information has been made.
Breast cancer (Breast cancer Currently in remission); Hypertension (Hypertension)
Medical History/Concurrent Conditions: Arthritis; Atrial fibrillation; Heart rate irregular (Irregular heart beat); Non-insulin-dependent diabetes mellitus (NIDDM)