Received Feb 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | IM |
it was an HSV outbreak; This non-serious case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 09-OCT-2024, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). In OCT-2024, 2 days after receiving Shingrix, the patient experienced herpes simplex (Verbatim: it was an HSV outbreak). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the herpes simplex was not resolved. It was unknown if the reporter considered the herpes simplex to be related to Shingrix. It was unknown if the company considered the herpes simplex to be related to Shingrix. Additional Information: GSK Receipt Date: 06-FEB-2025 The patient self-reported this case for himself. The patient received Shingrix vaccine and had a herpes virus outbreak. The patient reported that he received the 1st and only Shingrix vaccine at a local pharmacy. The patient did not have the lot number or expiry information and did not recall in which arm the vaccine was administered. The patient reported two days later he had a herpes virus reaction outbreak and he continue having it since. At the end of the call the patient clarified the virus information and stated it was a HSV (herpes simplex virus) outbreak. The patient reported he was prescribed Valtrex and wanted to know have GSK heard this before. This was a major problem and wanted to know has anyone else report this. The patient wanted to talk about filing a claim against GlaxoSmithKline guys due to a reaction to Shingrix vaccine. No additional information was reported. It was a potential legal case. Patient wanted to be contacted by GlaxoSmithKline.