Received May 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
burning lips; sensitive lips; Suspected Oral herpes zoster/I got a mild casr of shingles; sores around lips; This non-serious case was reported by a consumer via call center representative and described the occurrence of oral herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis. In APR-2025, the patient received Shingrix. In APR-2025, an unknown time after receiving Shingrix, the patient experienced oral herpes zoster (Verbatim: Suspected Oral herpes zoster/I got a mild casr of shingles) and sores lip (Verbatim: sores around lips). On 21-APR-2025, the patient experienced burning lips (Verbatim: burning lips) and sensitive lips (Verbatim: sensitive lips). The outcome of the oral herpes zoster was not reported and the outcome of the burning lips, sores lip and sensitive lips were not resolved. It was unknown if the reporter considered the oral herpes zoster, burning lips, sores lip and sensitive lips to be related to Shingrix. It was unknown if the company considered the oral herpes zoster, burning lips, sores lip and sensitive lips to be related to Shingrix. Additional Information: GSK receipt date: 07-MAY-2025 Reporter stated that vaccine she got was the Shingrix, and it was for shingles. And she was having, about 5 days after my vaccination, she had burning on her lips and tiny sores around the outside of her lips. At the time of reporting this was been going on about three weeks. a week after her first dose of Shingrix, lips got very sensitive and burning that was April 21, she initially thought it might be cold sores but still had not healed and it didn't respond to cold sore meds. Reporter asked was it possible that she got a mild case of Shingles from the vaccine.