Received Aug 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | IM / LA |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Recurrence of shingles; administered this vaccine four weeks after a mild case of the shingles; This non-serious case was reported by a consumer and described the occurrence of shingles in a 51-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included diabetes, esophageal acid reflux and hypothyroidism. Concomitant products included metformin hydrochloride (Metformin), tirzepatide (Mounjaro), omeprazole (Protonix) and levothyroxine sodium (Synthroid). On 16-JUN-2025, the patient received Shingles vaccine. On 16-JUN-2025, an unknown time after receiving Shingles vaccine, the patient experienced product use in unapproved indication (Verbatim: administered this vaccine four weeks after a mild case of the shingles). On 18-JUN-2025, the patient experienced shingles (Verbatim: Recurrence of shingles). The patient was treated with pregabalin. The outcome of the shingles was not resolved and the outcome of the product use in unapproved indication was not applicable. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 31-JUL-2025 The reporter reported that they had been to see the provider several times, been referred to pain management, and have been to an ear, nose and throat twice already as everyone has tried to manage this. The patient have spent a lot of money on medications already and according to the ear, nose and throat and could be looking at 3 to 4 months on antiviral medications at a minimum. The reporter did not know how long would be on the pain medication for the never pain. The patient was administered this vaccine four weeks after a mild case of the shingles after being told it was safe to do to. The sores are in the mouth, which has made eating hard and painful, wake up in pain because when the teeth touch each other had a lot of pain. The patients face hurts and the lips go numb at times. This whole thing sucks and while it was rare, it was still happening.
Diabetes; Esophageal acid reflux; Hypothyroidism
METFORMIN; MOUNJARO; Protonix; SYNTHROID