Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / RA |
got a little outbreak that was itchy on her right wrist, like a cluster of bubbles, another blister above her right wrist/chills, fever, headache, sleep excessive, lethargy, nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 22-AUG-2025 16:00, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On 22-AUG-2025, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: got a little outbreak that was itchy on her right wrist, like a cluster of bubbles, another blister above her right wrist/chills, fever, headache, sleep excessive, lethargy, nausea). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 19-SEP-2025 The patient self-reported this case. The patient received her first dose of Shingrix on Friday from her pharmacist, and that by midnight that evening, she was experiencing chills which lasted until dinnertime on Sunday. The patient developed a fever at 2 AM on Saturday, that felt like a sunburn and her temperature was 101.4 Fahrenheit when she got up that morning, with the highest recorded temperature of 101.7 Fahrenheit. The patient reported that her fever was 99.9 Fahrenheit on Sunday and 99.3 Fahrenheit on Monday then dissipated on Monday and had a very bad headache, like a migraine, all day on Saturday and she could not look at her phone or TV but had to be in the dark. The patient lost days of work as a result of the headache and did not normally have headaches, and could function better on Sunday, and had to sleep all day or was in bed all day on Saturday, through half the day on Sunday. The patient was lethargic and had no real strength on Saturday, but this was better on Sunday, and she had nausea the whole day on Saturday that was gone on Sunday. The patient had only had fluids all day on Saturday and had about 10 days to 2 weeks (no specific date provided) after receiving the first dose of Shingrix, she got a little outbreak that was itchy on her right wrist, like a cluster of bubbles, another blister above her right wrist, and also on her left inner shoulder. The patient had these areas were very itchy and she still had the itchiness today (on the reporting day) The patient had these itchy areas which were not healing quickly and were leaving a mark. The patient did have these itchy areas checked out and whomever checked them out, did not know what they were. The patient reported that she did not normally had reactions to vaccines and had a solid immune system.