Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Hives; she was sick; Suspected cold; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 03-JAN-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: Hives), sickness (Verbatim: she was sick) and cold (Verbatim: Suspected cold). The outcome of the hives was resolved and the outcome of the sickness and cold were not reported. It was unknown if the reporter considered the hives, sickness and cold to be related to Shingrix. It was unknown if the company considered the hives, sickness and cold to be related to Shingrix. Additional Information: GSK receipt date: 29-AUG-2025 Patient received shot 1 of Shingrix on 03-Jan-2025 and her "docket" said that she could get shot number 2 between 28-FEB-2025 and 30-AUG-2025. Reporter explained that shot number 2 should be given 2 to 6 months later (between 03-MAR-2025 and 03-JUL-2025) and she had missed 6-month window. She was going to try to get the pharmacy to administer shot on the day of reporting. She mentioned that she had intended to come in for shot on earlier occasions but was prevented from doing so because she was sick. She did not specify the type of sickness perhaps a cold etc. She mentioned that after getting Shingrix shot 1 she got a little reaction of hives and was told that she should take Zyrtec (antihistamine) for a week before getting Shingrix shot 2.