Received Jul 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Rash full body/ intensely pruritic/ higgers type rash to wheels all over his upper body - both arms, chest, back, abdomen, neck, eyes were swollen, hands swollen, even lips looked a little swollen; This serious case was reported by a physician via sales rep and described the occurrence of wheals in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included arthropod bite and hay fever. On 18-JUN-2026, the patient received the 1st dose of Shingrix. On 24-JUN-2026, 6 days after receiving Shingrix, the patient experienced wheals (Verbatim: Rash full body/ intensely pruritic/ higgers type rash to wheels all over his upper body - both arms, chest, back, abdomen, neck, eyes were swollen, hands swollen, even lips looked a little swollen) (serious criteria other: Serious as per reporter). The patient was treated with prednisone, famotidine (Pepcid) and cetirizine hydrochloride (Zyrtec). The outcome of the wheals was resolving. It was unknown if the reporter considered the wheals to be related to Shingrix. The company considered the wheals to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 29-JUN-2026 A request was made to contact the Shingrix representative regarding the patient. The patient was evaluated on 16-Jun for a rash that appeared consistent with chigger bites following hay-baling activities. The patient was diagnosed with chiggers at that time. The patient received the first dose of Shingrix on 18-Jun Following vaccination, the rash worsened significantly and spread across the upper body. The patient returned for evaluation on 24-Jun At that visit, the patient presented with widespread hives involving the upper body. Swelling was noted around the eyes and hands, and possible lip swelling was observed. The rash was bilateral and was more pronounced on the right side, where the vaccine had been administered. The patient did not report chest pain or shortness of breath. Vital signs remained within normal limits. A hypersensitivity reaction with a histamine-mediated response was suspected. The patient had no known history of vaccine reactions or allergies. The batch number was not provided upon follow up with the reporter; Sender's Comments: A case of urticaria 6 days after receiving a dose of Shingrix vaccine, in a male subject. Report is inconsistent with causal relation to the vaccine product, considering: Alternative etiology (arthropod bite and hay fever).
Arthropod bite; Hay fever