Received Jun 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
acute pericarditis; Improper schedule of vaccination; This serious case was reported by a consumer via call center representative and described the occurrence of acute pericarditis in a 76-year-old female patient who received Herpes zoster (Shingrix) solution for injection for prophylaxis. The patient's past medical history included pericarditis. In JUN-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced acute pericarditis (Verbatim: acute pericarditis) (serious criteria hospitalization and GSK medically significant) and incomplete course of vaccination (Verbatim: Improper schedule of vaccination). The patient was treated with colchicine. The outcome of the acute pericarditis was not reported and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the acute pericarditis to be related to Shingrix. The company considered the acute pericarditis to be unrelated to Shingrix. Additional Information: GSK Receipt Date:27-MAY-2026 The patient received her first dose of Shingrix in JUN-2024, and she was recently hospitalized for acute pericarditis. The patient stated that she had been prescribed Colchicine for pericarditis and would coordinate with her healthcare professional to receive her second dose of Shingrix. The batch number was not provided upon follow up with the reporter.; Sender's Comments: A case of Pericarditis, unknown time and not applicable after receiving 1st dose and 2nd dose of Shingrix in a 76-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (medical history of pericarditis).
Medical History/Concurrent Conditions: Pericarditis