Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Heart attack; Congestive heart failure; Broken ankle; Inappropriate schedule of vaccine administered; This serious case was reported by a consumer via call center representative and described the occurrence of heart attack in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In APR-2024, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient did not receive the 2nd dose of Shingrix. In APR-2024, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced heart attack (Verbatim: Heart attack) (serious criteria hospitalization and GSK medically significant), congestive heart failure (Verbatim: Congestive heart failure) (serious criteria hospitalization and GSK medically significant) and ankle fracture (Verbatim: Broken ankle) (serious criteria hospitalization). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the heart attack, congestive heart failure and ankle fracture were resolved with sequelae and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the heart attack, congestive heart failure and ankle fracture to be related to Shingrix. The company considered the heart attack, congestive heart failure and ankle fracture to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 24-FEB-2025 The reporter stated she received first dose of Shingrix vaccine in April 2024. She stated that shortly thereafter she had broken her ankle and was in the hospital with a heart attack and congestive heart failure. She was now recovered and ambulatory and wanted to get dose 2 of vaccine Till the time of reporting, the patient did not receive the second dose of Shingrix vaccine, which led to incomplete course of vaccination.; Sender's Comments: Myocardial infarction, Cardiac failure congestive and Ankle fracture are unlisted events which are considered unrelated to GSK vaccine Shingrix.