Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Heart failure; Heart attack; Broken ankle; This serious case was reported by a consumer via call center representative and described the occurrence of cardiac failure in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included type i diabetes mellitus (Diabetes type 1 (diagnosed prior the administration of Shingrix)) and cardiac failure (Heart failures before and after the first dose of Shingrix). On 10-APR-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced cardiac failure (Verbatim: Heart failure) (serious criteria GSK medically significant), heart attack (Verbatim: Heart attack) (serious criteria GSK medically significant) and ankle fracture (Verbatim: Broken ankle). The outcome of the cardiac failure, heart attack and ankle fracture were unknown. The reporter considered the cardiac failure, heart attack and ankle fracture to be unrelated to Shingrix. The company considered the cardiac failure, heart attack and ankle fracture to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 24-FEB-2025 A member of the public call to asked if she could receive directly the second dose of Shingrix after she had the first one on 10th April 2024, or if she should restart the first dose to finally get that second. She mentioned to be diagnosed with diabetes type I before having the first dose, but also to have had a broken ankle, a heart attack and a heart failure were unrelated to the vaccine administration, since the first dose was given to date. Patient had heart attack, heart failure, broken ankle after Shingrix first dose.; Sender's Comments: Cardiac failure and Myocardial infarction are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Cardiac failure (Heart failures before and after the first dose of Shingrix); Type I diabetes mellitus (Diabetes type 1 (diagnosed prior the administration of Shingrix))