Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
reduced cardiac function; elevated cardiac enzymes; low blood pressure; weakness; low grade fever; elevated pro-BNP; This serious case was reported by a physician via sales rep and described the occurrence of cardiac function decreased in a 22-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included heart transplant (Patient undergone Heart transplant 2 years ago). On an unknown date, the patient received the 2nd dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced cardiac function decreased (Verbatim: reduced cardiac function) (serious criteria GSK medically significant), cardiac enzymes increased (Verbatim: elevated cardiac enzymes) (serious criteria GSK medically significant), blood pressure decreased (Verbatim: low blood pressure), weakness (Verbatim: weakness), low grade fever (Verbatim: low grade fever) and nt-probnp increased (Verbatim: elevated pro-BNP). The outcome of the cardiac function decreased was not reported and the outcome of the cardiac enzymes increased, blood pressure decreased, weakness, low grade fever and nt-probnp increased were resolved. It was unknown if the reporter considered the cardiac function decreased to be related to Shingrix. The reporter considered the cardiac enzymes increased, blood pressure decreased, weakness, low grade fever and nt-probnp increased to be related to Shingrix. The company considered the cardiac function decreased, cardiac enzymes increased, blood pressure decreased, weakness, low grade fever and nt-probnp increased to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 02-APR-2025 Reporter stated that patient who is about 22-year-old and 2 years post-heart transplant on IC who received second dose of Shingrix vaccine and within 12 hours started having symptoms low BP, weakness and low-grade fever. He was seen at ED, ECHO performed showed reduced cardiac function no values provided for LVEF. Lab work showed elevated pro-BNP and cardiac enzymes. The patient did not require hospitalization and was only seen for follow-up at the clinic.; Sender's Comments: Cardiac dysfunction and Myocardial necrosis marker increased are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Medical History/Concurrent Conditions: Heart transplant (Patient undergone Heart transplant 2 years ago)
Test Name: blood pressure; Result Unstructured Data: (Test Result:low,Unit:unknown,Normal Low:,Normal High:); Test Name: body temperature; Result Unstructured Data: (Test Result:low grade fever,Unit:unknown,Normal Low:,Normal High:); Test Name: ECHO; Result Unstructured Data: (Test Result:reduced cardiac function,Unit:unknown,Normal Low:,Normal High:); Test Name: LVEF; Result Unstructured Data: (Test Result:unknown,Unit:unknown,Normal Low:,Normal High:); Test Name: cardiac enzyme; Result Unstructured Data: (Test Result:elevated,Unit:unknown,Normal Low:,Normal High:); Test Name: pro-BNP level; Result Unstructured Data: (Test Result:elevated,Unit:unknown,Normal Low:,Normal High:)