Received Jul 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (TIV DRESDEN) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / LA |
stemi; This 77-year-old male subject was enrolled in a blinded study titled A Phase 2a randomized, observer-blind, study to evaluate the immunogenicity and safety of mRNA based multivalent seasonal influenza vaccine candidates in adults 18 years of age and older. The subject received the 1st dose of Flu mRNA vs Flublok vs Flu D-TIV vs Fluzone (intramuscular, left deltoid) on 08-SEP-2025 14:22, for prophylaxis. Previously administered products included influenza seasonal vaccine (INTRAMUSCULAR). Concurrent medical conditions included stable angina pectoris (stable angina), hypertension (High BP), coronary artery disease, obesity, seasonal allergy, allergy to antibiotic (biaxin drug allergy) and allergy to antibiotic (bactrim drug allergy). Concomitant products included clopidogrel, isosorbide, metoprolol, acetylsalicylic acid (Baby Aspirin), ranolazine (Ranolazine Extended Release), glyceryl trinitrate (Nitroglycerin), enoxaparin sodium (Lovenox), heparin, fentanyl, ondansetron and midazolam hydrochloride (Versed). On 29-SEP-2025, 21 days after receiving Flu mRNA vs Flublok vs Flu D-TIV vs Fluzone, the subject developed severe - grade 3 st segment elevation myocardial infarction (Verbatim: stemi). Serious criteria included hospitalization and clinically significant/intervention required. The subject was treated with verapamil and clopidogrel. The outcome of st segment elevation myocardial infarction was resolved on 30-SEP-2025. Relevant Tests: On 29-SEP-2025 15:56 cardiac catheterization showed occlusion in vessels, lead to stent placement (see details in narrative). The investigator considered that there was no reasonable possibility that the st segment elevation myocardial infarction may have been caused by Flu mRNA vs Flublok vs Flu D-TIV vs Fluzone. The company considered that there was no reasonable possibility that the st segment elevation myocardial infarction may have been caused by Flu mRNA vs Flublok vs Flu D-TIV vs Fluzone. Linked case(s) involving the same subject: US2026032583 Additional Information: Subject had a positive outpatient cardiac stress test on 22-SEP-2025. Due to subject's insurance requirements, subject had to be admitted as an inpatient for a heart catheterization. Subject presented to the hospital on 29-SEP-2025., for the scheduled procedure. A percutaneous coronary intervention (PCI) was performed, and three stents were placed in the circumflex artery, the left main coronary artery, and the obtuse marginal vessel at 10:56. After the procedure, subject complained of chest pain, and an ST-segment elevation myocardial infarction (STEMI) was noted on the electrocardiogram (ECG). Subject was taken back for a second heart catheterization. The procedures performed included a transradial left heart catheterization with bypass study and coronary angiography, moderate conscious sedation for more than 15 minutes, a percutaneous coronary intervention (PCI) of an acute myocardial infarction (MI) in the vein graft to the posterior descending artery (PDA), and intravascular ultrasound (IVUS) of the saphenous vein graft (SVG) to the posterior descending artery. This second procedure occurred at 19:07. Subject was observed overnight and was discharged home the following day, on 30-SEP-2025. The serious adverse event (SAE) was not related to study participation activities other than the study treatment. Subject event became serious was 29-SEP-2025 GSK Received initial date 20-APR-2026, 21-APR-2026, 23-APR-2026. Follow up information received on 07-JUL-2026 End of study Unblinding completed.; Sender's Comments: A case of Acute myocardial infarction, 21 days after receiving 1st dose of Flu mRNA vs Flublok vs Flu D-TIV vs Fluzone, in a 77-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factors (concurrent stable angina pectoris, hypertension, coronary artery disease, obesity).
Allergy to antibiotic (biaxin drug allergy); Allergy to antibiotic (bactrim drug allergy); Coronary artery disease; Hypertension (High BP); Obesity; Seasonal allergy; Stable angina pectoris (stable angina)
CLOPIDOGREL; ISOSORBIDE; METOPROLOL; BABY ASPIRIN; RANOLAZINE EXTENDED RELEASE; NITROGLYCERIN; Lovenox; HEPARIN; FENTANYL; ONDANSETRON; VERSED
Comments: On 29-SEP-2025 15:56 cardiac catheterization showed occlusion in vessels, lead to stent placement (see details in narrative)