Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Acute myocardial infarction, Troponin I increased
Clinical narrative: NSTEMI; Initial information received on 21-May-2024 regarding a solicited valid serious case received from a physician, in the scope of company sponsored study.  This case involves a 71-year-old male subject who experienced NSTEMI (Non-ST-elevation myocardial infarction), during the study participation.  The subject's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The subject's past medical history and concomitant medications were not provided.   On 13-May-2024, the subject received a dose 01 of suspect investigational QIV MRNA VS QIV-SD AND QIV-HD AND RIV4 Suspension for injection at an unknown dosage via intramuscular route in the upper right arm prophylactic vaccination. On the same day at 17:32, Troponin I value was within normal range at 9.3 pg/ml (0-44.8).  On 15-May-2024 after visit 02, i.e., 2 days following the administration of QIV MRNA VS QIV-SD AND QIV-HD AND RIV4, at 14:00, Troponin I value was out of normal range at 2128.8 pg/ml (0-44.8) and the subject was diagnosed with NSTEMI (Acute myocardial infarction). The subject was hospitalized for this event.  Maximum intensity of the event was Grade 3. The event (NSTEMI) qualified for Adverse Event and the event was assessed.  On 20-May-2024 at 13:10, Troponin I value was out of normal range at 312.4 pg/ml (0-44.8).  On 23-May-2024 at 09:50, Troponin I value was out of normal range at 128.9 pg/ml (0-44.8).  Action taken with QIV MRNA VS QIV-SD AND QIV-HD AND RIV4 was not applicable.  No corrective treatment was received for the event (NSTEMI).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.  NSTEMI was considered to be related to QIV MRNA VS QIV-SD AND QIV-HD AND RIV4 by the reporter and reportable by the company based on company causality assessment.  Relationship between NSTEMI and the study procedure was not reported by the reporter and by the company based on company causality assessment.  Based on the information received on 21-May-2024, the study code has been broken for regulatory purposes, since the event NSTEMI is unexpected according to reference safety information in force at time of the event onset.  Additional information received on 25-May-2024 (significant; all were processed together, due to system limitation we are not able to change the date from 25-May-2024 to 21-May-2024): Event verbatim was updated from critical elevated troponin levels to NSTEMI, seriousness criteria updated from medically significant to hospitalization, lab tests were added. Narrative amended accordingly.; Sender's Comments: Sanofi Company Comment dated on 25-May-2024:   This case involves 71-year-old male participant who received investigational vaccine. Post vaccination, the participant was asymptomatic and hospitalized for examination because of very high level of troponin I. He was diagnosed with NSTEMI in the hospital. Other information from the hospital is pending. Based on the information provided, the causal relationship of company investigational product (IP) cannot be excluded for serious event of NSTEMI considering the plausible temporal relationship. Moreover, the subject's elderly age could act as confounding factors. The case will be re-evaluated once the follow up information is received.