Case #1380716 received by VAERS on 6/8/2021: “Missed second dose; Heart attack; heart was racing; stomach bothering him; 101.4 degrees fever; chills; some headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 22-year-old male patient who received mRNA-1273 (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient’s past medical history included Flu in February 2020. Concurrent medical conditions included Muscular dystrophy. On 21-Apr-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 01-May-2021, the patient experienced TACHYCARDIA (heart was racing), ABDOMINAL DISCOMFORT (stomach bothering him), PYREXIA (101.4 degrees fever), CHILLS (chills) and HEADACHE (some headaches). On 16-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. The patient died on 16-May-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, PRODUCT DOSE OMISSION ISSUE (Missed second dose), TACHYCARDIA (heart was racing), ABDOMINAL DISCOMFORT (stomach bothering him), PYREXIA (101.4 degrees fever), CHILLS (chills) and HEADACHE (some headaches) outcome was unknown. No Concomitant product use was provided This is a case of product dose omission issue. Very limited information regarding this patient’s death has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Significant follow up received :- Patient died, Reporter email and phone number added, patient’s medical history added,events updated; Sender’s Comments: This is a case of product dose omission issue. Very limited information regarding this patient’s death has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Heart Attack”
Date of COVID-19 Vaccination: 4/21/2021. Date of Death: 5/16/2021.
Case #1403396 received by VAERS on 6/16/2021: “On Friday night, April 16,2021, after working all day for his job, [22 year-old] Pt told his roomates that he wasn’t feeling well, was throwing up, had the chills and was going to lay down. When the roomates didn’t see him Monday morning, April 19, 2021, they went into his room and found him unresponsive. The medical examiner ruled death due to cancer which appears incorrect considering the evidence.”
History: “Colon cancer. At the last visit to infushion center for chemo on April 9, 2021 , blood counts indicated no imminent organ failure and he was not jaundice.”
Date of COVID-19 Vaccination: 4/11/2021. Date of Death: 4/19/2021.
Case #960841 received by VAERS on 1/21/2021: “[23 year-old] Patient developed 104.4 temp approximately 48 hours after being given the vaccine. I treated him with antibiotics, IV fluids, cooling methods. CXR does show a new right perihilar infiltrate. However, his fever came down within the next 24-48 hours. Unfortunately, he suffered a cardiac arrest on 1/21/21 in the early morning and expired.”
Date of COVID-19 Vaccination: 1/17/2021. Date of Death: 1/21/2021.
Case #1204016 received by VAERS on 4/13/2021: “[23 year-old] HE DIED SUDDENLY !!!!! JUST COLLAPSED !!!!”
Date of COVID-19 Vaccination: 4/9/2021. Date of Death: 4/13/2021.
Case #1321517 received by VAERS on 5/16/2021: “[23 year-old] He did not told me about any symptoms. He just died the next day of the vaccine. Still today doesn’t know why he died. He appeared to be in good health.”
Date of COVID-19 Vaccination: 4/30/2021. Date of Death: 5/1/2021.
Established in 1990, the Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.
VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern.