Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Died of Cardiac arrest) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (Died of Cardiac arrest) (seriousness criteria death and medically significant) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age of vaccine administered). The patient died on an unknown date. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. At the time of death, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age of vaccine administered) outcome was unknown. No Concomitant and Treatment Medication was provided by reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This fatal spontaneous case concerns a 15yearold female patient, with no medical history reported, who received the second dose of her COVID19 immunization schedule with mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected event of cardiac arrest. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. No further information regarding the event, death date and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. Product administered to patient of inappropriate age was also considered in the case. The benefit risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up received and does not contain any new information. On 14-May-2021: Follow-up received and does not contain any new information. On 17-May-2021: Follow-up received and does not contain any new information. On 22-Jul-2021: Follow-up received and does not contain any new information. Sender's Comments: This fatal spontaneous case concerns a 15yearold female patient, with no medical history reported, who received the second dose of her COVID19 immunization schedule with mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected event of cardiac arrest. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. No further information regarding the event, death date and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. Product administered to patient of inappropriate age was also considered in the case. The benefit risk relationship of mRNA-1273 is not affected by this report. Reported Cause(s) of Death: Cardiac arrest.