Adverse Event Reporting

VAERS ID 2557921
Gender Male
Age 82
StateCode FR
Pharmaceutical Company MODERNA
Lot Number D17K21A
Number of vaccinations 3
Vaccinated 2021-07-30
Onset 2022-12-11
Condition Died
Symptoms
  • Depressed level of consciousness

Current Illness

Preexisting Conditions

Other Medications

Previous Vaccinations

Allergies

Laboratory Data

Write-up

DECREASE IN SENSORIUM; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (DECREASE IN SENSORIUM) in an 82-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos.
D17K21A and FM7375) for COVID-19 prophylaxis.
Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.
No Medical History information was reported.
On 30-Jul-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form.
On 23-May-2022, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form.
On 27-Sep-2022, received third dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form.
On 11-Dec-2022, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (DECREASE IN SENSORIUM) (seriousness criteria death and medically significant).
The reported cause of death was decrease in sensorium.
It is unknown if an autopsy was performed.
For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.
No concomitant information was reported.
No treatment information was reported.
Company comment: This regulatory authority case concerns an elderly 82-year-old male patient with interchange of vaccine products who experienced the unexpected serious (fatal and medically significant) event of Depressed level of consciousness which occurred about 2 months and 15 days after administration of third dose of mRNA-1273 vaccine.
Other details are not available for medical review.
It is unknown whether an autopsy was performed.
Patient received a dose of COVID-19 VACCINE NRVV AD26 prior to receiving 2 doses of mRNA-1273.
The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: This regulatory authority case concerns an elderly 82-year-old male patient with interchange of vaccine products who experienced the unexpected serious (fatal and medically significant) event of Depressed level of consciousness which occurred about 2 months and 15 days after administration of third dose of mRNA-1273 vaccine.
Other details are not available for medical review.
It is unknown whether an autopsy was performed.
Patient received a dose of COVID-19 VACCINE NRVV AD26 prior to receiving 2 doses of mRNA-1273.
The benefit-risk relationship of mRNA-1273 is not affected by this report; Reported Cause(s) of Death: DECREASE IN SENSORIUM