Adverse Event Reporting

VAERS ID 2112416
Gender Male
Age 83
StateCode FR
Pharmaceutical Company MODERNA
Lot Number
Number of vaccinations 3
Vaccinated 2022-01-17
Onset 2022-01-19
Condition Life Threatening
Symptoms
  • Hypotension
  • Thrombocytopenia
  • Respiratory failure
  • Shock
  • Cytokine storm
  • Renal failure

Current Illness

Preexisting Conditions

Other Medications

Previous Vaccinations

Allergies

Laboratory Data

Write-up

Thrombocytopenia; Cytokine storm, hypotension and shock, respiratory failure, renal failure; Cytokine storm, hypotension and shock, respiratory failure, renal failure; Cytokine storm, hypotension and shock, respiratory failure, renal failure; Cytokine storm, hypotension and shock, respiratory failure, renal failure; Cytokine storm, hypotension and shock, respiratory failure, renal failure; This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOCYTOPENIA (Thrombocytopenia), CYTOKINE STORM (Cytokine storm, hypotension and shock, respiratory failure, renal failure), HYPOTENSION (Cytokine storm, hypotension and shock, respiratory failure, renal failure), SHOCK (Cytokine storm, hypotension and shock, respiratory failure, renal failure), RESPIRATORY FAILURE (Cytokine storm, hypotension and shock, respiratory failure, renal failure) and RENAL FAILURE (Cytokine storm, hypotension and shock, respiratory failure, renal failure) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.
No Medical History information was reported.
On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.
On 19-Jan-2022, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criterion life threatening), CYTOKINE STORM (Cytokine storm, hypotension and shock, respiratory failure, renal failure) (seriousness criterion life threatening), HYPOTENSION (Cytokine storm, hypotension and shock, respiratory failure, renal failure) (seriousness criterion life threatening), SHOCK (Cytokine storm, hypotension and shock, respiratory failure, renal failure) (seriousness criterion life threatening), RESPIRATORY FAILURE (Cytokine storm, hypotension and shock, respiratory failure, renal failure) (seriousness criterion life threatening) and RENAL FAILURE (Cytokine storm, hypotension and shock, respiratory failure, renal failure) (seriousness criterion life threatening).
At the time of the report, THROMBOCYTOPENIA (Thrombocytopenia), CYTOKINE STORM (Cytokine storm, hypotension and shock, respiratory failure, renal failure), HYPOTENSION (Cytokine storm, hypotension and shock, respiratory failure, renal failure), SHOCK (Cytokine storm, hypotension and shock, respiratory failure, renal failure), RESPIRATORY FAILURE (Cytokine storm, hypotension and shock, respiratory failure, renal failure) and RENAL FAILURE (Cytokine storm, hypotension and shock, respiratory failure, renal failure) was resolving.
Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
No concomitant medication were reported.
No treatment information were reported.
The patient age was reported as 83.
3 .
On 18-Jan-2022, the patient went to hospital for medical treatment due to general discomfort, loss of appetite and fever, and was admitted to hospital after the condition was evaluated by an outpatient physician.
After admission, the patient had symptoms like hypotension, oliguria, and dyspnea.
On 19-Jan-2022, the patient continued to have severe chest pain, dyspnea, hypotension, shock, respiratory failure, renal failure and other symptoms, and was transferred to the Hospital.
On 20-Jan-2022, the attending physician reported a suspected adverse event after COVID-19 vaccination.
The lab test was reported as Anti-Platelet Factor 4 Antibody test with unknown results.
Company Comment This is a regulatory case concerning a 83-year-old male patient with no medical history reported,who experienced the serious unexpected AESI events of Thrombocytopenia, Cytokine storm and Renal failure and serious unexpected events of Hypotension, Shock and Respiratory failure.
The events occurred 2 days after administration of the third dose of mRNA-1273 (Spikevax).
The patient's advanced age remains a confounder limited information regarding these events have been provided at this time.
The benefit-risk relationship of mRNA-1273 (Spikevax) Vaccine is not affected by this report.
Limited information regarding these events has been provided at this time.
patient's medical history, complete reports of diagnostic tests, and hospital records not reported; Sender's Comments: This is a regulatory case concerning a 83-year-old male patient with no medical history reported,who experienced the serious unexpected AESI events of Thrombocytopenia, Cytokine storm and Renal failure and serious unexpected events of Hypotension, Shock and Respiratory failure.
The events occurred 2 days after administration of the third dose of mRNA-1273 (Spikevax).
The patient's advanced age remains a confounder limited information regarding these events have been provided at this time.
The benefit-risk relationship of (Spikevax) Vaccine is not affected by this report.