Adverse Event Reporting

VAERS ID 1699733
Gender Male
Age 31
StateCode FR
Pharmaceutical Company MODERNA
Lot Number
Number of vaccinations
Vaccinated
Onset 2021-08-16
Condition
Symptoms
  • Dyspnoea
  • Chest pain
  • Malaise
  • Pulmonary embolism
  • Radioisotope scan

Current Illness

Preexisting Conditions

Other Medications

Previous Vaccinations

Allergies

Laboratory Data

Test Date: 20210825; Test Name: pulmonary Scintigraphy; Result Unstructured Data: embolic findings on the right

Write-up

embolic findings; Malaise; This case was initially received via the RA (Reference number: IT-MINISAL02-778498) on 07-Sep-2021.
The most recent information was received on 07-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.
This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (embolic findings) in a 31-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation.
The occurrence of additional non-serious events is detailed below.
No Medical History information was reported.
On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form.
On 16-Aug-2021, the patient experienced CHEST PAIN, DYSPNOEA and MALAISE (Malaise).
On 25-Aug-2021, the patient experienced PULMONARY EMBOLISM (embolic findings) (seriousness criterion medically significant).
At the time of the report, PULMONARY EMBOLISM (embolic findings) and MALAISE (Malaise) outcome was unknown and CHEST PAIN and DYSPNOEA had not resolved.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, Radioisotope scan: embolic findings on the right (abnormal) embolic findings on the right.
For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.
Concomitant medications were not reported.
The patient arrived in the emergency room (ER) on 16-Aug-2021 for chest pain and non-specific malaise onset the day after the Moderna COVID vaccine.
Performed pulmonary scintigraphy on 25-Aug-2021 that documented embolic findings on the right.
Started anticoagulant therapy.
Company Comment: Very limited information regarding these events has been provided at this time.
Based on the current available information the causality for the events is assessed as unlikely related to mRNA-1273.
Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Translated document received on 10-Sep-2021 included additional event (serious), lab data, treatment information and narrative.
; Sender's Comments: Very limited information regarding these events has been provided at this time.
Based on the current available information the causality for the events is assessed as unlikely related to mRNA-1273.