Vaer Report Details
Age: 41 years old
Gender: Male
State: Outside US
- Patient Died?
- No
- Vaccine information
-
Name: COVID19 (COVID19 (MODERNA))
Type: Coronavirus 2019 vaccine
Manufacturer: MODERNA
Lot: unknown
- Date report was received
- 2022-03-04
- Date form completed
- Date Vaccinated
- 2022-01-09
- Date of Onset
- 17
- Number of days (onset date – vaccination date)
- 17
- Adverse Event Description
-
pulmonary embolism; this case was received (reference number: gr-greof-202200751) on 25-feb-2022 and was forwarded to moderna on 25-feb-2022. this regulatory authority case was reported by a physician and describes the occurrence of pulmonary embolism (pulmonary embolism) in a 41-year-old male patient who received mrna-1273 (spikevax) for covid-19 vaccination. the patient's past medical history included smoker (10 p/y). concomitant products included levothyroxine sodium (thyrohormone) for an unknown indication. on 09-jan-2022, the patient received third dose of mrna-1273 (spikevax) (unknown route) 1 dosage form. on 26-jan-2022, the patient experienced pulmonary embolism (pulmonary embolism) (seriousness criteria hospitalization, medically significant and life threatening). at the time of the report, pulmonary embolism (pulmonary embolism) was resolving. for mrna-1273 (spikevax) (unknown), the reporter did not provide any causality assessments. additional information on concomitant product was reported as thyrohormone levothyroxine sodium. treatment details was not reported by the reporter. company comment: this regulatory case concerns a 41-year-old, male patient with no relevant medical history, who experienced the unexpected, serious (seriousness criteria life-threatening, hospitalization and medically significant), aesi of pulmonary embolism 17 days after the third dose of mrna-1273. at the time of report, outcome of the event was resolving. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report. the case was assessed as serious as per regulatory authority report.; sender's comments: this regulatory case concerns a 41-year-old, male patient with no relevant medical history, who experienced the unexpected, serious (seriousness criteria life-threatening, hospitalization and medically significant), aesi of pulmonary embolism 17 days after the third dose of mrna-1273. at the time of report, outcome of the event was resolving. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report. the case was assessed as serious as per regulatory authority report
- Lab Data
-
na
- List of symptoms
-
pulmonary embolism
- Patient Died?
- No
- Date Died
- NA
- Birth defect
- false
- Vaccine Administered By:
- Unknown
- Vaccine Purchased By:
- Unknown
- Patient visit ER?
- No
- Patient Hospitalized?
- Yes
- Stay in hospital
- No
- Days in hospital
- Unspecified
- Permanent disability?
- No
- Allergies:
-
na
- Current Illness
-
na