Vaer Report Details
Age: 66 years old
Gender: Male
State: Outside US
- Patient Died?
- No
- Vaccine information
-
Name: COVID19 (COVID19 (MODERNA))
Type: Coronavirus 2019 vaccine
Manufacturer: MODERNA
Lot: 000004a
- Date report was received
- 2022-03-04
- Date form completed
- Date Vaccinated
- 2022-01-31
- Date of Onset
- 2
- Number of days (onset date – vaccination date)
- 2
- Adverse Event Description
-
bilateral pulmonary embolism; this case was received via agency (reference number: it-minisal02-841004) on 24-feb-2022 and was forwarded to moderna on 24-feb-2022. this regulatory authority case was reported by a physician and describes the occurrence of pulmonary embolism (bilateral pulmonary embolism) in a 66-year-old male patient who received mrna-1273 (spikevax) (batch no. 000004a) for covid-19 vaccination. no medical history information was reported. on 31-jan-2022, the patient received dose of mrna-1273 (spikevax) (intramuscular) .25 milliliter. on 02-feb-2022, after starting mrna-1273 (spikevax), the patient experienced pulmonary embolism (bilateral pulmonary embolism) (seriousness criterion hospitalization). at the time of the report, pulmonary embolism (bilateral pulmonary embolism) had not resolved. for mrna-1273 (spikevax) (intramuscular), the reporter did not provide any causality assessments. no concomitant medications were mentioned. no treatment details were reported. it was reported that patient had bilateral pulmonary embolism two weeks after 3-dose sars-cov2 vaccine with moderna vaccine. all diagnostic-instrumental tests were performed which excluded all other possible causes of embolism. company comment: this regulatory case concerns a 66-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant according to authority report), event of pulmonary embolism (adverse event of special interest), 2 days after the third dose of mrna-1273 vaccine. clinical details, treatment not reported. it was reported that all diagnostic tests were performed which excluded all other possible causes of embolism. outcome was reported as not resolved at the time of reporting. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report.; reporter's comments: bilateral pulmonary embolism two weeks after 3-dose sars-cov2 vaccine with moderna vaccine. all diagnostic-instrumental tests were performed which exclude all other possible causes of embolism.; sender's comments: this regulatory case concerns a 66-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant according to authority report), event of pulmonary embolism (adverse event of special interest), 2 days after the third dose of mrna-1273 vaccine. clinical details, treatment not reported. it was reported that all diagnostic tests were performed which excluded all other possible causes of embolism. outcome was reported as not resolved at the time of reporting. the benefit-risk relationship of mrna-1273 vaccine is not affected by this 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