Vaer Report Details
Age: 21 years old
Gender: Female
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
- 2021-06-16
- Date of Onset
- 182
- Number of days (onset date – vaccination date)
- 182
- Adverse Event Description
-
pericardite; this case was received via regulatory authority(reference number: it-ra02-840728) on 24-feb-2022 and was forwarded to moderna on 24-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of pericarditis (pericardite) in a 21-year-old female patient who received mrna-1273 (spikevax) for covid-19 vaccination. the patient's past medical history included epilepsy (epilepsy). on 16-jun-2021, the patient received dose of mrna-1273 (spikevax) (unknown route) 1 dosage form. on 15-dec-2021, the patient experienced pericarditis (pericardite) (seriousness criterion medically significant). at the time of the report, pericarditis (pericardite) had not resolved. the action taken with mrna-1273 (spikevax) (unknown) was unknown. patient's medical history included chromosome 7 long arm partial trisomy epilepsy the event was severe. no concomitant medication information was reported no treatment medication information was reported company comment: this regulatory case concerns a 21-year-old, female patient with no relevant medical history reported, who experienced serious (medically significant) unexpected aesi event of pericarditis, 6 months after receiving a dose of mrna-1273 vaccine. at the time of the report, event had not resolved. the benefit-risk relationship of mrna-1273 is not affected by this report. event seriousness assessed as per regulatory authority reporting. most recent follow-up information incorporated above includes: on 25-feb-2022: significant follow-up contains, dose start date added. reporter's comments: chromosome 7 long arm partial trisomy epilepsy 08/02/2022 severity modified on the basis of the ime list from non-serious to 'severe-other clinically relevant condition; sender's comments: this regulatory case concerns a 21-year-old, female patient with no relevant medical history reported, who experienced serious (medically significant) unexpected aesi event of pericarditis, 6 months after receiving a dose of mrna-1273 vaccine. at the time of the report, event had not resolved. the benefit-risk relationship of mrna-1273 is not affected by this report. event seriousness assessed as per regulatory authority reporting
- Lab Data
-
na
- List of symptoms
-
pericarditis
- Patient Died?
- No
- Date Died
- NA
- Birth defect
- false
- Vaccine Administered By:
- Unknown
- Vaccine Purchased By:
- Unknown
- Patient visit ER?
- No
- Patient Hospitalized?
- No
- Stay in hospital
- No
- Days in hospital
- Unspecified
- Permanent disability?
- No
- Allergies:
-
na
- Current Illness
-
na