National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts.org
Search Results

This is VAERS ID 1720572

Government Disclaimer on use of this data

History of Changes from the VAERS Wayback Machine

First Appeared on 9/24/2021

VAERS ID: 1720572
VAERS Form:2
Age:13.0
Sex:Female
Location:Foreign
Vaccinated:2021-08-19
Onset:2021-08-19
Submitted:0000-00-00
Entered:2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214016 / UNK - / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Angioedema, Urticaria, Accidental underdose

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': ESMODERNATX, INC.MOD20213

Write-up: Angioedema; Urticaria; Accidental underdose; This case was received via Medicines Agency (Reference number: ES-AEMPS-992998 ) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ANGIOEDEMA (Angioedema) and URTICARIA (Urticaria) in a 13-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214016) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .3 milliliter. On 19-Aug-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), URTICARIA (Urticaria) (seriousness criterion medically significant) and ACCIDENTAL UNDERDOSE (Accidental underdose). On 19-Aug-2021, ACCIDENTAL UNDERDOSE (Accidental underdose) had resolved. At the time of the report, ANGIOEDEMA (Angioedema) and URTICARIA (Urticaria) outcome was unknown. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 19-Aug-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No Treatment medication was provided by the reporter. No Concomitant medication was provided by the reporter. Company Comment: This case involves a 13-year-old female (adolescent) patient with unknown medical history who experienced the unexpected serious AEs Angioedema and Urticaria (both medically significant) on the same day she received her first dose of Spikevax(19-August-2021). As a result, the drug was withdrawn. No reporter causality was provided. The benefit risk relationship of the drug.mRNA-1273 is not affected by this report. this case also reports an "accidental underdose". Sender''s Comments: This case involves a 13-year-old female (adolescent) patient with unknown medical history who experienced the unexpected serious AEs Angioedema and Urticaria (both medically significant) on the same day she received her first dose of Spikevax(19-August-2021). As a result, the drug was withdrawn. No reporter causality was provided. The benefit risk relationship of the drug.mRNA-1273 is not affected by this report. this case also reports an "accidental underdose"

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?IDNUMBER=1720572&WAYBACKHISTORY=ON


Copyright © 2022 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166