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This is VAERS ID 1772492

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History of Changes from the VAERS Wayback Machine

First Appeared on 10/15/2021

VAERS ID: 1772492
VAERS Form:2
Age:14.0
Sex:Female
Location:Foreign
Vaccinated:2021-08-16
Onset:2021-08-16
Submitted:0000-00-00
Entered:2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005695 / UNK - / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Angioedema

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: This case was received via Regulatory Authority (Reference number: ES-AEMPS-1009414) on 30-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANGIOEDEMA in a 14-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005695) for SARS-CoV-2 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced ANGIOEDEMA (seriousness criterion medically significant). On 16-Aug-2021, ANGIOEDEMA had resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications provided. No treatment medications provided. Patient experienced lips and hands angioedema. Company Comment: This case concerns a 14 year old female patient with no relevant medical history, who experienced the unexpected event of angioedema. The event occurred on the same day after a dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Translation received on 04 Oct 2021, expiry date of vaccine added and translated verbatim added in narrative.; Sender''s Comments: This case concerns a 14 year old female patient with no relevant medical history, who experienced the unexpected event of angioedema. The event occurred on the same day after a dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.

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