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This is VAERS ID 1796798

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History of Changes from the VAERS Wayback Machine

First Appeared on 10/22/2021

VAERS ID: 1796798
VAERS Form:2
Age:17.0
Sex:Female
Location:Foreign
Vaccinated:2021-08-03
Onset:2021-08-24
Submitted:0000-00-00
Entered:2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004731 / 1 LA / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Angioedema, Influenza like illness

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': FRMODERNATX, INC.MOD20213

Write-up: Giant urticaria; Influenza like illness; This case was received via Regulatory Agency (Reference number: FR-AFSSAPS-LY202111406) on 11-Oct-2021 and was forwarded to Moderna on 11-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANGIOEDEMA (Giant urticaria) in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3004234 and 3004731) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced ANGIOEDEMA (Giant urticaria) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (Influenza like illness). At the time of the report, ANGIOEDEMA (Giant urticaria) and INFLUENZA LIKE ILLNESS (Influenza like illness) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment medication was not provided. Company comment: This case concerns a 27-year-old female patient with no reported medical history, who experienced the unexpected event of angioedema. The event occurred on the same day after the administration of the second dose of mRNA-1273 (Spikevax). The rechallenge was not applicable as the event occurred after the second vaccine dosing. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report. Event assessed as serious per Regulatory authority as the events were noted as medically significant and is an important medical event. Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Translation received on 13-Oct-2021 contain Dose 1 details was updated.; Sender''s Comments: This case concerns a 27-year-old female patient with no reported medical history, who experienced the unexpected event of angioedema. The event occurred on the same day after the administration of the second dose of mRNA-1273 (Spikevax). The rechallenge was not applicable as the event occurred after the second vaccine dosing. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report. Event assessed as serious per Regulatory authority as the events were noted as medically significant and is an important medical event.

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