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This is VAERS ID 1757839

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First Appeared on 10/15/2021

VAERS ID: 1757839
VAERS Form:2
Age:34.0
Sex:Female
Location:Foreign
Vaccinated:2021-09-13
Onset:2021-09-13
Submitted:0000-00-00
Entered:2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Chills, Dizziness, Headache, Vomiting

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

Write-up: This case was received via European Medicines Agency (Reference number: SE-MPA-2021-084137) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of CHILLS, HEADACHE, DIZZINESS and VOMITING in a 34-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced CHILLS (FROSSA) (seriousness criterion hospitalization), HEADACHE (seriousness criterion hospitalization), DIZZINESS (seriousness criterion hospitalization) and VOMITING (seriousness criterion hospitalization). On 14-Sep-2021, VOMITING had resolved. At the time of the report, CHILLS, HEADACHE and DIZZINESS was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was reported. No treatment information was reported. Company Comment: This case concerns a 34-year-old, female patient with no relevant medical history, who experienced the unexpected events of chills headache, dizziness and vomiting which required hospitalization. The events occurred on the same day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29 SEP 2021 which contains no new information.; Sender''s Comments: This case concerns a 34-year-old, female patient with no relevant medical history, who experienced the unexpected events of chills headache, dizziness and vomiting which required hospitalization. The events occurred on the same day after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.

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