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This is VAERS ID 1730636

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First Appeared on 9/24/2021

VAERS ID: 1730636
VAERS Form:2
Age:13.0
Sex:Female
Location:Foreign
Vaccinated:2021-09-02
Onset:2021-09-02
Submitted:0000-00-00
Entered:2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Dyspnoea, Headache, Malaise

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': ESMODERNATX, INC.MOD20213

Write-up: Dyspnoea; Malaise; Headache; This case was received via regulatory authority (Reference number: ES-AEMPS-998365) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MALAISE (Malaise), HEADACHE (Headache) and DYSPNOEA (Dyspnoea) in a 13-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 02-Sep-2021, the patient experienced MALAISE (Malaise) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 03-Sep-2021, the patient experienced DYSPNOEA (Dyspnoea) (seriousness criterion medically significant). On 03-Sep-2021, DYSPNOEA (Dyspnoea) had resolved. At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) was resolving. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 02-Sep-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported by reporter. Treatment information was not provided by reporter. Batch number of the suspect product was unknown. Company Comment: This case concerns a 13-year-old, female patient with no relevant medical history, who experienced the serious unexpected events of malaise, headache and dyspnoea. The events of malaise and headache occurred during the same day after the second dose of Spikevax, and the event of dyspnoea occurred one day after the second dose was given. The event dyspnoea resolved, and malaise and headache were resolving at the time of the report. It should be noted that action taken was reported as drug withdrawn per RA source document, and taking into consideration that the events resolved/were resolving, dechallenge was considered as positive, and rechallenge was considered as not applicable taking into consideration action taken with the suspect drug. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 21-Sep-2021 - Suspect product details updated.; Sender''s Comments: This case concerns a 13-year-old, female patient with no relevant medical history, who experienced the serious unexpected events of malaise, headache and dyspnoea. The events of malaise and headache occurred during the same day after the second dose of Spikevax, and the event of dyspnoea occurred one day after the second dose was given. The event dyspnoea resolved, and malaise and headache were resolving at the time of the report. It should be noted that action taken was reported as drug withdrawn per RA source document, and taking into consideration that the events resolved/were resolving, dechallenge was considered as positive, and rechallenge was considered as not applicable taking into consideration action taken with the suspect drug. The benefit-risk relationship of Spikevax is not affected by this report.

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