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This is VAERS ID 1730831

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First Appeared on 9/24/2021

VAERS ID: 1730831
VAERS Form:2
Age:13.0
Sex:Male
Location:Foreign
Vaccinated:2021-09-04
Onset:2021-09-04
Submitted:0000-00-00
Entered:2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214021 / UNK - / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Asthenia, Pain in extremity, Type I hypersensitivity

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': FRMODERNATX, INC.MOD20213

Write-up: Immediate hypersensitivity reaction; Pain in arm; Asthenia; This case was received via regulatory authority (Reference number: FR-AFSSAPS-NT20213819) 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 TYPE I HYPERSENSITIVITY (Immediate hypersensitivity reaction) in a 13-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214021) for SARS-CoV-2 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced TYPE I HYPERSENSITIVITY (Immediate hypersensitivity reaction) (seriousness criteria hospitalization and medically significant), PAIN IN EXTREMITY (Pain in arm) and ASTHENIA (Asthenia). At the time of the report, TYPE I HYPERSENSITIVITY (Immediate hypersensitivity reaction) had resolved and PAIN IN EXTREMITY (Pain in arm) and ASTHENIA (Asthenia) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Company Comment: This case concerns a 13 year-old, male patient with no relevant medical history, who experienced the unexpected event of Type I hypersensitivity reaction. The event occurred on the same day after the first dose of Spikevax (Moderna COVID-19 vaccine) requiring hospitalization. The rechallenge was not applicable since the event occurred after the first dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 21-Sep-2021 and contain no new information.; Sender''s Comments: This case concerns a 13 year-old, male patient with no relevant medical history, who experienced the unexpected event of Type I hypersensitivity reaction. The event occurred on the same day after the first dose of Spikevax (Moderna COVID-19 vaccine) requiring hospitalization. The rechallenge was not applicable since the event occurred after the first dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.

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