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This is VAERS ID 1783264

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History of Changes from the VAERS Wayback Machine

First Appeared on 10/15/2021

VAERS ID: 1783264
VAERS Form:2
Age:16.0
Sex:Male
Location:Foreign
Vaccinated:2021-09-19
Onset:2021-09-19
Submitted:0000-00-00
Entered:2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214008 / UNK - / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Anaphylactic reaction

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? Yes, days:     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC 'Split Type': DEMODERNATX, INC.MOD20213

Write-up: This case was received via a regulatory authority (Reference number: DE-PEI-202100199425) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION in a 16-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214008) for COVID-19 vaccination. No Medical History information was reported. On 19-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced ANAPHYLACTIC REACTION (seriousness criteria hospitalization and medically significant). On 19-Sep-2021, ANAPHYLACTIC REACTION had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant medication was not provided. Treatment medication was not provided. Patient had experienced questionable anaphylactic reaction which started at 8.15 am and lasted until 8.54 am. Patient had also experienced hemodynamic instability and vomiting and no medication was taken for that. Company Comment: This case concerns a 16-year-old, male patient with no previous relevant medical history, who experienced the expected event of Anaphylactic reaction. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Translation received on 07-OCT-2021: No new information was upadated; Sender''s Comments: This case concerns a 16-year-old, male patient with no previous relevant medical history, who experienced the expected event of Anaphylactic reaction. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The benefit-risk relationship of Spikevax is not affected by this report.

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