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Life Threatening? No
Write-up: Loss of consciousness; vasovagal reflex; This case was received via the RA (Reference number: JP-TAKEDA-2021TJP093152) on 11-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This case, reported by a physician, was received by the RA via Moderna''s adverse reaction reporting site (TASK0021675), and reported to the RA by a physician, was received via the RA (Ref, v21126553). Loss of consciousness was assessed as serious by the RA. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 11-Sep-2021, at 14:12, the patient received the 1st dose of the vaccine. At 14:25, vasovagal reflex developed while the patient was sitting. The patient had giddiness and lost consciousness for about 10 seconds. Subsequently, the symptoms resolved. The outcome of loss of consciousness and vasovagal reflex was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 19-year-old, female patient with no relevant medical history, who experienced the unexpected event of Loss of consciousness. The event occurred on the same day after the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as not related. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.
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