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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA||3005288 / UNK||- / OT|
Administered by: Unknown Purchased by: ??
Symptoms: Bradycardia, Loss of consciousness, Presyncope
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Diagnostic Lab Data:
CDC 'Split Type': JPMODERNATX, INC.MOD20213
Write-up: Loss of consciousness; Bradycardia; Vasovagal reflex; This case was received via Regulatory Authority (Reference number: 2021TJP093153) on 11-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This case, reported by a physician, was received by Regulatory Authority via Moderna''s adverse reaction reporting site (TASK0021679), and reported to the Regulatory Authority by a physician, was received via the Regulatory Authority (Ref, v21126564). Loss of consciousness and bradycardia were assessed as serious by the MAH. On an unknown date, body temperature before the vaccination: 36.7 degrees Celsius. On 11-Sep-2021, at 16:27, the patient received the 1st dose of the vaccine. Immediately after the vaccination, vasovagal reflex developed. The patient experienced sleepiness and difficulty breathing and then lost consciousness for 10 seconds. Bradycardia and decreased blood pressure were noted. Subsequently, recovery of the symptoms was confirmed. The outcome of vasovagal reflex, loss of consciousness, and bradycardia 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 22-year-old male patient with no relevant medical history, who experienced the unexpected events of Loss of consciousness and Bradycardia 1 day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable as no rechallenge was done. The event causality was considered no reasonable plausibility to the vaccine per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
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