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This is VAERS ID 1739272

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First Appeared on 10/15/2021

VAERS ID: 1739272
VAERS Form:2
Age:62.0
Sex:Female
Location:Foreign
Vaccinated:2021-09-03
Onset:2021-09-04
Submitted:0000-00-00
Entered:2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown      Purchased by: ??
Symptoms: Fatigue, Loss of consciousness, Pain, Pyrexia

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': ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority case (Reference number: IT-MINISAL02-781861) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS in a 62-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005689) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS, FATIGUE and PYREXIA. At the time of the report, LOSS OF CONSCIOUSNESS, PAIN, FATIGUE and PYREXIA was resolving. No concomitant and treatment information was provided. This case concerns a 62-year-old female patient with no relevant medical history who experienced serious unexpected event of Loss of consciousness, non-serious unexpected event of Pain and non-serious expected events of Fatigue and Pyrexia. The events occurred one day following the dose of Spikevax. The rechallenge was unknown as it was not provided whether the patient received the first or the second dose of the vaccine. The event Loss of consciousness was classified as non-serious by RA, however, as per IME list was upgraded to serious and retained as such based on medical judgment. The events Fatigue and Pyrexia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 62-year-old female patient with no relevant medical history who experienced serious unexpected event of Loss of consciousness, non-serious unexpected event of Pain and non-serious expected events of Fatigue and Pyrexia. The events occurred one day following the dose of Spikevax. The rechallenge was unknown as it was not provided whether the patient received the first or the second dose of the vaccine. The event Loss of consciousness was classified as non-serious by RA, however, as per IME list was upgraded to serious and retained as such based on medical judgment. The events Fatigue and Pyrexia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.

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