이상반응 보고

VAERS ID	2247508
성별	여성
나이	68세
주 코드	FR
제약회사	MODERNA
로트 번호
예방접종 횟수	2
접종일	2021-10-14
발병일	2021-10-21
상태	입원

증상

• 질병 재발(Disease recurrence)

이환 중 질병

지병

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임상 검사

증상 상세

Recurrence of diffused atypical mycobacterium tuberculosis, suspected to be stimulated by Moderna vaccine; This regulatory authority case was reported by an other health care professional and describes the occurrence of DISEASE RECURRENCE (Recurrence of diffused atypical mycobacterium tuberculosis, suspected to be stimulated by Moderna vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.
No Medical History information was reported.
On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.
On 21-Oct-2021, the patient experienced DISEASE RECURRENCE (Recurrence of diffused atypical mycobacterium tuberculosis, suspected to be stimulated by Moderna vaccine) (seriousness criterion hospitalization).
At the time of the report, DISEASE RECURRENCE (Recurrence of diffused atypical mycobacterium tuberculosis, suspected to be stimulated by Moderna vaccine) was resolving.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
No Concomitant medications were reported.
On 21-Oct-2021, Patient had swelling and pain of right elbow and right foot began.
On 24-Dec-2021, Patient was admitted treatment due to above reasons.
On 07-Jan-2022, patient was discharged and currently the condition improved upon follow up and treatment carried out in the out patient department.
Company Comment: This regulatory case concerns a 68-year-old female patient with no report of medical history, who experienced the unexpected serious event of Disease recurrence (Recurrence of diffused atypical mycobacterium tuberculosis, suspected to be stimulated by Moderna vaccine), that occurred 7 days after receiving the second dose of mRNA-1273 vaccine and led to hospitalization.
Patient presented with swelling and pain of right elbow and right foot 7 days post vaccination and was admitted approximately 2 months later for treatment.
Patient was discharged 2 weeks after with improved condition.
No laboratory tests were reported.
There is no information provided on the first dose of COVID-19 vaccination.
The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
The case seriousness was assessed as per Regulatory Authority report.
; Sender's Comments: This regulatory case concerns a 68-year-old female patient with no report of medical history, who experienced the unexpected serious event of Disease recurrence (Recurrence of diffused atypical mycobacterium tuberculosis, suspected to be stimulated by Moderna vaccine), that occurred 7 days after receiving the second dose of mRNA-1273 vaccine and led to hospitalization.
Patient presented with swelling and pain of right elbow and right foot 7 days post vaccination and was admitted approximately 2 months later for treatment.
Patient was discharged 2 weeks after with improved condition.
No laboratory tests were reported.
There is no information provided on the first dose of COVID-19 vaccination.
The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
The case seriousness was assessed as per Regulatory Authority report.