이상반응 보고
| VAERS ID | 2298421 |
|---|---|
| 성별 | 여성 |
| 나이 | 56세 |
| 주 코드 | CO |
| 제약회사 | MODERNA |
| 로트 번호 | 031L20A |
| 예방접종 횟수 | |
| 접종일 | 2021-02-13 |
| 발병일 | 2021-02-13 |
| 상태 |
증상
- 품질이 좋지 않은 제품이 관리됨(Poor quality product administered)
- 제품 온도 편차 문제(Product temperature excursion issue)
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증상 상세
administered with vaccine that experienced more than 1 temperature excursion; administered with vaccine that experienced more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.
031L20A) for COVID-19 vaccination.
No Medical History information was reported.
On 13-Feb-2021 at 9:06 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .
5 milliliter.
On 13-Feb-2021 at 9:06 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion).
On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion).
At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) outcome was unknown.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age of the patient was reported as 56.
10.
Concomitant medication of the patient was not reported.
Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature of 32 degrees Fahrenheit at 09:00 AM.
These vials were moved to fridge on 09-Feb-2021 and beyond use date for the vials was reported as 10-Mar-2021.
The vaccines moved to clinic on 13-Jan-2021.
Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.
Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination.
Vials were only punctured right before administration.
Vaccines were not frozen at time of administration and prior to administration.
It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.
The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.
No treatment information was provided by the reporter.
This case was linked to MOD-2022-566976 (Patient Link).