이상반응 보고
| VAERS ID | 2298526 |
|---|---|
| 성별 | 여성 |
| 나이 | 65세 |
| 주 코드 | CO |
| 제약회사 | MODERNA |
| 로트 번호 | 041L20A |
| 예방접종 횟수 | |
| 접종일 | 2021-01-12 |
| 발병일 | 2021-01-12 |
| 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
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.
041L20A) for COVID-19 vaccination.
No Medical History information was reported.
On 12-Jan-2021 at 2:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .
5 milliliter.
On 12-Jan-2021 at 2:49 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion).
On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion).
At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after 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 patient was reported as 65.
28 for dose administered on 12-Jan-2021.
Concomitant products were not provided.
On 12-Jan-2021, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 12-Jan-2021.
3 vials were sent to clinic.
Vaccine BUD date was 07-Feb-2021.
The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.
Temperature recordings were taken using a traceable temperature monitor at every hour.
After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.
It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.
The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.
Treatment medications were not reported.
This case was linked to MOD-2022-566976 (Patient Link).