이상반응 보고
| VAERS ID | 2298517 |
|---|---|
| 성별 | 남성 |
| 나이 | 65세 |
| 주 코드 | CO |
| 제약회사 | MODERNA |
| 로트 번호 | 030B21A |
| 예방접종 횟수 | |
| 접종일 | 2021-04-03 |
| 발병일 | 2021-04-03 |
| 상태 |
증상
- 품질이 좋지 않은 제품이 관리됨(Poor quality product administered)
- 제품 온도 편차 문제(Product temperature excursion issue)
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임상 검사
증상 상세
Dose administered after 1 temperature excursion during a period of 33 weeks in 2021; Dose administered after 1 temperature excursion during a period of 33 weeks in 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.
030B21A) for COVID-19 vaccination.
No Medical History information was reported.
On 03-Apr-2021 at 10:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .
5 milliliter.
On 03-Apr-2021 at 10:52 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021).
On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021).
At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after 1 temperature excursion during a period of 33 weeks in 2021) outcome was unknown.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
An age of patient was reported as 65.
64 for dose administered on 03-Apr-2021.
No concomitant medications were reported.
It was reported that for the vial Batch number of 030B21A, it was moved to fridge on 30-Mar-2021 that underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09 AM.
The product was moved to clinic on 03-Apr-2021 and beyond use date for the vial was reported as 29-Apr-2021.
The vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.
The vials were only punctured right before administration.
The vaccines were not frozen at time of 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 temperature recordings were taken using a traceable temperature monitor at every hour.
No treatment medications were reported.
This case was linked to MOD-2022-566976 (Patient Link).