이상반응 보고
| VAERS ID | 2298450 |
|---|---|
| 성별 | 여성 |
| 나이 | 57세 |
| 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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증상 상세
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 57-year-old female 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 9:46 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .
5 milliliter.
On 03-Apr-2021 at 9:46 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021).
On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021).
At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.
For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient age was reported as 57.
96 No concomitant medications were reported.
The vial underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit and the vial was initially moved to the fridge on 30-Mar-2021 and proposed beyond use date was 29-Apr-2021.
The vial got moved to clinic on 03-Apr-2021.
The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.
It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.
On the date of administration, at 08:00 A.
M.
, the temperature recorded was 38 degree Fahrenheit and at 09:00 A.
M.
, the temperature recorded was 34 degree Fahrenheit that has been reached by the vial.
Temperature recordings were taken using a traceable temperature monitor at every hour.
The vial was not in a frozen state at the time of vaccine administration.
After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.
No treatment information was provided.