이상반응 보고
| VAERS ID | 2298419 |
|---|---|
| 성별 | 여성 |
| 나이 | 68세 |
| 주 코드 | CO |
| 제약회사 | MODERNA |
| 로트 번호 | 008C21A |
| 예방접종 횟수 | |
| 접종일 | 2021-06-22 |
| 발병일 | 2021-06-22 |
| 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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.
008C21A) for COVID-19 vaccination.
No Medical History information was reported.
On 22-Jun-2021 at 8:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .
5 milliliter.
On 22-Jun-2021 at 8:40 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (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.
Age of patient was reported as 68.
73.
No concomitant medications were reported.
Batch number 008C21A underwent temperature excursion on 22-Jun-2021 with temperature 35 degrees Fahrenheit at 08:00 AM.
This vial was moved to fridge on 27-May-2021.
Product moved to clinic on 22-Jun-2021.
and BUD for the vial was reported as 26-Jun-2021.
Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.
Vials were only punctured right before administration.
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.
Temperature recordings were taken at every hour.
All doses were drawn from the vial due to high-pace clinic.
After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.
No treatment medications were reported.