이상반응 보고
| VAERS ID | 2298415 |
|---|---|
| 성별 | 여성 |
| 나이 | 83세 |
| 주 코드 | CO |
| 제약회사 | MODERNA |
| 로트 번호 | 014M20A |
| 예방접종 횟수 | |
| 접종일 | 2021-02-28 |
| 발병일 | 2021-02-28 |
| 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 an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.
014M20A) for COVID-19 vaccination.
No Medical History information was reported.
On 28-Feb-2021 at 2:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .
5 milliliter.
On 28-Feb-2021 at 2:57 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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.
The age of patient was provided as 83.
94.
Concomitant products were not provided.
On 28-Feb-2021, Excursion time was 9 AM, temp was 27 and at 1 PM temp was 26; total doses given for the day was 152, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021.
20 vial was moved to clinic.
Vaccine BUD date was 26-Mar-2021.
Vial was stored on cooler 1, on 28-Feb-2021, Excursion duration At 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM : 26, 2 PM : 37, 3 PM: 43 and 4 PM: 45.
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 Fisherbrand 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.
It was reported that unknown number of patients were 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.