이상반응 보고
| VAERS ID | 2298518 |
|---|---|
| 성별 | 여성 |
| 나이 | 60세 |
| 주 코드 | CO |
| 제약회사 | MODERNA |
| 로트 번호 | 014M20A |
| 예방접종 횟수 | |
| 접종일 | 2021-03-03 |
| 발병일 | 2021-03-01 |
| 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
Vaccines administered after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos.
014M20A and 030B21A) for COVID-19 vaccination.
No Medical History information was reported.
On 03-Mar-2021 at 10:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .
5 milliliter.
On 31-Mar-2021 at 10:23 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .
5 milliliter.
In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion).
On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion).
At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines 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.
The patient age was reported as 60.
24 years for dose administered on 03-Mar-2021 and 60.
32 years for dose administered on 31-Mar-2021.
No concomitant product use was reported.
It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 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.
On 03-Mar-2021, Excursion temperature at 09 AM was 51, at 10AM was 34 and 1 pm was 35, total doses given for the day was 200, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 03-Mar-2021.
20 vials were moved to clinic.
Vaccine BUD date was 26-Mar-2021 for batch number 014M20A.
On 31-Mar-2021, Excursion temperature at 8AM and 09 AM was 32, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021.
14 vials were moved to clinic.
Vaccine BUD date was 29-Apr-2021 for batch number 030B21A.
Temperature recordings were taken by using a traceable temperature monitor at every hour.
The vials were only punctured right before administration and 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 information was provided.
This case was linked to MOD-2022-566976 (Patient Link).