Adverse Event Reporting
| VAERS ID | 2298523 |
|---|---|
| Gender | Male |
| Age | 67 |
| StateCode | CO |
| Pharmaceutical Company | MODERNA |
| Lot Number | 019B21A |
| Number of vaccinations | |
| Vaccinated | 2021-03-31 |
| Onset | 2021-03-31 |
| Condition |
Symptoms
- Poor quality product administered
- Product temperature excursion issue
Current Illness
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
dose administered to patient 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 PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and 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) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.
019B21A) for COVID-19 vaccination.
No Medical History information was reported.
On 31-Mar-2021 at 8:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .
5 milliliter.
On 31-Mar-2021 at 8:54 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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 (dose administered to patient after more than 1 temperature excursion).
At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and 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) 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 67.
72 No concomitant medications were reported.
Batch number 019B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 8 AM.
This vial was moved to fridge on 23-03-2021 and beyond use date for the vial was reported as 22-Apr-2021.
Product moved to clinic on 31-Mar-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 using a traceable temperature monitor at every hour.
No treatment medications were reported.
This case was linked to MOD-2022-566976 (Patient Link).