Adverse Event Reporting

VAERS ID 2300360
Gender Female
Age 47
StateCode CO
Pharmaceutical Company MODERNA
Lot Number 044B21A
Number of vaccinations
Vaccinated 2022-04-15
Onset 2021-04-15
Condition
Symptoms
  • Poor quality product administered
  • Product temperature excursion issue

Current Illness

Preexisting Conditions

Other Medications

Previous Vaccinations

Allergies

Laboratory Data

Write-up

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 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no.
044B21A) for COVID-19 vaccination.
No Medical History information was reported.
On 15-Apr-2022 at 1:31 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .
5 milliliter.
On 15-Apr-2021 at 1:31 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 46.
33.
Batch number 044B21A underwent temperature excursion on 15-April-2021 with temperature 34 degrees Fahrenheit from 09:00 AM.
This vial was moved to fridge on 06-April-2021 and beyond use date for the vial was reported as 09-May-2021.
Product moved to clinic on 15-April-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.
No concomitant medications were reported.
This case was linked to MOD-2022-566976 (Patient Link).