Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue, Vaccination site pain
Clinical narrative: Possible AE: doses might have been administered after 24 hour exposure to RT/Vaccine administered to 2 patients from a vial that was post temperature excursion; Possible AE: doses might have been administered after 24 hour exposure to RT/Vaccine administered to 2 patients from a vial that was post temperature excursion; Arm soreness; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Arm soreness), PRODUCT TEMPERATURE EXCURSION ISSUE (Possible AE: doses might have been administered after 24 hour exposure to RT/Vaccine administered to 2 patients from a vial that was post temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Possible AE: doses might have been administered after 24 hour exposure to RT/Vaccine administered to 2 patients from a vial that was post temperature excursion) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 045A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021 at 7:03 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021 at 7:58 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Nov-2021 at 4:09 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Possible AE: doses might have been administered after 24 hour exposure to RT/Vaccine administered to 2 patients from a vial that was post temperature excursion). In November 2021, the patient experienced VACCINATION SITE PAIN (Arm soreness). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Possible AE: doses might have been administered after 24 hour exposure to RT/Vaccine administered to 2 patients from a vial that was post temperature excursion). On 07-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Possible AE: doses might have been administered after 24 hour exposure to RT/Vaccine administered to 2 patients from a vial that was post temperature excursion) had resolved. In November 2021, VACCINATION SITE PAIN (Arm soreness) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Possible AE: doses might have been administered after 24 hour exposure to RT/Vaccine administered to 2 patients from a vial that was post temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment medication was not reported.  The maximum temperature used was 56.3 degrees Fahrenheit. Excursion duration was 4 hours that is from 05:00 AM till 09:00 AM, on 06 Nov 2021. These vials later returned to refrigerator. 1 dial, 14 doses were impacted.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow-up received include patient's information and product details. On 16-Nov-2021: Follow up received-- Patient demographics, product details and event added.