Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine lot 033K212A manufacturer expiration date 05/20/2022 was taken out of freezer on 04/20/2022. Out of freezer expiration date 05/20/2022; Patient was given expired (4 days expired) Moderna vaccine lot 033K212A manufacturer expiration date 05/20/2022 IM 0.25mL as a fourth dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine lot 033K212A manufacturer expiration date 05/20/2022 IM 0.25mL as a fourth dose) and PRODUCT STORAGE ERROR (Moderna vaccine lot 033K212A manufacturer expiration date 05/20/2022 was taken out of freezer on 04/20/2022. Out of freezer expiration date 05/20/2022) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A, 042L20A, 013M20A and 011F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine lot 033K212A manufacturer expiration date 05/20/2022 IM 0.25mL as a fourth dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine lot 033K212A manufacturer expiration date 05/20/2022 was taken out of freezer on 04/20/2022. Out of freezer expiration date 05/20/2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine lot 033K212A manufacturer expiration date 05/20/2022 IM 0.25mL as a fourth dose) and PRODUCT STORAGE ERROR (Moderna vaccine lot 033K212A manufacturer expiration date 05/20/2022 was taken out of freezer on 04/20/2022. Out of freezer expiration date 05/20/2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  There were 12 to 14 booster doses in 1 vial.  The vial did not undergo any temperature excursions.  Moderna vaccine lot 033K212A manufacturer expiration date was reported as 20 May 2022 and was taken out of freezer on 20 Apr 2022. Out of freezer expiration date was reported as 20 May 2022.  No treatment medication information provided.   This case was linked to MOD-2022-590546, MOD-2022-590542, MOD-2022-590544, MOD-2022-590553 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2022: Follow up received. Validity changed to valid case. Added secondary reporter. Patient initials, demographics, dosage regimen added, event verbatim and inarrative supplement updated.