Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 03-Aug-23.; No Adverse event; Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 03-Aug-23.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 03-Aug-23.), PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 03-Aug-23.) and NO ADVERSE EVENT (No Adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Aug-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Aug-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 03-Aug-23.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 03-Aug-23.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 03-Aug-23.), PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 03-Aug-23.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 03-Aug-23.) and PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 03-Aug-23.).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.