Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator (lot number: 069H22a) on 18-Apr-2023 and vaccine was administered on 19-May-2023; no adverse event; 10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number 069H22A; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number 069H22A), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: 069H22a) on 18-Apr-2023 and vaccine was administered on 19-May-2023) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number 069H22A). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: 069H22a) on 18-Apr-2023 and vaccine was administered on 19-May-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number 069H22A), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: 069H22a) on 18-Apr-2023 and vaccine was administered on 19-May-2023) 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 (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number 069H22A) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: 069H22a) on 18-Apr-2023 and vaccine was administered on 19-May-2023).    Concomitant medication details not reported by the reporter. Dosage text was reported as Unknown. Batch number was reported as 069H22a and AS7173B. Vial with batch number 069H22a was initially stored in refrigerator on 18-APR-2023 and vial with batch number AS7173B initially stored in refrigerator on 06-MAR-2023. Vial did not undergo temperature excursion. Treatment details was not reported by the reporter. This case contains information of 1st patient out of 10 patient.   This case was linked to US-MODERNATX, INC.-MOD-2023-728206, US-MODERNATX, INC.-MOD-2023-728207, US-MODERNATX, INC.-MOD-2023-728208, US-MODERNATX, INC.-MOD-2023-728210, US-MODERNATX, INC.-MOD-2023-728209, US-MODERNATX, INC.-MOD-2023-728215, US-MODERNATX, INC.-MOD-2023-728212, US-MODERNATX, INC.-MOD-2023-728211, US-MODERNATX, INC.-MOD-2023-728216 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728208:Patient no 4 out of 10 US-MODERNATX, INC.-MOD-2023-728206:(Patient no-7 out of 10 ) US-MODERNATX, INC.-MOD-2023-728207:Patient no 2  out of 10 US-MODERNATX, INC.-MOD-2023-728211:Patient no 6 out of 10 US-MODERNATX, INC.-MOD-2023-728216:Patient no 3 out of 10 US-MODERNATX, INC.-MOD-2023-728209:Patient no 5 out of 10 US-MODERNATX, INC.-MOD-2023-728212:(Patient no-9 out of 10 ) US-MODERNATX, INC.-MOD-2023-728210:(Patient no-8 out of 10 ) US-MODERNATX, INC.-MOD-2023-728215:(Patient no-10 out of 10 )