Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Malaise, Product storage error
Clinical narrative: she did not feel well for one day; frozen expiration date was 05/07/23, it was placed in the refrigerator on 09/03/22 and was administered past the 30 day thaw date; Frozen expiration Date was 05/07/23 had been read as Thawed Expiration Date, administered past the 30 day thawdate; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (she did not feel well for one day), EXPIRED PRODUCT ADMINISTERED (Frozen expiration Date was 05/07/23 had been read as Thawed Expiration Date, administered past the 30 day thawdate) and PRODUCT STORAGE ERROR (frozen expiration date was 05/07/23, it was placed in the refrigerator on 09/03/22 and was administered past the 30 day thaw date) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Frozen expiration Date was 05/07/23 had been read as Thawed Expiration Date, administered past the 30 day thawdate). On an unknown date, the patient experienced MALAISE (she did not feel well for one day) and PRODUCT STORAGE ERROR (frozen expiration date was 05/07/23, it was placed in the refrigerator on 09/03/22 and was administered past the 30 day thaw date). At the time of the report, MALAISE (she did not feel well for one day) had resolved and EXPIRED PRODUCT ADMINISTERED (Frozen expiration Date was 05/07/23 had been read as Thawed Expiration Date, administered past the 30 day thawdate) and PRODUCT STORAGE ERROR (frozen expiration date was 05/07/23, it was placed in the refrigerator on 09/03/22 and was administered past the 30 day thaw date) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. On 09/03/22 1800 Doses of Lot AS7140C were received in facility frozen. Product were refrigerated upon arrival. 900 doses were sent to alternate location and 900 remained in our facility.  On 10/17/22; 11/03/22; 11/07/22; 11/14/22; and 01/06/23; 251 people were given COVID Bivalent Booster vaccines at on site clinics in Moderna, our facility through an outside nursing agency. All attendees provided proof of eligibility to receive the bivalent booster. There was a clinic on 10/03/22 in which was on the cusp. An additional 66 people were vaccinated in our facility on that day. On 01/09/23, it was discovered that vials from LOT AS7140C frozen expiration date was 05/07/23. There were no temperature excursions in the frozen or refrigerate storage. Moderna conducted a lot of analysis through 01/07/23 and determined with 99% confidence that the doses maintained the mRNA purity levels for a valid dose.  Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-707022, US-MODERNATX, INC.-MOD-2023-695799 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707022:Employee 1 US-MODERNATX, INC.-MOD-2023-695799:Cluster case of 251 patients + Employee 2