Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Myalgia, Product storage error, Pyrexia
Clinical narrative: body aches; Fever; Her dose was given 14 days past the refrigerated thaw date; Her dose was given 14 days past the refrigerated thaw date; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (body aches), PYREXIA (Fever), EXPIRED PRODUCT ADMINISTERED (Her dose was given 14 days past the refrigerated thaw date) and PRODUCT STORAGE ERROR (Her dose was given 14 days past the refrigerated 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.    On an unknown date, 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. On an unknown date, the patient experienced MYALGIA (body aches), PYREXIA (Fever), EXPIRED PRODUCT ADMINISTERED (Her dose was given 14 days past the refrigerated thaw date) and PRODUCT STORAGE ERROR (Her dose was given 14 days past the refrigerated thaw date). At the time of the report, MYALGIA (body aches), PYREXIA (Fever), EXPIRED PRODUCT ADMINISTERED (Her dose was given 14 days past the refrigerated thaw date) and PRODUCT STORAGE ERROR (Her dose was given 14 days past the refrigerated 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.   No concomitant medications were reported.   On 03-Sep-2022, 1800 doses of lot number AS7140C were received and were refrigerated upon arrival. Refrigerated temperatures were in range (checked daily manually). Dose of 0.5 milliliter was administered with each dose. Frozen expiration date was 07-May-2023 had been read as thawed expiration date. 251 vaccines were given bivalent booster dose on the following dates: 17-Oct-2022, 03-Nov-2022, 07-Nov-2022, 14-Nov-2022 and 06-Jan-2023. There was a clinic on 03-Oct-2022 in which additional 66 people were vaccinated on that day. On 09-Jan-2023, it was discovered that vials from lot number AS7140C's frozen expiration date was 07-May-2023, however was placed in the refrigerator on 03-Sep-2022 and was administered past the 30-day thaw date. There were no temperature excursions in the frozen or refrigerate storage. Moderna conducted a lot analysis through 07-Jan-2023 and determined with 99% confidence that the doses maintained the mRNA purity levels for a valid dose. One patient experienced adverse events and a separate VAERS report was entered as she had not completed one for her symptoms of body aches and fever. Her dose was given 14 days past the refrigerated thaw date.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-695799, US-MODERNATX, INC.-MOD-2023-707023 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695799:Cluster case of 251 patients + Employee 2 US-MODERNATX, INC.-MOD-2023-707023:Employee 3