Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Excursion occurred on 10Feb2023: 10.2 F for 1 hour and 11 minutes; No adverse event; Patients received expired doses of Moderna monovalent/patients were given expired vaccine on 27Mar2023; Poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses of Moderna monovalent/patients were given expired vaccine on 27Mar2023), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10Feb2023: 10.2 F for 1 hour and 11 minutes) 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. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses of Moderna monovalent/patients were given expired vaccine on 27Mar2023) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10Feb2023: 10.2 F for 1 hour and 11 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses of Moderna monovalent/patients were given expired vaccine on 27Mar2023), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10Feb2023: 10.2 F for 1 hour and 11 minutes) 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 (Patients received expired doses of Moderna monovalent/patients were given expired vaccine on 27Mar2023), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion occurred on 10Feb2023: 10.2 F for 1 hour and 11 minutes).    This case was concerned with 1st adult patient received expired vaccine on 27Mar2023.  No concomitant medications were reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Dates the vial was initially stored in the refrigerator were 26Mar2023 and 29Mar2023. Vial was stored to 4 adult patients out of which 2 were vaccinated with expired vaccine on 27Mar2023 and 2 were given expired vaccine on 30Mar2023. Vial underwent temperature excursion issue on 10Feb2023, 10.2 F for 1 hour and 11 minutes.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-718348, US-MODERNATX, INC.-MOD-2023-718379, US-MODERNATX, INC.-MOD-2023-718423 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Apr-2023: Significant follow up added. Reporter added. Patient age group added.  Product coding and administration date updated. New events added. Narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718348:2nd adult patient vaccine administer on 27Mar2023. US-MODERNATX, INC.-MOD-2023-718423:(2nd adult patient vaccine administer on 30Mar2023). US-MODERNATX, INC.-MOD-2023-718379:1st adult patient vaccine administer on 30Mar2023