Age: 0.83
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially moved from the refrigerator and stored in the freezer on 22-Jun-2023, Vaccine was administered on 17-Aug-2023.; No adverse event; Vaccine was initially moved from the refrigerator and stored in the freezer on 22-Jun-2023, Vaccine was administered on 17-Aug-2023.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was initially moved from the refrigerator and stored in the freezer on 22-Jun-2023, Vaccine was administered on 17-Aug-2023.), PRODUCT STORAGE ERROR (Vaccine was initially moved from the refrigerator and stored in the freezer on 22-Jun-2023, Vaccine was administered on 17-Aug-2023.) and NO ADVERSE EVENT (No adverse event) in a 10-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7645B and AS7645B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: DTAP, Polio, Hib, MMR, Rotavirus, Pneumococcal Conjugate, HEP B and HEP A. Past adverse reactions to the above products included No adverse event with DTAP, HEP A, HEP B, Hib, MMR, Pneumococcal Conjugate, Polio and Rotavirus.   On 14-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Aug-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 17-Aug-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was initially moved from the refrigerator and stored in the freezer on 22-Jun-2023, Vaccine was administered on 17-Aug-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially moved from the refrigerator and stored in the freezer on 22-Jun-2023, Vaccine was administered on 17-Aug-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was initially moved from the refrigerator and stored in the freezer on 22-Jun-2023, Vaccine was administered on 17-Aug-2023.), PRODUCT STORAGE ERROR (Vaccine was initially moved from the refrigerator and stored in the freezer on 22-Jun-2023, Vaccine was administered on 17-Aug-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 (Vaccine was initially moved from the refrigerator and stored in the freezer on 22-Jun-2023, Vaccine was administered on 17-Aug-2023.) and PRODUCT STORAGE ERROR (Vaccine was initially moved from the refrigerator and stored in the freezer on 22-Jun-2023, Vaccine was administered on 17-Aug-2023.).    It was reported that patient received other vaccine in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Suspect vaccine expiry date was reported as 14-Oct-2023 for both the doses. No reported symptoms after receiving this dose of the vaccine. No additional doses, medications or treatments had been administered in response to this error.  Treatment information was not provided.