Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration error, Product preparation error
Clinical narrative: No adverse event; Excess pool from multiple vials/patient received pooled vaccine from the Moderna bivalent vaccine.; Patients received pooled vaccine from the Moderna bivalent vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT PREPARATION ERROR (Excess pool from multiple vials/patient received pooled vaccine from the Moderna bivalent vaccine.), PRODUCT ADMINISTRATION ERROR (Patients received pooled vaccine from the Moderna bivalent vaccine.) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 07-Oct-2022, the patient experienced PRODUCT PREPARATION ERROR (Excess pool from multiple vials/patient received pooled vaccine from the Moderna bivalent vaccine.) and PRODUCT ADMINISTRATION ERROR (Patients received pooled vaccine from the Moderna bivalent vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT PREPARATION ERROR (Excess pool from multiple vials/patient received pooled vaccine from the Moderna bivalent vaccine.), PRODUCT ADMINISTRATION ERROR (Patients received pooled vaccine from the Moderna bivalent vaccine.) 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 PRODUCT PREPARATION ERROR (Excess pool from multiple vials/patient received pooled vaccine from the Moderna bivalent vaccine.) and PRODUCT ADMINISTRATION ERROR (Patients received pooled vaccine from the Moderna bivalent vaccine.).    No concomitant medications were reported.   It was reported that patient that received a Moderna bivalent vaccine from excess pool from multiple vials.  Patient took Moderna first  dose on 07-Jun-2021, Lot Number 036C21A, with an expiration date of 01-Nov-2021. Patient took Moderna second dose on 06-Jul-2021, Lot Number 008C21A, with an expiration date of 13-Oct-2021. Patient took Moderna first booster of 0.25 mL on 11-Mar-2022, Lot number 066K21A, with an expiration date of 07-Jul-2022.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-658197, US-MODERNATX, INC.-MOD-2022-658264 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2022: Live follow-up received included patient demographics, suspect product details and narrative updated. On 12-Oct-2022: Live follow-up received and patient's age group added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658197:Patient 2 (bivalent) US-MODERNATX, INC.-MOD-2022-658264:Patient 2 (dose 2)