Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; Two Moderna COVID-19 vaccines administered seven days after the vials were punctured/ initially punctured on 23-JUN-2022 and administered on 30-JUN-2022; initially punctured on 23-JUN-2022 and administered on 30-JUN-2022/ Punctured and administered and placed back in fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two Moderna COVID-19 vaccines administered seven days after the vials were punctured/ initially punctured on 23-JUN-2022 and administered on 30-JUN-2022), PRODUCT STORAGE ERROR (initially punctured on 23-JUN-2022 and administered on 30-JUN-2022/ Punctured and administered and placed back in fridge) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B, 076C21A, DUP019E21 and 010A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced PRODUCT STORAGE ERROR (initially punctured on 23-JUN-2022 and administered on 30-JUN-2022/ Punctured and administered and placed back in fridge). On 30-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Two Moderna COVID-19 vaccines administered seven days after the vials were punctured/ initially punctured on 23-JUN-2022 and administered on 30-JUN-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two Moderna COVID-19 vaccines administered seven days after the vials were punctured/ initially punctured on 23-JUN-2022 and administered on 30-JUN-2022), PRODUCT STORAGE ERROR (initially punctured on 23-JUN-2022 and administered on 30-JUN-2022/ Punctured and administered and placed back in fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Two Moderna COVID-19 vaccines administered seven days after the vials were punctured/ initially punctured on 23-JUN-2022 and administered on 30-JUN-2022) and PRODUCT STORAGE ERROR (initially punctured on 23-JUN-2022 and administered on 30-JUN-2022/ Punctured and administered and placed back in fridge).    No concomitant product reported by reporter.  The vial was initially punctured on 23-JUN-2022 and administered on 30-JUN-2022. Punctured and administered and placed back in fridge did not exceed 12 hours. Vial was stored in refrigerator. Vial did not undergone and temperature excursion issue. Patient did not experienced any adverse event.  No additional doses, medications, or treatments have been administered in response at this time.   This case was linked to US-MODERNATX, INC.-MOD-2022-637101 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2022: Live Follow-up received. Reporter contact information updated. Patient information updated. Vaccine information added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-637101:Male patient