Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 07 Apr 2022 and administered on 11 May 2022  and given beyond 30 days in fridge and expired dose administered after 30-day Use By Date; Vial was initially stored in the refrigerator on 07 Apr 2022 and administered on 11 May 2022  and given beyond 30 days in fridge and expired dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the refrigerator on 07 Apr 2022 and administered on 11 May 2022  and given beyond 30 days in fridge and expired dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 07 Apr 2022 and administered on 11 May 2022  and given beyond 30 days in fridge and expired dose administered after 30-day Use By Date) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the refrigerator on 07 Apr 2022 and administered on 11 May 2022  and given beyond 30 days in fridge and expired dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 07 Apr 2022 and administered on 11 May 2022  and given beyond 30 days in fridge and expired dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the refrigerator on 07 Apr 2022 and administered on 11 May 2022  and given beyond 30 days in fridge and expired dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 07 Apr 2022 and administered on 11 May 2022  and given beyond 30 days in fridge and expired dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided Treatment medication was not provided by the reporter  On 16 May 2022- the case was considered as invalid as it has no patient identifiers  The HCP stated that they had administered 3 vaccine doses past 30 days beyond use by date after being thawed There were 2 different vials with same Lot and expiration date however 1 dose was administered from 1 vial and 2 doses were administered from 2nd vial and dose administered after 30-day Use By Date or after manufacturer date of expiry  Number of doses or vials: 2 vials but 3 doses were administered from 2 separate vials and Date the vial was initially stored in the refrigerator on 07 Apr 2022 The vial did not undergo any temperature excursions   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2022: Significant follow up was received. Report type was updated. Secondary reporter was updated. Patient demographic details were updated. Suspect drug administration date, dose number, dose, units, expiration date was updated. Event (product storage error) was updated. Narrative was updated.