Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, SARS-CoV-2 test
Clinical narrative: The vial was initially stored in refrigerator on 14-Jul-2022 and was admininstered on 17-Aug-2022; No adverse event; Patient was administered with a booster dose of the Moderna Covid 19, after its expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with a booster dose of the Moderna Covid 19, after its expiration date.), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 14-Jul-2022 and was admininstered on 17-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose,Lot#: FEA092681) on 19-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd Dose,Lot#: ER8734) on 09-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (1st Booster dose andLot#: FH8028) on 18-Nov-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 17-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with a booster dose of the Moderna Covid 19, after its expiration date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 14-Jul-2022 and was admininstered on 17-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with a booster dose of the Moderna Covid 19, after its expiration date.), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 14-Jul-2022 and was admininstered on 17-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive 2 months ago.     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 (Patient was administered with a booster dose of the Moderna Covid 19, after its expiration date.) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 14-Jul-2022 and was admininstered on 17-Aug-2022).    No concomitant medications were reported. The expiration date of vial was 13-Aug-2022. The vial was initially placed in the refrigerator on 14-Jul-2022. The vial did not undergo temperature excursion.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2022: Follow-up received included vaccine refrigeration date was updated.