Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Expired product administered, SARS-CoV-2 test
Clinical narrative: COVID-19; given a vaccine flagged as expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given a vaccine flagged as expired) and COVID-19 (COVID-19) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 002F21A, 027A21A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Non-cirrhotic portal hypertension and Liver transplant (non cirrhotic hypertension 8 years) in 2014. Concurrent medical conditions included Food allergy (corn), Fish allergy, Device allergy (bandages), Drug allergy (erythromycin), Blood disorder and Diabetes.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (given a vaccine flagged as expired). On 21-Jul-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given a vaccine flagged as expired) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Number of doses and vials was 1 dose. The event does not cause the patient to seek medical care. Patient had no vaccine on the same day or within one month prior to Moderna vaccine. The patient had not experienced similar adverse event in the past. Vial undergoes any temperature excursions was unknown. Vial initially stored in the refrigerator was unknown.  Treatment medication included antibody infusion.  Company comment-This spontaneous case concerns a 38-year-old, male patient with relevant medical history of liver transplant for non-cirrhotic hypertension 8 years back reported, who experienced the unexpected, non- serious, AESI of COVID-19(with positive SARS-CoV-2 test). Additional non-serious event of Expired product administered was also reported. He had the vaccine (4th dose of mRNA-1273) that the lot number that was administered to him was flagged as expired at the time of administration.  The event COVID-19 occurred 58 days after the 4th dose of mRNA-1273 vaccination. Patient was quarantined for 20 days, was given the antibody infusion. Outcome of the events was unknown at the time of report. Patient had received initial two doses of same vaccine at an interval of 28 days followed by 3rd dose 5.5 months later subsequently 4th dose 5.5 months later. Current COVID-19 pandemic could be confounder and relevant medical history could be risk factor to the event covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 38-year-old, male patient with relevant medical history of liver transplant for non-cirrhotic hypertension 8 years back reported, who experienced the unexpected, non- serious, AESI of COVID-19(with positive SARS-CoV-2 test). Additional non-serious event of Expired product administered was also reported. He had the vaccine (4th dose of mRNA-1273) that the lot number that was administered to him was flagged as expired at the time of administration.  The event COVID-19 occurred 58 days after the 4th dose of mRNA-1273 vaccination. Patient was quarantined for 20 days, was given the antibody infusion. Outcome of the events was unknown at the time of report. Patient had received initial two doses of same vaccine at an interval of 28 days followed by 3rd dose 5.5 months later subsequently 4th dose 5.5 months later. Current COVID-19 pandemic could be confounder and relevant medical history could be risk factor to the event covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.