Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Expired product administered, Inappropriate schedule of product administration, Product storage error, SARS-CoV-2 test
Clinical narrative: Patient was Covid-19 positive; Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022; Patient received 1st dose on 13-Jan-2022 and 2nd dose on 17-May-2022; Patient received Moderna vaccine that had been expired for 2 weeks; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Patient was Covid-19 positive), EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks), PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 13-Jan-2022 and 2nd dose on 17-May-2022) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 083J21A and 067F21A) for COVID-19 vaccination.     The patient had no known drug allergies.    On 13-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks). On an unknown date, the patient experienced COVID-19 (Patient was Covid-19 positive), PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 13-Jan-2022 and 2nd dose on 17-May-2022). At the time of the report, COVID-19 (Patient was Covid-19 positive), EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks), PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 13-Jan-2022 and 2nd dose on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter reported that, the expiration date was not written on the vial and did not noticed it had already expired.  Number of doses/vials were 26 doses   The vial did not undergo any temperature excursions.  The vial was stored in refrigerator on 17-May-2022.  No treatment medications were reported. Company comment: This spontaneous case concerns a 20-year-old patient of unknown gender with no reported medical history, who experienced the unexpected, non-serious of COVID-19. The events Product storage error, Inappropriate schedule of product administration and Expired product administration were also reported. The exact date of onset of the event COVID-19 was not specified in respect to the administration of mRNA-1273, hence latency could not be assessed. The initial two doses of mRNA-1273 have an interval of 124 days. On an unknown date, SARS-CoV-2 test was done which revealed a positive result. It has been reported that the expiration was not written on the vial and did not notice it was already expired. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 20-year-old patient of unknown gender with no reported medical history, who experienced the unexpected, non-serious of COVID-19. The events Product storage error, Inappropriate schedule of product administration and Expired product administration were also reported. The exact date of onset of the event COVID-19 was not specified in respect to the administration of mRNA-1273, hence latency could not be assessed. The initial two doses of mRNA-1273 have an interval of 124 days. On an unknown date, SARS-CoV-2 test was done which revealed a positive result. It has been reported that the expiration was not written on the vial and did not notice it was already expired. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.