Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna vaccine administered to patient post temperature excursion of about 5 hours; Moderna vaccine administered to patient post temperature excursion of about 5 hours; First dose of Moderna vaccine taken on 21-Oct-2021 and second dose of Moderna vaccine taken on 10-May-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patient post temperature excursion of about 5 hours), POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine administered to patient post temperature excursion of about 5 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna vaccine taken on 21-Oct-2021 and second dose of Moderna vaccine taken on 10-May-2022) in a 69-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if the patient was diagnosed or tested positive for COVID-19 or not. It was unknown if the patient was having chronic or long standing health condition or not.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 10-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine administered to patient post temperature excursion of about 5 hours). 10-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna vaccine taken on 21-Oct-2021 and second dose of Moderna vaccine taken on 10-May-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patient post temperature excursion of about 5 hours). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patient post temperature excursion of about 5 hours), POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine administered to patient post temperature excursion of about 5 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna vaccine taken on 21-Oct-2021 and second dose of Moderna vaccine taken on 10-May-2022) outcome was unknown. Not provided.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna vaccine administered to patient post temperature excursion of about 5 hours) and POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine administered to patient post temperature excursion of about 5 hours) to have an unknown relationship. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna vaccine taken on 21-Oct-2021 and second dose of Moderna vaccine taken on 10-May-2022).    No concomitant medications were reported.  The vaccine was stored at the refrigerated storage condition at the time of the excursion and it had undergone freezing in the refrigerator a day before administration for about 5 hours.  At the time of excursion, the minimum temperature reached by the vial was 26 degree Fahrenheit and average temperature reached by the vial was 28 degree Fahrenheit. The excursion duration was 15 minutes at minimum temperature and total excursion duration was 5 hours.  Currently, all the vaccines in the vial which was stored was used up to administer to patients. No change was noticed in vaccine state change. The vial had not undergone any previous temperature excursion in the past.  It was reported that the patient did not report any adverse effects after vaccination.  No treatment information was reported.