Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administrated after temperature excursion; Vaccine administrated after temperature excursion; 1st Dose of Moderna on 2-Jan-2021 and 2nd Dose on 26-Jan-2021; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administrated after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administrated after temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose of Moderna on 2-Jan-2021 and 2nd Dose on 26-Jan-2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 029H21B, 043L20A and 025L20A) for COVID-19 prophylaxis.     Patient had no acute illnesses at the time of vaccination and up to one month before Patient had no Chronic or long-standing health conditions.  The patient's past medical history included COVID-19 (Unknown date).   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2022 at 10:59 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose of Moderna on 2-Jan-2021 and 2nd Dose on 26-Jan-2021). On 06-Jun-2022 at 10:59 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administrated after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administrated after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administrated after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administrated after temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose of Moderna on 2-Jan-2021 and 2nd Dose on 26-Jan-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received the booster dose (Dose 4).  No concomitant medications information was reported.  It was reported that vaccine was thawed at the time of excursion (Lot 059A22A). Lowest reading was 35.6 for a total time of 30 minutes.Vaccines remained in travel cooler.No visible changes to vial was noted. At 11:18 am vaccines were placed in refrigerator. Total 1 vial was affected.  There was no adverse reaction with the administration of this vaccine.  On 06-Jun-2022, reporter noticed that the datalogger from the travel cooler was out of range, the necessary actions was taken to bring the cooler back within range. It took approximetly 6 mins for the temperture to be regualted. The datalogger failed to alert of the excursion of approximately 36 minutes.  The manufacturer was adviced of the excursion and of the administration of the booster.  The response from the manufacture is that the vaccine was not affected, therefore being a viable booster dose.  No treatment medications were provided.   This case was linked to MOD-2022-588299 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2022: Follow-up document received contains no new information.