Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 2:02 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 2:04 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient on 28- Feb-2021 was provided as 48.74. The age of patient on 28- Mar-2021 was provided as 48.82. Concomitant medication was not provided. On 28-FEB-2021, Excursion time was 09 AM and 1PM. temperature was 27 and 26 respectively. total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-FEB-2021, vial was moved to clinic on 27-FEB-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-MAR-2021. Manufacturer expiry was on 12-Aug-2021. On 28-FEB-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45. On 28-Mar-2021, Excursion time was 10 AM with temperature as 35. Total doses given for the day was 150. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 23-Mar-2021. Vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. Temperature recordings were taken using a brand traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. All doses were drawn from vial due to high-pace clinic. Poor quality products were administered on 28-Feb-2021 and 28-Mar-2021 respectively. Lot number 014M20A went thought accidental refreeze second excursion On 28-Feb-2021, Liquid vaccine stored in the cooler experienced a temperature excursion to a minimum temperature of 26F and was out of range for 2 hours.  Based on the information provided it was possible the vaccine would have started to refreeze and then thawed prior to administration. No treatment information reported The vaccines were being stored in the coolers as pre-drawn syringes in addition to extra vials for the morning and afternoon clinics. Vaccines were packed layered in the following order: Conditioned water bottle, bubble wrap, cardboard, vaccine in the box in a pharmacy light prevention brown bag, cardboard, bubble wrap. Thermometer glycol placed with the vaccine layer.   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2022: Follow up received reporter added. On 23-May-2022: Follow up received expiry date of suspect was added. On 23-May-2022: Follow up received updated i-narrative. On 24-May-2022: Follow up received and narrative was updated.