Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions; Patients received the Moderna Covid-19 vaccine that had undergone multiple temperature excursions . Maximum Temperature is 49 degrees Farenheight, Minimum Temperature is 37.7 degrees Farenheight; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid-19 vaccine that had undergone multiple temperature excursions . Maximum Temperature is 49 degrees Farenheight, Minimum Temperature is 37.7 degrees Farenheight) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid-19 vaccine that had undergone multiple temperature excursions . Maximum Temperature is 49 degrees Farenheight, Minimum Temperature is 37.7 degrees Farenheight). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid-19 vaccine that had undergone multiple temperature excursions . Maximum Temperature is 49 degrees Farenheight, Minimum Temperature is 37.7 degrees Farenheight) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  The nurse reported that patient received vaccine in question as a booster dose, nurse did not have information on the patient's first two doses. It was not known which arm the patient received the vaccine. It was reported that 26 Patients received the Moderna Covid-19 vaccine that had undergone multiple temperature excursions. Storage condition at the time of the excursion: refrigerated storage.  The temperature excursions occurred on 4-Mar-2022, 5-Mar-2022, 7-Mar-2022, 8-MAR-2022, 9-MAR-2022 and 10-Mar-2022. Maximum Temperature was 49 degrees Fahrenheit, Minimum Temperature was 37.7 degrees Fahrenheit, excursion duration : several temperature excursions.  The vials were not visualized. Number of vials/doses impacted: 10 Vials 100 doses.  Proposed desired Use by Date: (date of vaccination clinic, patient appointments, etc. that HCP would like vaccine administered from the vials in question)- 16 MAR 2022 The nurse reported that patient did not experience any adverse reactions or side effects to the Moderna COVID-19 vaccine. Treatment information was not provided.