Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Maximum or minimum temperatures reached, as applicable (specify temp is in c or f): minimum -25.0, maximum- 14.6 c and excursion duration was 5 min.; Maximum or minimum temperatures reached, as applicable (specify temp is in c or f): minimum -25.0, maximum- 14.6 c and excursion duration was 5 min.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Maximum or minimum temperatures reached, as applicable (specify temp is in c or f): minimum -25.0, maximum- 14.6 c and excursion duration was 5 min.), PRODUCT STORAGE ERROR (Maximum or minimum temperatures reached, as applicable (specify temp is in c or f): minimum -25.0, maximum- 14.6 c and excursion duration was 5 min.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Maximum or minimum temperatures reached, as applicable (specify temp is in c or f): minimum -25.0, maximum- 14.6 c and excursion duration was 5 min.), PRODUCT STORAGE ERROR (Maximum or minimum temperatures reached, as applicable (specify temp is in c or f): minimum -25.0, maximum- 14.6 c and excursion duration was 5 min.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Maximum or minimum temperatures reached, as applicable (specify temp is in c or f): minimum -25.0, maximum- 14.6 c and excursion duration was 5 min.), PRODUCT STORAGE ERROR (Maximum or minimum temperatures reached, as applicable (specify temp is in c or f): minimum -25.0, maximum- 14.6 c and excursion duration was 5 min.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Maximum or minimum temperatures reached, as applicable (specify temp is in c or f): minimum -25.0, maximum- 14.6 c and excursion duration was 5 min.) and PRODUCT STORAGE ERROR (Maximum or minimum temperatures reached, as applicable (specify temp is in c or f): minimum -25.0, maximum- 14.6 c and excursion duration was 5 min.).    No concomitant medication information provided.  Storage condition at the time of the excursion: frozen storage / refrigerated storage / ambient room temperature: Freezer.  Lot number and Expiration Date: Pediatric: AR9236B- 11-Feb-2023 and AR5186C -17-Nov-2022 Adult: 083B22A- 28-Nov-2022.  The vials were stored in the freezer.  Visual inspection noting any vaccine state change: (e.g. were frozen vials thawed, were thawed vials re-frozen, were they visualized at all) Frozen.  Proposed desired Use by Date: (date of vaccination clinic, patient appointments, etc. that HCP would like vaccine administered from the vials in question) patients had received the vaccine.  Number of vials/doses impacted: Adults: 10 vials /100 doses.  Pediatric: dose 2 boxes of AR9236B 10 vials/200 dose AR5186C 8 vials/ 80 doses  Vaccine coordinator is following up on a previous temperature excursion 26-Aug-2022 for 5 minutes.  HCP wanted to clarify that no patients were vaccinated with the lot numbers provided.  Reporter says they are still being sent information to fill out for the patients when none of the vaccine from the excursion were administer.  It was reported that pediatric vial AR5186C was punctured and administered to unknown number of pediatric patients.  No treatment information provided.     On 06-Sep-2022: MOD-2022-639344 Case became Invalid as there was no patient details available in the case.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2022: The recent follow-up contains narrative was updated.