Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: given vaccines which potentially underwent temp excursion/47 doses have been administered since the excursion; given vaccines which potentially underwent temp excursion/47 doses have been administered since the excursion; given vaccines which potentially underwent temp excursion/47 doses have been administered since the excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccines which potentially underwent temp excursion/47 doses have been administered since the excursion), PRODUCT STORAGE ERROR (given vaccines which potentially underwent temp excursion/47 doses have been administered since the excursion), POOR QUALITY PRODUCT ADMINISTERED (given vaccines which potentially underwent temp excursion/47 doses have been administered since the excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 060A22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccines which potentially underwent temp excursion/47 doses have been administered since the excursion), PRODUCT STORAGE ERROR (given vaccines which potentially underwent temp excursion/47 doses have been administered since the excursion), POOR QUALITY PRODUCT ADMINISTERED (given vaccines which potentially underwent temp excursion/47 doses have been administered since the excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccines which potentially underwent temp excursion/47 doses have been administered since the excursion), PRODUCT STORAGE ERROR (given vaccines which potentially underwent temp excursion/47 doses have been administered since the excursion), POOR QUALITY PRODUCT ADMINISTERED (given vaccines which potentially underwent temp excursion/47 doses have been administered since the excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (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 (given vaccines which potentially underwent temp excursion/47 doses have been administered since the excursion), PRODUCT STORAGE ERROR (given vaccines which potentially underwent temp excursion/47 doses have been administered since the excursion) and POOR QUALITY PRODUCT ADMINISTERED (given vaccines which potentially underwent temp excursion/47 doses have been administered since the excursion).    Concomitant drugs were not reported.  It was reported that the monovalent vaccine was delivered on 23-May-2022 and was placed in the freezer and now there were just 2 vials left.  It was also reported that the digital logger was always within recommended temperature range when checked manually but when the state department uploaded the data logger digitally it gave them messed up information.  It was reported frozen storage condition at the time of the excursion.  Individual vials or unbroken cartons was 10 vials and vial size had 5.5 milliliter.  Maximum or minimum temperatures reached was -14.36C and excursion duration was 30 min.  It was reported no visual changes during visual inspection.  It was reported 47 patients had been administered since the excursion.  Treatment medications were not provided.  The case became invalid as no patient identifiers were reported and multiple patients had been involved.   This case was linked to US-MODERNATX, INC.-MOD-2022-655046 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2022: The recent follow-up contains number of Patient and  Narrative Updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-655046:Bivalent Dose