Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered that went under temperature excursion.; Vaccine administered that went under temperature excursion.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     The patient did not had an allergic reaction to polysorbate polyethylene glycol, or a previous dose of COVID-19 vaccine. The patient never had severe allergic reaction (anaphylaxis) to foods, pets, venom. environmental or oral medications. The patient did have a bleeding disorder, and was on a long-term aspirin therapy or taking other blood thinners. The patient never had Guillain-Barre Syndrome (a type of temporary sever muscle weakness) after receiving a vaccine. The patient never received any dermal fillers (Juvaderm, Restylane, etc) nor had a history of blood clots, nor had myocarditis or pericarditis, nor had heparin-induced thrombocytopenia(HIT), nor had Multisystem inflammatory syndrome known as MIS-C after a COVID-19 infection.  Concurrent medical conditions included Bleeding (on long-term aspirin therapy or taking other blood-thinners.).    On 15-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took the booster dose on 15-Jun-2022. No concomitant medications was reported. Patient did not have a fever on 15-Jun-2022 Reporter stated that the data logger was not set with correct parameters and excursion happened for 15 mins at the site +1.9 C. Storage condition at the time of the excursion: Refrigerator Maximum or minimum temperatures reached, as applicable: +1.9 C to +6.4C Excursion duration: 15 min Date vial moved from freezer to refrigerator: 08-Jun-2022 and 1 vial on 15-Jun-2022 Currently the vials kept in fridge (quarantined) Visual inspection noting any vaccine state change: Thawed Proposed desired use by date was reported as afternoon of the day of reporting. Number of doses/vials: 2 (1 punctured and 1 not punctured.) Date and time vial was first punctured: 15-Jun-2022 at 9.15 AM The vial was stored in a portable fridge post puncture. Was the vail exposed to room temperature for greater than 24 hours: All were in fridge. No treatment medications were provided.