Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered that went under temperature excursion for 15 minutes at the site 1.9 Celsius; Vaccine administered that went under temperature excursion for 15 minutes at the site 1.9 Celsius; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion for 15 minutes at the site 1.9 Celsius) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion for 15 minutes at the site 1.9 Celsius) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     The patient did not have an allergic reaction to polysorbate, polyethylene glycol or a previous dose of COVID-19 vaccine. The patient did not have a serious allergic reaction (anaphylaxis) to another vaccine, injectable medications, food, pets, venom environmental or oral medications. The patient does not have a bleeding disorder or was on a long term aspirin therapy or other blood thinners. The patient has not had Guillain-Barre syndrome after receiving the vaccine. The patient had not received dermal fillers. The patient does not have a history of myocarditis, pericarditis, heparin induced thrombocytopenia (HIT).  The patient did not have Multisystem  inflammatory syndrome (MUS-A) in adults after a COVID-19 infection. The patient was not immunocompromised.     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 for 15 minutes at the site 1.9 Celsius). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion for 15 minutes at the site 1.9 Celsius). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion for 15 minutes at the site 1.9 Celsius) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion for 15 minutes at the site 1.9 Celsius) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received booster dose on 15-Jun-2022. Concomitant medications were not reported. Number of doses/vials that were administered from that lot was 2 (1 punctured and 1 not punctured). The vial was previously stored in fridge. The vial was moved from freezer to refrigerator on 15-Jun-2022. The vial was first punctured on 15-Jun-2022 at 9.15 AM. The vial was stored in portable fridge post puncture. The vial underwent temperature excursion for about 15 minutes having minimum temperature of 1.9 degree Celsius and maximum temperature of 6.4 degree Celsius. The dose was administered to the patient within less than 12 hours post puncture. Proposed desired use by date and time of the vial was 15-Jun-2022 (afternoon). The vial was returned to fridge and quarantined after administration. Treatment information was not provided.