Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Vaccination site reaction
Clinical narrative: had normal side effects; First dose administered after exposure to room temperature >24 hours; Fridge's door was not closed all the way, and temperature was out of range for about 1 hour and 20 minutes, reaching a maximum of 10 degrees Celsius.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First dose administered after exposure to room temperature >24 hours), PRODUCT STORAGE ERROR (Fridge's door was not closed all the way, and temperature was out of range for about 1 hour and 20 minutes, reaching a maximum of 10 degrees Celsius.) and VACCINATION SITE REACTION (had normal side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (First dose administered after exposure to room temperature >24 hours) and PRODUCT STORAGE ERROR (Fridge's door was not closed all the way, and temperature was out of range for about 1 hour and 20 minutes, reaching a maximum of 10 degrees Celsius.). On an unknown date, the patient experienced VACCINATION SITE REACTION (had normal side effects). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (First dose administered after exposure to room temperature >24 hours) and PRODUCT STORAGE ERROR (Fridge's door was not closed all the way, and temperature was out of range for about 1 hour and 20 minutes, reaching a maximum of 10 degrees Celsius.) had resolved. At the time of the report, VACCINATION SITE REACTION (had normal side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINATION SITE REACTION (had normal side effects) to be possibly related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (First dose administered after exposure to room temperature >24 hours) and PRODUCT STORAGE ERROR (Fridge's door was not closed all the way, and temperature was out of range for about 1 hour and 20 minutes, reaching a maximum of 10 degrees Celsius.).    No treatment drugs were reported. No concomitants were reported. This is a case of Expired product administered and Product storage error for this patient of an unknown age and gender. Reportedly, the patient received the dose of the vaccine which was exposed to room temperature more than 24 hours. In addition, it was also stated that the vial was out of temperature range of the fridge for about 1 hour and 20 minutes, reaching a maximum of 10 degrees Celsius. The patient reportedly experienced the unexpected unspecified non-serious event of Vaccination complication (Vaccination adverse reaction, as it was stated that the patient "experienced normal side effects"). The outcome of the event remained unknown without further details. The re-challenge for this event cannot be determined, as the outcome of the event was unknown and no information regarding the second dose was provided. The company causality for the events of Expired product administered and Product storage error is not applicable, while the causality for the event of Vaccination complication cannot be excluded. The benefit risk relationship of vaccine is not affected by this report.   This case was linked to MOD-2021-374037 (Patient Link).; Sender's Comments: This is a case of Expired product administered and Product storage error for this patient of an unknown age and gender. Reportedly, the patient received the dose of the vaccine which was exposed to room temperature more than 24 hours. In addition, it was also stated that the vial was out of temperature range of the fridge for about 1 hour and 20 minutes, reaching a maximum of 10 degrees Celsius. The patient reportedly experienced the unexpected unspecified non-serious event of Vaccination complication (Vaccination adverse reaction, as it was stated that the patient "experienced normal side effects"). The outcome of the event remained unknown without further details. The re-challenge for this event cannot be determined, as the outcome of the event was unknown and no information regarding the second dose was provided. The company causality for the events of Expired product administered and Product storage error is not applicable, while the causality for the event of Vaccination complication cannot be excluded. The benefit risk relationship of vaccine is not affected by this report.