chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 606 doses were given after expiration date; product stored refrigerator after expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (product stored refrigerator after expiry date) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (product stored refrigerator after expiry date). On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (product stored refrigerator after expiry date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. On 18-Oct-2021, the vial was placed in the refrigerator. The vial did not had any temperature excursion and the patient had no adverse event. No Treatment medication reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired vaccine was stored and then administered; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine was stored and then administered) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine was stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine was stored and then administered) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  It was mentioned that the vial was initially refrigerated on 29-Oct-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.  No treatment medication was provided by the reporter.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. On 21-Sep-2021, the vial was stored in the refrigerator. The vial did not go undergo any temperature excursion. HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. The patient had no any adverse event post administration of expired vaccine.  Treatment information was not provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion"; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion") in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion"). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. There had been no power outages that would have impacted the Moderna vaccine. She stated that because their facility had not been able to download the digital data logger for the months of Dec2021, Jan2022, and Feb2022. Thus, they considered to treat this issue as a temperature excursion. No adverse event was reported. No treatment medication was reported.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion); Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. No Treatment information was reported. Reporter had stated that no adverse events were reported by patient.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was expired on 09-OCT-2021, placed in the refrigerator on 21-SEP-2021 and administered on 18-OCT-2021; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (The vaccine was expired on 09-OCT-2021, placed in the refrigerator on 21-SEP-2021 and administered on 18-OCT-2021) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was expired on 09-OCT-2021, placed in the refrigerator on 21-SEP-2021 and administered on 18-OCT-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (The vaccine was expired on 09-OCT-2021, placed in the refrigerator on 21-SEP-2021 and administered on 18-OCT-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in the refrigerator on 21-SEP-2021. Vial did not undergo any temperature excursion. No adverse event was reported.  No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored on refrigerator on 29-Oct-2021 and then administered on 08-NOV-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 29-Oct-2021 and then administered on 08-NOV-2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 29-Oct-2021 and then administered on 08-NOV-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 29-Oct-2021 and then administered on 08-NOV-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. On 29 Oct 2021, the vial was placed in the refrigerator. The vial did not have any temperature excursion and the patient had no adverse event. No Treatment medication reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine is stored on 29-Oct-2021 and then administered on 08-Nov-2021; 601 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored on 29-Oct-2021 and then administered on 08-Nov-2021) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored on 29-Oct-2021 and then administered on 08-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored on 29-Oct-2021 and then administered on 08-Nov-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vaccine was placed in refrigerator on 29-Oct-2021 There was no temperature excursion. No adverse event was reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine stored in refrigerator on 26-Oct-2021, product expired on 13-Oct-2021, product administered on 01-Nov-2021.; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 26-Oct-2021, product expired on 13-Oct-2021, product administered on 01-Nov-2021.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 26-Oct-2021, product expired on 13-Oct-2021, product administered on 01-Nov-2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 26-Oct-2021, product expired on 13-Oct-2021, product administered on 01-Nov-2021.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date place in refrigerator : 26-OCT-2021  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-491837 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine is placed in refrigerator on 29-Oct-2021, expired product date on 13-Oct-2021, administration date on 09-NOV-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 29-Oct-2021, expired product date on 13-Oct-2021, administration date on 09-NOV-2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 29-Oct-2021, expired product date on 13-Oct-2021, administration date on 09-NOV-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 29-Oct-2021, expired product date on 13-Oct-2021, administration date on 09-NOV-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. No treatment medication information was provided. No temperature excursion was reported. Date place in refrigerator 29-Oct-2021.   This case was linked to MOD-2022-491837 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine was stored and then administered; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that vaccine did not undergo any temperature excursion and patient did not experienced any adverse event and the date vaccine placed in refrigerator was on 26-Oct-2021.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine stored in refrigerator 18-Oct-2021, expired product 13-Oct-2021, administered date on 27-Oct-2021; Expired Vaccine Used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator 18-Oct-2021, expired product 13-Oct-2021, administered date on 27-Oct-2021) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator 18-Oct-2021, expired product 13-Oct-2021, administered date on 27-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator 18-Oct-2021, expired product 13-Oct-2021, administered date on 27-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 18-Oct-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 40-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment information was reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 606 doses were given after expiration date; Expired vaccine was stored in Refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored in Refrigerator) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in Refrigerator). On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored in Refrigerator) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that vaccine was placed in refrigerator on 27-Nov-2021 and patient had no adverse events. There was no temperature excursion. No treatment medication was reported.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine is stored on refrigerator on 18-Oct-2021 and then administered on 27-Oct-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored on refrigerator on 18-Oct-2021 and then administered on 27-Oct-2021) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored on refrigerator on 18-Oct-2021 and then administered on 27-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored on refrigerator on 18-Oct-2021 and then administered on 27-Oct-2021) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in the refrigerator on 18-Oct-2021.Vial did not undergo any temperature excursion. No adverse event was reported.  No treatment medications were reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 606 doses were given after expiration date; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date place in refrigerator 29-10-2021 No concomitant medication were provided No treatment details were provided
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 606 doses were given after expiration date; Vaccine stored in refrigerator on 27-Nov-2021, expired product on 13-Oct-2021 and administered on 01-Dec-2021; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 27-Nov-2021, expired product on 13-Oct-2021 and administered on 01-Dec-2021) and EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 27-Nov-2021, expired product on 13-Oct-2021 and administered on 01-Dec-2021). On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date). At the time of the report, PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 27-Nov-2021, expired product on 13-Oct-2021 and administered on 01-Dec-2021) and EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. The reporter stated that initially there were 606 doses from expired lot and they found out later that some patients that were impacted had received the Janssen COVID-19 vaccine. Date the vial placed in refrigerator was on 27-Nov-2021. There was no temperature excursion. The patient had no adverse event. No Treatment information was reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was stored in the refrigeration; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (vial was stored in the refrigeration) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was stored in the refrigeration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (vial was stored in the refrigeration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient received booster dose. The vial was placed in the refrigerator on 29-Oct-2021. Vial did not undergone any temperature excursion. No adverse event was reported. No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine stored on 18-Oct-2021 and then administered on 26-Oct-2021; 601 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine stored on 18-Oct-2021 and then administered on 26-Oct-2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine stored on 18-Oct-2021 and then administered on 26-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine stored on 18-Oct-2021 and then administered on 26-Oct-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Date the vial was placed in refrigerator was on 18-Oct-2021. Temperature excursion was not reported. The patient did not experience any adverse event. The reporter stated that initially there were 606 doses from expired lot and they found out later that some patients that were impacted had received the Janssen COVID-19 vaccine. Treatment information was not provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 13-OCT-2021 and placed in refrigerator on 27-NOV-2021; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 27-NOV-2021) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 27-NOV-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-OCT-2021 and placed in refrigerator on 27-NOV-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. No treatment information was provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 38-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  Reporter stated that no adverse reactions were reported by any patients.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. The reporter stated that because their facility was not able to download the digital data logger, they were put on hold by the State at the moment and could not administer the Moderna COVID-19 vaccine to patients, until an assessment by the State was made. There  were no power outages that would have impacted the Moderna vaccine. They needed to treat that issue as a temperature excursion. No adverse reactions were reported by any patients. No treatment medication were provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. No adverse reactions were reported by patient.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was infection control manager.  Concomitant medication of the patient was not reported.  There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491837 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired vaccine is stored on refrigerator on 29-Oct-2021 and then administered on 03-NOV-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored on refrigerator on 29-Oct-2021 and then administered on 03-NOV-2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine is stored on refrigerator on 29-Oct-2021 and then administered on 03-NOV-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored on refrigerator on 29-Oct-2021 and then administered on 03-NOV-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The vial was placed in the refrigerator on 29-Oct-2021.Vial did not undergo any temperature excursion.  No adverse event was reported.