chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient received booster dose instead of full dose for 3rd dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received booster dose instead of full dose for 3rd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received booster dose instead of full dose for 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received booster dose instead of full dose for 3rd dose) 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 reported wanted to know that if an immunocompromised patient received a two-dose primary series followed by a booster 5 months later, but should have received a third primary dose, should a a fourth dose (full dose) be given and at what timing post booster.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was reported. No concomitant medication was reported. Vial was moved to fridge on 06-Oct-2021. Vaccine was administered past the 30-day from the initial storage at 2 degree Celsius to 8 degree Celsius.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient MRN Id was 00422227. No concomitant medications were reported. No treatment medications were reported. It was reported that the vial was moved to fridge on 06-Oct-2021. The storage condition of the vial at the time of the excursion was frozen storage/refrigerated storage/ambient room temperature frozen storage/refrigerated storage. The state of the vaccine at the time of the excursion was reported as partially thawed/liquid. The maximum or minimum temperature reached by the vial was 8 degree Celsius. It was reported that the total duration of excursion at refrigerated temperature was for a maximum of 4 hours. It was reported that the vials were re-frozen. Temperature fluctuations had occurred from frozen state to refrigerated state to being re-frozen.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival; Total duration of the excursion refrigerated temps for max of 4 hrs; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Total duration of the excursion refrigerated temperature for maximum of 4 hour. On 06 Oct 2021, vial was moved to fridge. The facility thought that the vials are received frozen from  Moderna so they had unpacked them and put them back into the facility freezer.They just recently found out that the vials are received in refrigerated temperatures and not frozen. They have been accidentally administering refrozen vials to their patients. Vaccine administered post 30 days from the initial storage at 2 degree Celsius to 8 degree Celsius.  Treatment information was not provided.   This case was linked to MOD-2022-496015 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date; Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) and PRODUCT STORAGE ERROR (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.  On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced PRODUCT STORAGE ERROR (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date). On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) and PRODUCT STORAGE ERROR (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-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 healthcare professional (HCP) wanted to know whether the patient should revaccinate or not.  The vial was initially stored in the refrigerator on 10-Jan-2022.  The vials did not undergo any temperature excursions.  No treatment medications were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022; Patient received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022) and EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022) and EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) 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 initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022. It was reported that the vial had not undergone any temperature excursions.   This case was linked to MOD-2022-500959 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022; Patients received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022) 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.  It was reported that the vial had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-500959 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022; Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022) 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 healthcare professional (HCP) wanted to know whether the patient should revaccinate or not.  The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022.  The vials did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-500959 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on 1-Dec-2021 vaccine was moved to fridge and vaccine administrered post 30 days from the initial storage at 2C to 8C.  No concomitant were reported. No treatment were reported.   This case was linked to MOD-2022-496015.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received first dose of Moderna COVID-19 vaccine from a vial left in the room temperature overnight; Vial left in the room temperature overnight, From 10:39AM on 01MAR2022 till 02MAR2022 11:45AM; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received first dose of Moderna COVID-19 vaccine from a vial left in the room temperature overnight) and PRODUCT STORAGE ERROR (Vial left in the room temperature overnight, From 10:39AM on 01MAR2022 till 02MAR2022 11:45AM) in a 38-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022 at 11:45 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced PRODUCT STORAGE ERROR (Vial left in the room temperature overnight, From 10:39AM on 01MAR2022 till 02MAR2022 11:45AM). On 02-Mar-2022 at 11:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received first dose of Moderna COVID-19 vaccine from a vial left in the room temperature overnight). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received first dose of Moderna COVID-19 vaccine from a vial left in the room temperature overnight) and PRODUCT STORAGE ERROR (Vial left in the room temperature overnight, From 10:39AM on 01MAR2022 till 02MAR2022 11:45AM) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  Date the vial was initially stored in the refrigerator was 28FEB2022.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival; Total duration of the excursion refrigerated temps for max of 4 hrs; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) 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.  It was reported that, the vaccine was moved to fridge date was 06-OCT-2021.  Vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 8-degree Celsius, total duration of the excursion refrigerated temperature for maximum of 4 hours.  No treatment details were provided.   This case was linked to MOD-2022-496015 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.; Total duration of the excursion refrigerated temps for max of 4 hrs.; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was unknown if the vial was undergone a previous temperature excursion. The storage condition at the time of the excursion was frozen storage/refrigerated storage. The state of the vaccine at the time of the excursion was partially thawed/liquid. The maximum temperature reached was 8°C. the total duration of the excursion refrigerated temps for max of 4 hours. The temperature fluctuations occurred as frozen-refrigerated and refrozen.  It was also reported that on 01-Dec-2021, the vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2°C to 8°C.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival; Total duration of the excursion refrigerated temps for max of 4 hrs; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Reporter stated that it was unknown if the vial was undergone a previous temperature excursion. The storage condition at the time of the excursion was frozen storage/refrigerated storage. The state of the vaccine at the time of the excursion was partially thawed/liquid. The maximum temperature reached was 8 degree Celsius. The total duration of the excursion refrigerated temperatures for max of 4 hours. The temperature fluctuations occurred as frozen-refrigerated and refrozen.  And also stated that the vial was moved to the fridge on 06-Oct-2021 and administered post 30 days.  No treatment information was provided.   This case was linked to MOD-2022-496015 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Expired product administered
Clinical narrative: patient passed away; patient was administered from an expired vaccine /misadministration; This spontaneous case was reported by a nurse and describes the occurrence of DEATH (patient passed away) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine /misadministration). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine /misadministration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  it was reported that the dose administered was after 30-day use by date or after manufacturer date of expiry. 50 expired vaccine doses were administered to patients and staff. Date the vial was initially stored in the refrigerator: 04-Nov-2021. Date(s) of administration of vaccine was reported as some 05-Nov-2021 and the other doses on 12-Nov-2021. Vial did not undergo any temperature excursions.  No adverse event was reported  as a result of this misadministration, patients were monitored.  Company comment: This is a case of Expired product administered for this 77-year-old male patient, with no medical history reported, who died after the administration of a dose of mRNA-1273 vaccine. It was reported that vaccine was administered after 30-day Use By Date or after manufacturer date of expiry. The patient received a dose in November 2021, he died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time, further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-501813 (Patient Link).; Sender's Comments: This is a case of Expired product administered for this 77-year-old male patient, with no medical history reported, who died after the administration of a dose of mRNA-1273 vaccine. It was reported that vaccine was administered after 30-day Use By Date or after manufacturer date of expiry. The patient received a dose in November 2021, he died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. Very limited information regarding this event has been provided at this time, further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was moved to fridge on 06-Oct-2021.  PAT_MRN_ID was  reported as 06011954 It was unknown that if the lot number undergone to temperature excursion on not.  The state of the vaccine was partially thawed/liquid at the time of excursion. The vials size were 5.5 mL or 7.5 mL. Total duration of excursion was reported as maximus as 4 hours.  No treatment medications were reported.   This case was linked to MOD-2022-496015 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2022-496015 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.; Total duration of the excursion refrigerated temps for max of 4 hrs.; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge).), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs.) 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 information was provided. No treatment medication were provided. It was reported that total duration of the excursion refrigerated temperature for maximum of 4 hour. On 01-Dec-2021 Vial was moved to fridge. State of the vaccine at the time of excursion was partially thawed/liquid.   This case was linked to MOD-2022-496015 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temperature, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temperature, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temperature, re-frozen at ti me of arrival). At the time of the report, PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temperature, re-frozen at ti me of arrival) 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. No treatment was provided by the reporter.   This case was linked to MOD-2022-496015 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival; Total duration of the excursion refrigerated temps for max of 4 hrs; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.    No concomitant medication were reported.  Vial was moved to fridge on 19-Jan-2022.Temperature was fluctuated Frozen-refrigerated and again re frozen. Frozen vails removed and transported ate refrigerated temperature and refrozen at time of arrival. Total duration of excursion refrigerated temperature for max 4 hours. Temperature reached to 8 degrees Celsius. Vials size was 5.5 mL and 7.5 Ml. Partially thawed liquid state at the time of excursion.  No treatment drug were reported.