chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge).    Concomitant product use was not provided by the reporter.  Best used date was reported as 30-Jul-2021. Patient did not report any side effects.  Treatment information was not provided. This case included information for patient 3 out of 31.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case ID
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication of the patient was not reported.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021.Best used date was reported as 30-Jul-2021. Doses were administered between 02-Aug-2021 and 20-Sep-2021. Patient did not report any side effects.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case ID
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication of the patient was not reported.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021 and best used date was reported as 30-Jul-2021.  The patient did not report any side effects. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case ID
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; The patient received vaccine after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    Concomitant medication of the patient was not reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021.  The patient did not report any side effects. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; The patient received vaccine after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received vaccine after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication of the patient was not reported.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021 and best used date was reported as 30-Jul-2021.  The patient did not report any side effects.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge).    Concomitant product use was not provider by the reporter.  The vaccines were stored in the fridge on 30-Jun-2021. Best used date was reported as 30-Jul-2021. Doses were administered between 02-Aug-2021 and 20-Sep-2021. Patient did not report any side effects.  Treatment information was not provided. This case included information for patient 23 out of 31.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired device used, No adverse event, Product storage error
Clinical narrative: The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    Concomitant product use was not provider by the reporter. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The vaccines were stored in the fridge on 30-Jun-2021. Best used date was reported as 30-Jul-2021. Doses were administered between 02-Aug-2021 and 20-Sep-2021. Patient did not report any side effects.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case ID
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 14-Sep-2022; No adverse event; 4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 14-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 14-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 14-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 14-Sep-2022).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication of the patient was not reported.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 18-Jul-2022 and best used date was reported as 17-Aug-2022.  The patient did not report any side effects. No treatment information was provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-699002 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-699002: Master case ID
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were stored in the fridge on 30Jun2021 and administered on 04-Aug-2021; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 04-Aug-2021) and NO ADVERSE EVENT (No adverse event) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 04-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 04-Aug-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 04-Aug-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 04-Aug-2021).    No concomitant and treatment medications were reported.  Reported that 40 patients received the Moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge. Vaccines were stored in the fridge on 30Jun2021, there are different administration dates, starting on 02Aug2021 until 20Sep2021 being the last one. Patients did not report any side effects.   This case reported for patient 5 of 31 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case ID
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored).    Concomitant and treatment medications were not provided. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021 and best used date was reported as 30-Jul-2021. The patient did not report any side effects. This case belongs to patient no 20 reported in source document.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case ID
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product storage error; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vaccines were stored in the fridge on 30-Jun-2021, there were different administration dates, starting on 02-Aug-2021 until 20-Sep-2021 being the last one. Patients did not report any side effects.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case ID
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    No concomitant and treatment medications were reported.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021.  Patients did not report any side effects.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were stored in the fridge on 30Jun2021 and administered on 31-Aug-2021; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 31-Aug-2021) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 31-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 31-Aug-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 31-Aug-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 31-Aug-2021).    No concomitant and treatment medications were reported.  Reported that 40 patients received the Moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge. Vaccines were stored in the fridge on 30Jun2021, there are different administration dates, starting on 02Aug2021 until 20Sep2021 being the last one. Patients did not report any side effects.   This case reported for patient 25 of 31 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case ID
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; Product storage error; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (No adverse event), EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Product storage error) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, NO ADVERSE EVENT (No adverse event), EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vaccines were stored in the fridge on 30-Jun-2021, there were different administration dates, starting on 02-Aug-2021 until 20-Sep-2021 being the last one. Patients did not report any side effects.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were stored in the fridge on 30Jun2021 and administered on 16-Aug-2021; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 16-Aug-2021) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 16-Aug-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 16-Aug-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administered on 16-Aug-2021).    No concomitant and treatment medications were reported.  Reported that 40 patients received the Moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge. Vaccines were stored in the fridge on 30Jun2021, there are different administration dates, starting on 02Aug2021 until 20Sep2021 being the last one. Patients did not report any side effects.   This case reported for patient 13 of 31 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 07-SEP-2021; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 07-SEP-2021) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 07-SEP-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 07-SEP-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18-Jul-2022, and the administration date was 07-SEP-2021).    Concomitant and treatment medications were not provided. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021 and best used date was reported as 30-Jul-2021. The patient did not report any side effects.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case
Age: 76.0
Sex: U
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (received a 2nd dose of Moderna Covid-19 vaccine, Bivalent) and NO ADVERSE EVENT (No Adverse Event) in a 76-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Jan-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2023, the patient experienced EXTRA DOSE ADMINISTERED (received a 2nd dose of Moderna Covid-19 vaccine, Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXTRA DOSE ADMINISTERED (received a 2nd dose of Moderna Covid-19 vaccine, Bivalent) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.           No concomitant and treatment medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (They went and took another shot today which was the Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7172B and AS7163B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse reaction with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.   On 25-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jan-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (They went and took another shot today which was the Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (They went and took another shot today which was the Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (They went and took another shot today which was the Bivalent booster).