chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vials were initially stored in the fridge on 08-Jul-2022 and administered on 11-Aug-2022; HCP was not aware of any symptoms for any patient after the vaccine was given; Patient was administered with vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 11-Aug-2022) and NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given) in a 2-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 11-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 11-Aug-2022) and NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 11-Aug-2022) and NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 11-Aug-2022).    No concomitant medication was reported.  On 08-Jul-2022, the vials were initially stored in the refrigerator.  Vial did not undergo any temperature excursions.  The healthcare professional was not aware of any symptoms for any patient after the vaccine was given.  No treatment medication was reported.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the fridge on 08-Jul-2022 and administered to patient after 30 day use by date; No adverse event; Dose administered to patient after 30-day Use by Date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30-day Use by Date), PRODUCT STORAGE ERROR (The vial was initially stored in the fridge on 08-Jul-2022 and administered to patient after 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 12-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30-day Use by Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the fridge on 08-Jul-2022 and administered to patient after 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30-day Use by Date), PRODUCT STORAGE ERROR (The vial was initially stored in the fridge on 08-Jul-2022 and administered to patient after 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after 30-day Use by Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the fridge on 08-Jul-2022 and administered to patient after 30 day use by date).    Concomitant medications were not reported.  Number of doses/vials that were administered to the patients were around 50 doses from 5 vials.  The vial was initially refrigerated on 08-Jul-2022.  The vial did not undergo any temperature excursions.  Treatment details was not provided.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 08-Aug-2022; No adverse event; Patient was administered with vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 08-Aug-2022). Concomitant drugs were not reported. Number of doses/vials: around 50 doses from 5 vials. The vials were initially refrigerated on 08-Jul-2022. The vial did not undergo any temperature excursions. Treatment details were not given.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 08-Aug-2022; No adverse event; Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 2-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 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 08-Aug-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 (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 08-Aug-2022). No concomitant product use was reported. The number of doses/vials -around 50 doses from 5 vials. On 08-Jul-2022 the vials were initially stored in the refrigerator. The vaccines were administered from the 07-Aug-2022 until the 11-Aug-2022 Vial did not undergone any temperature excursions. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. No treatment information was provided.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 08-Aug-2022; No adverse event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 08-Aug-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 vaccination.     No Medical History information was reported.    On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 08-Aug-2022).    No concomitant medication was reported.  On 08-Jul-2022, the vials were initially stored in the refrigerator.  Vial did not undergo any temperature excursions.  The healthcare professional was not aware of any symptoms for any patient after the vaccine was given.  No treatment medication was reported.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was refrigerated on 08-Jul-2022 and administered to patient on 08-Aug-2022.; No adverse event; Patient received vaccine after 30-day Use by Date.; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date.), PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 08-Aug-2022.) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 08-Aug-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date.), PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 08-Aug-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date.) and PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 08-Aug-2022.).    Concomitant drugs were not reported. Number of doses/vials: around 50 doses from 5 vials. Date of Vaccination was from 07-Aug-2022 to 11-Aug-2022. The vials were initially refrigerated on 08-Jul-2022. The vial did not undergo any temperature excursions. Treatment details were not given.
Age: 1.42
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-AUG-2022; No adverse event; Administered Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-AUG-2022) and NO ADVERSE EVENT (No adverse event) in a 17-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-AUG-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-AUG-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-AUG-2022).    No concomitant medications were reported.   The healthcare professional was not aware of any symptoms for any patient after the vaccine was given.  The vial did not undergo any temperature excursions.  No treatment details were reported.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 09-Aug-2022; No Adverse Event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. as1414b) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator of 08-Jul-2022 and was administered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator of 08-Jul-2022 and was administered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator of 08-Jul-2022 and was administered on 09-Aug-2022). No concomitant medications was provided by the reporter. The vial did not undergo the temperature excursion. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. No treatment medications was provided by the reporter.
Age: 1.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 09-Aug-2022; No Adverse Event; Administered Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a 21-month-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 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 09-Aug-2022). No concomitant medications were reported. Treatment information was not provided.  The vial did not undergo any temperature excursions. No treatment details were reported.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022; No Adverse Event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022).    No concomitant medications was provided by the reporter. The vial did not undergo the temperature excursion. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. the vial was initially stored in the refrigerator on 08-jul-2022 was vaccine was administered since 07-aug-2022 to 11-Aug-2022 No treatment medications was provided by the reporter.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.; No Adverse Event; Patient received vaccine after 30-day Use by Date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date), PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.) and NO ADVERSE EVENT (No Adverse Event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date), PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use by Date) and PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.).    Concomitant drugs were not reported.  Number of doses/vials: around 50 doses from 5 vials.  Date of Vaccination was from 07-Aug-2022 to 11-Aug-2022  The vials were initially refrigerated on 08-Jul-2022.  The vial did not undergo any temperature excursions.  Treatment details were not given.
Age: 1.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022; No adverse event; Administered Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 21-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022). No concomitant medications were reported. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. The vial did not undergo any temperature excursions. No treatment details were reported.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 09-Aug-2022; No Adverse Event; Administered Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 09-Aug-2022).    No concomitant medications were reported.  The reporter mentioned that the vials were initially stored in the fridge on 08-Jul-2022, and vaccine was administered on 09-Aug-2022. The reporter was not aware of any symptoms for any patient after the vaccine was given. Reportedly, the vial didn't undergo any temperature excursions.  No treatment information was provided by the reporter.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022; No Adverse Event; Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022).    No concomitant product use was reported. The number of doses/vials -around 50 doses from 5 vials. On 08-Jul-2022 the vials were initially stored in the refrigerator. The vaccines were administered from the 07-Aug-2022 until the 11-Aug-2022 Vial did not undergone any temperature excursions. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. No treatment information was provided.
Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.; No Adverse Event; Patient received vaccine after 30-day Use By Date.; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use By Date.), PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.) and NO ADVERSE EVENT (No Adverse Event) in an 18-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use By Date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use By Date.), PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30-day Use By Date.) and PRODUCT STORAGE ERROR (The vial was refrigerated on 08-Jul-2022 and administered to patient on 09-Aug-2022.).    Concomitant drugs were not reported.  Number of doses/vials: around 50 doses from 5 vials.  The vials were initially refrigerated on 08-Jul-2022.  The vial did not undergo any temperature excursions.  Treatment details were not given.
Age: 1.08
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 13-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis. No Medical History information was reported. On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 09-Aug-2022). No concomitant product use was reported. On 08-Jul-2022, the vials were initially stored in the refrigerator. Vial did not undergo any temperature excursions. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine stored in refrigerator on 11-Jul-2022/Vaccine administered on 13-Aug-2022; No adverse event; Patient administered vaccine from a vial that was beyond the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine from a vial that was beyond the 30-day use by date), PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11-Jul-2022/Vaccine administered on 13-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine from a vial that was beyond the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11-Jul-2022/Vaccine administered on 13-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine from a vial that was beyond the 30-day use by date), PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11-Jul-2022/Vaccine administered on 13-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine from a vial that was beyond the 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11-Jul-2022/Vaccine administered on 13-Aug-2022).    No concomitant medications were reported.  The reporter wanted to know if the dose was stable and whether or not had to re-dose.   Number of doses or vials was 1 dose or 1 vial. The vial was initially stored in the refrigerator on 11-Jul-2022. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received Moderna Covid-19 vaccine past the 30 day beyond use date.), PRODUCT STORAGE ERROR (Expired vial was not discarded after the use by date) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1 (primary series)), Pfizer vaccine (first booster) and Pfizer vaccine (Dose 2 (primary series)). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. On 02-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received Moderna Covid-19 vaccine past the 30 day beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was not discarded after the use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients received Moderna Covid-19 vaccine past the 30 day beyond use date.), PRODUCT STORAGE ERROR (Expired vial was not discarded after the use by date) 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 (6 patients received Moderna Covid-19 vaccine past the 30 day beyond use date.) and PRODUCT STORAGE ERROR (Expired vial was not discarded after the use by date).  No concomitant medications information was reported. The vial was initially stored in the refrigerator on 2-JUN-2022. Pharmacist is aware of any temperature excursions undergone by the vial. It was reported that there were no known adverse events. No treatment medications were provided. This case was linked to MOD-2022-629202, MOD-2022-629207, MOD-2022-629208, MOD-2022-629210 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Decreased activity, Fatigue, Feeling abnormal, Lethargy, Malaise
Clinical narrative: his father felt bad for a couple days; Didn't feel well; Similar type of reaction as far as lethargy and fatigue following the first three Covid-19 vaccines; Similar type of reaction as far as lethargy and fatigue following the first three Covid-19 vaccines; Father laid around a little more and was less active; This is a spontaneous report received from contactable reporter (Consumer (patient's son)).  An elderly male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: Diabetes Diagnosed for possibly 5-10 years.; "Congestive heart failure", start date: Feb2021 (ongoing), notes: CHF; "TIA" (unspecified if ongoing), notes: had multiple TIA's in the past that have worn away at his cognitive ability; "Cardiac stent" (unspecified if ongoing), notes: Cardiac stent within the last 20 years; "Triple bypass" (unspecified if ongoing), notes: Triple bypass In 1998 or 1999; "pacemaker" (unspecified if ongoing), notes: installed 1.5-2 years ago; "Pain" (unspecified if ongoing); "bowel regularity" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior to receiving any vaccines; was hospitalized and previously in rehab from that Covid infection; "worn away at his cognitive ability" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; OMEPRAZOLE; METFORMIN; FUROSEMIDE; METHYL SALICYLATE; FERROUS SULFATE; BISOPROLOL oral; METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID] taken for constipation; POTASSIUM CHLORIDE; LOSARTAN; ACETAMINOPHEN taken for pain; ATORVASTATIN; NITROGLYCERIN; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "his father felt bad for a couple days"; MALAISE (non-serious), outcome "unknown", described as "Didn't feel well"; LETHARGY (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Similar type of reaction as far as lethargy and fatigue following the first three Covid-19 vaccines"; DECREASED ACTIVITY (non-serious), outcome "unknown", described as "Father laid around a little more and was less active". Additional information: For concomitant medication nitroglycerin, it was reported that the patient had a pacemaker installed 1.5-2 years ago and the patient rarely takes nitroglycerin anymore. Possibly over a year since he's taken it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201051311 same patient and different vaccine dose, different event separated in time;
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased activity, Fatigue, Feeling abnormal, Lethargy, Malaise
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer (patient's son)). An elderly male patient received BNT162b2 (BNT162B2), on 19Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 80 years for COVID-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: Diabetes Diagnosed for possibly 5-10 years; "Congestive heart failure", start date: Feb2021 (ongoing); "Triple by pass" (unspecified if ongoing), notes: Triple bypass In 1998 or 1999; "Cardiac stent" (unspecified if ongoing), notes: Cardiac stent within the last 20 years; "TIA's" (unspecified if ongoing), notes: multiple TIA's in the past that have worn away at his cognitive ability; "worn away at his cognitive ability" (unspecified if ongoing); "pacemaker" (unspecified if ongoing), notes: installed 1.5-2 years ago; "pain" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: contracted prior to receiving any vaccines; "bowel regularity" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; OMEPRAZOLE; METFORMIN; FUROSEMIDE; METHYL SALICYLATE; FERROUS SULFATE; BISOPROLOL oral; METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID] taken for constipation; POTASSIUM CHLORIDE; LOSARTAN; ACETAMINOPHEN taken for pain; ATORVASTATIN; NITROGLYCERIN; ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number unknown), for COVID-19 immunization, reaction(s): "Father laid around a little more and was less active", "fatigue", "his father felt bad for a couple days", "lethargy", "Didn't feel well"; BNT162b2 (DOSE 2, SINGLE, Lot number unknown), for COVID-19 immunization, reaction(s): "Father laid around a little more and was less active", "fatigue", "his father felt bad for a couple days", "lethargy", "Didn't feel well". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Didn't feel well"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "his father felt bad for a couple days"; LETHARGY (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Similar type of reaction as far as lethargy and fatigue following the first three Covid-19 vaccines"; DECREASED ACTIVITY (non-serious), outcome "unknown", described as "Father laid around a little more and was less active". Additional information: For concomitant medication nitroglycerin, it was reported that the patient had a pacemaker installed 1.5-2 years ago and the patient rarely takes nitroglycerin anymore. Possibly over a year since he's taken it. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : PFIZER INC-202201051311 Same patient and different vaccine dose, different event separated in time; PFIZER INC-202201051311 same patient and different vaccine dose, different event separated in time;