chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 2:09 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Nov-2021 at 2:09 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was unknown whether patient was ever diagnosed with COVID-19.  The information about acute illnesses, chronic or long standing health conditions, information about other medications(prescription, OTC, dietary supplements or herbal remedies) at the time of vaccination or at time of reporting were unknown.  The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit.  The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been.  The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator.  The vials were returned to the freezer/refrigerator, or maintained at room temperature.   The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator.  No vaccine state changes were noticed. The vaccine was never refrozen.  None of the vials were punctured. No Previous temperature excursions was reported.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 1:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 1:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions were reported.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 1:55 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 1:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the patient had allergies to food, medications or other products.  It was unknown if the patient was tested positive for COVID-19 or not.  No concomitant medications were reported.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion and stored in a super cold Freezer. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. On 19-Nov-2021, the vial moved from freezer to refrigerator, the day when Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. The vials were not punctured and temperature excursion was not reported previously.  No vaccine state changes were noticed. The vaccine was never refrozen.  No treatment medications were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 3:15 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions was reported.   This case was linked to MOD-2021-402935 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: Developed dermatographia her skin itches and has raised welts.; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Developed dermatographia her skin itches and has raised welts.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 048B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced MECHANICAL URTICARIA (Developed dermatographia her skin itches and has raised welts.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MECHANICAL URTICARIA (Developed dermatographia her skin itches and has raised welts.) outcome was unknown. No concomitant medications were reported.  The patient had received the first, second and booster dose in her left arm shoulder deltoid muscle. Patient did not experience any adverse with primary series of vaccination. Patient has not seen a doctor for the condition. Patient mentioned regarding a group where other patients reports dermatographia and urticaria after receiving the Moderna Covid-19 vaccine booster dose.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: subsequently received a booster dose of the Moderna Covid-19 vaccine.One patient is a cancer patient; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (subsequently received a booster dose of the Moderna Covid-19 vaccine.One patient is a cancer patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (subsequently received a booster dose of the Moderna Covid-19 vaccine.One patient is a cancer patient). At the time of the report, ACCIDENTAL UNDERDOSE (subsequently received a booster dose of the Moderna Covid-19 vaccine.One patient is a cancer patient) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. Patients had been administered the two full primary series Moderna Covid-19 vaccines. The patient was cancer patient. No treatment medication details were provided.   This case was linked to MOD-2022-494052, MOD-2022-494052 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (received 1st dose of the Moderna COVID-19 vaccine on Jan 28, 2022, after the manufacturer expiration of Jan 21, 2022) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 020F21A) for COVID-19  immunization. No medical history reported. On Jan 28, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 28, 2022, patient administered expired product (received 1st dose of the Moderna COVID-19 vaccine on Jan 28, 2022, after the manufacturer expiration of Jan 21, 2022). At the time of the report, administered expired product (received 1st dose of the Moderna COVID-19 vaccine on Jan 28, 2022, after the manufacturer expiration of Jan 21, 2022) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Echocardiogram
Clinical narrative: Shortness of breath a few days after booster; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (Shortness of breath a few days after booster) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker (totally healthy and non smoker).   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced DYSPNOEA (Shortness of breath a few days after booster). At the time of the report, DYSPNOEA (Shortness of breath a few days after booster) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: clear (normal) clear. In 2021, Echocardiogram: clear (normal) clear.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that he still had shortness of breath and can not figure out what was wrong with him. No concomitant medication information was provided. No treatment medication information was provided. Lab tests Echo and cardiogram were all clear.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired  5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired  5 doses had been given at that point) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired  5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired  5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Moderna vaccine was pulled from freezer on 16-Dec-2021. Beyond use date of 15-Jan-2022 was printed in red and taped to the top of boxes.  On 26-Jan-2022, Staff noticed that vaccine was still in the fridge and expired and 5 doses had been given at that point. On 31-Jan-2022, Moderna confirmed that revaccination was not required. The patient denies any adverse effects.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses were given from a vial that had been more than 12 hours after the first puncture; More than 27 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given from a vial that had been more than 12 hours after the first puncture) and PRODUCT STORAGE ERROR (More than 27 hours at room temperature) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given from a vial that had been more than 12 hours after the first puncture) and PRODUCT STORAGE ERROR (More than 27 hours at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given from a vial that had been more than 12 hours after the first puncture) and PRODUCT STORAGE ERROR (More than 27 hours at room temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that there were no reported symptoms and no additional doses or treatments. Also stated that on 14-Feb-2022 the vial was initially stored in the refrigerator, on 15-Feb-2022 at 11:42 AM vial was first punctured. And after administration of vaccine on 16-Feb-2022 the total amount of time the vial exposed to room temperature range (8 degree Celsius to 25 degree Celsius which is equal to 46 degree Fahrenheit to 77 degree Fahrenheit) was more than 27 hours. And the vial did not undergo any temperature excursions.   This case was linked to MOD-2022-494549, MOD-2022-494555 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: more than 12 hours after the first puncture; 27 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (more than 12 hours after the first puncture) and PRODUCT STORAGE ERROR (27 hours at room temperature) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (more than 12 hours after the first puncture) and PRODUCT STORAGE ERROR (27 hours at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (more than 12 hours after the first puncture) and PRODUCT STORAGE ERROR (27 hours at room temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2022-494555, MOD-2022-494521 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administration of expired vaccine/ vial was stored at room temperature; administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) and PRODUCT STORAGE ERROR (administration of expired vaccine/ vial was stored at room temperature ) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 022C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2022 at 2:45 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administration of expired vaccine/ vial was stored at room temperature ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) and PRODUCT STORAGE ERROR (administration of expired vaccine/ vial was stored at room temperature ) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no allergies. Patient had no history of covid.  No treatments were given. No concomitant meds taken.  It was reported that a vial that was opened at 9am of 22Feb2022 was administered to a patient earlier around 2:45pm of 23Feb2022. The vial was used for 1-2 doses last 22Feb2022 and was stored at room temperature thereafter. Then around 2:45pm of 23Feb2022, they used it to administer a booster shot to a patient. AE did not cause to seek medical care. No other AE after the administration. Patient had no primary doctor in the area.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. It was reported that the Moderna COVID-19 vaccine provided to the patient was the first, second, third or booster dose.  Furthermore, it stated that the expiration date was always changing and stated that Moderna was not transparent with the information that was provided and wanted more information about stability as stated Moderna obviously had a problem with stability of the vaccine, if not they wouldn't be changing the expiration date all the time.   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (patient received expired first dose after 30-day use-by-date) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 068H21A) for COVID-19 immunization. No medical history reported. On Feb 24, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 24, 2022, patient administered expired product (patient received expired first dose after 30-day use-by-date). At the time of the report, administered expired product (patient received expired first dose after 30-day use-by-date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The vial was initially stored in the refrigerator on January 24, 2022. It did not undergo any temperature excursions. This case linked to MOD-2022-494857 (patient link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022 at 1:59 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022 at 1:59 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Moderna vaccine was pulled from freezer on 16 Dec 2021. Beyond use date of 15 Jan 2022 was printed in red and taped to the top of boxes. On 26 Jan 2022, Staff noticed that vaccine was still in the fridge and expired and 5 doses had been given at that point. On 31 Jan 2022, Moderna confirmed that revaccination was not required.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 1:55 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Jan-2022 at 1:55 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. On 16-Dec-2021 vial was initially stored in the refrigerator. 5 doses of the Moderna COVID-19 Vaccine were given past the beyond use date of 15-Jan-2022. The vial was still in the fridge and expired. The patient notified of error and that a repeat vaccine was not required. Patient denies any adverse effects. The vial did not undergone any temperature excursions. Treatment information was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired-5 doses had been given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 7:11 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  The dose volume was provided as 0.5 with an unknown unit. On 16-Dec-2021 vial was initially stored in the refrigerator. 5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15-Jan-2022. Patient was notified of the error and patient denied adverse effects.  Treatment information was not provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired-5 doses had been given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022 at 11:02 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Jan-2022 at 11:02 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were reported. Reporter stated that Moderna vaccine pulled from freezer 16 Dec 2021, BUD date of 15 Jan 2022 printed in red and taped to the top of the boxes. On 26 Jan 2022, staff brought it to attention that it was still in the fridge and expired and 5 doses had been given. On 31 Jan 2022, responded that revaccination was not required. No treatment information details were reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired  5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired  5 doses had been given at that point) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired  5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired  5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported.  Reporter stated that Moderna vaccine pulled from freezer 16 Dec 2021, BUD date of 15 Jan 2022 printed in red and taped to the top of the boxes. On 26 Jan 2022, staff brought it to attention that it was still in the fridge and expired and 5 doses had been given. On 31 Jan 2022, responded that revaccination was not required.  No treatment information details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of Breath after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath after second vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of Breath after second vaccine). At the time of the report, DYSPNOEA (Shortness of Breath after second vaccine) outcome was unknown.            No Concomitant Medications were provided by the Reporter  No Treatment Information were provided by the Reporter   Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired Moderna COVID-19 vaccine after 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Moderna COVID-19 vaccine after 30 day use by date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Moderna COVID-19 vaccine after 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Moderna COVID-19 vaccine after 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that there was one vial with 10 dose each and from them 2 doses injected past its expiration date. The vial was initially stored in the refrigerator on 24 Jan 2022 and the vial did not undergo any temperature excursions. No treatment information was provided.   This case was linked to MOD-2022-494719 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination complication
Clinical narrative: Expired vaccine used; She did report a more intense response than with previous 2 Pfizers; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (She did report a more intense response than with previous 2 Pfizers) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer and Pfizer. Past adverse reactions to the above products included Vaccination adverse reaction with Pfizer and Pfizer. Concurrent medical conditions included Penicillin allergy.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In January 2022, the patient experienced VACCINATION COMPLICATION (She did report a more intense response than with previous 2 Pfizers). On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, VACCINATION COMPLICATION (She did report a more intense response than with previous 2 Pfizers) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided.26-JAN-2022, the staff brought the attention it was still fridge and expired 5 doses and been at the point.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nausea
Clinical narrative: The patient's face felt numb all over including the forehead; Felt nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (The patient's face felt numb all over including the forehead) and NAUSEA (Felt nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (patient has a history of mild asthma). Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for an unknown indication.    On 24-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2022, the patient experienced HYPOAESTHESIA (The patient's face felt numb all over including the forehead) and NAUSEA (Felt nauseous). At the time of the report, HYPOAESTHESIA (The patient's face felt numb all over including the forehead) and NAUSEA (Felt nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.  After 15 minutes from vaccination, while the patient was walking out of the facility, the patient experienced the adverse events. The patient wanted to know whether those symptoms were normal or not.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Tremor
Clinical narrative: shaking in the body, legs, arms, teeth and face; shaking in the body, legs, arms, teeth and face; Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of TREMOR (shaking in the body, legs, arms, teeth and face), TACHYCARDIA (Tachycardia) and the second episode of TREMOR (shaking in the body, legs, arms, teeth and face) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022j21a and 060H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2022, the patient experienced the first episode of TREMOR (shaking in the body, legs, arms, teeth and face) and TACHYCARDIA (Tachycardia). On 23-Feb-2022, the patient experienced the second episode of TREMOR (shaking in the body, legs, arms, teeth and face). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 23-Feb-2022, last episode of TREMOR (shaking in the body, legs, arms, teeth and face) had resolved. At the time of the report, TACHYCARDIA (Tachycardia) had not resolved.            Concomitant medications were not reported. Shaking in the body legs arms teeth and face which last 5-6 minutes   This case was linked to MOD-2022-494953, MOD-2022-494980 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired  5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired  5 doses had been given at that point) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired  5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired  5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported.  It was reported that Moderna vaccine was pulled from freezer on 16-Dec-2021 and beyond use date was 15-Jan-2022. On 26-Jan-2022, staff brought it to attention that it was still in fridge and expired and 5 doses had been given. Patient denied any adverse effects. On 31-Jan-2022 Moderna responded that revaccination was not required.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired 5 doses had been given at that point.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given at that point.) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given at that point.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given at that point.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the Moderna vaccine was pulled from freezer on 16-Dec-2021. The Beyond use date of 15-Jan-2022 was printed in red and taped to the top of the boxes.  On 26-Jan-2022, the staff brought it to attention that it was still in the fridge and expired-5 doses had been given at that point. On 27-Jan-2022, the remaining sites checked. All other clinics found to have some error of not noticing the beyond use date. Moderna contacted and report filed. The beyond use date added to the daily Covid usage report. Staff re-education provided.  On 31-Jan-2022, Moderna responded- revaccination not required, but VAERS needed to be completed.  It was also reported that the patient was notified of error and that a repeat vaccine was not required. The patient denied any adverse effects.  The patient had no known drug allergy.  No treatment information was provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance, Hypoaesthesia, Inappropriate schedule of product administration, Paraesthesia
Clinical narrative: Feet tingles/tingles a lot and sometimes the tingles even shock him, It was also stated that tingles sometimes are worse; Makes it hard for him to walk; Throws the patient off balance; Feet fall asleep; Patient received 2nd dose on 36th day after 1st dose/Patient received 2nd dose >35 days since receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Feet tingles/tingles a lot and sometimes the tingles even shock him, It was also stated that tingles sometimes are worse), GAIT DISTURBANCE (Makes it hard for him to walk), BALANCE DISORDER (Throws the patient off balance), HYPOAESTHESIA (Feet fall asleep) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose on 36th day after 1st dose/Patient received 2nd dose >35 days since receiving 1st dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Haldol), Drug allergy (Allergy to Seroquel) and Mental disorder since 1997.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose on 36th day after 1st dose/Patient received 2nd dose >35 days since receiving 1st dose). On an unknown date, the patient experienced PARAESTHESIA (Feet tingles/tingles a lot and sometimes the tingles even shock him, It was also stated that tingles sometimes are worse), GAIT DISTURBANCE (Makes it hard for him to walk), BALANCE DISORDER (Throws the patient off balance) and HYPOAESTHESIA (Feet fall asleep). At the time of the report, PARAESTHESIA (Feet tingles/tingles a lot and sometimes the tingles even shock him, It was also stated that tingles sometimes are worse), GAIT DISTURBANCE (Makes it hard for him to walk), BALANCE DISORDER (Throws the patient off balance), HYPOAESTHESIA (Feet fall asleep) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose on 36th day after 1st dose/Patient received 2nd dose >35 days since receiving 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication included multiple medications but did not mention them. Patient stated on the call that patient  had 3 different tests the doctors ran and cannot figure out what was going on. The patient had symptoms since patient got the covid vaccine shot. No treatment medications were reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A and 022j21a) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Tachycardia). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Tachycardia) outcome was unknown.            No concomitant medication information was reported. The patient experienced the same reaction to the vaccine as the patient's wife did.   This case was linked to MOD-2022-494916, MOD-2022-494953 (Patient Link).