chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: FEVER; VOMITING; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, the patient experienced fever, and vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and vomiting was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 07-MAR-2021, the patient experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unspecified adverse event. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Heart rate, Heart rate increased, Myalgia, Oxygen saturation
Clinical narrative: Rapid heart rate; Fever; Chills; Body aches; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (Rapid heart rate), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced CHILLS (Chills) and MYALGIA (Body aches). On 29-Dec-2020, the patient experienced HEART RATE INCREASED (Rapid heart rate) and PYREXIA (Fever). At the time of the report, HEART RATE INCREASED (Rapid heart rate), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Heart rate: 72 72 heart beats per minute. On 29-Dec-2020, Oxygen saturation: normal (normal) normal. On 29-Dec-2020, Vital signs measurement: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Reporter's Comments: This case concerns a 64-year-old male who experienced a NS unexpected event of heart rate increased and nonserious expected events of pyrexia, chills, and myalgia. Event onset was the same day as the first dose of mRNA-1273. Treatment included acetaminophen. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vital signs measurement
Clinical narrative: Rapid heart rate; Fever; Chills; Body aches; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (Rapid heart rate), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced CHILLS (Chills) and MYALGIA (Body aches). On 29-Dec-2020, the patient experienced HEART RATE INCREASED (Rapid heart rate) and PYREXIA (Fever). At the time of the report, HEART RATE INCREASED (Rapid heart rate), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Heart rate: 72 72 heart beats per minute. On 29-Dec-2020, Oxygen saturation: normal (normal) normal. On 29-Dec-2020, Vital signs measurement: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Reporter's Comments: This case concerns a 64-year-old male who experienced a NS unexpected event of heart rate increased and nonserious expected events of pyrexia, chills, and myalgia. Event onset was the same day as the first dose of mRNA-1273. Treatment included acetaminophen. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Death, Tremor
Clinical narrative: His father died just after receiving the vaccine; Patient experienced tremors on his hands just after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (His father died just after receiving the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 DEATH (His father died just after receiving the vaccine) (seriousness criteria death and medically significant) and TREMOR (Patient experienced tremors on his hands just after getting the vaccine). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, TREMOR (Patient experienced tremors on his hands just after getting the vaccine) outcome was unknown.            No concomitant medication details were provided. No treatment medication details were provided.  On an unknown date, patient died just after receiving the vaccine. After getting the vaccine, patient started to experience tremors on hands and doctors finished with patient at the hospital, where patient died.  Reporter was hoping this should be covered up by Moderna, also was very upset and abruptly hung up before agent could ask for any detail on the case. Company comment This spontaneous fatal case concerns a male patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of DEATH, and the unexpected non-serious event of tremor. On an unknown date, patient experienced tremors on his hands just after receiving a dose of mRNA-1273 vaccine (unknown number and schedule). Doctors finished with patient at the hospital, where patient died. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous fatal case concerns a male patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of DEATH, and the unexpected non-serious event of tremor. On an unknown date, patient experienced tremors on his hands just after receiving a dose of mRNA-1273 vaccine (unknown number and schedule). Doctors finished with patient at the hospital, where patient died. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients from a nursing home facility received expired doses of the Moderna COVID19; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients from a nursing home facility received expired doses of the Moderna COVID19) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 050e21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients from a nursing home facility received expired doses of the Moderna COVID19). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients from a nursing home facility received expired doses of the Moderna COVID19) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Upon internal review on 10-MAR-2022, significant correction was performed. Suspect product recoded as per RA. On 03-Mar-2022: Non-significant follow-up On 04-Mar-2022: Non Significant Follow-up
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Pemphigoid
Clinical narrative: Diagnosed with Bullous Pemphigoid; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGOID (Diagnosed with Bullous Pemphigoid) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (Autoimmune disease).    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2022, the patient experienced PEMPHIGOID (Diagnosed with Bullous Pemphigoid) (seriousness criterion medically significant). At the time of the report, PEMPHIGOID (Diagnosed with Bullous Pemphigoid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2022, Biopsy: abnormal (abnormal) A biopsy done and patient was diagnosed with Bullous Pemphigoid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had tried Steroids and Antirejection medications. Now they were thinking of giving patient a chemo. Patient does not have cancer but an autoimmune disease.  Company comment: This case concerns a 84-year-old male patient with concurrent medical condition of autoimmune disease, who experienced the serious (seriousness medically significant) unexpected event of Pemphigoid. The event occurred 1 year 1 month 2 days after the dose of mRNA-1273 vaccine. At the time of the report, outcome of the event was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-390433.; Sender's Comments: This case concerns a 84-year-old male patient with concurrent medical condition of autoimmune disease, who experienced the serious (seriousness medically significant) unexpected event of Pemphigoid. The event occurred 1 year 1 month 2 days after the dose of mRNA-1273 vaccine. At the time of the report, outcome of the event was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Illness, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER (Diagnosed with breast cancer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Tumor (She had tumor before getting the vaccine). In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (Diagnosed with breast cancer) (seriousness criterion medically significant), ILLNESS (Sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). At the time of the report, BREAST CANCER (Diagnosed with breast cancer) and ILLNESS (Sick) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. During chemo she was sick, so she did not get the 2nd dose at the scheduled time. This is a spontaneous case concerning a female of unknown age with a medical history of "tumor" who experienced the serious (medically significant), unexpected event of breast cancer. The event began at an unknown time after the first dose of RNA-1273. No testing is reported and the treatment is chemotherapy. The outcome is unknown. The history of tumor is a confounder as the event is likely the same tumor given the short time after vaccine the event was diagnosed as it is medically improbable the event could have been caused by the vaccine and been diagnosed in the time frame. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a female of unknown age with a medical history of "tumor" who experienced the serious (medically significant), unexpected event of breast cancer. The event began at an unknown time after the first dose of RNA-1273. No testing is reported and the treatment is chemotherapy. The outcome is unknown. The history of tumor is a confounder as the event is likely the same tumor given the short time after vaccine the event was diagnosed as it is medically improbable the event could have been caused by the vaccine and been diagnosed in the time frame. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient received booster dose (half a dose) as a second dose; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received booster dose (half a dose) as a second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2022, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, the patient experienced UNDERDOSE (Patient received booster dose (half a dose) as a second dose). At the time of the report, UNDERDOSE (Patient received booster dose (half a dose) as a second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. It had been stated that Patient received the booster dose (half a dose) as a second dose. HCP did not had information regarding the patient and the first dose of Moderna received, as well as information from the dose received. Patient had not any symptoms after receiving the Moderna vaccine. Patient did not received any other vaccine apart from Moderna.  Patient was taking any regular medication reported unknown. It had been stated that patient was not allergic and also reported Unknown COVID-19 history. No Treatment medication reported.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose was drawn from a vial that was outside in room temperature for more than 12 hours; dose was drawn from a vial that was outside in room temperature for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was drawn from a vial that was outside in room temperature for more than 12 hours) and PRODUCT STORAGE ERROR (dose was drawn from a vial that was outside in room temperature for more than 12 hours) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In February 2022, the patient experienced PRODUCT STORAGE ERROR (dose was drawn from a vial that was outside in room temperature for more than 12 hours). On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was drawn from a vial that was outside in room temperature for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was drawn from a vial that was outside in room temperature for more than 12 hours) and PRODUCT STORAGE ERROR (dose was drawn from a vial that was outside in room temperature for more than 12 hours) 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 the vial was initially stored in the refrigerator within the last 2-3 weeks, specific date was unknown. The date and time vial first punctured was on 24-Feb-2022 at 10:00 AM. Date and time of administration of vaccine was on 25Feb2022 around 1 PM. Vial was stored post puncture at room temperature and had not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degrees C= 46 Celsius to 77 Celsius F): 14-15 hours. It was also reported from the pharmacist that the patient had not received the primary series from their pharmacy, so the pharmacist does not have that information. The pharmacist had confirmed that the patient was within the recommended time frame to receive the booster.   No treatment medications were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients. The reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.  No treatment medications were reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient administered moderna covid vaccine while temperature excursion was ongoing; Patient administered moderna covid vaccine while temperature excursion was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter confirmed that patients had been administered doses while the temperature excursion assessment was ongoing.  No treatment medications were reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Vials stored in the refrigerator on 22-Sep-2021. No temperature excursions and no adverse event were noted.  Treatment details was not reported by the reporter.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported   Reporter stated that on 16-Oct- 2021, the vial was stored in the refrigerator. No temperature excursions were noted and no adverse events were noted in the patient.  No treatment medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because  facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by any patients. No treatment information was provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date place in refrigerator-12-Nov-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator-12-Nov-2021) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date place in refrigerator-12-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator-12-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The vial was placed in refrigerator on 12-Nov-2021. It was reported that the expired lots were administered due to the confusion with expiry date printed in the carton and the expiration date when the QR code was scanned. The vials did not undergo temperature excursion. The patient did not experience any adverse event.  No treatment information were provided.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Date of placed in refrigerator was on 17-Nov-2021. Vaccine did not undergone any temperature excursion. No other events were reported for patient. No treatment information was reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient received booster shot. No Concomitant information was reported. Date of placed in refrigerator was on 29-Oct-2021. Vaccine did not undergone any temperature excursion. No other events were reported for patient. No Treatment information was reported. This case was linked to MOD-2022-491837 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 13 Oct 2021/ refrigerated on 18 Oct 2021/ administered on 20 Oct 2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021/ refrigerated on 18 Oct 2021/ administered on 20 Oct 2021) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021/ refrigerated on 18 Oct 2021/ administered on 20 Oct 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021/ refrigerated on 18 Oct 2021/ administered on 20 Oct 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in the refrigerator on 18-OCT-2021 and not undergone any temperature excursion.  No adverse events were reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  HCP said that there was a confusion between the expiration date printed in the carton and the expiration date when the quick response (QR) code scanned. On 12 OCT 2021, vial was initially stored in the refrigerator. No temperature excursions was noted and patient did not experience any adverse event.  Treatment medications were not reported.
Age: 66.0
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 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, 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.   The reporter was infection control manager.  Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 31-May-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491837 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine is stored in refrigerator on 04-Oct-2021 and then administered on 18-Oct-2021; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored in refrigerator on 04-Oct-2021 and then administered on 18-Oct-2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.    Medical History information was reported. On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine is stored in refrigerator on 04-Oct-2021 and then administered on 18-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine is stored in refrigerator on 04-Oct-2021 and then administered on 18-Oct-2021) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported.  It was reported that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. No adverse events were reported. Vial did not undergo any temperature excursion. Vial was placed in refrigerator on 04-Oct-2021.  No treatment medications were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11/17/2021, expired product 10/03/2021, administered date on 11/24/2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11/17/2021, expired product 10/03/2021, administered date on 11/24/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 11/17/2021, expired product 10/03/2021, administered date on 11/24/2021) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medication was not reported. No adverse events reported. No temperature excursion of the product was reported. Date place in refrigerator: 17-Nov-2021.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial refrigerated on 29-10-2021 / expiry date 13-10-2021/product administered on 9-11-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 29-10-2021 / expiry date 13-10-2021/product administered on 9-11-2021) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial refrigerated on 29-10-2021 / expiry date 13-10-2021/product administered on 9-11-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 29-10-2021 / expiry date 13-10-2021/product administered on 9-11-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. The date of placed in refrigerator was on29-OCT-2021 and vaccine did not undergone any temperature excursion. No other adverse events were reported for patient. No Treatment information was reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Patients administered Moderna vaccine while temperature excursion assessment was ongoing; Patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. Patient didn't report any adverse events.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine kept in refrigerator on 11/17/2021, expiration date is 10/3/2021, administered on 11/29/2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 11/17/2021, expiration date is 10/3/2021, administered on 11/29/2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 11/17/2021, expiration date is 10/3/2021, administered on 11/29/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 11/17/2021, expiration date is 10/3/2021, administered on 11/29/2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 17-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date of vial placed in refrigerator was on 12-OCT-2021 and vaccine did not undergone any temperature excursion. Patient did not experience any adverse event. No concomitant were reported. No treatment were reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The vial was placed in refrigerator on 04-Nov-2021. Vial did not undergone to any temperature excursion. No adverse event was reported. No treatment medications were reported. This case was linked to MOD-2022-491837 (Patient Link).