chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored past its use beyond date.; past beyond use date Moderna Covid-19 vaccine given to 6 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (past beyond use date Moderna Covid-19 vaccine given to 6 patients.) and PRODUCT STORAGE ERROR (Vaccine was stored past its use beyond date.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (past beyond use date Moderna Covid-19 vaccine given to 6 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored past its use beyond date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (past beyond use date Moderna Covid-19 vaccine given to 6 patients.) and PRODUCT STORAGE ERROR (Vaccine was stored past its use beyond date.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Vial was initially stored in the refrigerator on 23 March 2022 and the vial didn't undergo any temperature excursions. It was reported that dose administered after 30-day use By date or after manufacturer date of expiry and beyond use date was 17-APR-2022.   No treatment medication information was provided.   This case was linked to MOD-2022-546563, MOD-2022-546566, MOD-2022-546561, MOD-2022-546544 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2022: Follow-up  received included date of administration of expired vaccine  and event onset date updated.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I had big side efforts with the Moderna; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had big side efforts with the Moderna) in a female patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had big side efforts with the Moderna). At the time of the report, VACCINATION COMPLICATION (I had big side efforts with the Moderna) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant information was reported. Information about allergies to vaccines, medications, food and other products were unknown. Potential cause of the event was unknown and event caused the patient to seek medical care was unknown. No treatment information was reported.   This case was linked to MOD-2022-546564 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was placed in refrigerator on 23-Mar-2022, Beyond use date on 17-Apr-2022 administration date on 19-Apr-2022; Past beyond use date Moderna Covid-19 vaccine given to 6 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 23-Mar-2022, Beyond use date on 17-Apr-2022 administration date on 19-Apr-2022) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 23-Mar-2022, Beyond use date on 17-Apr-2022 administration date on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past beyond use date Moderna Covid-19 vaccine given to 6 patients.) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 23-Mar-2022, Beyond use date on 17-Apr-2022 administration date on 19-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 23 Mar 2022. Beyond use date was on 17 Apr 2022. The vial did not undergo any temperature excursions.   The treatment information was unknown.   This case was linked to MOD-2022-546561, MOD-2022-546566, MOD-2022-546544, MOD-2022-546563, MOD-2022-546559 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2022: Follow-up received contains Significant information date of administration of vaccine was updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Expired product administered, Product storage error
Clinical narrative: Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022; Dose administered after 30-day Use by Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date or after manufacturer date of expiry) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ceftin allergy), Drug allergy (Losartan allergy), Drug allergy (Potassium allergy) and Hepatitis C. Concomitant products included VARENICLINE TARTRATE (CHANTIX), COLECALCIFEROL (VIT D3), METHIMAZOLE, AMLODIPINE and PRAVASTATIN SODIUM for an unknown indication.    On 06-Apr-2022 at 9:32 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 9:32 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022). At the time of the report, PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date or after manufacturer date of expiry) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: not tested covid positive within last month (Negative) not tested Covid positive within last month.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had not tested positive for COVID  within last month. The expiration date was 25-Mar-2022. Date and time the vial was initially stored in the refrigerator on 25-Feb-2022. Vial didn't undergo any temperature excursions. It was reported that the patient did not experienced any side effects yet. No treatment medication information provided
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022; Dose administered after 30-day Use by Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Amoxicillin allergy). Concomitant products included SALBUTAMOL SULFATE (VENTOLIN HFA) for an unknown indication.    On 06-Apr-2022 at 11:24 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 11:24 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had not tested COVID positive within last month. The expiration date was 25 Mar 2022. Date and time the vial was initially stored in the refrigerator on 25 Feb 2022. Vial didn't undergo any temperature excursions. It was reported that the patient did not experienced any side effects yet. No treatment medication information provided
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation reaction
Clinical narrative: he states that his wife is deadly ill; patient stated that his wife "has all of them" (side effects); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he states that his wife is deadly ill) and VACCINATION COMPLICATION (patient stated that his wife "has all of them" (side effects)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced ILLNESS (he states that his wife is deadly ill) and VACCINATION COMPLICATION (patient stated that his wife "has all of them" (side effects)). At the time of the report, ILLNESS (he states that his wife is deadly ill) and VACCINATION COMPLICATION (patient stated that his wife "has all of them" (side effects)) outcome was unknown.            No concomitant drug was reported.  The reporter stated that his wife was deadly ill and had all of the side effects.The only thing different they did was to take the Moderna booster on 20-Apr-2022. Reporter stated that he would take his wife to the hospital instead.  No treatment drug was reported.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2022-546697, MOD-2022-546695, MOD-2022-546699 (Patient Link).
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Heart rate, Oxygen consumption, White blood cell count, White blood cell count increased
Clinical narrative: big jump in While Blood Cells; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (big jump in While Blood Cells) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication.    Concurrent medical conditions included Chronic lymphocytic leukemia (CLL "a type of Leukemia", diagnosis goes back at least a year or two), High cholesterol and Blood pressure abnormal. Concomitant products included ZINC, VITAMIN C [ASCORBIC ACID] and ACALABRUTINIB (CALQUENCE) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient received dose of INFLUENZA VACCINE (FLU) (unknown route) 1 dosage form. In March 2022, the patient experienced WHITE BLOOD CELL COUNT INCREASED (big jump in While Blood Cells). The patient was treated with PARACETAMOL (TYNELOL) at an unspecified dose and frequency. At the time of the report, WHITE BLOOD CELL COUNT INCREASED (big jump in While Blood Cells) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, White blood cell count: high (High) big jump in While Blood Cells. On an unknown date, Heart rate: normal (normal) normal. On an unknown date, Oxygen consumption: normal (normal) normal.         Other concomitant drugs included blood pressure medicine, Glameron and high cholesterol medicine. The patient had no history of COVID. The patient had a medical history which included CLL, a type of Leukemia and started taking (Calquence) on the 07-April but had since stopped taking it until follow-up with oncologist. The patient stated Leukemia diagnosis goes back at least a year or two (but could not give specifics). The oncologist was taking blood tests up until this time (for WBC) but then there was a big jump in While Blood Cells in the middle of Mar-2022.   This case was linked to MOD-2022-546508, MOD-2022-546692 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: nausea; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills). At the time of the report, NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) outcome was unknown.            No concomitant medication information provided. No treatment medication information provided.   This case was linked to MOD-2022-546661, MOD-2022-546697, MOD-2022-546699 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: nausea; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills). At the time of the report, NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-546661, MOD-2022-546695, MOD-2022-546699 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, COVID-19
Clinical narrative: Caught COVID less than 3 months ago; Less than a week after first dose lost sense of smell, still can't smell anything; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Less than a week after first dose lost sense of smell, still can't smell anything) and COVID-19 (Caught COVID less than 3 months ago) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091DZA) for COVID-19 vaccination.     Patient had no Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No allergies.     On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced ANOSMIA (Less than a week after first dose lost sense of smell, still can't smell anything). On an unknown date, the patient experienced COVID-19 (Caught COVID less than 3 months ago). At the time of the report, ANOSMIA (Less than a week after first dose lost sense of smell, still can't smell anything) had not resolved and COVID-19 (Caught COVID less than 3 months ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided. No treatment medication was provided.  COMPANY COMMNET: This spontaneous case concerns a 53-year-old, male patient with no medical history reported, who experienced unexpected non serious AESI events of anosmia, Covid-19 (reported as Caught COVID less than 3 months ago), which occurred unspecified days after first dose of mRNA-1273 vaccine. The patient received the second dose 9 months after the first dose, which is not in accordance with the recommended vaccine interval. Lack of efficacy is not concluded. Anosmia can be secondary to COVID 19. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected.   This case was linked to MOD-2022-546723 (Patient Link).; Sender's Comments: This spontaneous case concerns a 53-year-old, male patient with no medical history reported, who experienced unexpected non serious AESI events of anosmia, Covid-19 (reported as Caught COVID less than 3 months ago), which occurred unspecified days after first dose of mRNA-1273 vaccine. The patient received the second dose 9 months after the first dose, which is not in accordance with the recommended vaccine interval.Lack of efficacy is not concluded. Anosmia can be secondary to COVID 19.Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 07-Mar-2022, dose administered after 30 days use by date on 11 -Apr-2022; Vaccine was stored in refrigerator on 07-Mar-2022, dose administered after 30 days use by date on 11 -Apr-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 07-Mar-2022, dose administered after 30 days use by date on 11 -Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 07-Mar-2022, dose administered after 30 days use by date on 11 -Apr-2022) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 07-Mar-2022, dose administered after 30 days use by date on 11 -Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 07-Mar-2022, dose administered after 30 days use by date on 11 -Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 07-Mar-2022, dose administered after 30 days use by date on 11 -Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 07-Mar-2022, dose administered after 30 days use by date on 11 -Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 07-Mar-2022, dose administered after 30 days use by date on 11 -Apr-2022) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 07-Mar-2022, dose administered after 30 days use by date on 11 -Apr-2022).    Concomitant product use was not provided by the reporter. Vaccine was received in refrigerator on 07-Mar-2022 in appropriate temperature (2-8 Celsius). Vaccine was administered to patient 5 days past the 30 day time in refrigerator. Vial did not undergo any temperature excursions. The patient received  Moderna vaccine  Booster on 11-Apr-2022. Vaccine was given beyond use date. The event did not cause the patient to seek medical care. There were no any other potential causes. Treatment information was not provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered, Product storage error
Clinical narrative: Vaccine was administered to patient 2 days past the 30-day time in refrigerator; Dose/volume 0.5 ml/Patient received Moderna vaccine Booster on 04/08/2022; Vaccine was given beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was administered to patient 2 days past the 30-day time in refrigerator), ACCIDENTAL OVERDOSE (Dose/volume 0.5 ml/Patient received Moderna vaccine Booster on 04/08/2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was given beyond use date) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     The patient had no known drug allergy. Acute illnesses at the time of vaccination and up to one month before was reported as none. Chronic or long-standing health conditions were reported as unknown.     On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Apr-2022, the patient experienced ACCIDENTAL OVERDOSE (Dose/volume 0.5 ml/Patient received Moderna vaccine Booster on 04/08/2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was given beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered to patient 2 days past the 30-day time in refrigerator). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was administered to patient 2 days past the 30-day time in refrigerator), ACCIDENTAL OVERDOSE (Dose/volume 0.5 ml/Patient received Moderna vaccine Booster on 04/08/2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was given beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine was given beyond use date) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vaccine was administered to patient 2 days past the 30-day time in refrigerator) and ACCIDENTAL OVERDOSE (Dose/volume 0.5 ml/Patient received Moderna vaccine Booster on 04/08/2022).    Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event was reported as unknown. The patient received Moderna vaccine booster on 08-Apr-2022. Vaccine was given beyond use date. Vaccine was received in refrigerator on 07-Mar-2022 in appropriate temperature (2-8 Celsius). Vaccine was administered to patient 2 days past the 30-day time in refrigerator. The vial did not undergo any temperature excursion. The event did not cause the patient to seek medical care. There were no any other potential causes. No treatment medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient recieved first dose on 12-Aug-2021 and Second dose on 7-Oct-2021 beyond a month duration; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 12-Aug-2021 and Second dose on 7-Oct-2021 beyond a month duration) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 037C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Metformin allergy).   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 07-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 12-Aug-2021 and Second dose on 7-Oct-2021 beyond a month duration). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 12-Aug-2021 and Second dose on 7-Oct-2021 beyond a month duration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  Weight of the patient was given as 139 (No units provided).   Patient not had acute illnesses at the time of vaccination and up to one month before.  Race reported as private.  No treatment medications were reported   This case was linked to MOD-2022-546709 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vials was stored in a refrigerator post expiration date; Vaccine expired on 25 mar 2022 and was administered on 01 apr 2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 25 mar 2022 and was administered on 01 apr 2022.) and PRODUCT STORAGE ERROR (Vials was stored in a refrigerator post expiration date) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     The patient had no known drug allergies to medications and food. It was reported that the patient had no Acute or chronic illness. The patient was not tested positive or negative within last month.     On 01-Apr-2022 at 11:26 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 11:26 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 25 mar 2022 and was administered on 01 apr 2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials was stored in a refrigerator post expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 25 mar 2022 and was administered on 01 apr 2022.) and PRODUCT STORAGE ERROR (Vials was stored in a refrigerator post expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was not taking any daily medications.  The patient received the booster dose on 01-Apr-2022 at 11:26AM.  The date and time the vial initially stored in the refrigerator was 25-Feb-2022. The vial didn't undergo any temperature excursions. The patient received a vaccine past the 30 day storage on the refrigerator. The patient was vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022. The patient was not experiencing any side effects yet.  No treatment information was provided.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 30 Mar 2022; doses administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 30 Mar 2022) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no known drug allergies and no acute/ chronic illnesses.   On 30-Mar-2022 at 8:47 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022 at 8:47 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 30 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 30 Mar 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Patient had No Covid-19 within last month..  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  Dose administered after 30 day use by date or after manufacturer date of expiry. Number of doses or vials administered 36 doses. Date and time the vial was initially stored in the refrigerator 25-Feb-2022. Date and time of administration of vaccine was 01-Apr-2022 and 08-Apr-2022. The vial had not undergone any temperature excursion.  No treatment medications were reported
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in refrigerator beyond 30 day use.; Vaccine was received in refrigerator on 03/07/2022/ received  Moderna vaccine  Booster on 04/08/2022/used beyond 20 day use; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator beyond 30 day use.) and EXPIRED PRODUCT ADMINISTERED (Vaccine was received in refrigerator on 03/07/2022/ received  Moderna vaccine  Booster on 04/08/2022/used beyond 20 day use) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 004C21A and 031B21A) for COVID-19 vaccination.     It was unknown that patient was diagnosed or tested positive for COVID-19. Diagnosed acute illness at the time of vaccination and up to one month before was unknown. Chronic or long-standing health conditions was unknown.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 08-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was received in refrigerator on 03/07/2022/ received  Moderna vaccine  Booster on 04/08/2022/used beyond 20 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator beyond 30 day use.). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator beyond 30 day use.) and EXPIRED PRODUCT ADMINISTERED (Vaccine was received in refrigerator on 03/07/2022/ received  Moderna vaccine  Booster on 04/08/2022/used beyond 20 day use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Patient race was reported as private and patient received booster dose. Adverse event did not cause the patient to seek medical care. There was no any potential causes was reported. It was reported vaccine was received in refrigerator on 07 Mar 2022 in appropriate temperature (2-8 Celsius).  Vials did not undergone any temperature excursions. No treatment information was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022; 36 doses administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (36 doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no known allergies.  Concurrent medical conditions included Gastritis. Concomitant products included OMEPRAZOLE and ASCORBIC ACID, FERROUS FUMARATE (VITRON C [ASCORBIC ACID;FERROUS FUMARATE]) for an unknown indication.    On 13-Apr-2022 at 3:16 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022 at 3:16 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (36 doses administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (36 doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 25-Feb-2022. The vial did not undergo any temperature excursions. No treatment medication information was provided.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator 25Feb2022 and date administered on 8 Apr 2022; dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and date administered on 8 Apr 2022) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no allergies, no acute/ chronic illnesses.     On 08-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and date administered on 8 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and date administered on 8 Apr 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Patient had no Covid-19 infection within last month..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  Dose administered after 30 day use by date or after manufacturer date of expiry. Number of doses or vials administered 36 doses. Date and time the vial was initially stored in the refrigerator 25-Feb-2022. The vial had not undergone any temperature excursion.  No treatment medications were reported
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was received in refrigerator on 03/07/2022 in appropriate temperature (2-8 Celsius).; Patient received Moderna vaccine Booster on 04/08/2022. Vaccine was given beyond use date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 04/08/2022. Vaccine was given beyond use date.) and PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 03/07/2022 in appropriate temperature (2-8 Celsius).) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 032M20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 08-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 04/08/2022. Vaccine was given beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 03/07/2022 in appropriate temperature (2-8 Celsius).). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 04/08/2022. Vaccine was given beyond use date.) and PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 03/07/2022 in appropriate temperature (2-8 Celsius).) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 04/08/2022. Vaccine was given beyond use date.) and PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 03/07/2022 in appropriate temperature (2-8 Celsius).) to be not related.    Race of the patient was given No concomitant medications were reported  The reporter reported that they had refrigerated some vials of moderna covid-19 vaccine more than 30days. Reporter would like to know if the vaccine is still viable 30 days after the vaccine had been in the fridge. Reporter further stated  that it was stored between 2 and 8 Celsius degrees.  Dose was administered after 30 day use by date or after manufacture date of expiry. Lot number  046L21A No of doses or vials: 9 doses. Date the vial was initially stored in the refrigerator 07-Mar-2022. The vial had not undergone any temperature excursions.  No treatment medications were reported
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose recieved more than the 35 days duration after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose recieved more than the 35 days duration after first dose) in a 53-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 056A22A and 091DZA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Less than 3 months ago).   On 17-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose recieved more than the 35 days duration after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose recieved more than the 35 days duration after first dose) outcome was unknown.            No concomitant medication was reported.  Patient did not have acute and chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  No treatment medication was reported.   This case was linked to MOD-2022-546698 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022; vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No known allergy was reported to medications, food, and other products.  Concurrent medical conditions included Osteoarthritis. Concomitant products included OMEPRAZOLE, AMLODIPINE, ESCITALOPRAM, ERGOCALCIFEROL, IBUPROFEN, ACETAMINOPHEN and TRIAMCINOLONE for an unknown indication.    On 13-Apr-2022 at 4:03 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022 at 4:03 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 25-Feb-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not experienced covid infection within last month.  The vial was initially stored in refrigerator on 25-Feb-2022. The vial did not undergo temperature excursion. it was reported that the patient was vaccinated post 30 day use period (expiration date 25-Mar-2022). The patient did not experience any side effects.  No treatment medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine past the 30 day storage on the refrigerator and administered on 20-Apr-2022 after expiration; vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (vaccine past the 30 day storage on the refrigerator and administered on 20-Apr-2022 after expiration) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Amoxicillin) and Hyperlipidemia. Concomitant products included SIMVASTATIN for an unknown indication.    On 20-Apr-2022 at 9:10 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 9:10 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine past the 30 day storage on the refrigerator and administered on 20-Apr-2022 after expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with the Moderna Vaccine after the expiration of 25-Mar-2022) and PRODUCT STORAGE ERROR (vaccine past the 30 day storage on the refrigerator and administered on 20-Apr-2022 after expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in refrigerator on 25-Feb-2022. The vial did not undergo temperature excursion. it was reported that the patient was vaccinated post 30 day use period. The patient did not experience any side effects.  No treatment details were reported.