chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 40th of 40 adult patients.  Concomitant product use was not provided by the reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product storage error; no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and PRODUCT STORAGE ERROR (Product storage error).    This case contains information for the 4 out of 15 patients as described by the reporter.  No concomitant medication information was provided.  It was reported that that they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date. Lot number AS7168B, beyond use date 08Jan2023. Administration dates were as follows: 09-Jan-2023 (2 patients) 10-Jan-2023 (2 patients) 11-Jan-2023 (4 patients) 12-Jan-2023 (4 patients) 13-Jan-2023 (3 patients). All of the patients were 12years and above but HCP did not have the information if some of them were below 17 years old.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient was administered bivalent vaccine which was beyond the 30 use by date; no adverse event; Patient was administered bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine which was beyond the 30 use by date) and PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date).    No concomitant medications were reported.  The beyond use date was reported as 08-Jan-2023 and all of the patients were 12 years and above but HCP did not have the information if some of them were below17 years old.  No treatment medications were reported.  This case contains information for the 1st of 15th adult patients (1st of 4th patient, administered on 11-Jan-2023) described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:Master case
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vials were initially stored in refrigerator on 14-Dec-2022 and was administered on 18-Jan-2023; No Adverse Event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vials were initially stored in refrigerator on 14-Dec-2022 and was administered on 18-Jan-2023) and NO ADVERSE EVENT (No Adverse Event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 18-Jan-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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 vials were initially stored in refrigerator on 14-Dec-2022 and was administered on 18-Jan-2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vials were initially stored in refrigerator on 14-Dec-2022 and was administered on 18-Jan-2023) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vials were initially stored in refrigerator on 14-Dec-2022 and was administered on 18-Jan-2023).    Concomitant medication was not provided.  Reporter reported that the vial was one vial and size were 10 dose vial. The vials were initially stored in refrigerator on 14-Dec-2022 and was administered on 18-Jan-2023. The vial did not undergo any temperature excursion.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient was administered bivalent vaccine which was beyond the 30 use by date; No adverse event; They inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (They inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (They inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date).    No concomitant medications were reported. The beyond use date was reported as 08-Jan-2023 and all of the patients were 12 years and above but HCP did not have the information if some of them were below17 years old. No treatment details were reported. This case contains information for the 6th of 15th adult patients (2nd of 4th patient, administered on 11-Jan-2023) described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    No concomitant products reported.  Nurse supervisor reported that they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date. The beyond use date was 08-Jan-2023. The patient was 12 years and above but HCP did not have the information if some of them were below 17 years old.   No treatment products reported.  This case contains information for the 7th of 15 adult patients described by the reporter, 3 of 4 patient who was administered  bivalent dose on 11-Jan-2023.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient was administered bivalent vaccine which was beyond the 30 use by date; no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The beyond use date was reported as 08-Jan-2023 and all of the patients were 12 years and above but HCP did not have the information if some of them were below17 years old. No treatment details were reported. This case contains information for the 8th of 15th adult patients (4th of 4th patient, administered on 11-Jan-2023) described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:MASTER  CASE
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    No concomitant medications was reported.  Beyond use date was reported as 08-Jan-2023. Administration dates are as follows: 09-Jan-2023 (2 patients), 10-Jan-2023 (2 patients), 11-Jan-2023 (4 patients), 12-Jan-2023 (4 patients), 13-Jan-2023 (3 patients). All of the patients were 12years and above but HCP did not have the information if some of them were below 17 years old.  No treatment medications was reported.  This case contains information for the 09 out of 15 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:Master case
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: No adverse event; Patient received her first dose of Moderna Covid-19 vaccine on 06-Jan-2022 and would like to receive her second dose of the Moderna Covid-19 vaccine on 19-Jan-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient received her first dose of Moderna Covid-19 vaccine on 06-Jan-2022 and would like to receive her second dose of the Moderna Covid-19 vaccine on 19-Jan-2023) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient received her first dose of Moderna Covid-19 vaccine on 06-Jan-2022 and would like to receive her second dose of the Moderna Covid-19 vaccine on 19-Jan-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient received her first dose of Moderna Covid-19 vaccine on 06-Jan-2022 and would like to receive her second dose of the Moderna Covid-19 vaccine on 19-Jan-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient received her first dose of Moderna Covid-19 vaccine on 06-Jan-2022 and would like to receive her second dose of the Moderna Covid-19 vaccine on 19-Jan-2023).    No concomitant medication information was provided.  It was reported that patient received her first dose of Moderna Covid-19 vaccine on 06-Jan-2022 and would like to receive her second dose of the Moderna Covid-19 vaccine on 19-Jan-2023. No lot number is known by the Pharmacist as the patient received this vaccine in another pharmacy. No adverse reactions to the first dose are known of.  No treatment medications were provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caller states they tested positive for Covid19 on 11Dec2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller states they tested positive for Covid19 on 11Dec2022) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 32M20A and 0114214) for COVID-19 prophylaxis.     Concurrent medical conditions included Food allergy (Apple allergy).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2022, the patient experienced COVID-19 (Caller states they tested positive for Covid19 on 11Dec2022). At the time of the report, COVID-19 (Caller states they tested positive for Covid19 on 11Dec2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Dec-2022, SARS-CoV-2 test: Positive. On 21-Dec-2022, SARS-CoV-2 test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient was tested positive for Covid-19 on 11-Dec2022, after 10 days they tested negative and she would like to know if she can now receive the Moderna Covid 19 Bivalent vaccine. She heard from a friend that it could reactivate the virus and she wanted to know what was the recommendation. When she tested positive she had fever and cold like symptoms, but her biggest fear was to have respiratory complications. As treatment she took antivirals but does not remember the name.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bone pain, Immunisation reaction, Mobility decreased, Myalgia
Clinical narrative: Every bone in body ached; Experienced a reaction where it was very nasty; Could hardly move; Muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Every bone in body ached), IMMUNISATION REACTION (Experienced a reaction where it was very nasty), MOBILITY DECREASED (Could hardly move) and MYALGIA (Muscle soreness) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) tablet for an unknown indication.    No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient started PALBOCICLIB (IBRANCE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BONE PAIN (Every bone in body ached), IMMUNISATION REACTION (Experienced a reaction where it was very nasty), MOBILITY DECREASED (Could hardly move) and MYALGIA (Muscle soreness). At the time of the report, BONE PAIN (Every bone in body ached), IMMUNISATION REACTION (Experienced a reaction where it was very nasty), MOBILITY DECREASED (Could hardly move) and MYALGIA (Muscle soreness) outcome was unknown.            No concomitant medications was reported. The patient received the Moderna booster vaccine in October or September. It was reported that for couple of times the doctor held off her dose for a week due to low levels then continued it a week later. Drug-drug interaction (DDI) check showed category D between Ibrance and Xgeva and Ibrance and Omeprazole.  No treatment drug details was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Heart problems; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart problems) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Heart problems). At the time of the report, CARDIAC DISORDER (Heart problems) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant information was reported.  Now after the Pfizer patient got worry about a stroke. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product storage error; no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Product storage error ) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error ) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Product storage error ) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and PRODUCT STORAGE ERROR (Product storage error ).    This case contains information for the 10 out of 15 patients as described by the reporter.  No concomitant medication information was provided.  It was reported that that they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date. Lot number AS7168B, beyond use date 08Jan2023. Administration dates were as follows: 09-Jan-2023 (2 patients) 10-Jan-2023 (2 patients) 11-Jan-2023 (4 patients) 12-Jan-2023 (4 patients) 13-Jan-2023 (3 patients). All of the patients were 12years and above but HCP did not have the information if some of them were below 17 years old.  No treatment medications were provided.   This case was linked to MODERNATX, INC.-MOD-2023-698566 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698566:MASTER  CASE
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    No concomitant medicine were reported. No treatment medicine were reported.   This case was linked to MODERNATX, INC.-MOD-2023-698746 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698746:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product storage error; No adverse event; Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and PRODUCT STORAGE ERROR (Product storage error).    Concomitant medication was not reported. Patient administered doses of the bivalent vaccine which was beyond use date on 08-Jan2-023. Administration dates are reported as 09Jan2023 (2 patients) 10Jan2023 (2 patients) 11Jan3023 (4 patients) 12Jan2023 (4 patients) 13Jan2023 (3 patients). All the patients were 12 years and above, but HCP did not have the information if some of them were below 17 years old.   Case contains the information regarding patient 11 of 15 reported.  Treatment drug was not reported.   This case was linked to MODERNATX, INC.-MOD-2023-698566 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698566: Master case
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare
Clinical narrative: granuloma annulare; This spontaneous case was reported by a physician and describes the occurrence of GRANULOMA ANNULARE (granuloma annulare) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 000000) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Jan-2023, the patient experienced GRANULOMA ANNULARE (granuloma annulare). At the time of the report, GRANULOMA ANNULARE (granuloma annulare) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered GRANULOMA ANNULARE (granuloma annulare) to be related.    Concomitant medication of the patient was not reported.  It was reported by the reporter that the 2nd Moderna booster dose which his wife had received, might be the cause of the granuloma annulare.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    No concomitant medication was provided by reporter.  Nurse supervisor reports that they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date. Lot number AS7168B, beyond use date 08Jan2023. Administration dates are as follows: 09Jan2023 (2 patients) 10Jan2023 (2 patients) 11Jan3023 (4 patients) 12Jan2023 (4 patients) 13Jan2023 (3 patients). All of the patients were 12years and above, but HCP did not have the information if some of them were below 17 years old.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    No concomitant products reported.  Nurse supervisor reported that they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date. The beyond use date was 08 Jan 2023. The patient was 12 years and above but HCP did not have the information if some of them were below 17 years old.   This case contains information for patient 13th out of 15 patients who were administered bivalent dose on 13 Jan 2023, 1 out of 3 reported by the reporter.  No treatment products reported.   This case was linked to MODERNATX, INC.-MOD-2023-698566 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698566: Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    Concomitant medications were not reported. All of the patients were 12years and above but HCP did not have the information if some of them were below 17 years old.                                     No treatment information was provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-698566 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698566: Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and PRODUCT STORAGE ERROR (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    No concomitant medications were reported.   Beyond use date was reported as 08-Jan-2023. All the patients were 12 years and above, but HCP did not have the information if some of them were below 17 years old.   No treatment details were reported.  This case contains information for the 15 out of 15 patients as described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-698566 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698566:Master case