chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pyrexia
Clinical narrative: patient got a dose from a vial punctured more than 12 hours before; slight fever; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got a dose from a vial punctured more than 12 hours before) and PYREXIA (slight fever) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got a dose from a vial punctured more than 12 hours before) and PYREXIA (slight fever). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got a dose from a vial punctured more than 12 hours before) and PYREXIA (slight fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  concomitant medication provided by the reporter. no treatment information provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a 2nd dose of the Moderna COVID 19 vaccine that was beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a 2nd dose of the Moderna COVID 19 vaccine that was beyond use date.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a 2nd dose of the Moderna COVID 19 vaccine that was beyond use date.). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received a 2nd dose of the Moderna COVID 19 vaccine that was beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Right arm was swollen/ woke up with whole arm swollen where got the shot, on the right side; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Right arm was swollen/ woke up with whole arm swollen where got the shot, on the right side) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced PERIPHERAL SWELLING (Right arm was swollen/ woke up with whole arm swollen where got the shot, on the right side). At the time of the report, PERIPHERAL SWELLING (Right arm was swollen/ woke up with whole arm swollen where got the shot, on the right side) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications included sugar pill and cholesterol pill (unspecified).  Patient did not take medication to treat symptoms.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not provided.  Treatment information was not provided.  The patient will take second shot on 24-Sep-2021
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time). At the time of the report, PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information reported.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Product dose omission issue
Clinical narrative: Had adverse reaction; More than 36 days from fist vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Had adverse reaction) and PRODUCT DOSE OMISSION ISSUE (More than 36 days from fist vaccination) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Had adverse reaction) and PRODUCT DOSE OMISSION ISSUE (More than 36 days from fist vaccination). At the time of the report, ADVERSE REACTION (Had adverse reaction) and PRODUCT DOSE OMISSION ISSUE (More than 36 days from fist vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Menopausal symptoms
Clinical narrative: She started with hot flashes very badly/She still experiences hot flashes; In June, she started having menopausal symptoms; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (She started with hot flashes very badly/She still experiences hot flashes) and MENOPAUSAL SYMPTOMS (In June, she started having menopausal symptoms) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced HOT FLUSH (She started with hot flashes very badly/She still experiences hot flashes) and MENOPAUSAL SYMPTOMS (In June, she started having menopausal symptoms). At the time of the report, HOT FLUSH (She started with hot flashes very badly/She still experiences hot flashes) had not resolved and MENOPAUSAL SYMPTOMS (In June, she started having menopausal symptoms) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date) in a 57-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 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) to be not applicable.    No concomitant medication was provided No treatment received by the patient
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Vaccination complication
Clinical narrative: did have a kind of a long term reaction / that's the way my body reacts.; i'm fine, it is nothing serious, just not feeling that great; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (did have a kind of a long term reaction / that's the way my body reacts.) and VACCINATION COMPLICATION (i'm fine, it is nothing serious, just not feeling that great) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (did have a kind of a long term reaction / that's the way my body reacts.) and VACCINATION COMPLICATION (i'm fine, it is nothing serious, just not feeling that great). At the time of the report, ADVERSE REACTION (did have a kind of a long term reaction / that's the way my body reacts.) and VACCINATION COMPLICATION (i'm fine, it is nothing serious, just not feeling that great) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She stated that's  she had bad reaction to shots and that the way her body reacts.   Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria
Clinical narrative: Painful urination; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (Painful urination) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included LOVASTATIN, GABAPENTIN, DULOXETINE and SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSURIA (Painful urination). At the time of the report, DYSURIA (Painful urination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided. it was reported patient had painful urination few minutes earlier.   This case was linked to MOD-2021-316173 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Mobility decreased, Pain in extremity
Clinical narrative: Patient received first dose on 10Feb2021/second dose on 18Mar2021; couldn't move her arm/the movement of her arm just kept getting worse/She can't reach behind her.; arm was in excruciating pain/severe pain/couldn't even touch her arm/it hurts the whole arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 10Feb2021/second dose on 18Mar2021), PAIN IN EXTREMITY (arm was in excruciating pain/severe pain/couldn't even touch her arm/it hurts the whole arm) and MOBILITY DECREASED (couldn't move her arm/the movement of her arm just kept getting worse/She can't reach behind her.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was in excruciating pain/severe pain/couldn't even touch her arm/it hurts the whole arm). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 10Feb2021/second dose on 18Mar2021) and MOBILITY DECREASED (couldn't move her arm/the movement of her arm just kept getting worse/She can't reach behind her.). The patient was treated with CORTISONE for Pain, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 10Feb2021/second dose on 18Mar2021) outcome was unknown and PAIN IN EXTREMITY (arm was in excruciating pain/severe pain/couldn't even touch her arm/it hurts the whole arm) and MOBILITY DECREASED (couldn't move her arm/the movement of her arm just kept getting worse/She can't reach behind her.) had not resolved.            She does not have a diagnose yet although she has consulted doctors, the X-Ray did not show injuries or anything, and they are going to do a MRI in about 4 weeks. She started going to the Orthopedist and now is doing physical therapy.  No concomitant medications were reported   This case was linked to MOD-2021-024087 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heavy menstrual bleeding, Nausea, Pyrexia
Clinical narrative: The bleeding continued after the second dose and is not stopping even with treatment by physicians; Dizziness; three days of being in bed with bad fever and nausea; three days of being in bed with bad fever and nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (The bleeding continued after the second dose and is not stopping even with treatment by physicians), DIZZINESS (Dizziness), PYREXIA (three days of being in bed with bad fever and nausea) and NAUSEA (three days of being in bed with bad fever and nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM and TRAZODONE for an unknown indication.   On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (The bleeding continued after the second dose and is not stopping even with treatment by physicians), DIZZINESS (Dizziness), PYREXIA (three days of being in bed with bad fever and nausea) and NAUSEA (three days of being in bed with bad fever and nausea). At the time of the report, HEAVY MENSTRUAL BLEEDING (The bleeding continued after the second dose and is not stopping even with treatment by physicians), DIZZINESS (Dizziness), PYREXIA (three days of being in bed with bad fever and nausea) and NAUSEA (three days of being in bed with bad fever and nausea) had not resolved.            The patient did not provide her age but reported that she was in her 20s. After receiving the first dose, upon the end of the cycle of first period after the patient was having constant breakthrough bleeding. The bleeding continued after the second dose and was not stopping even with treatment by physicians. The bleeding episodes have never occurred prior to the vaccine according to the patient.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-315665 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Illness, Lymphadenopathy
Clinical narrative: Became ill after first dose; fatigue; high fever; dizziness; sweating; glands swollen and achy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Became ill after first dose), DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy) and FATIGUE (fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: TYPHOID VACCINE (In 1983 and Experienced similar events) in 1983. Concurrent medical conditions included Allergy to antibiotic (Tetracycline), Allergy to antibiotic (Dicloxacillin), Allergy to antibiotic (Levofloxacin), Hypertension, Lymphadenopathy, Drug allergy (Compazine), Drug allergy (Statins) and Drug allergy (Prochlorperazine). Concomitant products included CITALOPRAM from 07-Jul-2021 to an unknown date for Anxiety, TELMISARTAN from 24-Aug-2021 to an unknown date for Hypertension, AMITRIPTYLINE and MELATONIN from 17-Jul-2021 to an unknown date for Sleep disorder NOS, ACETYLSALICYLIC ACID (ASPIRIN) from 16-Mar-2021 to an unknown date for an unknown indication.    On 05-Feb-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy) and PYREXIA (high fever). On an unknown date, the patient experienced ILLNESS (Became ill after first dose) and FATIGUE (fatigue). At the time of the report, ILLNESS (Became ill after first dose), DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy), FATIGUE (fatigue) and PYREXIA (high fever) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2021, Thyroid gland scan abnormal: abnormal (abnormal) Very small nodules bilaterally in the thyroid, nonspecific appearing and difficult to characterize further because of small size. No surrounding adenopathy noted..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ILLNESS (Became ill after first dose), DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy), FATIGUE (fatigue) and PYREXIA (high fever) to be possibly related.    No  treatment medications were provided   This case was linked to MOD-2021-300020 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Thyroid gland scan abnormal
Clinical narrative: Became ill after first dose; fatigue; high fever; dizziness; sweating; glands swollen and achy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Became ill after first dose), DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy) and FATIGUE (fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: TYPHOID VACCINE (In 1983 and Experienced similar events) in 1983. Concurrent medical conditions included Allergy to antibiotic (Tetracycline), Allergy to antibiotic (Dicloxacillin), Allergy to antibiotic (Levofloxacin), Hypertension, Lymphadenopathy, Drug allergy (Compazine), Drug allergy (Statins) and Drug allergy (Prochlorperazine). Concomitant products included CITALOPRAM from 07-Jul-2021 to an unknown date for Anxiety, TELMISARTAN from 24-Aug-2021 to an unknown date for Hypertension, AMITRIPTYLINE and MELATONIN from 17-Jul-2021 to an unknown date for Sleep disorder NOS, ACETYLSALICYLIC ACID (ASPIRIN) from 16-Mar-2021 to an unknown date for an unknown indication.    On 05-Feb-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy) and PYREXIA (high fever). On an unknown date, the patient experienced ILLNESS (Became ill after first dose) and FATIGUE (fatigue). At the time of the report, ILLNESS (Became ill after first dose), DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy), FATIGUE (fatigue) and PYREXIA (high fever) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2021, Thyroid gland scan abnormal: abnormal (abnormal) Very small nodules bilaterally in the thyroid, nonspecific appearing and difficult to characterize further because of small size. No surrounding adenopathy noted..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ILLNESS (Became ill after first dose), DIZZINESS (dizziness), HYPERHIDROSIS (sweating), LYMPHADENOPATHY (glands swollen and achy), FATIGUE (fatigue) and PYREXIA (high fever) to be possibly related.    No  treatment medications were provided   This case was linked to MOD-2021-300020 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Pain in extremity
Clinical narrative: she had with the first dose was a sore arm that went away after 2 days; Painful urination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she had with the first dose was a sore arm that went away after 2 days) and DYSURIA (Painful urination) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included LOVASTATIN, GABAPENTIN, DULOXETINE and HYDROCHLOROTHIAZIDE, SPIRONOLACTONE (ALDACTONE 50 HCT) for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Sep-2021, the patient experienced DYSURIA (Painful urination). On an unknown date, the patient experienced PAIN IN EXTREMITY (she had with the first dose was a sore arm that went away after 2 days). At the time of the report, PAIN IN EXTREMITY (she had with the first dose was a sore arm that went away after 2 days) had resolved and DYSURIA (Painful urination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details provided.   This case was linked to MOD-2021-316145 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Muscular weakness, Pain in extremity, Skin warm
Clinical narrative: My arm is now very red and  warm.; It is starting to feel like my arm is weak and achy; My arm is now very red and  warm.; It is starting to feel like my arm is weak and achy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (My arm is now very red and  warm.), PAIN IN EXTREMITY (It is starting to feel like my arm is weak and achy), SKIN WARM (My arm is now very red and  warm.) and MUSCULAR WEAKNESS (It is starting to feel like my arm is weak and achy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced ERYTHEMA (My arm is now very red and  warm.), PAIN IN EXTREMITY (It is starting to feel like my arm is weak and achy), SKIN WARM (My arm is now very red and  warm.) and MUSCULAR WEAKNESS (It is starting to feel like my arm is weak and achy). At the time of the report, ERYTHEMA (My arm is now very red and  warm.), PAIN IN EXTREMITY (It is starting to feel like my arm is weak and achy), SKIN WARM (My arm is now very red and  warm.) and MUSCULAR WEAKNESS (It is starting to feel like my arm is weak and achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date refrigerated: 13-Apr-2021. Temperature changes (in F): 37-40.  No treatment medications were reported   This case was linked to MOD-2021-316323 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered past the 30 day refrigeration time; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product details were provided by the reporter. No Treatment information was provided.  Linked to master case: MOD-2021-315260
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue, Mobility decreased, Myalgia, Pain
Clinical narrative: Pain for a couple days; Hard to get up; All muscles hurt; Received second dose almost 8 weeks after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain for a couple days), MOBILITY DECREASED (Hard to get up), MYALGIA (All muscles hurt) and INTENTIONAL PRODUCT USE ISSUE (Received second dose almost 8 weeks after first dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID in August 2020.) and Pericarditis (Patient has a past history of Pericarditis that happened 4 years ago during an autoimmune attack.). Concurrent medical conditions included ADD, Thyroid disorder, Ulcerative colitis, Blood sugar decreased and Blood pressure abnormal (Patient's blood pressure has been going up and down.). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for ADD, HYDROXYCHLOROQUINE for Blood sugar decreased, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, MESALAZINE (LIALDA) for Ulcerative colitis.    On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2021, the patient experienced PAIN (Pain for a couple days), MOBILITY DECREASED (Hard to get up), MYALGIA (All muscles hurt) and INTENTIONAL PRODUCT USE ISSUE (Received second dose almost 8 weeks after first dose). On 03-Sep-2021, INTENTIONAL PRODUCT USE ISSUE (Received second dose almost 8 weeks after first dose) had resolved. At the time of the report, PAIN (Pain for a couple days), MOBILITY DECREASED (Hard to get up) and MYALGIA (All muscles hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported. Patient had COVID 19 in August 2020. Since then, her blood pressure has been going up and down, so patient takes some drug that helps BP remain constant.   This case was linked to MOD-2021-316301 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: have diarrhea and nausea over a week after getting 1st dose; have diarrhea and nausea over a week after getting 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (have diarrhea and nausea over a week after getting 1st dose) and NAUSEA (have diarrhea and nausea over a week after getting 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (have diarrhea and nausea over a week after getting 1st dose) and NAUSEA (have diarrhea and nausea over a week after getting 1st dose). At the time of the report, DIARRHOEA (have diarrhea and nausea over a week after getting 1st dose) and NAUSEA (have diarrhea and nausea over a week after getting 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pain, Productive cough, Seasonal allergy
Clinical narrative: Sinus congestion; Like hay fever symptoms; Coughing; Stuff coming out while she cough like phlegm; Shortness of breath when walking, A little shortness of breath at rest; Lot more pain than with the first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Lot more pain than with the first shot), SINUS CONGESTION (Sinus congestion), SEASONAL ALLERGY (Like hay fever symptoms), COUGH (Coughing) and PRODUCTIVE COUGH (Stuff coming out while she cough like phlegm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939676 and 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pericarditis. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Attention deficit hyperactivity disorder, HYDROXYCHLOROQUINE for Diabetes mellitus, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, MESALAZINE (LIALDA) for Ulcerative colitis.   On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced PAIN (Lot more pain than with the first shot). On 04-Sep-2021, the patient experienced SINUS CONGESTION (Sinus congestion), SEASONAL ALLERGY (Like hay fever symptoms), COUGH (Coughing), PRODUCTIVE COUGH (Stuff coming out while she cough like phlegm) and DYSPNOEA (Shortness of breath when walking, A little shortness of breath at rest). At the time of the report, PAIN (Lot more pain than with the first shot), SINUS CONGESTION (Sinus congestion), SEASONAL ALLERGY (Like hay fever symptoms), COUGH (Coughing), PRODUCTIVE COUGH (Stuff coming out while she cough like phlegm) and DYSPNOEA (Shortness of breath when walking, A little shortness of breath at rest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, COVID-19 Test: negative Negative.         No treatment information was provided.   This case was linked to MOD-2021-316241 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: Sinus congestion; Like hay fever symptoms; Coughing; Stuff coming out while she cough like phlegm; Shortness of breath when walking, A little shortness of breath at rest; Lot more pain than with the first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Lot more pain than with the first shot), SINUS CONGESTION (Sinus congestion), SEASONAL ALLERGY (Like hay fever symptoms), COUGH (Coughing) and PRODUCTIVE COUGH (Stuff coming out while she cough like phlegm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939676 and 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pericarditis. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Attention deficit hyperactivity disorder, HYDROXYCHLOROQUINE for Diabetes mellitus, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, MESALAZINE (LIALDA) for Ulcerative colitis.   On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced PAIN (Lot more pain than with the first shot). On 04-Sep-2021, the patient experienced SINUS CONGESTION (Sinus congestion), SEASONAL ALLERGY (Like hay fever symptoms), COUGH (Coughing), PRODUCTIVE COUGH (Stuff coming out while she cough like phlegm) and DYSPNOEA (Shortness of breath when walking, A little shortness of breath at rest). At the time of the report, PAIN (Lot more pain than with the first shot), SINUS CONGESTION (Sinus congestion), SEASONAL ALLERGY (Like hay fever symptoms), COUGH (Coughing), PRODUCTIVE COUGH (Stuff coming out while she cough like phlegm) and DYSPNOEA (Shortness of breath when walking, A little shortness of breath at rest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, COVID-19 Test: negative Negative.         No treatment information was provided.   This case was linked to MOD-2021-316241 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Per reporter,the Moderna COVID Vaccine was refrigerated on 20-APR-2021, and administered to the patient on 27-AUG-2021.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered past the 30 day refrigeration time; administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2021-316219 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Product administration error
Clinical narrative: Mixed Moderna and Pfizer dose; first dose of Pfizer; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed Moderna and Pfizer dose) and PRODUCT ADMINISTRATION ERROR (first dose of Pfizer) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination.    No Medical History information was reported.   On 20-Aug-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 10-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 20-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION ERROR (first dose of Pfizer). On 10-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed Moderna and Pfizer dose). On 20-Aug-2021, PRODUCT ADMINISTRATION ERROR (first dose of Pfizer) had resolved. On 10-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Mixed Moderna and Pfizer dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medication was provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left sore arm) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 05ZE21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE PAIN (left sore arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 2 dosage form. At the time of the report, VACCINATION SITE PAIN (left sore arm) outcome was unknown.            The concomitant medications information was not reported. The patient had no known allergies.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; Headaches after each dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (Headaches after each dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack (History of 3 heart attacks) and Stent placement. Concomitant products included LISINOPRIL, METOPROLOL and CLOPIDOGREL for an unknown indication.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headaches after each dose). At the time of the report, FATIGUE (Fatigue) had not resolved and HEADACHE (Headaches after each dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-316410 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: running high fever; chills; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (running high fever), CHILLS (chills) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (running high fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, PYREXIA (running high fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  No Treatment medication was provided.