chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion/beyond use date excursion; Temperature excursion/beyond use date excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion/beyond use date excursion) and EXPIRED PRODUCT ADMINISTERED (Temperature excursion/beyond use date excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Temperature excursion/beyond use date excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion/beyond use date excursion). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Temperature excursion/beyond use date excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion/beyond use date excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: temperature excursion; the temp excursion/beyond use date excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the temp excursion/beyond use date excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (the temp excursion/beyond use date excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (the temp excursion/beyond use date excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Temp excursion/beyond use date excursion I called about on1/21/22.; Temp excursion/beyond use date excursion I called about on1/21/22.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion I called about on1/21/22.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion I called about on1/21/22.) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion I called about on1/21/22.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion I called about on1/21/22.). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion I called about on1/21/22.) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion I called about on1/21/22.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Temp excursion/beyond use date excursion; Temp excursion/beyond use date excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Total 15 patient were involved. No concomitant product were reported. Treatment information was not reported
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acquired haemophilia
Clinical narrative: acquired haemophilia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jan-2022 and was forwarded to Moderna on 25-Jan-2022.    This literature-non-study case was reported in a literature article and describes the occurrence of ACQUIRED HAEMOPHILIA (acquired haemophilia) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.        No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACQUIRED HAEMOPHILIA (acquired haemophilia) (seriousness criterion medically significant). At the time of the report, ACQUIRED HAEMOPHILIA (acquired haemophilia) 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 considered ACQUIRED HAEMOPHILIA (acquired haemophilia) to be related.    Concomitant medications were not reported.  Company comment: This is a literature case concerning a 70-year-old male patient with no medical history reported, who experienced the unexpected serious event of Acquired haemophilia eight days after the first dose of mRNA-1273 vaccine. The outcome was reported as unknown. Patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a literature case concerning a 70-year-old male patient with no medical history reported, who experienced the unexpected serious event of Acquired haemophilia eight days after the first dose of mRNA-1273 vaccine. The outcome was reported as unknown. Patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients; Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) 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 medications were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Temp excursion/beyond use date excursion I called about on1/21/22.; Temp excursion/beyond use date excursion I called about on1/21/22.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion I called about on1/21/22.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion I called about on1/21/22.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion I called about on1/21/22.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion I called about on1/21/22.). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion I called about on1/21/22.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion I called about on1/21/22.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took booster dose.  Concomitant information was not provided.  Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Here is the patient info for the temp excursion; Here is the patient info for the temp excursion/beyond use date excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Vaccine administration error; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine administration error) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine administration error). At the time of the report, PRODUCT ADMINISTRATION ERROR (Vaccine administration error) 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 medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: second one was worse than when she had COVID; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (second one was worse than when she had COVID) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (second one was worse than when she had COVID). At the time of the report, VACCINATION COMPLICATION (second one was worse than when she had COVID) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2022-460563 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart was racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart was racing) 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 PALPITATIONS (Heart was racing). At the time of the report, PALPITATIONS (Heart was racing) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided by reporter. No treatment information was provided by reporter. It was reported that a few minutes after the first vaccination patient heart was racing.   This case was linked to MOD-2022-460586 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Hyperhidrosis, Illness, Palpitations
Clinical narrative: so sick  But was better 4 days later; heart racing; sweating; heaviness in my chest thought I was gonna faint Like I was having a heart attack,It last about 5-10 minutes.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (so sick  But was better 4 days later), PALPITATIONS (heart racing), HYPERHIDROSIS (sweating) and CHEST DISCOMFORT (heaviness in my chest thought I was gonna faint Like I was having a heart attack,It last about 5-10 minutes.) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (so sick  But was better 4 days later), PALPITATIONS (heart racing), HYPERHIDROSIS (sweating) and CHEST DISCOMFORT (heaviness in my chest thought I was gonna faint Like I was having a heart attack,It last about 5-10 minutes.). At the time of the report, ILLNESS (so sick  But was better 4 days later) was resolving and PALPITATIONS (heart racing), HYPERHIDROSIS (sweating) and CHEST DISCOMFORT (heaviness in my chest thought I was gonna faint Like I was having a heart attack,It last about 5-10 minutes.) had resolved.            No concomitant medications reported,   Patient went and got heart checked all are normal. Patient was obviously allergic to something in it. The patient thought patient was gonna faint. Like patient was having the heart attack.  No treatment medications reported,   This case was linked to MOD-2022-460579.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Nausea; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (Nausea) and FATIGUE (Fatigue) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Echocardiogram, Ejection fraction, Electrocardiogram, Magnetic resonance imaging heart
Clinical narrative: Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was treated with METOPROLOL for Myocarditis, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: negative (Negative) Negative. On an unknown date, Echocardiogram: abnormal (abnormal) revealed an ejection fraction of 55% with no wall motion abnormalities.. On an unknown date, Ejection fraction: 55 percent 55 percent with no wall motion abnormalities. On an unknown date, Electrocardiogram: normal (normal) Normal. On an unknown date, Magnetic resonance imaging heart: abnormal (abnormal) showed an area of myocardial hyper-enhancement in the apical anterior segment suggesting the diagnosis of myocarditis. On an unknown date, Red blood cell sedimentation rate: negative (Negative) Negative. On an unknown date, Troponin: 1.7 (High) 1.7 Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be related.    No concomitant medications were reported.  The symptoms included burning chest pain associated with orthopnea and paroxysmal nocturnal dyspnea. Patient was discharged with Metoprolol and was instructed to refrain from strenuous exercise. Patient was seen outpatient, and endorsed to still experience intermittent burning substernal chest pain.  Company comment: This is a literature case concerning a 31-year-old male patient with no medical history reported, who experienced the expected serious AESI of Myocarditis two days after the second dose of mRNA-1273 vaccine. The patient was hospitalized and the diagnosis was established by cardiac magnetic resonance imaging. The outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a literature case concerning a 31-year-old male patient with no medical history reported, who experienced the expected serious AESI of Myocarditis two days after the second dose of mRNA-1273 vaccine. The patient was hospitalized and the diagnosis was established by cardiac magnetic resonance imaging. The outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Red blood cell sedimentation rate, Troponin
Clinical narrative: Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was treated with METOPROLOL for Myocarditis, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: negative (Negative) Negative. On an unknown date, Echocardiogram: abnormal (abnormal) revealed an ejection fraction of 55% with no wall motion abnormalities.. On an unknown date, Ejection fraction: 55 percent 55 percent with no wall motion abnormalities. On an unknown date, Electrocardiogram: normal (normal) Normal. On an unknown date, Magnetic resonance imaging heart: abnormal (abnormal) showed an area of myocardial hyper-enhancement in the apical anterior segment suggesting the diagnosis of myocarditis. On an unknown date, Red blood cell sedimentation rate: negative (Negative) Negative. On an unknown date, Troponin: 1.7 (High) 1.7 Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be related.    No concomitant medications were reported.  The symptoms included burning chest pain associated with orthopnea and paroxysmal nocturnal dyspnea. Patient was discharged with Metoprolol and was instructed to refrain from strenuous exercise. Patient was seen outpatient, and endorsed to still experience intermittent burning substernal chest pain.  Company comment: This is a literature case concerning a 31-year-old male patient with no medical history reported, who experienced the expected serious AESI of Myocarditis two days after the second dose of mRNA-1273 vaccine. The patient was hospitalized and the diagnosis was established by cardiac magnetic resonance imaging. The outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a literature case concerning a 31-year-old male patient with no medical history reported, who experienced the expected serious AESI of Myocarditis two days after the second dose of mRNA-1273 vaccine. The patient was hospitalized and the diagnosis was established by cardiac magnetic resonance imaging. The outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Vaccination complication
Clinical narrative: As bad as when I had Covid; Covid sick 10 days, each shot 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (As bad as when I had Covid) and ILLNESS (Covid sick 10 days, each shot 24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 VACCINATION COMPLICATION (As bad as when I had Covid) and ILLNESS (Covid sick 10 days, each shot 24 hours). At the time of the report, VACCINATION COMPLICATION (As bad as when I had Covid) outcome was unknown and ILLNESS (Covid sick 10 days, each shot 24 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2022: Follow up received included updated event  information
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised patient got booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient got booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient got booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient got booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   An immunocompromised patient, received a booster dose of 0.25 mL instead of a third full dose of 0.5 mL
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Myocarditis
Clinical narrative: mRNA vaccine induced myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (mRNA vaccine induced myocarditis) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   The patient's past medical history included COVID-19 (Patient had been diagnosed with confirmed COVID-19 infection seven months prior to presentation.). Concurrent medical conditions included Asthma.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (mRNA vaccine induced myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (mRNA vaccine induced myocarditis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: abnormal (abnormal) Elevated cardiac and infammatory markers, but further workup was negative for signifcant coronary artery disease.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (mRNA vaccine induced myocarditis) to be related.    The disease course was mild. Treatment was conservative and  he experienced resolution of most of the reported symptoms. Follow up was reassuring.   The diagnosis was made based on the constellation of clinical fndings, exclusion of other causes of myocarditis and the temporal relationship to C-19 vaccine administration. Notably, the case occurred in patient with confrmed previous COVID-19 infection.  Company comment: This is a literature case concerning a 30-year-old male patient with medical history of COVID-19 infection seven months prior to presentation and asthma, who experienced the expected serious AESI of Myocarditis 24 hours after the second dose of mRNA-1273 vaccine. The outcome was reported as recovering. Medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-460665 (Patient Link).; Sender's Comments: This is a literature case concerning a 30-year-old male patient with medical history of COVID-19 infection seven months prior to presentation and asthma, who experienced the expected serious AESI of Myocarditis 24 hours after the second dose of mRNA-1273 vaccine. The outcome was reported as recovering. Medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Pain in extremity
Clinical narrative: pain in the left arm; it was strange; Pain in elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the left arm), FEELING ABNORMAL (it was strange) and ARTHRALGIA (Pain in elbow) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 11J20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic, Blood pressure high and Allergy. Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-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 PAIN IN EXTREMITY (pain in the left arm), FEELING ABNORMAL (it was strange) and ARTHRALGIA (Pain in elbow). At the time of the report, PAIN IN EXTREMITY (pain in the left arm) had resolved, FEELING ABNORMAL (it was strange) outcome was unknown and ARTHRALGIA (Pain in elbow) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter. Patient took High blood pressure pills and allergy medication. Patient took Xanax occasionally. Patient is Pre-Diabetic controlling with diet and exercise.   This case was linked to MOD-2022-460646 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.   Reporter did not allow further contact
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Here is the patient info for the temp excursion/beyond use date excursion; Here is the patient info for the temp excursion/beyond use date excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatments medications were reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: I have vitiligo and am seeing a trigger of increased vitiligo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 (Lot number: Fc3182) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "vitiligo" (unspecified if ongoing). Concomitant medication(s) included: PROPECIA. The following information was reported: VITILIGO (non-serious), outcome "not recovered", described as "I have vitiligo and am seeing a trigger of increased vitiligo". Therapeutic measures were not taken as a result of vitiligo.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Vitamin multi, Propecia within 2 weeks of vaccination.  The patient was not diagnosed with COVID-19 Prior to vaccination. The patient has not been tested for Covid-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was really painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 06Feb2021 (Lot number: EN6202) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm was really painful". No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Immunisation, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Booster; significantly swollen lymph nodes and pain; significantly swollen lymph nodes and pain; chest pain; swelling in neck/face/chest on side of injection; swelling in neck/face/chest on side of injection; swelling in neck/face/chest on side of injection; fever (at least 4 days); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE: 1), for COVID-19 immunization; Comirnaty (DOSE: 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "significantly swollen lymph nodes and pain"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pain"; PYREXIA (non-serious), outcome "recovered", described as "fever (at least 4 days)"; SWELLING (non-serious), SWELLING FACE (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "swelling in neck/face/chest on side of injection".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Vaccination site swelling
Clinical narrative: Booster; significantly swollen lymph nodes and pain; significantly swollen lymph nodes and pain; chest pain; swelling in neck/face/chest on side of injection; swelling in neck/face/chest on side of injection; swelling in neck/face/chest on side of injection; fever (at least 4 days); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE: 1), for COVID-19 immunization; Comirnaty (DOSE: 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "significantly swollen lymph nodes and pain"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pain"; PYREXIA (non-serious), outcome "recovered", described as "fever (at least 4 days)"; SWELLING (non-serious), SWELLING FACE (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "swelling in neck/face/chest on side of injection".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: white patches on their skin/vitaligo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VITILIGO (non-serious), outcome "unknown", described as "white patches on their skin/vitaligo".  Additional information: Caller stated that her 87-year-old husband had a blood clot in his brain after getting the Pfizer Covid vaccine. He couldn't walk and was in the hospital for two weeks and was doing physical therapy now. Doctor said the vaccine could have contributed to it. She stated called twice to report it, first on the day it happened when he couldn't walk and then when he was in the hospital. She got a report number, but it is "in the other room" and did not provide it. She also says she knows someone who was paralyzed after getting the vaccine and couldn't walk, someone who had a stroke in the eye, and 2 others who developed white patches on their skin/vitaligo after getting the vaccine. She stated doesn't had their information, but they all received the Pfizer Covid 19 vaccine. She refused to be transferred to DSU. Consumer does not wish to be contacted any further but stated her husband was 2 weeks in the hospital with a blood clot in the brain. Her friends neighbor had a stroke in the eye and another person was 1 week paralyzed and couldn't walk.  Follow-up (10Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101530936 same reporter/product/event, different patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Immunisation, Nausea, Rash
Clinical narrative: itched after it faded; nausea; dizziness; developed a rash on her back and stomach/Rash moved to neck; felt flush; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Nov2021 15:00 (Lot number: FH8027) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D NOS; KARIVA taken for contraception (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8734, Location of injection: Arm Left, Route of Administration: Intramuscular, time: 01:00 pm), administration date: 03Apr2021, when the patient was 51 years old, for Covid-19 Immunization, reaction(s): "No known adverse events"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 13Mar2021, when the patient was 51 years old, for COVID-19 Immunization, reaction(s): "No known adverse events". The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021 15:00, outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset 14Nov2021 03:00, outcome "recovering", described as "nausea"; DIZZINESS (non-serious) with onset 14Nov2021 03:00, outcome "recovering", described as "dizziness"; RASH (non-serious) with onset 14Nov2021 03:00, outcome "recovering", described as "developed a rash on her back and stomach/Rash moved to neck"; FLUSHING (non-serious) with onset 14Nov2021 03:00, outcome "recovering", described as "felt flush"; RASH PRURITIC (non-serious) with onset 15Nov2021, outcome "recovering", described as "itched after it faded". Therapeutic measures were not taken as a result of nausea, dizziness, rash, flushing.  Adverse event: 12 hours post 3rd vaccine booster, patient experienced nausea and dizziness. The nausea and dizziness subsided and then 12 hours later patient developed a rash on her back and stomach and felt flush. 3rd BNT162B2 booster received the afternoon of 13Nov2021. Early morning (02:00 AM) of 14Nov2021 experienced nausea and dizziness. Subsided a few hours later on 14Nov2021 mid-afternoon, a rash formed on stomach/back which itched as it faded. Rash moved to neck on 15Nov2021 which itched after it faded. After all rashes faded, no other known event occurred. No known adverse events occurred with the first 2 dosed (dose 1 and 2). Other medications in two weeks: Birth control, vitamin D supplement and multivitamin supplement. Known allergies: None. Other medical history: None. Patient did not receive any other vaccine in four weeks.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itched after it faded; nausea; dizziness; developed a rash on her back and stomach/Rash moved to neck; felt flush; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Nov2021 15:00 (Lot number: FH8027) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D NOS; KARIVA taken for contraception (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8734, Location of injection: Arm Left, Route of Administration: Intramuscular, time: 01:00 pm), administration date: 03Apr2021, when the patient was 51 years old, for Covid-19 Immunization, reaction(s): "No known adverse events"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 13Mar2021, when the patient was 51 years old, for COVID-19 Immunization, reaction(s): "No known adverse events". The following information was reported: IMMUNISATION (non-serious) with onset 13Nov2021 15:00, outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset 14Nov2021 03:00, outcome "recovering", described as "nausea"; DIZZINESS (non-serious) with onset 14Nov2021 03:00, outcome "recovering", described as "dizziness"; RASH (non-serious) with onset 14Nov2021 03:00, outcome "recovering", described as "developed a rash on her back and stomach/Rash moved to neck"; FLUSHING (non-serious) with onset 14Nov2021 03:00, outcome "recovering", described as "felt flush"; RASH PRURITIC (non-serious) with onset 15Nov2021, outcome "recovering", described as "itched after it faded". Therapeutic measures were not taken as a result of nausea, dizziness, rash, flushing.  Adverse event: 12 hours post 3rd vaccine booster, patient experienced nausea and dizziness. The nausea and dizziness subsided and then 12 hours later patient developed a rash on her back and stomach and felt flush. 3rd BNT162B2 booster received the afternoon of 13Nov2021. Early morning (02:00 AM) of 14Nov2021 experienced nausea and dizziness. Subsided a few hours later on 14Nov2021 mid-afternoon, a rash formed on stomach/back which itched as it faded. Rash moved to neck on 15Nov2021 which itched after it faded. After all rashes faded, no other known event occurred. No known adverse events occurred with the first 2 dosed (dose 1 and 2). Other medications in two weeks: Birth control, vitamin D supplement and multivitamin supplement. Known allergies: None. Other medical history: None. Patient did not receive any other vaccine in four weeks.  Follow-up attempts completed. No further information expected.