chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Unspecific Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unspecific Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No specified medical history has been 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 VACCINATION COMPLICATION (Unspecific Adverse event). At the time of the report, VACCINATION COMPLICATION (Unspecific Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea, Pain, Visual impairment
Clinical narrative: intense pain; migraine became more severe; affects vision/she can't read printed writing like a book unless she takes medication; nausea worsens; head hurts so bad even in the dark; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (intense pain), MIGRAINE (migraine became more severe), VISUAL IMPAIRMENT (affects vision/she can't read printed writing like a book unless she takes medication), NAUSEA (nausea worsens) and HEADACHE (head hurts so bad even in the dark) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Insulin-dependent diabetes mellitus. Concomitant products included INSULIN for Insulin-dependent diabetes mellitus, ONDANSETRON (ZOFRAN [ONDANSETRON]), HYDROCODONE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced PAIN (intense pain), MIGRAINE (migraine became more severe), VISUAL IMPAIRMENT (affects vision/she can't read printed writing like a book unless she takes medication), NAUSEA (nausea worsens) and HEADACHE (head hurts so bad even in the dark). The patient was treated with UBROGEPANT (UBRELVY) for Migraine, at an unspecified dose and frequency and CLONAZEPAM for Nausea, at an unspecified dose and frequency. At the time of the report, PAIN (intense pain), MIGRAINE (migraine became more severe), VISUAL IMPAIRMENT (affects vision/she can't read printed writing like a book unless she takes medication), NAUSEA (nausea worsens) and HEADACHE (head hurts so bad even in the dark) outcome was unknown.            Patient reported that, she had been taking a double dose of Zofran and when that doesn't work she takes clonazepam for her nausea. She also reports that, she doesn't eat until late sometimes because the migraines and that it affects her insulin dependent diabetes. She said that, she has breaks for 3 or 4 days without headache. She said, she has to keep the left eye closed and right eye open because her head hurts so bad even in the dark. She reports getting 24 Botox shots in the head last month by her neurologist.   This case was linked to MOD-2021-288701 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received doses from two different manufactures / first dose 04May2021 which was a Moderna / on 27July2021 and received a dose of Pfizer; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received doses from two different manufactures / first dose 04May2021 which was a Moderna / on 27July2021 and received a dose of Pfizer) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 04-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received doses from two different manufactures / first dose 04May2021 which was a Moderna / on 27July2021 and received a dose of Pfizer). On 04-May-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received doses from two different manufactures / first dose 04May2021 which was a Moderna / on 27July2021 and received a dose of Pfizer) 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 medication were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous, Skin reaction, Swelling
Clinical narrative: rash in the area, it is red; A barely perceptible/slight swelling; The reaction is localized; Every time she extended the arm it would hurt; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (rash in the area, it is red), SWELLING (A barely perceptible/slight swelling), SKIN REACTION (The reaction is localized) and PAIN IN EXTREMITY (Every time she extended the arm it would hurt) 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 09-Aug-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced PAIN IN EXTREMITY (Every time she extended the arm it would hurt). On 17-Aug-2021, the patient experienced RASH ERYTHEMATOUS (rash in the area, it is red), SWELLING (A barely perceptible/slight swelling) and SKIN REACTION (The reaction is localized). In August 2021, PAIN IN EXTREMITY (Every time she extended the arm it would hurt) had resolved. At the time of the report, RASH ERYTHEMATOUS (rash in the area, it is red), SWELLING (A barely perceptible/slight swelling) and SKIN REACTION (The reaction is localized) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: two individuals received the Moderna vaccine dose #2 at day 21; 2 of these 72 individuals who received the expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two individuals received the Moderna vaccine dose #2 at day 21) and EXPIRED PRODUCT ADMINISTERED (2 of these 72 individuals who received the expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two individuals received the Moderna vaccine dose #2 at day 21) and EXPIRED PRODUCT ADMINISTERED (2 of these 72 individuals who received the expired vaccine). On 02-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two individuals received the Moderna vaccine dose #2 at day 21) and EXPIRED PRODUCT ADMINISTERED (2 of these 72 individuals who received the expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 3 vials that were punctured and stayed at room temperature for longer than 12 hours; There were 3 doses given to patients out of expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There were 3 doses given to patients out of expired vial) and PRODUCT STORAGE ERROR (3 vials that were punctured and stayed at room temperature for longer than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (There were 3 doses given to patients out of expired vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (3 vials that were punctured and stayed at room temperature for longer than 12 hours). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (There were 3 doses given to patients out of expired vial) had resolved. At the time of the report, PRODUCT STORAGE ERROR (3 vials that were punctured and stayed at room temperature for longer than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: The nurse messed up the dates and she didn't get her 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (The nurse messed up the dates and she didn't get her 2nd dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The nurse messed up the dates and she didn't get her 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (The nurse messed up the dates and she didn't get her 2nd dose) had resolved.            Concomitant product information was not provided. Treatment information was not provided.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fever; chills; headache; fatigue; severe pain; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe pain), PAIN (body aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced PAIN (severe pain), PAIN (body aches), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PAIN (severe pain), PAIN (body aches), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient called and said she and her other two sons already got the vaccine. Her youngest son side effects included fever chills, severe pain, trebles, headache.  No Concomitant drugs were reported.  No Treatment information  was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: have experienced a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (have experienced a side effect) 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 VACCINATION COMPLICATION (have experienced a side effect). At the time of the report, VACCINATION COMPLICATION (have experienced a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medications were provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Angiocardiogram, Brain natriuretic peptide, Electrocardiogram, Magnetic resonance imaging, Magnetic resonance imaging heart
Clinical narrative: Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis associated with mRNA COVID-19 vaccination. Radiology. 2021:211430     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 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). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging heart: abnormal (abnormal) Late Gadolinium Enhancement (LGE): epicardial left ventricular(LV) inferior basal wall, lateral wall mid ventricle, anterolateral wall apical.T2w signal abnormality in corresponding locations as LGE. Pericardial enhancement and borderline effusion. Left Ventricular Ejection Fraction(LVEF) was 57%, Right Ventricular Ejection Fraction (RVEF) was 54%. Ipsilateral axillary lymphadenopathy.. On an unknown date, Angiocardiogram: negative (Negative) Negative. On an unknown date, Brain natriuretic peptide: 38 pg/ml (normal) 38 pg/ml. On an unknown date, Electrocardiogram: abnormal (abnormal) Nonspecific T-wave abnormality anterolateral leads, RSR' pattern in V1. On an unknown date, Magnetic resonance imaging: negative (Negative) Negative. On an unknown date, Troponin I: 4.00ng/ml (abnormal) Troponin-I at peak was 4.00ng/ml.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    No concomitant medication was provided by the reporter.  Patients was hospitalized due to acute onset of chest pain with diagnosis of acute myocarditis. Patient had received their second dose of mRNA-1273 three days before onset of chest pain. Patient had following symptoms after vaccination subjective mild fever, chills, malaise, chest pain and dyspnea. COVID-19 test was negative for 4 patients out of 5 patients.  No treatment medication information was provided by the reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-293277 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin I
Clinical narrative: Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis associated with mRNA COVID-19 vaccination. Radiology. 2021:211430     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 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). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging heart: abnormal (abnormal) Late Gadolinium Enhancement (LGE): epicardial left ventricular(LV) inferior basal wall, lateral wall mid ventricle, anterolateral wall apical.T2w signal abnormality in corresponding locations as LGE. Pericardial enhancement and borderline effusion. Left Ventricular Ejection Fraction(LVEF) was 57%, Right Ventricular Ejection Fraction (RVEF) was 54%. Ipsilateral axillary lymphadenopathy.. On an unknown date, Angiocardiogram: negative (Negative) Negative. On an unknown date, Brain natriuretic peptide: 38 pg/ml (normal) 38 pg/ml. On an unknown date, Electrocardiogram: abnormal (abnormal) Nonspecific T-wave abnormality anterolateral leads, RSR' pattern in V1. On an unknown date, Magnetic resonance imaging: negative (Negative) Negative. On an unknown date, Troponin I: 4.00ng/ml (abnormal) Troponin-I at peak was 4.00ng/ml.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    No concomitant medication was provided by the reporter.  Patients was hospitalized due to acute onset of chest pain with diagnosis of acute myocarditis. Patient had received their second dose of mRNA-1273 three days before onset of chest pain. Patient had following symptoms after vaccination subjective mild fever, chills, malaise, chest pain and dyspnea. COVID-19 test was negative for 4 patients out of 5 patients.  No treatment medication information was provided by the reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-293277 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: nausea; bad headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NAUSEA (nausea) and HEADACHE (bad headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006021A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced NAUSEA (nausea) and HEADACHE (bad headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with ACETYLSALICYLIC ACID, DIPHENHYDRAMINE CITRATE, PARACETAMOL (EXCEDRIN PM HEADACHE) for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea) outcome was unknown and HEADACHE (bad headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 16 year old patient received two doses of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received two doses of the Moderna COVID-19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received two doses of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received two doses of the Moderna COVID-19 vaccine) had resolved.            No Concomitant drugs were reported. No Treatment information  were reported.  The patient is scheduled to receive her third dose of the Moderna COVID-19 vaccine on 22AUG2021. The reporter confirmed that it has been greater than 28 days since the patient received two doses of the Moderna COVID-19 vaccine.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Blood chloride, Carbon dioxide, Lipids, Therapeutic response unexpected
Clinical narrative: after I received both of my Moderna Covid-19 vaccines. My .Rheumatoid Arthritis got better.  My lipid panels got better as well. I take Lithium and my Lithium level increased. My Chloride level got higher and my Carbon Dioxide level got lower.; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (after I received both of my Moderna Covid-19 vaccines. My .Rheumatoid Arthritis got better.  My lipid panels got better as well. I take Lithium and my Lithium level increased. My Chloride level got higher and my Carbon Dioxide level got lower.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included LITHIUM for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (after I received both of my Moderna Covid-19 vaccines. My .Rheumatoid Arthritis got better.  My lipid panels got better as well. I take Lithium and my Lithium level increased. My Chloride level got higher and my Carbon Dioxide level got lower.). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (after I received both of my Moderna Covid-19 vaccines. My .Rheumatoid Arthritis got better.  My lipid panels got better as well. I take Lithium and my Lithium level increased. My Chloride level got higher and my Carbon Dioxide level got lower.) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood chloride: higher (High) Higher. On an unknown date, Carbon dioxide: lower (Low) Lower. On an unknown date, Lipids: got better Got Better.         Lithium levels Increased. No treatment medications were provided.   This case was linked to MOD-2021-211489 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive for Covid; severe illness; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for Covid) and ILLNESS (severe illness) 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 20-Jul-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 SARS-COV-2 TEST POSITIVE (Positive for Covid) and ILLNESS (severe illness). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for Covid) and ILLNESS (severe illness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Extra dose administered, Lymphadenopathy, Skin warm, Swelling
Clinical narrative: shoulder warm; shoulder swollen; Extra dose administered; swollen lymph node under arm; Shoulder sore; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (shoulder warm), SWELLING (shoulder swollen), EXTRA DOSE ADMINISTERED (Extra dose administered), LYMPHADENOPATHY (swollen lymph node under arm) and ARTHRALGIA (Shoulder sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-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 third 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 SKIN WARM (shoulder warm), SWELLING (shoulder swollen), EXTRA DOSE ADMINISTERED (Extra dose administered), LYMPHADENOPATHY (swollen lymph node under arm) and ARTHRALGIA (Shoulder sore). At the time of the report, SKIN WARM (shoulder warm), SWELLING (shoulder swollen), LYMPHADENOPATHY (swollen lymph node under arm) and ARTHRALGIA (Shoulder sore) outcome was unknown and EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved.            Patient is taking steroids. No treatment medications were reported   This case was linked to MOD-2021-294169 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Vaccination complication
Clinical narrative: a little bit of a reaction; was kind of foggy headed/didn't see good for about a week or so/but nothing real bad; had pain in his arm for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a little bit of a reaction), FEELING ABNORMAL (was kind of foggy headed/didn't see good for about a week or so/but nothing real bad) and PAIN IN EXTREMITY (had pain in his arm for 2 days) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, 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 (a little bit of a reaction), FEELING ABNORMAL (was kind of foggy headed/didn't see good for about a week or so/but nothing real bad) and PAIN IN EXTREMITY (had pain in his arm for 2 days). At the time of the report, VACCINATION COMPLICATION (a little bit of a reaction) and FEELING ABNORMAL (was kind of foggy headed/didn't see good for about a week or so/but nothing real bad) outcome was unknown and PAIN IN EXTREMITY (had pain in his arm for 2 days) had resolved.        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   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow up contains updated Reporter details, patient initials, gender, dose details and events details like pain in extremity and feeling abnormal.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Mild symptoms from first shot; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Mild symptoms from first shot) in an 82-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 in January 2020.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Mild symptoms from first shot). At the time of the report, VACCINATION COMPLICATION (Mild symptoms from first shot) 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.   Concomitant medication not provided by reporter. Treatment information not provided by reporter.   This case was linked to MOD-2021-294314 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Patient demographic details were added and route of administration of vaccine was added On 30-Aug-2021: Follow up received on 30- AUG-2021 contain non-significant information.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity, Pyrexia
Clinical narrative: pain on his arm; lost range of motion in his left shoulder; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on his arm), JOINT RANGE OF MOTION DECREASED (lost range of motion in his left shoulder) and PYREXIA (fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016321a and 020b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PYREXIA (fever). In May 2021, the patient experienced PAIN IN EXTREMITY (pain on his arm) and JOINT RANGE OF MOTION DECREASED (lost range of motion in his left shoulder). On 26-Apr-2021, PYREXIA (fever) had resolved. At the time of the report, PAIN IN EXTREMITY (pain on his arm) and JOINT RANGE OF MOTION DECREASED (lost range of motion in his left shoulder) had not resolved.            No concomitant medication reported. No treatment medication reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Induration, Joint swelling
Clinical narrative: Swelling extended down the wrist; Tired; Little bit of headache; Red; Paretic; Itchy; Induration/not painful but there was induration; Arm was swollen at injection site; Arm was sore/arm was sore, similar as previous vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm was sore/arm was sore, similar as previous vaccination), ERYTHEMA (Red), PARESIS (Paretic), PRURITUS (Itchy) and INDURATION (Induration/not painful but there was induration) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunosuppression (Immune suppressive disease). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore/arm was sore, similar as previous vaccination). On 18-Aug-2021, the patient experienced ERYTHEMA (Red), PARESIS (Paretic), PRURITUS (Itchy), INDURATION (Induration/not painful but there was induration), VACCINATION SITE SWELLING (Arm was swollen at injection site), FATIGUE (Tired) and HEADACHE (Little bit of headache). On 20-Aug-2021, the patient experienced JOINT SWELLING (Swelling extended down the wrist). The patient was treated with HYDROCORTISONE (topical) at a dose of 1.5 %. On 18-Aug-2021, FATIGUE (Tired) and HEADACHE (Little bit of headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore/arm was sore, similar as previous vaccination), ERYTHEMA (Red), PARESIS (Paretic), PRURITUS (Itchy) and INDURATION (Induration/not painful but there was induration) outcome was unknown and VACCINATION SITE SWELLING (Arm was swollen at injection site) and JOINT SWELLING (Swelling extended down the wrist) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information also included: Anti histamines   This case was linked to MOD-2021-294494 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paresis, Pruritus, Vaccination site swelling
Clinical narrative: Swelling extended down the wrist; Tired; Little bit of headache; Red; Paretic; Itchy; Induration/not painful but there was induration; Arm was swollen at injection site; Arm was sore/arm was sore, similar as previous vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm was sore/arm was sore, similar as previous vaccination), ERYTHEMA (Red), PARESIS (Paretic), PRURITUS (Itchy) and INDURATION (Induration/not painful but there was induration) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunosuppression (Immune suppressive disease). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore/arm was sore, similar as previous vaccination). On 18-Aug-2021, the patient experienced ERYTHEMA (Red), PARESIS (Paretic), PRURITUS (Itchy), INDURATION (Induration/not painful but there was induration), VACCINATION SITE SWELLING (Arm was swollen at injection site), FATIGUE (Tired) and HEADACHE (Little bit of headache). On 20-Aug-2021, the patient experienced JOINT SWELLING (Swelling extended down the wrist). The patient was treated with HYDROCORTISONE (topical) at a dose of 1.5 %. On 18-Aug-2021, FATIGUE (Tired) and HEADACHE (Little bit of headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore/arm was sore, similar as previous vaccination), ERYTHEMA (Red), PARESIS (Paretic), PRURITUS (Itchy) and INDURATION (Induration/not painful but there was induration) outcome was unknown and VACCINATION SITE SWELLING (Arm was swollen at injection site) and JOINT SWELLING (Swelling extended down the wrist) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information also included: Anti histamines   This case was linked to MOD-2021-294494 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant drugs were reported.  No Treatment information  were reported.   This case was linked to MOD-2021-294383, MOD-2021-294508 (Patient Link).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered and temperature exposure > 24 hours; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered and temperature exposure > 24 hours) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021 at 8:19 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021 at 8:19 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered and temperature exposure > 24 hours). On 20-Aug-2021 at 8:19 AM, EXPIRED PRODUCT ADMINISTERED (vaccine administered and temperature exposure > 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (vaccine administered and temperature exposure > 24 hours) to be possibly related.    It was reported that the vial was punctured on 11-Aug-2021 and kept in fridge for 9 days. The expired vaccine was administered to five patients.  Concomitant drug was not reported. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Sep-2021: Follow-up information contains additional reporter, patient initials, dose details, event details and Race.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Most people get anxious; 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 ANXIETY (Most people get anxious) 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 ANXIETY (Most people get anxious). At the time of the report, ANXIETY (Most people get anxious) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 1 punctured vial exposed to refrigerator temperature range (2-8 C) for "48 hours"; Expired vaccine administered to patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (1 punctured vial exposed to refrigerator temperature range (2-8 C) for "48 hours") 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.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (1 punctured vial exposed to refrigerator temperature range (2-8 C) for "48 hours"). In 2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved. At the time of the report, PRODUCT STORAGE ERROR (1 punctured vial exposed to refrigerator temperature range (2-8 C) for "48 hours") had resolved.        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 information was reported. No treatment medications were provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Feeling abnormal, Illness, Impaired work ability, Malaise
Clinical narrative: Extra dose administered; wasn't feeling good; it was really awful/felt so terrible all over/Her head was fuzzy.; couldn't function/still felt that she could hardly get around; having ill; they said this is probably a reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (wasn't feeling good), FEELING ABNORMAL (it was really awful/felt so terrible all over/Her head was fuzzy.), IMPAIRED WORK ABILITY (couldn't function/still felt that she could hardly get around), ILLNESS (having ill) and VACCINATION COMPLICATION (they said this is probably a reaction to the vaccine) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 046B21A and 006BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (She received cancer treatment prior to vaccination.). Concomitant products included PANCREATIN (CREON) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced MALAISE (wasn't feeling good), FEELING ABNORMAL (it was really awful/felt so terrible all over/Her head was fuzzy.), IMPAIRED WORK ABILITY (couldn't function/still felt that she could hardly get around), ILLNESS (having ill) and VACCINATION COMPLICATION (they said this is probably a reaction to the vaccine). On 23-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 23-Aug-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. At the time of the report, MALAISE (wasn't feeling good), FEELING ABNORMAL (it was really awful/felt so terrible all over/Her head was fuzzy.), IMPAIRED WORK ABILITY (couldn't function/still felt that she could hardly get around), ILLNESS (having ill) and VACCINATION COMPLICATION (they said this is probably a reaction to the vaccine) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Patients reported that no treatment medications were received.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination complication
Clinical narrative: Extra dose administered; wasn't feeling good; it was really awful/felt so terrible all over/Her head was fuzzy.; couldn't function/still felt that she could hardly get around; having ill; they said this is probably a reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (wasn't feeling good), FEELING ABNORMAL (it was really awful/felt so terrible all over/Her head was fuzzy.), IMPAIRED WORK ABILITY (couldn't function/still felt that she could hardly get around), ILLNESS (having ill) and VACCINATION COMPLICATION (they said this is probably a reaction to the vaccine) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 046B21A and 006BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (She received cancer treatment prior to vaccination.). Concomitant products included PANCREATIN (CREON) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced MALAISE (wasn't feeling good), FEELING ABNORMAL (it was really awful/felt so terrible all over/Her head was fuzzy.), IMPAIRED WORK ABILITY (couldn't function/still felt that she could hardly get around), ILLNESS (having ill) and VACCINATION COMPLICATION (they said this is probably a reaction to the vaccine). On 23-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 23-Aug-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. At the time of the report, MALAISE (wasn't feeling good), FEELING ABNORMAL (it was really awful/felt so terrible all over/Her head was fuzzy.), IMPAIRED WORK ABILITY (couldn't function/still felt that she could hardly get around), ILLNESS (having ill) and VACCINATION COMPLICATION (they said this is probably a reaction to the vaccine) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Patients reported that no treatment medications were received.