chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Periarthritis, Product administered at inappropriate site, Pyrexia
Clinical narrative: sickness; capsulitis; fever; tiredness; injection was "higher" than it should have been, was not in the deltoid; shoulder feels hot; jolt of pain into her shoulder; pain and hot burning at the injection site; lymph nodes in my arm are swollen; arm feels stiff; hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm; This spontaneous case was reported by a consumer and describes the occurrence of JOINT WARMTH (shoulder feels hot), ILLNESS (sickness), MUSCULOSKELETAL STIFFNESS (arm feels stiff), INJECTED LIMB MOBILITY DECREASED (hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm) and PERIARTHRITIS (capsulitis) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced JOINT WARMTH (shoulder feels hot), MUSCULOSKELETAL STIFFNESS (arm feels stiff), INJECTED LIMB MOBILITY DECREASED (hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm), VACCINATION SITE PAIN (pain and hot burning at the injection site), LYMPHADENOPATHY (lymph nodes in my arm are swollen) and ARTHRALGIA (jolt of pain into her shoulder). On an unknown date, the patient experienced ILLNESS (sickness), PERIARTHRITIS (capsulitis), PYREXIA (fever), FATIGUE (tiredness) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (injection was "higher" than it should have been, was not in the deltoid). At the time of the report, JOINT WARMTH (shoulder feels hot), ILLNESS (sickness), MUSCULOSKELETAL STIFFNESS (arm feels stiff), INJECTED LIMB MOBILITY DECREASED (hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm), PERIARTHRITIS (capsulitis), VACCINATION SITE PAIN (pain and hot burning at the injection site), LYMPHADENOPATHY (lymph nodes in my arm are swollen), PYREXIA (fever), FATIGUE (tiredness), ARTHRALGIA (jolt of pain into her shoulder) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (injection was "higher" than it should have been, was not in the deltoid) outcome was unknown.            The patient treatment medication included Tylenol and advil, also using ice for shoulder pain. Also prescribed steroid for 5 days but she had not taken yet.   This case was linked to MOD-2021-311116 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sickness; capsulitis; fever; tiredness; injection was "higher" than it should have been, was not in the deltoid; shoulder feels hot; jolt of pain into her shoulder; pain and hot burning at the injection site; lymph nodes in my arm are swollen; arm feels stiff; hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm; This spontaneous case was reported by a consumer and describes the occurrence of JOINT WARMTH (shoulder feels hot), ILLNESS (sickness), MUSCULOSKELETAL STIFFNESS (arm feels stiff), INJECTED LIMB MOBILITY DECREASED (hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm) and PERIARTHRITIS (capsulitis) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced JOINT WARMTH (shoulder feels hot), MUSCULOSKELETAL STIFFNESS (arm feels stiff), INJECTED LIMB MOBILITY DECREASED (hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm), VACCINATION SITE PAIN (pain and hot burning at the injection site), LYMPHADENOPATHY (lymph nodes in my arm are swollen) and ARTHRALGIA (jolt of pain into her shoulder). On an unknown date, the patient experienced ILLNESS (sickness), PERIARTHRITIS (capsulitis), PYREXIA (fever), FATIGUE (tiredness) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (injection was "higher" than it should have been, was not in the deltoid). At the time of the report, JOINT WARMTH (shoulder feels hot), ILLNESS (sickness), MUSCULOSKELETAL STIFFNESS (arm feels stiff), INJECTED LIMB MOBILITY DECREASED (hard time moving my arm up or forward,cannot put on my shirt by myself,can't put on deodorant by myself,cannot lift my arm), PERIARTHRITIS (capsulitis), VACCINATION SITE PAIN (pain and hot burning at the injection site), LYMPHADENOPATHY (lymph nodes in my arm are swollen), PYREXIA (fever), FATIGUE (tiredness), ARTHRALGIA (jolt of pain into her shoulder) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (injection was "higher" than it should have been, was not in the deltoid) outcome was unknown.            The patient treatment medication included Tylenol and advil, also using ice for shoulder pain. Also prescribed steroid for 5 days but she had not taken yet.   This case was linked to MOD-2021-311116 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Someone told her that a magnet would stick to the injection site after taking the first injection, and it did; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Someone told her that a magnet would stick to the injection site after taking the first injection, and it did) 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, the patient experienced VACCINATION COMPLICATION (Someone told her that a magnet would stick to the injection site after taking the first injection, and it did). At the time of the report, VACCINATION COMPLICATION (Someone told her that a magnet would stick to the injection site after taking the first injection, and it did) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Musculoskeletal stiffness, Myalgia, Paraesthesia
Clinical narrative: She has tingling and numbness in fingers of both hands.; She has tingling and numbness in fingers of both hands.; Stiffness in both hands; 2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.; 2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (She has tingling and numbness in fingers of both hands.), HYPOAESTHESIA (She has tingling and numbness in fingers of both hands.), MUSCULOSKELETAL STIFFNESS (Stiffness in both hands), MYALGIA (2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.) and ARTHRALGIA (2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma (Eye drops for glaucoma.). Concomitant products included ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced MYALGIA (2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.) and ARTHRALGIA (2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.). On an unknown date, the patient experienced PARAESTHESIA (She has tingling and numbness in fingers of both hands.), HYPOAESTHESIA (She has tingling and numbness in fingers of both hands.) and MUSCULOSKELETAL STIFFNESS (Stiffness in both hands). The patient was treated with IBUPROFEN for Adverse reaction, at an unspecified dose and frequency and PREDNISONE for Adverse reaction, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (She has tingling and numbness in fingers of both hands.), HYPOAESTHESIA (She has tingling and numbness in fingers of both hands.), MUSCULOSKELETAL STIFFNESS (Stiffness in both hands), MYALGIA (2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.) and ARTHRALGIA (2-3 days later(after 2nd dose), she started getting muscle and joint aches all over her body.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications includes Eye drops for glaucoma.   Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2021: Added treatment medication (Prednisone) and new event (Stiffness in both hands).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood pressure measurement, Blood pressure systolic decreased, Diarrhoea, Fatigue
Clinical narrative: lethargy; a very severe reaction; sore arm; not feeling well; trouble with balance; Systolic blood pressure <90 mmHg; Diarrhoea; really bad fatigue; bouts of nausea; vomited; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a very severe reaction), MALAISE (not feeling well), BALANCE DISORDER (trouble with balance), LETHARGY (lethargy) and BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced BALANCE DISORDER (trouble with balance), FATIGUE (really bad fatigue), NAUSEA (bouts of nausea) and VOMITING (vomited). 01-Sep-2021, the patient experienced BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg) and DIARRHOEA (Diarrhoea). On 07-Sep-2021, the patient experienced MALAISE (not feeling well). On an unknown date, the patient experienced VACCINATION COMPLICATION (a very severe reaction), LETHARGY (lethargy) and MYALGIA (sore arm). At the time of the report, VACCINATION COMPLICATION (a very severe reaction), MALAISE (not feeling well), BALANCE DISORDER (trouble with balance), LETHARGY (lethargy), BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg), DIARRHOEA (Diarrhoea), FATIGUE (really bad fatigue), NAUSEA (bouts of nausea), VOMITING (vomited) and MYALGIA (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, Blood pressure measurement: 110/75 (normal) 110/75. On an unknown date, Blood pressure measurement: 88/70 (Low) 88/70 and 115/75 (normal) 115/75.         Concomitant medications were not provided.  No Treatment information was provided   This case was linked to MOD-2021-311336, MOD-2021-311337 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Significant follow-up adr form received,events added
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Myalgia, Nausea, Vaccination complication
Clinical narrative: lethargy; a very severe reaction; sore arm; not feeling well; trouble with balance; Systolic blood pressure <90 mmHg; Diarrhoea; really bad fatigue; bouts of nausea; vomited; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a very severe reaction), MALAISE (not feeling well), BALANCE DISORDER (trouble with balance), LETHARGY (lethargy) and BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced BALANCE DISORDER (trouble with balance), FATIGUE (really bad fatigue), NAUSEA (bouts of nausea) and VOMITING (vomited). 01-Sep-2021, the patient experienced BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg) and DIARRHOEA (Diarrhoea). On 07-Sep-2021, the patient experienced MALAISE (not feeling well). On an unknown date, the patient experienced VACCINATION COMPLICATION (a very severe reaction), LETHARGY (lethargy) and MYALGIA (sore arm). At the time of the report, VACCINATION COMPLICATION (a very severe reaction), MALAISE (not feeling well), BALANCE DISORDER (trouble with balance), LETHARGY (lethargy), BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg), DIARRHOEA (Diarrhoea), FATIGUE (really bad fatigue), NAUSEA (bouts of nausea), VOMITING (vomited) and MYALGIA (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, Blood pressure measurement: 110/75 (normal) 110/75. On an unknown date, Blood pressure measurement: 88/70 (Low) 88/70 and 115/75 (normal) 115/75.         Concomitant medications were not provided.  No Treatment information was provided   This case was linked to MOD-2021-311336, MOD-2021-311337 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Significant follow-up adr form received,events added
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: lethargy; a very severe reaction; sore arm; not feeling well; trouble with balance; Systolic blood pressure <90 mmHg; Diarrhoea; really bad fatigue; bouts of nausea; vomited; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a very severe reaction), MALAISE (not feeling well), BALANCE DISORDER (trouble with balance), LETHARGY (lethargy) and BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced BALANCE DISORDER (trouble with balance), FATIGUE (really bad fatigue), NAUSEA (bouts of nausea) and VOMITING (vomited). 01-Sep-2021, the patient experienced BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg) and DIARRHOEA (Diarrhoea). On 07-Sep-2021, the patient experienced MALAISE (not feeling well). On an unknown date, the patient experienced VACCINATION COMPLICATION (a very severe reaction), LETHARGY (lethargy) and MYALGIA (sore arm). At the time of the report, VACCINATION COMPLICATION (a very severe reaction), MALAISE (not feeling well), BALANCE DISORDER (trouble with balance), LETHARGY (lethargy), BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg), DIARRHOEA (Diarrhoea), FATIGUE (really bad fatigue), NAUSEA (bouts of nausea), VOMITING (vomited) and MYALGIA (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, Blood pressure measurement: 110/75 (normal) 110/75. On an unknown date, Blood pressure measurement: 88/70 (Low) 88/70 and 115/75 (normal) 115/75.         Concomitant medications were not provided.  No Treatment information was provided   This case was linked to MOD-2021-311336, MOD-2021-311337 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Significant follow-up adr form received,events added
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Off label use, Pain, Tenderness, Vaccination complication
Clinical narrative: off label use; Tenderness; Vaccination adverse reaction; myalgia; pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), MYALGIA (myalgia), PAIN (pain), TENDERNESS (Tenderness) and OFF LABEL USE (off label use) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Sep-2021, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction), MYALGIA (myalgia) and PAIN (pain). On 07-Sep-2021, the patient experienced TENDERNESS (Tenderness). On an unknown date, the patient experienced OFF LABEL USE (off label use). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), MYALGIA (myalgia), PAIN (pain), TENDERNESS (Tenderness) and OFF LABEL USE (off label use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received her first dose of Moderna COVID19 Vaccine on 23Feb2021 and second dose on 24Mar2021. She received her third dose on 05Sep2021. The patient asks if getting the booster was too early. No concomitant medication was reported.  No treatment medication use was reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was 31-Aug-2021. Date first punctured: 05-Sep-2021 at 11AM Kept in Refrigerator Date of administration of vaccine when applicable: 06-Sep-2021 4:30PM Room Temperature on 06-Sep-2021 then discarded the vial. The vial did not undergo any previous temperature excursions. Total amount of time the vial was exposed to room temperature range (46° to 77° F): From 06-Sep-2021 9:00AM and discarded vial after 4:30PM.   This case was linked to MOD-2021-311383 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got covid-19 11 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got covid-19 11 days after 1st dose) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got covid-19 11 days after 1st dose). At the time of the report, COVID-19 (Got covid-19 11 days after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-311244 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pyrexia
Clinical narrative: Diagnosed with COVID-19 after both doses of Moderna COVID-19 vaccine; Horrendous cough; Went to ER with high fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19 after both doses of Moderna COVID-19 vaccine), COUGH (Horrendous cough) and PYREXIA (Went to ER with high fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Obesity and Pancreatitis. Concurrent medical conditions included Diabetes.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced COVID-19 (Diagnosed with COVID-19 after both doses of Moderna COVID-19 vaccine), COUGH (Horrendous cough) and PYREXIA (Went to ER with high fever). On 07-Sep-2021, COVID-19 (Diagnosed with COVID-19 after both doses of Moderna COVID-19 vaccine) and COUGH (Horrendous cough) had resolved. At the time of the report, PYREXIA (Went to ER with high fever) had resolved.            It was reported that the patient had Hormone Replacement Therapy , also Concomitant medications include chronic hormones, as patient is transgender. on 27-Aug-2021 the patient received monoclonal antibody treatment.   This case was linked to MOD-2021-311283 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Followup document contain no new information.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Off label use, Somnolence
Clinical narrative: tired and sleepy; tired and sleepy; received third dose but he is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (received third dose but he is not immunocompromised), SOMNOLENCE (tired and sleepy) and FATIGUE (tired and sleepy) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 039K20A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 15-Jan-1992 and High cholesterol since 15-Jan-2015. Concomitant products included EPLERENONE from 15-Jan-2015 to an unknown date, AMLODIPINE from 15-Jan-1992 to an unknown date and HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE) from 15-Jan-1992 to an unknown date for Blood pressure, ATORVASTATIN from 15-Jan-2011 to an unknown date for Cholesterol, MELOXICAM from 10-Oct-2011 to an unknown date for an unknown indication.   On 12-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced OFF LABEL USE (received third dose but he is not immunocompromised). On an unknown date, the patient experienced SOMNOLENCE (tired and sleepy) and FATIGUE (tired and sleepy). At the time of the report, OFF LABEL USE (received third dose but he is not immunocompromised) had resolved and SOMNOLENCE (tired and sleepy) and FATIGUE (tired and sleepy) outcome was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication use was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: follow-up Information Included patient demographic details, Concomitant medication, concurrent condition and new event added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue [after second dose]; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue [after second dose]) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 032L20VT) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-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 FATIGUE (Fatigue [after second dose]). At the time of the report, FATIGUE (Fatigue [after second dose]) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-311231 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Additional document received with no new information.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Heart rate, Heart rate abnormal, Malaise
Clinical narrative: I actually thought I was going to die; I'm not better yet; I almost went blind in my right eye; My heart feels like it could explode after climbing a flight of stairs; I can't catch myb reath when I walk any distance at all.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I actually thought I was going to die), MALAISE (I'm not better yet), OCULAR DISCOMFORT (I almost went blind in my right eye), HEART RATE ABNORMAL (My heart feels like it could explode after climbing a flight of stairs) and DYSPNOEA (I can't catch myb reath when I walk any distance at all.) in a male 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, the patient experienced FEELING ABNORMAL (I actually thought I was going to die), MALAISE (I'm not better yet), OCULAR DISCOMFORT (I almost went blind in my right eye), HEART RATE ABNORMAL (My heart feels like it could explode after climbing a flight of stairs) and DYSPNOEA (I can't catch myb reath when I walk any distance at all.). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (I actually thought I was going to die) had not resolved and MALAISE (I'm not better yet), OCULAR DISCOMFORT (I almost went blind in my right eye), HEART RATE ABNORMAL (My heart feels like it could explode after climbing a flight of stairs) and DYSPNOEA (I can't catch myb reath when I walk any distance at all.) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) 130's. On an unknown date, Oxygen saturation: low (Low) low 80's.         The consumer stated that he received second Moderna shot and felt like he was going to die and he is not better yet. during reporting.  The consumer stated that he almost went blind in his right eye and his heart feels like it could explode after climbing a flight of stairs. He also stated that he can't catch his breath when he walk any distance at all. His blood oxygen would drop to the low 80's and his pulse could go to into the 130's.   The consumer stated that he underwent a biopsy on his right temple artery.   The consumer stated that he was on a high dose of prednisone treatment medication.  The consumer stated that he was scheduled to see a specialist at in October.  No concomitant product use was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Ocular discomfort, Oxygen saturation
Clinical narrative: I actually thought I was going to die; I'm not better yet; I almost went blind in my right eye; My heart feels like it could explode after climbing a flight of stairs; I can't catch myb reath when I walk any distance at all.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I actually thought I was going to die), MALAISE (I'm not better yet), OCULAR DISCOMFORT (I almost went blind in my right eye), HEART RATE ABNORMAL (My heart feels like it could explode after climbing a flight of stairs) and DYSPNOEA (I can't catch myb reath when I walk any distance at all.) in a male 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, the patient experienced FEELING ABNORMAL (I actually thought I was going to die), MALAISE (I'm not better yet), OCULAR DISCOMFORT (I almost went blind in my right eye), HEART RATE ABNORMAL (My heart feels like it could explode after climbing a flight of stairs) and DYSPNOEA (I can't catch myb reath when I walk any distance at all.). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (I actually thought I was going to die) had not resolved and MALAISE (I'm not better yet), OCULAR DISCOMFORT (I almost went blind in my right eye), HEART RATE ABNORMAL (My heart feels like it could explode after climbing a flight of stairs) and DYSPNOEA (I can't catch myb reath when I walk any distance at all.) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) 130's. On an unknown date, Oxygen saturation: low (Low) low 80's.         The consumer stated that he received second Moderna shot and felt like he was going to die and he is not better yet. during reporting.  The consumer stated that he almost went blind in his right eye and his heart feels like it could explode after climbing a flight of stairs. He also stated that he can't catch his breath when he walk any distance at all. His blood oxygen would drop to the low 80's and his pulse could go to into the 130's.   The consumer stated that he underwent a biopsy on his right temple artery.   The consumer stated that he was on a high dose of prednisone treatment medication.  The consumer stated that he was scheduled to see a specialist at in October.  No concomitant product use was provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not provided Action taken with mRNA-1273 in response to the events was not applicable. The vial was first punctured on 05-Sep-2021 11am Kept in Refrigerator.Total amount of time the vial was exposed to room temperature range (46° to 77° F) from 06-Sep-2021 9:00AM and discarded vial after 4:30PM.   This case was linked to MOD-2021-311383 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: when I stood up, I got pains all my leg muscles all the way up to my buttocks/Terrible pain; having calf pain, muscle pains in my calf. It's gotten worse; having calf pain, muscle pains in my calf. It's gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (when I stood up, I got pains all my leg muscles all the way up to my buttocks/Terrible pain), PAIN IN EXTREMITY (having calf pain, muscle pains in my calf. It's gotten worse) and MYALGIA (having calf pain, muscle pains in my calf. It's gotten worse) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included CREST syndrome (autoimmune disease.).    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN (when I stood up, I got pains all my leg muscles all the way up to my buttocks/Terrible pain), PAIN IN EXTREMITY (having calf pain, muscle pains in my calf. It's gotten worse) and MYALGIA (having calf pain, muscle pains in my calf. It's gotten worse). At the time of the report, PAIN (when I stood up, I got pains all my leg muscles all the way up to my buttocks/Terrible pain), PAIN IN EXTREMITY (having calf pain, muscle pains in my calf. It's gotten worse) and MYALGIA (having calf pain, muscle pains in my calf. It's gotten worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-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 (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-311336, MOD-2021-311212 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Non-Significant Follow up on 13-SEP-2021 contain Race information and Ethnicity were added
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: >35 days from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days from the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-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 PRODUCT DOSE OMISSION ISSUE (>35 days from the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days from the first dose) had resolved.            No concomitant medications reported. The patient reported that a few things had happened that prevented her from going to get the second vaccine. No treatment medications reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021 at 4:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  On 31 Aug 2021 , the vial was initially stored in the refrigerator and on 05 Sep 2021 11 AM  vial was first punctured and kept in refrigerator. The vial did not undergo any previous temperature excursions. The total amount of time the vial was exposed to room temperature was from 06 Sep 2021 9.00 AM until the vial was discarded after 4.30 PM.   This case was linked to MOD-2021-311383 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Sep-2021 at 4:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 31-Aug-2021 , the vial was initially stored in refrigerator. On 05-Sep-2021 at 11 A.M the vial was first punctured and kept in refrigerator. On 06-Sep-2021 vial was discarded after 4:30 P.M.  Concomitant product use was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-311145, MOD-2021-311380, MOD-2021-311249, MOD-2021-311257, MOD-2021-311374, MOD-2021-311226, MOD-2021-311286 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt a little off for one day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt a little off for one day) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced MALAISE (Felt a little off for one day). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. In January 2021, MALAISE (Felt a little off for one day) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported.  Treatment includes Ice also.  Patient had second dose on 26 Feb 2021 and also a third booster dose due to her comorbidities. She experienced various side effects after each dose.   This case was linked to MOD-2021-014607, MOD-2021-311452 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia
Clinical narrative: experienced reported side effects of the vaccine which are the same as the symptoms of fibromyalgia; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (experienced reported side effects of the vaccine which are the same as the symptoms of fibromyalgia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (experienced reported side effects of the vaccine which are the same as the symptoms of fibromyalgia). At the time of the report, FIBROMYALGIA (experienced reported side effects of the vaccine which are the same as the symptoms of fibromyalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.                   No treatment medications were  reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: FU received on 13 Sep 2021 include no new information. On 13-Sep-2021: Follow-up received contains no new information
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Fatigue; Pain at the left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at the left arm injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (No hospitalization due to COVID-19. No treatment received.) in December 2020, Anxiety and Irregular periods. Concomitant products included FLUOXETINE for Anxiety.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at the left arm injection site). At the time of the report, FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at the left arm injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-311611 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow-up received contains no new information. On 13-Sep-2021: Follow-up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: she knows of people who have received a mix of the Pfizer and Moderna vaccines; 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 INTERCHANGE OF VACCINE PRODUCTS (she knows of people who have received a mix of the Pfizer and Moderna vaccines) 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 INTERCHANGE OF VACCINE PRODUCTS (she knows of people who have received a mix of the Pfizer and Moderna vaccines). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (she knows of people who have received a mix of the Pfizer and Moderna vaccines) had resolved.            No relevant concomitant medications were reported. Treatment information was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Symptoms of COVID-19 /COVID-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Symptoms of COVID-19 /COVID-19 positive) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 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) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Symptoms of COVID-19 /COVID-19 positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Symptoms of COVID-19 /COVID-19 positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, SARS-CoV-2 test: positive (Positive) Tested positive on Sunday, 06/Sep/2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported Treatment medication were not reported