chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest pain, Condition aggravated, Dyspnoea, Electrocardiogram
Clinical narrative: Chest pains; Can't breathe; Can't take more than a few steps; Can't do anything; Every day progressively getting worse; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pains), DYSPNOEA (Can't breathe), MOBILITY DECREASED (Can't take more than a few steps), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything) and CONDITION AGGRAVATED (Every day progressively getting worse) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and #029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONIDINE, OLMESARTAN and METOPROLOL for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced CHEST PAIN (Chest pains), DYSPNOEA (Can't breathe), MOBILITY DECREASED (Can't take more than a few steps), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything), CONDITION AGGRAVATED (Every day progressively getting worse) and FATIGUE (Fatigue). In June 2021, CHEST PAIN (Chest pains) had resolved. At the time of the report, DYSPNOEA (Can't breathe), MOBILITY DECREASED (Can't take more than a few steps), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything), CONDITION AGGRAVATED (Every day progressively getting worse) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Cardiac stress test: normal (normal) Normal. In May 2021, Electrocardiogram: normal (normal) Normal..         Patient was recommended  ECG and a nuclear stress test in mid May by heart doctor which showed no unusual findings.  No medication were taken by the patient for these symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Non-significant follow-up Appended
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Chest pains; Can't breathe; Can't take more than a few steps; Can't do anything; Every day progressively getting worse; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pains), DYSPNOEA (Can't breathe), MOBILITY DECREASED (Can't take more than a few steps), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything) and CONDITION AGGRAVATED (Every day progressively getting worse) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and #029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONIDINE, OLMESARTAN and METOPROLOL for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced CHEST PAIN (Chest pains), DYSPNOEA (Can't breathe), MOBILITY DECREASED (Can't take more than a few steps), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything), CONDITION AGGRAVATED (Every day progressively getting worse) and FATIGUE (Fatigue). In June 2021, CHEST PAIN (Chest pains) had resolved. At the time of the report, DYSPNOEA (Can't breathe), MOBILITY DECREASED (Can't take more than a few steps), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything), CONDITION AGGRAVATED (Every day progressively getting worse) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Cardiac stress test: normal (normal) Normal. In May 2021, Electrocardiogram: normal (normal) Normal..         Patient was recommended  ECG and a nuclear stress test in mid May by heart doctor which showed no unusual findings.  No medication were taken by the patient for these symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Non-significant follow-up Appended
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of lymph nodes; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (Swelling of lymph nodes) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRAZODONE, AMLODIPINE BESILATE (NORVASC), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), GABAPENTIN, LOSARTAN, BUPROPION, FLUOXETINE HYDROCHLORIDE (PROZAC) and LEVOTHYROXINE for an unknown indication.    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 LYMPHADENOPATHY (Swelling of lymph nodes). The patient was treated with PREDNISONE at a dose of 20 mg and AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AMOXYCILLIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Swelling of lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Platelet count decreased
Clinical narrative: low blood platelets; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (low blood platelets) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-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 PLATELET COUNT DECREASED (low blood platelets). At the time of the report, PLATELET COUNT DECREASED (low blood platelets) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: Low platelet count.         No concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) had resolved.            Concomitant information was not provided by the Reporter. Treatment information was not provided by the Reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received. Updated Event outcome to recovered.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Hyperhidrosis, Illness, Loss of consciousness, Loss of personal independence in daily activities
Clinical narrative: I was really unconscious; Unable to do anything for myself; so sick that I could not communicate with my family; had to remove my wet clothes due to the amount of sweat in my night clothes; high temperature; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (I was really unconscious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do anything for myself), ILLNESS (so sick that I could not communicate with my family), HYPERHIDROSIS (had to remove my wet clothes due to the amount of sweat in my night clothes) and PYREXIA (high temperature) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (I was really unconscious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do anything for myself), ILLNESS (so sick that I could not communicate with my family), HYPERHIDROSIS (had to remove my wet clothes due to the amount of sweat in my night clothes) and PYREXIA (high temperature). The patient was treated with PARACETAMOL (TYLENOL) for High temperature, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (I was really unconscious), ILLNESS (so sick that I could not communicate with my family), HYPERHIDROSIS (had to remove my wet clothes due to the amount of sweat in my night clothes) and PYREXIA (high temperature) outcome was unknown and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do anything for myself) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High.    No concomitant medications were reported.   Patient reported being sick for a couple of days but was unsure about the exact duration.  The patient had second vaccine which was horrible for patient as the patient had high temperature and had no idea what day it was so sick that the patient could not communicate with family. The patient was unable to do anything and when the temperature patient's son gave Tylenol. The patient was sick for at least 2 days and was really unconscious.  The action taken for m-RNA-1273 Covid-19 Moderna Vaccine was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I was really unconscious; Unable to do anything for myself; so sick that I could not communicate with my family; had to remove my wet clothes due to the amount of sweat in my night clothes; high temperature; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (I was really unconscious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do anything for myself), ILLNESS (so sick that I could not communicate with my family), HYPERHIDROSIS (had to remove my wet clothes due to the amount of sweat in my night clothes) and PYREXIA (high temperature) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (I was really unconscious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do anything for myself), ILLNESS (so sick that I could not communicate with my family), HYPERHIDROSIS (had to remove my wet clothes due to the amount of sweat in my night clothes) and PYREXIA (high temperature). The patient was treated with PARACETAMOL (TYLENOL) for High temperature, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (I was really unconscious), ILLNESS (so sick that I could not communicate with my family), HYPERHIDROSIS (had to remove my wet clothes due to the amount of sweat in my night clothes) and PYREXIA (high temperature) outcome was unknown and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do anything for myself) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High.    No concomitant medications were reported.   Patient reported being sick for a couple of days but was unsure about the exact duration.  The patient had second vaccine which was horrible for patient as the patient had high temperature and had no idea what day it was so sick that the patient could not communicate with family. The patient was unable to do anything and when the temperature patient's son gave Tylenol. The patient was sick for at least 2 days and was really unconscious.  The action taken for m-RNA-1273 Covid-19 Moderna Vaccine was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Night sweats, Splenomegaly
Clinical narrative: Splenomegaly; bloating/felt like pressure; night sweats; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of NIGHT SWEATS (night sweats), SPLENOMEGALY (Splenomegaly) and ABDOMINAL DISTENSION (bloating/felt like pressure) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced NIGHT SWEATS (night sweats). In May 2021, the patient experienced ABDOMINAL DISTENSION (bloating/felt like pressure). In June 2021, the patient experienced SPLENOMEGALY (Splenomegaly). At the time of the report, NIGHT SWEATS (night sweats), SPLENOMEGALY (Splenomegaly) and ABDOMINAL DISTENSION (bloating/felt like pressure) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that the same night that she received the second vaccine shot, she experienced profuse night sweats. The patient reported that in early May 2021, she began to experience pressure and bloating. She said that In June 2021, she had an ultrasound that diagnosed splenomegaly.  No information regarding concomitant medication was provided.  No information regarding treatment was provided.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Off label use
Clinical narrative: late second dose (37 day interval); arm was very sore; very bad headache; felt like nerves fired up throughout the body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like nerves fired up throughout the body), OFF LABEL USE (late second dose (37 day interval)), MYALGIA (arm was very sore) and HEADACHE (very bad headache) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 009D21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included MONTELUKAST, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE PROPIONATE (FLOVENT), MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced FEELING ABNORMAL (felt like nerves fired up throughout the body), MYALGIA (arm was very sore) and HEADACHE (very bad headache). On an unknown date, the patient experienced OFF LABEL USE (late second dose (37 day interval)). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Symptomatic treatment, at a dose of 1 dosage form. On 19-May-2021, HEADACHE (very bad headache) had resolved. On 21-May-2021, MYALGIA (arm was very sore) had resolved. At the time of the report, FEELING ABNORMAL (felt like nerves fired up throughout the body) had resolved and OFF LABEL USE (late second dose (37 day interval)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-237277 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little bit of sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little bit of sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (little bit of sore arm). On 21-Feb-2021, PAIN IN EXTREMITY (little bit of sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported by the reporter.  Treatment medication for these events were not reported by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: muscle stiffness and soreness; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (muscle stiffness and soreness) and ARTHRALGIA (joint pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 03-Mar-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 MUSCULOSKELETAL STIFFNESS (muscle stiffness and soreness) and ARTHRALGIA (joint pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (muscle stiffness and soreness) and ARTHRALGIA (joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment details were provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Insomnia, Muscle spasms, Myalgia, Pain
Clinical narrative: bad charlie horse; Charley horse/ cramps right leg and arm; suffered with sciatic nerve pain; walks slowly now; clothing she wears around her waist causes her pain.; hasn't slept but two hours each night; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (bad charlie horse), MUSCLE SPASMS (Charley horse/ cramps right leg and arm), SCIATICA (suffered with sciatic nerve pain), PAIN (clothing she wears around her waist causes her pain.) and INSOMNIA (hasn't slept but two hours each night) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033c21A and 039b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN (clothing she wears around her waist causes her pain.) and INSOMNIA (hasn't slept but two hours each night). On 24-Apr-2021, the patient experienced MUSCLE SPASMS (Charley horse/ cramps right leg and arm), SCIATICA (suffered with sciatic nerve pain) and GAIT DISTURBANCE (walks slowly now). On an unknown date, the patient experienced MYALGIA (bad charlie horse). At the time of the report, MYALGIA (bad charlie horse), MUSCLE SPASMS (Charley horse/ cramps right leg and arm), SCIATICA (suffered with sciatic nerve pain), PAIN (clothing she wears around her waist causes her pain.), INSOMNIA (hasn't slept but two hours each night) and GAIT DISTURBANCE (walks slowly now) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: significant Follow-up  received and events updated and added new events.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: bad charlie horse; Charley horse/ cramps right leg and arm; suffered with sciatic nerve pain; walks slowly now; clothing she wears around her waist causes her pain.; hasn't slept but two hours each night; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (bad charlie horse), MUSCLE SPASMS (Charley horse/ cramps right leg and arm), SCIATICA (suffered with sciatic nerve pain), PAIN (clothing she wears around her waist causes her pain.) and INSOMNIA (hasn't slept but two hours each night) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033c21A and 039b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN (clothing she wears around her waist causes her pain.) and INSOMNIA (hasn't slept but two hours each night). On 24-Apr-2021, the patient experienced MUSCLE SPASMS (Charley horse/ cramps right leg and arm), SCIATICA (suffered with sciatic nerve pain) and GAIT DISTURBANCE (walks slowly now). On an unknown date, the patient experienced MYALGIA (bad charlie horse). At the time of the report, MYALGIA (bad charlie horse), MUSCLE SPASMS (Charley horse/ cramps right leg and arm), SCIATICA (suffered with sciatic nerve pain), PAIN (clothing she wears around her waist causes her pain.), INSOMNIA (hasn't slept but two hours each night) and GAIT DISTURBANCE (walks slowly now) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: significant Follow-up  received and events updated and added new events.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Invalid Dose exceed 35 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Invalid Dose exceed 35 days) 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 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Invalid Dose exceed 35 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Invalid Dose exceed 35 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported. No Treatment Medications were reported.   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Myalgia, Pain
Clinical narrative: My blood pressure went up double from what it used to be; It is painful to open and then to close it back; Pain in right arm right at the wrist, running to my big thumb in my hand; Pain in right arm right at the wrist, running to my big thumb in my hand; This spontaneous case was reported by a patient and describes the occurrence of BLOOD PRESSURE INCREASED (My blood pressure went up double from what it used to be), PAIN (It is painful to open and then to close it back), ARTHRALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand) and MYALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand) 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-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 BLOOD PRESSURE INCREASED (My blood pressure went up double from what it used to be), PAIN (It is painful to open and then to close it back), ARTHRALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand) and MYALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand). At the time of the report, BLOOD PRESSURE INCREASED (My blood pressure went up double from what it used to be), PAIN (It is painful to open and then to close it back), ARTHRALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand) and MYALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) Blood pressure went up double from what it used to be. On an unknown date, X-ray: results not reported (Inconclusive) Results not reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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 product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-237415 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received contains updated patient demographics and start date of suspect.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: My blood pressure went up double from what it used to be; It is painful to open and then to close it back; Pain in right arm right at the wrist, running to my big thumb in my hand; Pain in right arm right at the wrist, running to my big thumb in my hand; This spontaneous case was reported by a patient and describes the occurrence of BLOOD PRESSURE INCREASED (My blood pressure went up double from what it used to be), PAIN (It is painful to open and then to close it back), ARTHRALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand) and MYALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand) 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-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 BLOOD PRESSURE INCREASED (My blood pressure went up double from what it used to be), PAIN (It is painful to open and then to close it back), ARTHRALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand) and MYALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand). At the time of the report, BLOOD PRESSURE INCREASED (My blood pressure went up double from what it used to be), PAIN (It is painful to open and then to close it back), ARTHRALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand) and MYALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) Blood pressure went up double from what it used to be. On an unknown date, X-ray: results not reported (Inconclusive) Results not reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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 product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-237415 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received contains updated patient demographics and start date of suspect.
Sex: U
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Night sweats post vaccine for 4 weeks; 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 NIGHT SWEATS (Night sweats post vaccine for 4 weeks) 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 NIGHT SWEATS (Night sweats post vaccine for 4 weeks). At the time of the report, NIGHT SWEATS (Night sweats post vaccine for 4 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) 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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of vaccination site discomfort (local discomfort) in a female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included hypertension since Sep 1, 2017. Concomitant products included telmisartan from Sep 1, 2017 to an unknown date for hypertension. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site discomfort (local discomfort). At the time of the report, vaccination site discomfort (local discomfort) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments or treatment information. Action taken with mRNA-1273 in response to the events: not applicable. This case linked to MOD-2021-080656 (patient link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed his second Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed his second Moderna vaccine) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-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 (missed his second Moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed his second Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.   The reporter stated that the patient was sick and was in and out of hospital, not due to the Moderna vaccine.  Treatment information not reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: passed 58 days without receiving the second dose/60 days since my first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (passed 58 days without receiving the second dose/60 days since my first dose) in a 37-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 28-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 (passed 58 days without receiving the second dose/60 days since my first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (passed 58 days without receiving the second dose/60 days since my first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.  Treatment medication not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information received on 25-JUN-2021 contains No Significant information.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Illness, Limb discomfort
Clinical narrative: Sick; Can't walk; Legs don't work; Never felt something like this before; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), GAIT DISTURBANCE (Can't walk), LIMB DISCOMFORT (Legs don't work) and FEELING ABNORMAL (Never felt something like this before) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick), GAIT DISTURBANCE (Can't walk), LIMB DISCOMFORT (Legs don't work) and FEELING ABNORMAL (Never felt something like this before). At the time of the report, ILLNESS (Sick), GAIT DISTURBANCE (Can't walk), LIMB DISCOMFORT (Legs don't work) and FEELING ABNORMAL (Never felt something like this before) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: experienced a side effect; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experienced a side effect). At the time of the report, VACCINATION COMPLICATION (experienced a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspepsia, Myalgia, Nausea, Pyrexia
Clinical narrative: Patient states feeling pain on the stomach; Burning stomach; vomiting/ nedded to go to the bathroom as feeling vomiting at that precise moment; nausea; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Patient states feeling pain on the stomach), DYSPEPSIA (Burning stomach), VOMITING (vomiting/ nedded to go to the bathroom as feeling vomiting at that precise moment), NAUSEA (nausea) and PYREXIA (fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 53C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced VOMITING (vomiting/ nedded to go to the bathroom as feeling vomiting at that precise moment), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (body aches). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Patient states feeling pain on the stomach) and DYSPEPSIA (Burning stomach). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ABDOMINAL PAIN UPPER (Patient states feeling pain on the stomach), DYSPEPSIA (Burning stomach), VOMITING (vomiting/ nedded to go to the bathroom as feeling vomiting at that precise moment), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. Treatment medication include blood pressure medicine.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient states feeling pain on the stomach; Burning stomach; vomiting/ nedded to go to the bathroom as feeling vomiting at that precise moment; nausea; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Patient states feeling pain on the stomach), DYSPEPSIA (Burning stomach), VOMITING (vomiting/ nedded to go to the bathroom as feeling vomiting at that precise moment), NAUSEA (nausea) and PYREXIA (fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 53C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced VOMITING (vomiting/ nedded to go to the bathroom as feeling vomiting at that precise moment), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (body aches). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Patient states feeling pain on the stomach) and DYSPEPSIA (Burning stomach). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ABDOMINAL PAIN UPPER (Patient states feeling pain on the stomach), DYSPEPSIA (Burning stomach), VOMITING (vomiting/ nedded to go to the bathroom as feeling vomiting at that precise moment), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. Treatment medication include blood pressure medicine.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash or rash-like lesions on various parts of body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash or rash-like lesions on various parts of body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash or rash-like lesions on various parts of body). At the time of the report, RASH (rash or rash-like lesions on various parts of body) outcome was unknown.            No concomitant medication reported. No treatment was provided. The action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow-up received on 27-JUN-2021 contains No New Information
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Bad effects from second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad effects from second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad effects from second shot). At the time of the report, VACCINATION COMPLICATION (Bad effects from second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to a patient) 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 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to a patient). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Balance disorder, Fatigue, Nervousness, Pain in extremity
Clinical narrative: anxiousness; nervousness; Fatigue; Leg pain; Imbalance; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), BALANCE DISORDER (Imbalance), ANXIETY (anxiousness), NERVOUSNESS (nervousness) and FATIGUE (Fatigue) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 027L20A) for COVID-19 vaccination.     Concomitant products included PREDNISOLONE for Inner ear inflammation.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Leg pain). 11-Feb-2021, the patient experienced BALANCE DISORDER (Imbalance) and FATIGUE (Fatigue). On an unknown date, the patient experienced ANXIETY (anxiousness) and NERVOUSNESS (nervousness). At the time of the report, PAIN IN EXTREMITY (Leg pain), BALANCE DISORDER (Imbalance) and FATIGUE (Fatigue) had resolved and ANXIETY (anxiousness) and NERVOUSNESS (nervousness) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-017948 (Patient Link).