chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Decreased appetite, Epistaxis, Headache
Clinical narrative: Nose blistered; Watering of eyes; Loss of appetite; Bleeding of left nose; Weak; Chills; Temperature 99.5; Pressure in chest; Pain in the left shoulder; Pain in left leg; Nose on the left side swell up to the size of golf ball; Stomach discomfort; Severe extreme painful headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Pressure in chest), EPISTAXIS (Bleeding of left nose), NASAL OEDEMA (Nose on the left side swell up to the size of golf ball), BLISTER (Nose blistered) and LACRIMATION INCREASED (Watering of eyes) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Severe extreme painful headache). On 01-Feb-2021, the patient experienced CHEST DISCOMFORT (Pressure in chest), PAIN IN EXTREMITY (Pain in left leg) and ARTHRALGIA (Pain in the left shoulder). 01-Feb-2021, the patient experienced NASAL OEDEMA (Nose on the left side swell up to the size of golf ball) and ABDOMINAL DISCOMFORT (Stomach discomfort). On an unknown date, the patient experienced EPISTAXIS (Bleeding of left nose), BLISTER (Nose blistered), LACRIMATION INCREASED (Watering of eyes), DECREASED APPETITE (Loss of appetite), ASTHENIA (Weak), CHILLS (Chills) and PYREXIA (Temperature 99.5). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Pressure in chest), NASAL OEDEMA (Nose on the left side swell up to the size of golf ball), BLISTER (Nose blistered), LACRIMATION INCREASED (Watering of eyes), ABDOMINAL DISCOMFORT (Stomach discomfort), ASTHENIA (Weak), PAIN IN EXTREMITY (Pain in left leg), ARTHRALGIA (Pain in the left shoulder), CHILLS (Chills) and PYREXIA (Temperature 99.5) outcome was unknown and EPISTAXIS (Bleeding of left nose), DECREASED APPETITE (Loss of appetite) and HEADACHE (Severe extreme painful headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (Inconclusive) 99.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Lacrimation increased, Nasal oedema, Pain in extremity, Pyrexia
Clinical narrative: Nose blistered; Watering of eyes; Loss of appetite; Bleeding of left nose; Weak; Chills; Temperature 99.5; Pressure in chest; Pain in the left shoulder; Pain in left leg; Nose on the left side swell up to the size of golf ball; Stomach discomfort; Severe extreme painful headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Pressure in chest), EPISTAXIS (Bleeding of left nose), NASAL OEDEMA (Nose on the left side swell up to the size of golf ball), BLISTER (Nose blistered) and LACRIMATION INCREASED (Watering of eyes) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Severe extreme painful headache). On 01-Feb-2021, the patient experienced CHEST DISCOMFORT (Pressure in chest), PAIN IN EXTREMITY (Pain in left leg) and ARTHRALGIA (Pain in the left shoulder). 01-Feb-2021, the patient experienced NASAL OEDEMA (Nose on the left side swell up to the size of golf ball) and ABDOMINAL DISCOMFORT (Stomach discomfort). On an unknown date, the patient experienced EPISTAXIS (Bleeding of left nose), BLISTER (Nose blistered), LACRIMATION INCREASED (Watering of eyes), DECREASED APPETITE (Loss of appetite), ASTHENIA (Weak), CHILLS (Chills) and PYREXIA (Temperature 99.5). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Pressure in chest), NASAL OEDEMA (Nose on the left side swell up to the size of golf ball), BLISTER (Nose blistered), LACRIMATION INCREASED (Watering of eyes), ABDOMINAL DISCOMFORT (Stomach discomfort), ASTHENIA (Weak), PAIN IN EXTREMITY (Pain in left leg), ARTHRALGIA (Pain in the left shoulder), CHILLS (Chills) and PYREXIA (Temperature 99.5) outcome was unknown and EPISTAXIS (Bleeding of left nose), DECREASED APPETITE (Loss of appetite) and HEADACHE (Severe extreme painful headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (Inconclusive) 99.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Malaise
Clinical narrative: Fatigue; Diarrhea; Feeling Unwell; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), DIARRHOEA (Diarrhea) and MALAISE (Feeling Unwell) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Blood Pressure Medication, PROPRANOLOL and Diuretic Pills for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced FATIGUE (Fatigue), DIARRHOEA (Diarrhea) and MALAISE (Feeling Unwell). At the time of the report, FATIGUE (Fatigue), DIARRHOEA (Diarrhea) and MALAISE (Feeling Unwell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 immunisation.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Pain
Clinical narrative: Body aches; difficulty breathing; Chest pressure; Chills; This spontaneous case was reported by a consumer and describes the occurrence of   in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Mar-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) (unknown route) 1 dosage form.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discomfort, Myalgia, Rhinorrhoea, Wheezing
Clinical narrative: Injection site discomfort; Sore shoulder; Wheezing; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing), RHINORRHOEA (Runny nose), INJECTION SITE DISCOMFORT (Injection site discomfort) and MYALGIA (Sore shoulder) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: Robaxin. Past adverse reactions to the above products included Hives with Robaxin. Concurrent medical conditions included Parkinson's disease, Obesity and High cholesterol.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced WHEEZING (Wheezing), RHINORRHOEA (Runny nose) and MYALGIA (Sore shoulder). On an unknown date, the patient experienced INJECTION SITE DISCOMFORT (Injection site discomfort). On 09-Feb-2021, WHEEZING (Wheezing), RHINORRHOEA (Runny nose) and MYALGIA (Sore shoulder) had resolved. At the time of the report, INJECTION SITE DISCOMFORT (Injection site discomfort) outcome was unknown. Not Provided      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 relevant concomitant medications were reported.  No treatment information was provided.  Patient took prednisone week before a time of vaccination which was not ongoing.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI Source doc On 09-Jul-2021: Follow up received on 09-Jul-2021, Patient details (height), concomitant medications, concurrent conditions were updated. New event was added.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness, Vasoconstriction
Clinical narrative: Blood vessels shrunk-cant see them as much; hand are ice cold; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VASOCONSTRICTION (Blood vessels shrunk-cant see them as much) and PERIPHERAL COLDNESS (hand are ice cold) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VASOCONSTRICTION (Blood vessels shrunk-cant see them as much) and PERIPHERAL COLDNESS (hand are ice cold). At the time of the report, VASOCONSTRICTION (Blood vessels shrunk-cant see them as much) and PERIPHERAL COLDNESS (hand are ice cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Bump/lump; Itchy; Swollen; Little burning; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little burning), VACCINATION SITE MASS (Bump/lump), PRURITUS (Itchy) and VACCINATION SITE SWELLING (Swollen) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20) 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-Feb-2021, the patient experienced VACCINATION SITE PAIN (Little burning). On 11-Feb-2021, the patient experienced VACCINATION SITE MASS (Bump/lump), PRURITUS (Itchy) and VACCINATION SITE SWELLING (Swollen). On 05-Feb-2021, VACCINATION SITE PAIN (Little burning) had resolved. At the time of the report, VACCINATION SITE MASS (Bump/lump), PRURITUS (Itchy) and VACCINATION SITE SWELLING (Swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Gait disturbance, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Face was red; Could hardly walk; Fever of 100.4; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Face was red), GAIT DISTURBANCE (Could hardly walk), PYREXIA (Fever of 100.4) and FATIGUE (Fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included PREDNISONE for Polymyalgia rheumatica.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Face was red), GAIT DISTURBANCE (Could hardly walk), PYREXIA (Fever of 100.4) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, Fever, Fatigue and Gait disturbance, at an unspecified dose and frequency. On 28-Feb-2021, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Face was red), GAIT DISTURBANCE (Could hardly walk), PYREXIA (Fever of 100.4) and FATIGUE (Fatigue) had resolved.            Concomitant medication include prednisone.  Treatment medication include Tylenol.  Action taken with mRNA-1273(Moderna COVID-19Vaccine) (intramuscular) was not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue
Clinical narrative: diarrhea; dizziness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DIZZINESS (dizziness) and FATIGUE (fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (dizziness) and FATIGUE (fatigue). At the time of the report, DIARRHOEA (diarrhea), DIZZINESS (dizziness) and FATIGUE (fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Information was not reported. Concomitant product information was not reported.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Fatigue, Feeling abnormal, Nausea
Clinical narrative: dizzines was turbulent; falling on floor, like she was serverly drunk; was very wonky, fogginess; nausea; not being able to get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzines was turbulent), FALL (falling on floor, like she was serverly drunk), FEELING ABNORMAL (was very wonky, fogginess), NAUSEA (nausea) and FATIGUE (not being able to get out of bed) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE BESILATE, TELMISARTAN (MICARDIS AMLO) and VITAMIN D AND ANALOGUES for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizzines was turbulent), FALL (falling on floor, like she was serverly drunk), FEELING ABNORMAL (was very wonky, fogginess), NAUSEA (nausea) and FATIGUE (not being able to get out of bed). On 03-Mar-2021, DIZZINESS (dizzines was turbulent), FALL (falling on floor, like she was serverly drunk), FEELING ABNORMAL (was very wonky, fogginess), NAUSEA (nausea) and FATIGUE (not being able to get out of bed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included ALLERGY MEDICATION. No treatment medication details was reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 38-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 02-Mar-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Jul-2020 and the estimated date of delivery was 03-May-2021. On 02-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 02-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2020, Glucose tolerance test:. On 28-Aug-2020, Pregnancy test: positive (Positive) Positive. In February 2021, Glucose tolerance test: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Sinusitis
Clinical narrative: headache; sinus infection; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SINUSITIS (sinus infection) and OROPHARYNGEAL PAIN (sore throat). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN BAMBINI) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, SINUSITIS (sinus infection), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm to touch; red, hot area, like a rash on my left arm; swollen; red, hot area, like a rash on my left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE ERYTHEMA (red, hot area, like a rash on my left arm), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE RASH (red, hot area, like a rash on my left arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included METFORMIN, FENOFIBRATE, SIMVASTATIN, DULAGLUTIDE, CETIRIZINE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE ERYTHEMA (red, hot area, like a rash on my left arm), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE RASH (red, hot area, like a rash on my left arm). At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE ERYTHEMA (red, hot area, like a rash on my left arm), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE RASH (red, hot area, like a rash on my left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: achiness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness) and HEADACHE (headache) 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 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN (achiness) and HEADACHE (headache). At the time of the report, PAIN (achiness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: Fatigue; Sore arm; Body ache; Chills; Fever; No taste; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), CHILLS (Chills), PYREXIA (Fever) and AGEUSIA (No taste) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included METOPROLOL, ROSUVASTATIN CALCIUM (CRESTOR), SPIRONOLACTONE and GABAPENTIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), CHILLS (Chills), PYREXIA (Fever) and AGEUSIA (No taste). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), CHILLS (Chills), PYREXIA (Fever), AGEUSIA (No taste) and FATIGUE (Fatigue) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test positive: other.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication include some non prescribed pain killers.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Fatigue; Sore arm; Body ache; Chills; Fever; No taste; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), CHILLS (Chills), PYREXIA (Fever) and AGEUSIA (No taste) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included METOPROLOL, ROSUVASTATIN CALCIUM (CRESTOR), SPIRONOLACTONE and GABAPENTIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), CHILLS (Chills), PYREXIA (Fever) and AGEUSIA (No taste). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), CHILLS (Chills), PYREXIA (Fever), AGEUSIA (No taste) and FATIGUE (Fatigue) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test positive: other.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication include some non prescribed pain killers.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Feeling hot, Heart rate increased
Clinical narrative: Blood pressure went up; Heart rate went up; He felt warm sensation when vaccine was going in the body; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure went up), HEART RATE INCREASED (Heart rate went up) and FEELING HOT (He felt warm sensation when vaccine was going in the body) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure went up), HEART RATE INCREASED (Heart rate went up) and FEELING HOT (He felt warm sensation when vaccine was going in the body). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure went up), HEART RATE INCREASED (Heart rate went up) and FEELING HOT (He felt warm sensation when vaccine was going in the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Lip blister, Myalgia
Clinical narrative: Arm ache; Body ache; Temperature of 100.3; lips blistered; little shortness of breath; stuffy nose; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm ache), MYALGIA (Body ache), PYREXIA (Temperature of 100.3), LIP BLISTER (lips blistered) and DYSPNOEA (little shortness of breath) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm ache), MYALGIA (Body ache), PYREXIA (Temperature of 100.3), LIP BLISTER (lips blistered), DYSPNOEA (little shortness of breath), NASAL CONGESTION (stuffy nose) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm ache), MYALGIA (Body ache), PYREXIA (Temperature of 100.3), LIP BLISTER (lips blistered), DYSPNOEA (little shortness of breath), NASAL CONGESTION (stuffy nose) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100.3 (High) 100.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications are provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia, Vaccination site pain
Clinical narrative: Arm ache; Body ache; Temperature of 100.3; lips blistered; little shortness of breath; stuffy nose; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm ache), MYALGIA (Body ache), PYREXIA (Temperature of 100.3), LIP BLISTER (lips blistered) and DYSPNOEA (little shortness of breath) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm ache), MYALGIA (Body ache), PYREXIA (Temperature of 100.3), LIP BLISTER (lips blistered), DYSPNOEA (little shortness of breath), NASAL CONGESTION (stuffy nose) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm ache), MYALGIA (Body ache), PYREXIA (Temperature of 100.3), LIP BLISTER (lips blistered), DYSPNOEA (little shortness of breath), NASAL CONGESTION (stuffy nose) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100.3 (High) 100.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications are provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Pain
Clinical narrative: slightly ill; achy; chills; A SPONTANEOUS report was received concerning a male patient who received Moderna's COVID-19 vaccine SHOT-2 on  23-feb-2021(mRNA-1273) and experienced slightly illness, achy and chills,     The patient's medical history was unknown / not provided     Event or Problem is unknown After the second shot, Ihe became slightly ill, achy, chills (went away after a day).     Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was not provided.     The outcome of the events were Recovered.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 27-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in September 2020 and the estimated date of delivery was 11-Jun-2021. On 04-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 04-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2020, Pregnancy test: positive (Positive) Positive.     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.   On an unknown date, an ultrasound and genetic testing were performed and resulted in normal findings.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Neck pain
Clinical narrative: soreness in arm; swollen lymph node in neck; discomfort in neck; 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 MYALGIA (soreness in arm), LYMPHADENOPATHY (swollen lymph node in neck) and NECK PAIN (discomfort in neck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 MYALGIA (soreness in arm), LYMPHADENOPATHY (swollen lymph node in neck) and NECK PAIN (discomfort in neck). At the time of the report, MYALGIA (soreness in arm) and NECK PAIN (discomfort in neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications was not provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pregnancy, Pyrexia
Clinical narrative: Pregnant; fever; chills; Body aches; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of PREGNANCY (Pregnant), PYREXIA (fever), CHILLS (chills) and MYALGIA (Body aches) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. The patient's last menstrual period was on 09-Jul-2020 and the estimated date of delivery was 11-Apr-2021. On an unknown date, the patient experienced PREGNANCY (Pregnant), PYREXIA (fever), CHILLS (chills) and MYALGIA (Body aches). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred.  At the time of the report, PREGNANCY (Pregnant), PYREXIA (fever), CHILLS (chills) and MYALGIA (Body aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder discomfort, Chills, Diarrhoea, Discomfort, Dizziness
Clinical narrative: after few hours, I started feeling dizzy; shaking; started having diarrhea; lost control of my body; wet my pants; I couldn't control my bladder; felt like this all day Friday; chills; threw up; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (after few hours, I started feeling dizzy), TREMOR (shaking), DIARRHOEA (started having diarrhea), URINARY INCONTINENCE (lost control of my body) and URINARY INCONTINENCE (wet my pants) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (after few hours, I started feeling dizzy), TREMOR (shaking), DIARRHOEA (started having diarrhea), URINARY INCONTINENCE (lost control of my body), URINARY INCONTINENCE (wet my pants), BLADDER DISCOMFORT (I couldn't control my bladder), DISCOMFORT (felt like this all day Friday), CHILLS (chills) and VOMITING (threw up). At the time of the report, DIZZINESS (after few hours, I started feeling dizzy), TREMOR (shaking), DIARRHOEA (started having diarrhea), URINARY INCONTINENCE (lost control of my body), URINARY INCONTINENCE (wet my pants), BLADDER DISCOMFORT (I couldn't control my bladder), DISCOMFORT (felt like this all day Friday), CHILLS (chills) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included drank plenty of water
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Urinary incontinence, Vomiting
Clinical narrative: after few hours, I started feeling dizzy; shaking; started having diarrhea; lost control of my body; wet my pants; I couldn't control my bladder; felt like this all day Friday; chills; threw up; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (after few hours, I started feeling dizzy), TREMOR (shaking), DIARRHOEA (started having diarrhea), URINARY INCONTINENCE (lost control of my body) and URINARY INCONTINENCE (wet my pants) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (after few hours, I started feeling dizzy), TREMOR (shaking), DIARRHOEA (started having diarrhea), URINARY INCONTINENCE (lost control of my body), URINARY INCONTINENCE (wet my pants), BLADDER DISCOMFORT (I couldn't control my bladder), DISCOMFORT (felt like this all day Friday), CHILLS (chills) and VOMITING (threw up). At the time of the report, DIZZINESS (after few hours, I started feeling dizzy), TREMOR (shaking), DIARRHOEA (started having diarrhea), URINARY INCONTINENCE (lost control of my body), URINARY INCONTINENCE (wet my pants), BLADDER DISCOMFORT (I couldn't control my bladder), DISCOMFORT (felt like this all day Friday), CHILLS (chills) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included drank plenty of water
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: had a reaction to the second dose; 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 ADVERSE REACTION (had a reaction to the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ADVERSE REACTION (had a reaction to the second dose). At the time of the report, ADVERSE REACTION (had a reaction to the second dose) outcome was unknown.            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 ADVERSE REACTION (reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ADVERSE REACTION (reaction).            This case was linked to MOD-2021-034310, MOD-2021-034310 (Patient Link).   Reporter did not allow further contact   This case was linked to MOD-2021-034310, MOD-2021-034310 (Patient Link).   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: sore arm; Headache; Body aches; A spontaneous report was received from a consumer, concerning  a 71 years adult female patient, who received Moderna COVID-19 Vaccine and experienced 2 doses.  The patient's medical history was not provided.  The concomitant products was not provided.  On  22-Jan-2021,prior to the onset of events,the patient received the first dose of  mRNA-1273(lot number: Unknown) and she had taken the second dose on 19-Feb-2021 route of administration is  intramuscular route for COVID-19 infection prophylaxis.  On 30JAN2021 she had a 3 inch square below her injection site which was really red, swollen and tender to touch which gradually spread to her elbow and shoulder. It did not hurt to use her arm. This lasted about a week after which she was fine. Her second dose was administered on Feb 19th. She experienced headache, body aches, no fever.   Treatment includes  Benadryl and Tylenol per doctor recommendation.  Action taken with mRNA-1273 in response to the events were not reported.  The Outcome of the event (Headache,Myalgia,Sorearm) was considered to be not resolved at the time of this report.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Myalgia, Pyrexia
Clinical narrative: had temp. 98.9 F; arm soreness,feeling lil pain in his arm; redness which is now 3-4 in long at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness which is now 3-4 in long at the site of injection), PYREXIA (had temp. 98.9 F) and MYALGIA (arm soreness,feeling lil pain in his arm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness which is now 3-4 in long at the site of injection) and MYALGIA (arm soreness,feeling lil pain in his arm). On an unknown date, the patient experienced PYREXIA (had temp. 98.9 F). At the time of the report, INJECTION SITE ERYTHEMA (redness which is now 3-4 in long at the site of injection), PYREXIA (had temp. 98.9 F) and MYALGIA (arm soreness,feeling lil pain in his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: like a cord from the swollen lymph node extending to the side of her breast; big lump on her left armpit/swollen lymph node; felt very tired; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (felt very tired), LYMPHADENOPATHY (big lump on her left armpit/swollen lymph node) and LYMPHADENOPATHY (like a cord from the swollen lymph node extending to the side of her breast) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (felt very tired). On 26-Jan-2021, the patient experienced LYMPHADENOPATHY (big lump on her left armpit/swollen lymph node). On 02-Feb-2021, the patient experienced LYMPHADENOPATHY (like a cord from the swollen lymph node extending to the side of her breast). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Tiredness, at an unspecified dose and frequency. On 23-Jan-2021, FATIGUE (felt very tired) had resolved. At the time of the report, LYMPHADENOPATHY (big lump on her left armpit/swollen lymph node) was resolving and LYMPHADENOPATHY (like a cord from the swollen lymph node extending to the side of her breast) 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 concomitation medication provided
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Constipation, Dizziness
Clinical narrative: dizziness; weakness; constipation; A spontaneous report was received from a healthcare professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, weakness, constipation.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) dizziness. weakness, constipation.  Treatment details included laxative.  Action taken with mRNA-1273 in response to the events were not applicable. The outcome of event(s) dizziness was considered resolved on 10 Feb 2021.The outcome of event(s) weakness was considered resolved on 10 Feb 2021. The outcome of event(s), constipation,  was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Long bruise-like and 2 inches wide; A spontaneous report  was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 5-inch long bruise-like and 2 inches wide.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On unknown date, prior to the onset of the event the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced big-like bruise on her 8 days after having the Moderna shot. On 21 Jan 2021, in evening patient experienced 5-inch long bruise-like and 2 inches wide.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, 5-inch long bruise-like and 2 inches wide was not reported.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded.