chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Angiocardiogram, Electrocardiogram, Magnetic resonance imaging, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis associated with mRNA COVID-19 vaccination. Radiology. 2021:211430     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: negative (Negative) Negative. In 2021, Magnetic resonance imaging heart: abnormal (abnormal) Late Gadolinium Enhancement (LGE): epicardial Left Ventricular (LV) inferior and anterolateral basal wall, epicardial and mid myocardial inferior wall mid ventricle and apical. T2w signal abnormality in corresponding locations as LGE. Pericardial enhancement, no effusion. Left Ventricular Ejection Fraction (LVEF): 54%, Right Ventricular Ejection Fraction (RVEF): 53%. Ipsilateral axillary lymphadenopathy. On an unknown date, Angiocardiogram: negative (Negative) Negative. On an unknown date, Electrocardiogram: abnormal (abnormal) Inferolateral T-wave inversion. On an unknown date, Troponin I: 12.19 ng/ml (abnormal) 12.19 ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    No concomitant medication was provided by the reporter  Patient was hospitalized due to acute onset of chest pain with diagnosis of acute myocarditis. Patient had received his second dose of mRNA-1273 vaccine 3 days before onset of chest pain and 5 days before onset of cardiac symptoms. Patient had following symptoms after vaccination subjective myalgias, malaise, nausea lightheadedness and chest pain. COVID-19 test was negative for 4 patients out of 5 patients.  No treatment medication information was provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-293220 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin I
Clinical narrative: Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis associated with mRNA COVID-19 vaccination. Radiology. 2021:211430     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: negative (Negative) Negative. In 2021, Magnetic resonance imaging heart: abnormal (abnormal) Late Gadolinium Enhancement (LGE): epicardial Left Ventricular (LV) inferior and anterolateral basal wall, epicardial and mid myocardial inferior wall mid ventricle and apical. T2w signal abnormality in corresponding locations as LGE. Pericardial enhancement, no effusion. Left Ventricular Ejection Fraction (LVEF): 54%, Right Ventricular Ejection Fraction (RVEF): 53%. Ipsilateral axillary lymphadenopathy. On an unknown date, Angiocardiogram: negative (Negative) Negative. On an unknown date, Electrocardiogram: abnormal (abnormal) Inferolateral T-wave inversion. On an unknown date, Troponin I: 12.19 ng/ml (abnormal) 12.19 ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    No concomitant medication was provided by the reporter  Patient was hospitalized due to acute onset of chest pain with diagnosis of acute myocarditis. Patient had received his second dose of mRNA-1273 vaccine 3 days before onset of chest pain and 5 days before onset of cardiac symptoms. Patient had following symptoms after vaccination subjective myalgias, malaise, nausea lightheadedness and chest pain. COVID-19 test was negative for 4 patients out of 5 patients.  No treatment medication information was provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-293220 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: patient is schedule to received third dose but is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (patient is schedule to received third dose but is not immunocompromised) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Flu (before the flu shot were available had frequent flus than leaded to bronchitis), Bronchitis and Pneumonia (sometimes reaching pneumonia, but is not immunocompromised). Concurrent medical conditions included Osteoporosis.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (patient is schedule to received third dose but is not immunocompromised). At the time of the report, OFF LABEL USE (patient is schedule to received third dose but is not immunocompromised) outcome was unknown.            No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter  The patient had received both doses of the Moderna vaccine, the second one was administered on 20Feb2021 and now signed up to get the third shot, the booster. Since the appointment for the third dose was schedule for 24Aug2021 and that was only 6 months and 4 days after the second dose they want to know if they should re-schedule for later.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: follow up document contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Left ankle/foot is swollen; Left ankle/foot is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left ankle/foot is swollen) and JOINT SWELLING (Left ankle/foot is swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced PERIPHERAL SWELLING (Left ankle/foot is swollen) and JOINT SWELLING (Left ankle/foot is swollen). At the time of the report, PERIPHERAL SWELLING (Left ankle/foot is swollen) and JOINT SWELLING (Left ankle/foot is swollen) outcome was unknown.            No concomitant products were reported.  No treatment information provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Enuresis, Headache, Illness, Influenza like illness
Clinical narrative: tingling in her knees and arms; she's just been in bed Friday, Saturday, Sunday, until now; wet the bed; had no control of her bladder; a lot of pain in her legs and her arms; severe headache; normal, kind of sick, in bed; like she had the flu; This spontaneous case was reported by a consumer and describes the occurrence of ENURESIS (wet the bed), URINARY INCONTINENCE (had no control of her bladder), PAIN IN EXTREMITY (a lot of pain in her legs and her arms), PARAESTHESIA (tingling in her knees and arms) and BEDRIDDEN (she's just been in bed Friday, Saturday, Sunday, until now) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (History of stroke 10 or 11 years ago). Concurrent medical conditions included Protein S deficiency.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced ILLNESS (normal, kind of sick, in bed) and INFLUENZA LIKE ILLNESS (like she had the flu). On 19-Aug-2021, the patient experienced ENURESIS (wet the bed), URINARY INCONTINENCE (had no control of her bladder), PAIN IN EXTREMITY (a lot of pain in her legs and her arms) and HEADACHE (severe headache). On 20-Aug-2021, the patient experienced BEDRIDDEN (she's just been in bed Friday, Saturday, Sunday, until now). On an unknown date, the patient experienced PARAESTHESIA (tingling in her knees and arms). On 16-Aug-2021, ILLNESS (normal, kind of sick, in bed) and INFLUENZA LIKE ILLNESS (like she had the flu) had resolved. On 23-Aug-2021, BEDRIDDEN (she's just been in bed Friday, Saturday, Sunday, until now) had resolved. At the time of the report, ENURESIS (wet the bed), URINARY INCONTINENCE (had no control of her bladder), PAIN IN EXTREMITY (a lot of pain in her legs and her arms), PARAESTHESIA (tingling in her knees and arms) and HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  On Friday 20-Aug-2021, patient went to see her doctor and took a UTI test, but it was negative. Patient went to urgent care later that day on 20-Aug-2021 and got a blood draw. The results have not come back yet as of 23-Aug-2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Urinary incontinence
Clinical narrative: tingling in her knees and arms; she's just been in bed Friday, Saturday, Sunday, until now; wet the bed; had no control of her bladder; a lot of pain in her legs and her arms; severe headache; normal, kind of sick, in bed; like she had the flu; This spontaneous case was reported by a consumer and describes the occurrence of ENURESIS (wet the bed), URINARY INCONTINENCE (had no control of her bladder), PAIN IN EXTREMITY (a lot of pain in her legs and her arms), PARAESTHESIA (tingling in her knees and arms) and BEDRIDDEN (she's just been in bed Friday, Saturday, Sunday, until now) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (History of stroke 10 or 11 years ago). Concurrent medical conditions included Protein S deficiency.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced ILLNESS (normal, kind of sick, in bed) and INFLUENZA LIKE ILLNESS (like she had the flu). On 19-Aug-2021, the patient experienced ENURESIS (wet the bed), URINARY INCONTINENCE (had no control of her bladder), PAIN IN EXTREMITY (a lot of pain in her legs and her arms) and HEADACHE (severe headache). On 20-Aug-2021, the patient experienced BEDRIDDEN (she's just been in bed Friday, Saturday, Sunday, until now). On an unknown date, the patient experienced PARAESTHESIA (tingling in her knees and arms). On 16-Aug-2021, ILLNESS (normal, kind of sick, in bed) and INFLUENZA LIKE ILLNESS (like she had the flu) had resolved. On 23-Aug-2021, BEDRIDDEN (she's just been in bed Friday, Saturday, Sunday, until now) had resolved. At the time of the report, ENURESIS (wet the bed), URINARY INCONTINENCE (had no control of her bladder), PAIN IN EXTREMITY (a lot of pain in her legs and her arms), PARAESTHESIA (tingling in her knees and arms) and HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  On Friday 20-Aug-2021, patient went to see her doctor and took a UTI test, but it was negative. Patient went to urgent care later that day on 20-Aug-2021 and got a blood draw. The results have not come back yet as of 23-Aug-2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Body temperature, Headache, Pyrexia
Clinical narrative: Blood Pressure started  fluctuating (169/122mmHg); Fever 101F; Bad Headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Blood Pressure started  fluctuating (169/122mmHg)), PYREXIA (Fever 101F) and HEADACHE (Bad Headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood Pressure started  fluctuating (169/122mmHg)), PYREXIA (Fever 101F) and HEADACHE (Bad Headache). The patient was treated with LISINOPRIL for Blood pressure fluctuation, at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE FLUCTUATION (Blood Pressure started  fluctuating (169/122mmHg)), PYREXIA (Fever 101F) and HEADACHE (Bad Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 169/122 (High) The patient's blood pressure was 169/122mmHg.. In 2021, Body temperature: 101 (High) The patient's body temperature was 101F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Dementia, Mobility decreased, Somatic dysfunction
Clinical narrative: Turned into a vegetable, full blown dementia; First dose hit her hard; Put her in bed for 24 hours a day; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (Turned into a vegetable, full blown dementia), SOMATIC DYSFUNCTION (First dose hit her hard) and MOBILITY DECREASED (Put her in bed for 24 hours a day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 DEMENTIA (Turned into a vegetable, full blown dementia), SOMATIC DYSFUNCTION (First dose hit her hard) and MOBILITY DECREASED (Put her in bed for 24 hours a day). At the time of the report, DEMENTIA (Turned into a vegetable, full blown dementia), SOMATIC DYSFUNCTION (First dose hit her hard) and MOBILITY DECREASED (Put her in bed for 24 hours a day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.    Treatment information was not  provided.  Before Vaccination although patient had mild dementia and was independent, cooked, cleaned, walked on her own. After 1st dose "all she could do was sit and rock in a chair"   This case was linked to MOD-2021-294412 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Follow-up received on 24 Aug 2021 included no new information.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: there is about 4 to 5 spots about a quarter size on his left forearm; it does itch; a rash appearing on his left arm where he got the initial shot; It is raised little bumps; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (there is about 4 to 5 spots about a quarter size on his left forearm), VACCINATION SITE PRURITUS (it does itch), VACCINATION SITE RASH (a rash appearing on his left arm where he got the initial shot) and VACCINATION SITE SWELLING (It is raised little bumps) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (there is about 4 to 5 spots about a quarter size on his left forearm), VACCINATION SITE PRURITUS (it does itch), VACCINATION SITE RASH (a rash appearing on his left arm where he got the initial shot) and VACCINATION SITE SWELLING (It is raised little bumps). The patient was treated with ALOE VERA (topical) for Vaccination site irritation, at a dose of UNK doage form and CAMPHOR, PHENOL (CAMPHO-PHENIQUE) for Vaccination site irritation, at a dose of UNK dosage form. At the time of the report, RASH MACULAR (there is about 4 to 5 spots about a quarter size on his left forearm), VACCINATION SITE PRURITUS (it does itch), VACCINATION SITE RASH (a rash appearing on his left arm where he got the initial shot) and VACCINATION SITE SWELLING (It is raised little bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site pain
Clinical narrative: has not gotten his second dose yet/they never came back to give my 2nd shot; experienced a sore arm at the injection site/sore arm at the place they put the needle; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not gotten his second dose yet/they never came back to give my 2nd shot) and VACCINATION SITE PAIN (experienced a sore arm at the injection site/sore arm at the place they put the needle) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced VACCINATION SITE PAIN (experienced a sore arm at the injection site/sore arm at the place they put the needle). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not gotten his second dose yet/they never came back to give my 2nd shot). On 03-Jul-2021, VACCINATION SITE PAIN (experienced a sore arm at the injection site/sore arm at the place they put the needle) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not gotten his second dose yet/they never came back to give my 2nd shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow-up received on 30-AUG-2021 contains new event
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Inflammation, Pain in extremity, Paraesthesia
Clinical narrative: Tingling  in  both  hands; Pain in both hands; inflammation and burning in my hands; inflammation and burning in my hands; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation and burning in my hands), BURNING SENSATION (inflammation and burning in my hands), PARAESTHESIA (Tingling  in  both  hands) and PAIN IN EXTREMITY (Pain in both hands) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included ESTRADIOL BENZOATE (ESTRADIOL [ESTRADIOL BENZOATE]) for Menopause, CORTISONE for an unknown indication, GABAPENTIN (NEURONTIN), IBUPROFEN (ADVIL [IBUPROFEN]), MELOXICAM (MOBIC) and LIDOCAINE.    On 21-Jan-2021 at 11:21 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced INFLAMMATION (inflammation and burning in my hands) and BURNING SENSATION (inflammation and burning in my hands). On 03-Feb-2021, the patient experienced PARAESTHESIA (Tingling  in  both  hands). 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in both hands). At the time of the report, INFLAMMATION (inflammation and burning in my hands), BURNING SENSATION (inflammation and burning in my hands), PARAESTHESIA (Tingling  in  both  hands) and PAIN IN EXTREMITY (Pain in both hands) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered INFLAMMATION (inflammation and burning in my hands), BURNING SENSATION (inflammation and burning in my hands), PARAESTHESIA (Tingling  in  both  hands) and PAIN IN EXTREMITY (Pain in both hands) to be possibly related.    Patient subsequently been to 7 different doctors for a diagnosis followed by 2 MRIs and several injections of cortisone  Patient went to an intervention Neurologist for special nerve blocks on July 21st and  still experiencing pain and the loss of feeling to fingers, causing the inability to do normal daily activities.  Patient had an autoimmune inflammatory response to the vaccines. patient stated that - Feb 11: Hand  surgeon,  Dr.;  Feb 16: Dr., neurologist;  Feb 18: back  to  Dr. forcortisone  shot.   This case was linked to MOD-2021-294574 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Significant Follow up includes: added patient race and ethnicity information and estradiol patch as a concomitant drug and pain in both hands and tingling in hands.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: It did swell a bit; It is itchy; Rash or small welts around the area I received my booster vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (It did swell a bit), VACCINATION SITE PRURITUS (It is itchy) and VACCINATION SITE RASH (Rash or small welts around the area I received my booster vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (It did swell a bit), VACCINATION SITE PRURITUS (It is itchy) and VACCINATION SITE RASH (Rash or small welts around the area I received my booster vaccine). At the time of the report, VACCINATION SITE SWELLING (It did swell a bit), VACCINATION SITE PRURITUS (It is itchy) and VACCINATION SITE RASH (Rash or small welts around the area I received my booster vaccine) outcome was unknown.            No concomitants were reported. No treatment is reported.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: it's been more than 42 days since he received his first vaccination. Has not received 2nd dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (it's been more than 42 days since he received his first vaccination. Has not received 2nd dose.) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-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 (it's been more than 42 days since he received his first vaccination. Has not received 2nd dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (it's been more than 42 days since he received his first vaccination. Has not received 2nd dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment history was reported.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash
Clinical narrative: Itch; Breaking out in a rash from the vacanation; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch) and VACCINATION SITE RASH (Breaking out in a rash from the vacanation) 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 PRURITUS (Itch) and VACCINATION SITE RASH (Breaking out in a rash from the vacanation). At the time of the report, PRURITUS (Itch) and VACCINATION SITE RASH (Breaking out in a rash from the vacanation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.   Reporter did not allow further contact
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Bone pain, Chest pain, Facial pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN, CHEST PAIN, FACIAL PAIN, INFLUENZA LIKE ILLNESS and PAIN OF SKIN in a 42-year-old male patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) (batch nos. 036A21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 30-Jul-2021, the patient received first dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced BONE PAIN (when he touches his bone there is physical pain), CHEST PAIN, FACIAL PAIN, INFLUENZA LIKE ILLNESS, PAIN OF SKIN, PARAESTHESIA, SKIN TIGHTNESS and ARTHRALGIA. 23-Aug-2021, the patient experienced SLEEP DISORDER (sleeping only 30 minutes intervals, he cannot get sleep. The sleep is a cycle.). 23-Aug-2021, the patient experienced PYREXIA (he states that immediately he had a fever within 5 minutes/the fever rotated from 97F-102F/he had a 102 Fever for the past 24 hours). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency and Bed rest (He took Advil and has been laying in bed.) for Pyrexia. At the time of the report, BONE PAIN (when he touches his bone there is physical pain), CHEST PAIN (He also mentions that the bones in his chest hurt), FACIAL PAIN (the bones in his face hurts), INFLUENZA LIKE ILLNESS (It is similar to how he reacts from the flu), PAIN OF SKIN (his skins hurts as if there is charcoal), SLEEP DISORDER (sleeping only 30 minutes intervals, he cannot get sleep. The sleep is a cycle.), PARAESTHESIA (When he wets his hair, it feels like pins and needles), SKIN TIGHTNESS (He feels like he has a mask on his face/tightness on his face), ARTHRALGIA (If he moves, there is pain in his shoulder and joints) and PYREXIA (he states that immediately he had a fever within 5 minutes/the fever rotated from 97F-102F/he had a 102 Fever for the past 24 hours) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 102 (High) he had a 102 Fever for the past 24 hours. On 23-Aug-2021, Body temperature: 97f-102f (High) 97F-102F. This case was linked to MOD-2021-294777 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain of skin, Paraesthesia, Pyrexia, Skin tightness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN, CHEST PAIN, FACIAL PAIN, INFLUENZA LIKE ILLNESS and PAIN OF SKIN in a 42-year-old male patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) (batch nos. 036A21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 30-Jul-2021, the patient received first dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced BONE PAIN (when he touches his bone there is physical pain), CHEST PAIN, FACIAL PAIN, INFLUENZA LIKE ILLNESS, PAIN OF SKIN, PARAESTHESIA, SKIN TIGHTNESS and ARTHRALGIA. 23-Aug-2021, the patient experienced SLEEP DISORDER (sleeping only 30 minutes intervals, he cannot get sleep. The sleep is a cycle.). 23-Aug-2021, the patient experienced PYREXIA (he states that immediately he had a fever within 5 minutes/the fever rotated from 97F-102F/he had a 102 Fever for the past 24 hours). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency and Bed rest (He took Advil and has been laying in bed.) for Pyrexia. At the time of the report, BONE PAIN (when he touches his bone there is physical pain), CHEST PAIN (He also mentions that the bones in his chest hurt), FACIAL PAIN (the bones in his face hurts), INFLUENZA LIKE ILLNESS (It is similar to how he reacts from the flu), PAIN OF SKIN (his skins hurts as if there is charcoal), SLEEP DISORDER (sleeping only 30 minutes intervals, he cannot get sleep. The sleep is a cycle.), PARAESTHESIA (When he wets his hair, it feels like pins and needles), SKIN TIGHTNESS (He feels like he has a mask on his face/tightness on his face), ARTHRALGIA (If he moves, there is pain in his shoulder and joints) and PYREXIA (he states that immediately he had a fever within 5 minutes/the fever rotated from 97F-102F/he had a 102 Fever for the past 24 hours) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 102 (High) he had a 102 Fever for the past 24 hours. On 23-Aug-2021, Body temperature: 97f-102f (High) 97F-102F. This case was linked to MOD-2021-294777 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN, CHEST PAIN, FACIAL PAIN, INFLUENZA LIKE ILLNESS and PAIN OF SKIN in a 42-year-old male patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) (batch nos. 036A21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 30-Jul-2021, the patient received first dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced BONE PAIN (when he touches his bone there is physical pain), CHEST PAIN, FACIAL PAIN, INFLUENZA LIKE ILLNESS, PAIN OF SKIN, PARAESTHESIA, SKIN TIGHTNESS and ARTHRALGIA. 23-Aug-2021, the patient experienced SLEEP DISORDER (sleeping only 30 minutes intervals, he cannot get sleep. The sleep is a cycle.). 23-Aug-2021, the patient experienced PYREXIA (he states that immediately he had a fever within 5 minutes/the fever rotated from 97F-102F/he had a 102 Fever for the past 24 hours). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency and Bed rest (He took Advil and has been laying in bed.) for Pyrexia. At the time of the report, BONE PAIN (when he touches his bone there is physical pain), CHEST PAIN (He also mentions that the bones in his chest hurt), FACIAL PAIN (the bones in his face hurts), INFLUENZA LIKE ILLNESS (It is similar to how he reacts from the flu), PAIN OF SKIN (his skins hurts as if there is charcoal), SLEEP DISORDER (sleeping only 30 minutes intervals, he cannot get sleep. The sleep is a cycle.), PARAESTHESIA (When he wets his hair, it feels like pins and needles), SKIN TIGHTNESS (He feels like he has a mask on his face/tightness on his face), ARTHRALGIA (If he moves, there is pain in his shoulder and joints) and PYREXIA (he states that immediately he had a fever within 5 minutes/the fever rotated from 97F-102F/he had a 102 Fever for the past 24 hours) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 102 (High) he had a 102 Fever for the past 24 hours. On 23-Aug-2021, Body temperature: 97f-102f (High) 97F-102F. This case was linked to MOD-2021-294777 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Rash vesicular
Clinical narrative: Blistering rash is present in the arms, back and neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH VESICULAR (Blistering rash is present in the arms, back and neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Hospitalized in December for a week before receiving 1 shot of the Moderna vaccine) in December 2020. Concurrent medical conditions included Fibromyalgia, Hypertension and Sleep disorder.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH VESICULAR (Blistering rash is present in the arms, back and neck). At the time of the report, RASH VESICULAR (Blistering rash is present in the arms, back and neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: higher (High) Higher.         Patient experienced blistering rash that she mentioned to be similar but of greater intensity as she experienced whit the first shoot of the vaccine.  No concomitant medications were provided by reporter.  No treatment medications were provided by reporter.   This case was linked to MOD-2021-295770, MOD-2021-295772 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Nausea, Pain
Clinical narrative: felt really terrible; pain all over; nauseated; achy all over/achy arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt really terrible), PAIN (pain all over), NAUSEA (nauseated) and MYALGIA (achy all over/achy arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced FEELING ABNORMAL (felt really terrible), PAIN (pain all over), NAUSEA (nauseated) and MYALGIA (achy all over/achy arm). At the time of the report, FEELING ABNORMAL (felt really terrible), PAIN (pain all over), NAUSEA (nauseated) and MYALGIA (achy all over/achy arm) outcome was unknown.      No Concomitant medications were provided.  No treatment medications were provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: tremendous hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (tremendous hair loss) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0461321A and 0081321-2A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-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 ALOPECIA (tremendous hair loss). At the time of the report, ALOPECIA (tremendous hair loss) outcome was unknown.            The patient reported that the symptoms stared 6 weeks after vaccination and had no other symptoms. Mentioned that he had not hair loss before and was been lasting 3 months. The patient was not tried any treatments.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 yo son got the Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yo son got the Moderna Covid-19 Vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yo son got the Moderna Covid-19 Vaccine). On 21-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yo son got the Moderna Covid-19 Vaccine) had resolved.            Concomitant medications were not reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Got his first Moderna dose in June. He was unable to get scheduled for second vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got his first Moderna dose in June. He was unable to get scheduled for second vaccine dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got his first Moderna dose in June. He was unable to get scheduled for second vaccine dose). On 24-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Got his first Moderna dose in June. He was unable to get scheduled for second vaccine dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was Not applicable.       Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: After the expiration date of 27Apr2021, about 180 patients received the vaccine between that date and 16Aug2021.; 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 EXPIRED PRODUCT ADMINISTERED (After the expiration date of 27Apr2021, about 180 patients received the vaccine between that date and 16Aug2021.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B12A) 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 27-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After the expiration date of 27Apr2021, about 180 patients received the vaccine between that date and 16Aug2021.). On 16-Aug-2021, EXPIRED PRODUCT ADMINISTERED (After the expiration date of 27Apr2021, about 180 patients received the vaccine between that date and 16Aug2021.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   42 cartons of Moderna COVID-19 vaccine were received on 27-MAR-2021, which were placed in refrigerator at a temperature of 7.5°C on 28-MAR-2021 and thus it was viable for 30 days.  No concomitant product information was provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Suspect drug Lot number, temperature details were updated. On 30-Aug-2021: Follow up received and contains no new information. On 30-Aug-2021: Follow up received and contains no new information. On 30-Aug-2021: Reporter's contact number and  the temperature range was 7.5°C for the refrigerator were added.
Age: 92.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Peripheral swelling
Clinical narrative: Feel it's a little different; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel it's a little different) and PERIPHERAL SWELLING (Swollen) in a 92-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063E21A) for COVID-19 vaccination.     Concomitant products included AMOXICILLIN, METOPROLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), ESCITALOPRAM OXALATE (LEXAPRO) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feel it's a little different) and PERIPHERAL SWELLING (Swollen). At the time of the report, FEELING ABNORMAL (Feel it's a little different) and PERIPHERAL SWELLING (Swollen) outcome was unknown.            Concomitant medications include cholesterol meds.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: severe sympton of whole body itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (severe sympton of whole body itching) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Depression. Concomitant products included VALPROATE SODIUM (ENCORATE) and MIRTAZAPINE for Depression.    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 PRURITUS (severe sympton of whole body itching). At the time of the report, PRURITUS (severe sympton of whole body itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Feeding disorder, Headache, Nausea
Clinical narrative: every time she drinks something it makes her stomach turn.; can't eat and unable to keep food or solids down. She reported that she is just able to drink fluids currently; wakes up in cold sweats at night; she became "queasy",; the chills like a burning cold sensation inside of her body; nausea; fever; headache; pain in right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in right arm), FEEDING DISORDER (can't eat and unable to keep food or solids down. She reported that she is just able to drink fluids currently), COLD SWEAT (wakes up in cold sweats at night), NAUSEA (she became "queasy",) and CHILLS (the chills like a burning cold sensation inside of her body) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine on 16-Mar-2021 and Pfizer COVID-19 vaccine on 07-Apr-2021.    On 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN IN EXTREMITY (pain in right arm), NAUSEA (nausea), PYREXIA (fever) and HEADACHE (headache). On 21-Aug-2021, the patient experienced FEEDING DISORDER (can't eat and unable to keep food or solids down. She reported that she is just able to drink fluids currently), COLD SWEAT (wakes up in cold sweats at night), NAUSEA (she became "queasy",) and CHILLS (the chills like a burning cold sensation inside of her body). On 24-Aug-2021, the patient experienced VOMITING (every time she drinks something it makes her stomach turn.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 18-Aug-2021, PAIN IN EXTREMITY (pain in right arm), NAUSEA (nausea), PYREXIA (fever) and HEADACHE (headache) had resolved. At the time of the report, FEEDING DISORDER (can't eat and unable to keep food or solids down. She reported that she is just able to drink fluids currently) and COLD SWEAT (wakes up in cold sweats at night) outcome was unknown and NAUSEA (she became "queasy",), CHILLS (the chills like a burning cold sensation inside of her body) and VOMITING (every time she drinks something it makes her stomach turn.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. On 22-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.         The patient was not taking any concomitant medications.  Patient stated that the doctor ordered some tests for her, but the results were not come back yet and mentioned her doctor thought the events could be associated with a stomach bug but was unsure.