chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Dizziness, Feeling drunk, Lip swelling, Swollen tongue
Clinical narrative: Tongue started swelling; Lips started swelling; Felt Dizzy; Felt Drunk; Blood pressure dropped; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue started swelling), LIP SWELLING (Lips started swelling), DIZZINESS (Felt Dizzy), FEELING DRUNK (Felt Drunk) and BLOOD PRESSURE DECREASED (Blood pressure dropped) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Food allergy (allergic to garlic, strawberry) since an unknown date, Allergy to nuts (peanut) since an unknown date, Allergy to molds since an unknown date, Allergy to animals (dogs, cats) since an unknown date, Pollen allergy since an unknown date, Grass allergy since an unknown date and Dust allergy since an unknown date.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 23-Mar-2021, the patient experienced SWOLLEN TONGUE (Tongue started swelling). 23-Mar-2021, the patient experienced LIP SWELLING (Lips started swelling), DIZZINESS (Felt Dizzy), FEELING DRUNK (Felt Drunk) and BLOOD PRESSURE DECREASED (Blood pressure dropped). On 24-Mar-2021, SWOLLEN TONGUE (Tongue started swelling) and LIP SWELLING (Lips started swelling) had resolved. On 26-Mar-2021, DIZZINESS (Felt Dizzy) and BLOOD PRESSURE DECREASED (Blood pressure dropped) had resolved. Benadryl helped with the reaction.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Blood pressure measurement: unk decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer reached out to her physician and cardiologist, who recommended she does not get the second dose of the vaccine. Consumer inquiring if she should get the 2nd dose of the vaccine. Consumer gave safety consent to follow up via phone  There is no product complaint associated with this case   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Scleral haemorrhage, Vaccine positive rechallenge
Clinical narrative: Scleral hemorrhaging of the right eye; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SCLERAL HAEMORRHAGE (Scleral hemorrhaging of the right eye) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus, Hypertension and High cholesterol.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SCLERAL HAEMORRHAGE (Scleral hemorrhaging of the right eye). On 16-Mar-2021, SCLERAL HAEMORRHAGE (Scleral hemorrhaging of the right eye) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SCLERAL HAEMORRHAGE (Scleral hemorrhaging of the right eye) to be possibly related.    Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-072123 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up information included Patient information, Event outcome, Other relevant history and dose information. On 27-Apr-2021: NNI; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. Further information has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Scleral haemorrhage
Clinical narrative: Scleral hemorrhaging of the right eye; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SCLERAL HAEMORRHAGE (Scleral hemorrhaging of the right eye) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus, Hypertension and High cholesterol.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SCLERAL HAEMORRHAGE (Scleral hemorrhaging of the right eye). On 16-Mar-2021, SCLERAL HAEMORRHAGE (Scleral hemorrhaging of the right eye) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SCLERAL HAEMORRHAGE (Scleral hemorrhaging of the right eye) to be possibly related.    Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-072123 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up information included Patient information, Event outcome, Other relevant history and dose information. On 27-Apr-2021: NNI; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. Further information has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Death, Malaise, Respiratory arrest, Resuscitation
Clinical narrative: He started experiencing achiness, fatigue and feeling under the weather the day after the vaccine.  Similiar to the normal vaccine reaction that people are experiencing.  But then he began saying that symptoms were coming in waves.   Was more fatigued. But then after dinner a little over 48 hours after the vaccine he went to lay down to rest and was found unresponsive 10 minutes later.  HE was unable to be revived and died at home at 8:15 PM 4/11/21 2 days after his vaccine
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: He started experiencing achiness, fatigue and feeling under the weather the day after the vaccine.  Similiar to the normal vaccine reaction that people are experiencing.  But then he began saying that symptoms were coming in waves.   Was more fatigued. But then after dinner a little over 48 hours after the vaccine he went to lay down to rest and was found unresponsive 10 minutes later.  HE was unable to be revived and died at home at 8:15 PM 4/11/21 2 days after his vaccine
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Back pain, Chest discomfort, Chest pain, Death, Fatigue
Clinical narrative: He started experiencing achiness, fatigue and feeling under the weather the day after the vaccine.  Similiar to the normal vaccine reaction that people are experiencing.  But then he began saying that symptoms were coming in waves.   Was more fatigued. But then after dinner a little over 48 hours after the vaccine he went to lay down to rest and was found unresponsive 10 minutes later.  HE was unable to be revived and died at home at 8:15 PM 4/11/21 2 days after his vaccine
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Resuscitation, Unresponsive to stimuli
Clinical narrative: He started experiencing achiness, fatigue and feeling under the weather the day after the vaccine.  Similiar to the normal vaccine reaction that people are experiencing.  But then he began saying that symptoms were coming in waves.   Was more fatigued. But then after dinner a little over 48 hours after the vaccine he went to lay down to rest and was found unresponsive 10 minutes later.  HE was unable to be revived and died at home at 8:15 PM 4/11/21 2 days after his vaccine
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Death, Fatigue, Myalgia, Pulse absent, Resuscitation
Clinical narrative: He started experiencing achiness, fatigue and feeling under the weather the day after the vaccine.  Similiar to the normal vaccine reaction that people are experiencing.  But then he began saying that symptoms were coming in waves.   Was more fatigued. But then after dinner a little over 48 hours after the vaccine he went to lay down to rest and was found unresponsive 10 minutes later.  HE was unable to be revived and died at home at 8:15 PM 4/11/21 2 days after his vaccine
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Autopsy, Cardiac hypertrophy, Congestive cardiomyopathy, Coronary artery disease, Fatigue
Clinical narrative: He started experiencing achiness, fatigue and feeling under the weather the day after the vaccine.  Similiar to the normal vaccine reaction that people are experiencing.  But then he began saying that symptoms were coming in waves.   Was more fatigued. But then after dinner a little over 48 hours after the vaccine he went to lay down to rest and was found unresponsive 10 minutes later.  HE was unable to be revived and died at home at 8:15 PM 4/11/21 2 days after his vaccine
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Malaise, Pain, Pulmonary oedema, Resuscitation, Sudden death
Clinical narrative: He started experiencing achiness, fatigue and feeling under the weather the day after the vaccine.  Similiar to the normal vaccine reaction that people are experiencing.  But then he began saying that symptoms were coming in waves.   Was more fatigued. But then after dinner a little over 48 hours after the vaccine he went to lay down to rest and was found unresponsive 10 minutes later.  HE was unable to be revived and died at home at 8:15 PM 4/11/21 2 days after his vaccine
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: He started experiencing achiness, fatigue and feeling under the weather the day after the vaccine.  Similiar to the normal vaccine reaction that people are experiencing.  But then he began saying that symptoms were coming in waves.   Was more fatigued. But then after dinner a little over 48 hours after the vaccine he went to lay down to rest and was found unresponsive 10 minutes later.  HE was unable to be revived and died at home at 8:15 PM 4/11/21 2 days after his vaccine
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to a patient under 18 years of age old.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a patient under 18 years of age old.) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a patient under 18 years of age old.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a patient under 18 years of age old.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Mobility decreased, Muscular weakness, Pain
Clinical narrative: injected arm was mostly limp at the shoulder; muscle weakness; sleep on and off until getting up at 17h after; pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (injected arm was mostly limp at the shoulder), MUSCULAR WEAKNESS (muscle weakness), HYPERSOMNIA (sleep on and off until getting up at 17h after) and VACCINATION SITE PAIN (pain) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Patient has not been diagnosed with/ tested positive for COVID-19.  The patient's past medical history included Sleep disorder and Kidney stones. Concurrent medical conditions included Drug allergy. Concomitant products included COLECALCIFEROL (VITAMIN D 3) from 02-Oct-2020 to an unknown date for Vitamin D deficiency.    On 17-Apr-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021 at 4:00 PM, the patient experienced VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (injected arm was mostly limp at the shoulder), MUSCULAR WEAKNESS (muscle weakness), HYPERSOMNIA (sleep on and off until getting up at 17h after) and VACCINATION SITE PAIN (pain). On 18-Apr-2021, VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (injected arm was mostly limp at the shoulder) and MUSCULAR WEAKNESS (muscle weakness) had resolved. At the time of the report, HYPERSOMNIA (sleep on and off until getting up at 17h after) and VACCINATION SITE PAIN (pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The consumer reportedly took 1 capsule of ibuprofen 18 hours after vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: non significant follow up appended
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersomnia, Muscular weakness, Vaccination site joint movement impairment, Vaccination site pain
Clinical narrative: injected arm was mostly limp at the shoulder; muscle weakness; sleep on and off until getting up at 17h after; pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (injected arm was mostly limp at the shoulder), MUSCULAR WEAKNESS (muscle weakness), HYPERSOMNIA (sleep on and off until getting up at 17h after) and VACCINATION SITE PAIN (pain) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Patient has not been diagnosed with/ tested positive for COVID-19.  The patient's past medical history included Sleep disorder and Kidney stones. Concurrent medical conditions included Drug allergy. Concomitant products included COLECALCIFEROL (VITAMIN D 3) from 02-Oct-2020 to an unknown date for Vitamin D deficiency.    On 17-Apr-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021 at 4:00 PM, the patient experienced VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (injected arm was mostly limp at the shoulder), MUSCULAR WEAKNESS (muscle weakness), HYPERSOMNIA (sleep on and off until getting up at 17h after) and VACCINATION SITE PAIN (pain). On 18-Apr-2021, VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (injected arm was mostly limp at the shoulder) and MUSCULAR WEAKNESS (muscle weakness) had resolved. At the time of the report, HYPERSOMNIA (sleep on and off until getting up at 17h after) and VACCINATION SITE PAIN (pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The consumer reportedly took 1 capsule of ibuprofen 18 hours after vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: non significant follow up appended
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Blood culture, Blood test, Haematocrit
Clinical narrative: I could barely stand; aches and pains came back; I can't work out like I used to and I tend to stay seated; low grade fever / 103 fever; PVC; Heart irregularities; joint pain; muscle pain; typical chills; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR EXTRASYSTOLES (PVC), HEART ALTERNATION (Heart irregularities), DYSSTASIA (I could barely stand), MYALGIA (aches and pains came back) and ARTHRALGIA (joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     current condition were not provided.  Concurrent medical conditions included Drug allergy (Allergic to sulfa). Concomitant products included BUPROPION and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). In March 2021, the patient experienced CHILLS (typical chills). On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART ALTERNATION (Heart irregularities). On 21-Mar-2021, the patient experienced VENTRICULAR EXTRASYSTOLES (PVC) and PYREXIA (low grade fever / 103 fever). On an unknown date, the patient experienced DYSSTASIA (I could barely stand), MYALGIA (aches and pains came back) and FATIGUE (I can't work out like I used to and I tend to stay seated). In March 2021, CHILLS (typical chills) had resolved. On 09-May-2021, VENTRICULAR EXTRASYSTOLES (PVC) and PYREXIA (low grade fever / 103 fever) had resolved. At the time of the report, HEART ALTERNATION (Heart irregularities), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had not resolved and DYSSTASIA (I could barely stand), MYALGIA (aches and pains came back) and FATIGUE (I can't work out like I used to and I tend to stay seated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: unknown (abnormal) Blood pressure increased.. In March 2021, Body temperature: 103 (High) Fever. On an unknown date, Blood test: unknown (normal) Normal. On an unknown date, SARS-CoV-2 test: unknown (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab tests  included Arthritic- ANA,ASO,RF,LYME,CCP,ESR ; CRP, Complete blood count, CK Total, comprehensive metabolic panel, TSH, FT4. Treatment  included acupuncture was noted.     Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: follow up received included new Adverse events and lab data allergy status,concomitant were added
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Palpitations, Pyrexia
Clinical narrative: I could barely stand; aches and pains came back; I can't work out like I used to and I tend to stay seated; low grade fever / 103 fever; PVC; Heart irregularities; joint pain; muscle pain; typical chills; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR EXTRASYSTOLES (PVC), HEART ALTERNATION (Heart irregularities), DYSSTASIA (I could barely stand), MYALGIA (aches and pains came back) and ARTHRALGIA (joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     current condition were not provided.  Concurrent medical conditions included Drug allergy (Allergic to sulfa). Concomitant products included BUPROPION and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). In March 2021, the patient experienced CHILLS (typical chills). On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART ALTERNATION (Heart irregularities). On 21-Mar-2021, the patient experienced VENTRICULAR EXTRASYSTOLES (PVC) and PYREXIA (low grade fever / 103 fever). On an unknown date, the patient experienced DYSSTASIA (I could barely stand), MYALGIA (aches and pains came back) and FATIGUE (I can't work out like I used to and I tend to stay seated). In March 2021, CHILLS (typical chills) had resolved. On 09-May-2021, VENTRICULAR EXTRASYSTOLES (PVC) and PYREXIA (low grade fever / 103 fever) had resolved. At the time of the report, HEART ALTERNATION (Heart irregularities), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had not resolved and DYSSTASIA (I could barely stand), MYALGIA (aches and pains came back) and FATIGUE (I can't work out like I used to and I tend to stay seated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: unknown (abnormal) Blood pressure increased.. In March 2021, Body temperature: 103 (High) Fever. On an unknown date, Blood test: unknown (normal) Normal. On an unknown date, SARS-CoV-2 test: unknown (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab tests  included Arthritic- ANA,ASO,RF,LYME,CCP,ESR ; CRP, Complete blood count, CK Total, comprehensive metabolic panel, TSH, FT4. Treatment  included acupuncture was noted.     Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: follow up received included new Adverse events and lab data allergy status,concomitant were added
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure measurement, Blood test, Body temperature, Chills
Clinical narrative: I could barely stand; aches and pains came back; I can't work out like I used to and I tend to stay seated; low grade fever / 103 fever; PVC; Heart irregularities; joint pain; muscle pain; typical chills; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR EXTRASYSTOLES (PVC), HEART ALTERNATION (Heart irregularities), DYSSTASIA (I could barely stand), MYALGIA (aches and pains came back) and ARTHRALGIA (joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     current condition were not provided.  Concurrent medical conditions included Drug allergy (Allergic to sulfa). Concomitant products included BUPROPION and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). In March 2021, the patient experienced CHILLS (typical chills). On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART ALTERNATION (Heart irregularities). On 21-Mar-2021, the patient experienced VENTRICULAR EXTRASYSTOLES (PVC) and PYREXIA (low grade fever / 103 fever). On an unknown date, the patient experienced DYSSTASIA (I could barely stand), MYALGIA (aches and pains came back) and FATIGUE (I can't work out like I used to and I tend to stay seated). In March 2021, CHILLS (typical chills) had resolved. On 09-May-2021, VENTRICULAR EXTRASYSTOLES (PVC) and PYREXIA (low grade fever / 103 fever) had resolved. At the time of the report, HEART ALTERNATION (Heart irregularities), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had not resolved and DYSSTASIA (I could barely stand), MYALGIA (aches and pains came back) and FATIGUE (I can't work out like I used to and I tend to stay seated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: unknown (abnormal) Blood pressure increased.. In March 2021, Body temperature: 103 (High) Fever. On an unknown date, Blood test: unknown (normal) Normal. On an unknown date, SARS-CoV-2 test: unknown (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab tests  included Arthritic- ANA,ASO,RF,LYME,CCP,ESR ; CRP, Complete blood count, CK Total, comprehensive metabolic panel, TSH, FT4. Treatment  included acupuncture was noted.     Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: follow up received included new Adverse events and lab data allergy status,concomitant were added
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Fatigue, Heart alternation, Myalgia, Pyrexia
Clinical narrative: I could barely stand; aches and pains came back; I can't work out like I used to and I tend to stay seated; low grade fever / 103 fever; PVC; Heart irregularities; joint pain; muscle pain; typical chills; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR EXTRASYSTOLES (PVC), HEART ALTERNATION (Heart irregularities), DYSSTASIA (I could barely stand), MYALGIA (aches and pains came back) and ARTHRALGIA (joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     current condition were not provided.  Concurrent medical conditions included Drug allergy (Allergic to sulfa). Concomitant products included BUPROPION and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). In March 2021, the patient experienced CHILLS (typical chills). On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART ALTERNATION (Heart irregularities). On 21-Mar-2021, the patient experienced VENTRICULAR EXTRASYSTOLES (PVC) and PYREXIA (low grade fever / 103 fever). On an unknown date, the patient experienced DYSSTASIA (I could barely stand), MYALGIA (aches and pains came back) and FATIGUE (I can't work out like I used to and I tend to stay seated). In March 2021, CHILLS (typical chills) had resolved. On 09-May-2021, VENTRICULAR EXTRASYSTOLES (PVC) and PYREXIA (low grade fever / 103 fever) had resolved. At the time of the report, HEART ALTERNATION (Heart irregularities), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had not resolved and DYSSTASIA (I could barely stand), MYALGIA (aches and pains came back) and FATIGUE (I can't work out like I used to and I tend to stay seated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: unknown (abnormal) Blood pressure increased.. In March 2021, Body temperature: 103 (High) Fever. On an unknown date, Blood test: unknown (normal) Normal. On an unknown date, SARS-CoV-2 test: unknown (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab tests  included Arthritic- ANA,ASO,RF,LYME,CCP,ESR ; CRP, Complete blood count, CK Total, comprehensive metabolic panel, TSH, FT4. Treatment  included acupuncture was noted.     Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: follow up received included new Adverse events and lab data allergy status,concomitant were added
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Ventricular extrasystoles
Clinical narrative: I could barely stand; aches and pains came back; I can't work out like I used to and I tend to stay seated; low grade fever / 103 fever; PVC; Heart irregularities; joint pain; muscle pain; typical chills; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR EXTRASYSTOLES (PVC), HEART ALTERNATION (Heart irregularities), DYSSTASIA (I could barely stand), MYALGIA (aches and pains came back) and ARTHRALGIA (joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     current condition were not provided.  Concurrent medical conditions included Drug allergy (Allergic to sulfa). Concomitant products included BUPROPION and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). In March 2021, the patient experienced CHILLS (typical chills). On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART ALTERNATION (Heart irregularities). On 21-Mar-2021, the patient experienced VENTRICULAR EXTRASYSTOLES (PVC) and PYREXIA (low grade fever / 103 fever). On an unknown date, the patient experienced DYSSTASIA (I could barely stand), MYALGIA (aches and pains came back) and FATIGUE (I can't work out like I used to and I tend to stay seated). In March 2021, CHILLS (typical chills) had resolved. On 09-May-2021, VENTRICULAR EXTRASYSTOLES (PVC) and PYREXIA (low grade fever / 103 fever) had resolved. At the time of the report, HEART ALTERNATION (Heart irregularities), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had not resolved and DYSSTASIA (I could barely stand), MYALGIA (aches and pains came back) and FATIGUE (I can't work out like I used to and I tend to stay seated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: unknown (abnormal) Blood pressure increased.. In March 2021, Body temperature: 103 (High) Fever. On an unknown date, Blood test: unknown (normal) Normal. On an unknown date, SARS-CoV-2 test: unknown (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab tests  included Arthritic- ANA,ASO,RF,LYME,CCP,ESR ; CRP, Complete blood count, CK Total, comprehensive metabolic panel, TSH, FT4. Treatment  included acupuncture was noted.     Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: follow up received included new Adverse events and lab data allergy status,concomitant were added
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Discomfort, Disturbance in attention, Headache
Clinical narrative: severe headache; high fever; Body ache; Excrutiating  right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 04-May-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Excrutiating  right arm), HEADACHE (severe headache), PYREXIA (high fever) and PAIN (Body ache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Pain (Pain currently at 2/10, though it was 5 to 6/10 earlier , and 10 being the highest she has experienced.) on 23-Apr-2021.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Excrutiating  right arm). On 23-Apr-2021, the patient experienced HEADACHE (severe headache), PYREXIA (high fever) and PAIN (Body ache). At the time of the report, PAIN IN EXTREMITY (Excrutiating  right arm) had not resolved and HEADACHE (severe headache), PYREXIA (high fever) and PAIN (Body ache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Pyrexia: 103.5 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       24 hours after the vaccine shot she took Ibuprofen (Advil) for fever and tramadol injection for the shoulder pain . she was also put on high dose of steroid pack, Methyl prednisolone, acetaminophen and oxytocom given by her primary care provider. Patient had a phone consultation with the neurologist and was prescribed ; Gabapentin , ibuprofen(Advil), Tramadol and she will be going for her next visit to the neurologist on 11 May2021 She added she also takes stamina oil capsules and Diphenhydramine to help with then pain.   This case was linked to MOD-2021-101838 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Insomnia, Neck pain, Paraesthesia, Pyrexia
Clinical narrative: severe headache; high fever; Body ache; Excrutiating  right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 04-May-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Excrutiating  right arm), HEADACHE (severe headache), PYREXIA (high fever) and PAIN (Body ache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Pain (Pain currently at 2/10, though it was 5 to 6/10 earlier , and 10 being the highest she has experienced.) on 23-Apr-2021.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Excrutiating  right arm). On 23-Apr-2021, the patient experienced HEADACHE (severe headache), PYREXIA (high fever) and PAIN (Body ache). At the time of the report, PAIN IN EXTREMITY (Excrutiating  right arm) had not resolved and HEADACHE (severe headache), PYREXIA (high fever) and PAIN (Body ache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Pyrexia: 103.5 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       24 hours after the vaccine shot she took Ibuprofen (Advil) for fever and tramadol injection for the shoulder pain . she was also put on high dose of steroid pack, Methyl prednisolone, acetaminophen and oxytocom given by her primary care provider. Patient had a phone consultation with the neurologist and was prescribed ; Gabapentin , ibuprofen(Advil), Tramadol and she will be going for her next visit to the neurologist on 11 May2021 She added she also takes stamina oil capsules and Diphenhydramine to help with then pain.   This case was linked to MOD-2021-101838 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Radiculitis brachial, Vomiting
Clinical narrative: severe headache; high fever; Body ache; Excrutiating  right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 04-May-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Excrutiating  right arm), HEADACHE (severe headache), PYREXIA (high fever) and PAIN (Body ache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Pain (Pain currently at 2/10, though it was 5 to 6/10 earlier , and 10 being the highest she has experienced.) on 23-Apr-2021.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Excrutiating  right arm). On 23-Apr-2021, the patient experienced HEADACHE (severe headache), PYREXIA (high fever) and PAIN (Body ache). At the time of the report, PAIN IN EXTREMITY (Excrutiating  right arm) had not resolved and HEADACHE (severe headache), PYREXIA (high fever) and PAIN (Body ache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Pyrexia: 103.5 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       24 hours after the vaccine shot she took Ibuprofen (Advil) for fever and tramadol injection for the shoulder pain . she was also put on high dose of steroid pack, Methyl prednisolone, acetaminophen and oxytocom given by her primary care provider. Patient had a phone consultation with the neurologist and was prescribed ; Gabapentin , ibuprofen(Advil), Tramadol and she will be going for her next visit to the neurologist on 11 May2021 She added she also takes stamina oil capsules and Diphenhydramine to help with then pain.   This case was linked to MOD-2021-101838 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: severe headache; high fever; Body ache; Excrutiating  right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 04-May-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Excrutiating  right arm), HEADACHE (severe headache), PYREXIA (high fever) and PAIN (Body ache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Pain (Pain currently at 2/10, though it was 5 to 6/10 earlier , and 10 being the highest she has experienced.) on 23-Apr-2021.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Excrutiating  right arm). On 23-Apr-2021, the patient experienced HEADACHE (severe headache), PYREXIA (high fever) and PAIN (Body ache). At the time of the report, PAIN IN EXTREMITY (Excrutiating  right arm) had not resolved and HEADACHE (severe headache), PYREXIA (high fever) and PAIN (Body ache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Pyrexia: 103.5 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       24 hours after the vaccine shot she took Ibuprofen (Advil) for fever and tramadol injection for the shoulder pain . she was also put on high dose of steroid pack, Methyl prednisolone, acetaminophen and oxytocom given by her primary care provider. Patient had a phone consultation with the neurologist and was prescribed ; Gabapentin , ibuprofen(Advil), Tramadol and she will be going for her next visit to the neurologist on 11 May2021 She added she also takes stamina oil capsules and Diphenhydramine to help with then pain.   This case was linked to MOD-2021-101838 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: fever of 102.5 degrees Fahrenheit; chills; muscle aches; swollen lymph node under arm for 2 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever of 102.5 degrees Fahrenheit), CHILLS (chills), MYALGIA (muscle aches) and LYMPHADENOPATHY (swollen lymph node under arm for 2 days) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PYREXIA (fever of 102.5 degrees Fahrenheit), CHILLS (chills), MYALGIA (muscle aches) and LYMPHADENOPATHY (swollen lymph node under arm for 2 days). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 24-Feb-2021, PYREXIA (fever of 102.5 degrees Fahrenheit), CHILLS (chills), MYALGIA (muscle aches) and LYMPHADENOPATHY (swollen lymph node under arm for 2 days) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5 (High) 102. degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.   This case was linked to MOD-2021-091776 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: fever of 102.5 degrees Fahrenheit; chills; muscle aches; swollen lymph node under arm for 2 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever of 102.5 degrees Fahrenheit), CHILLS (chills), MYALGIA (muscle aches) and LYMPHADENOPATHY (swollen lymph node under arm for 2 days) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PYREXIA (fever of 102.5 degrees Fahrenheit), CHILLS (chills), MYALGIA (muscle aches) and LYMPHADENOPATHY (swollen lymph node under arm for 2 days). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 24-Feb-2021, PYREXIA (fever of 102.5 degrees Fahrenheit), CHILLS (chills), MYALGIA (muscle aches) and LYMPHADENOPATHY (swollen lymph node under arm for 2 days) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5 (High) 102. degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.   This case was linked to MOD-2021-091776 (Patient Link).   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Pain in extremity, Rash erythematous
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), CONTUSION (Bruise on top of the rash), ERYTHEMA (Large red patch), PRURITUS (Occasional itch) and VACCINATION SITE RASH (Rash over left arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034CZ1A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hay fever and Hives. Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Seasonal allergy.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021 at 11:40 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction), CONTUSION (Bruise on top of the rash), ERYTHEMA (Large red patch), PRURITUS (Occasional itch), VACCINATION SITE RASH (Rash over left arm) and VACCINATION SITE ERYTHEMA (Redness below & to side of injection site). On 05-May-2021, HYPERSENSITIVITY (Hypersensitivity reaction), CONTUSION (Bruise on top of the rash), ERYTHEMA (Large red patch), PRURITUS (Occasional itch), VACCINATION SITE RASH (Rash over left arm) and VACCINATION SITE ERYTHEMA (Redness below & to side of injection site) had resolved.            No treatment medications were taken by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up information received on 11-JUN-2021 contains significant information: Added patient demographics, medical history (Hives/urticaria, Hay fever), 2nd dose vaccine information (start date, batch number, site of vaccine administration). On 29-APR-2021, new events "Hypersensitivity reaction", "Large red patch", "Occasional itch" were added which resolved on 05-MAY-2021.