chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Weight decreased
Clinical narrative: Not getting 2nd dose; Left breast is swollen; Shortness of breath; Loss of smell; Loss of taste; Lost a lot of weight; diarrhea; She can't lift arm, can't do all the things she used to be able to do; Left breast is very painful; She is afraid; Swollen lymph of nodes; Muscle fatigue; Lump at injection site; heart beats quickly; Headache every night; Feels like she is wasting away; This spontaneous case was reported by a consumer and describes the occurrence of CACHEXIA (Feels like she is wasting away) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced CACHEXIA (Feels like she is wasting away) (seriousness criterion medically significant), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful),  FEAR (She is afraid), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), INJECTION SITE MASS (Lump at injection site), HEART RATE INCREASED (heart beats quickly), and HEADACHE (Headache every night). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 UNK. At the time of the report, CACHEXIA (Feels like she is wasting away), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), HEART RATE INCREASED (heart beats quickly), INJECTION SITE MASS (Lump at injection site) and HEADACHE (Headache every night) had not resolved and FEAR (She is afraid) and PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Heart rate: increased (Inconclusive) heart beats quickly.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.        Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start  date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Loss of consciousness, Malaise, Myalgia
Clinical narrative: This morning I still felt bad but not as bad, felt exhausted; Still feel drained right now and sore, achy; Having aches; Chills; Passed out, became unconscious; Generally not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out, became unconscious) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DRONEDARONE HYDROCHLORIDE (MULTAQ), RISPERIDONE, METOPROLOL, APIXABAN (ELIQUIS), TEMAZEPAM and TOPIRAMATE for an unknown indication.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out, became unconscious) (seriousness criterion medically significant), MALAISE (Generally not feeling well), MYALGIA (Having aches) and CHILLS (Chills). On 13-Jun-2021, the patient experienced FATIGUE (This morning I still felt bad but not as bad, felt exhausted) and MYALGIA (Still feel drained right now and sore, achy). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 13-Jun-2021, LOSS OF CONSCIOUSNESS (Passed out, became unconscious), MALAISE (Generally not feeling well), MYALGIA (Having aches) and CHILLS (Chills) had resolved. At the time of the report, FATIGUE (This morning I still felt bad but not as bad, felt exhausted) and MYALGIA (Still feel drained right now and sore, achy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment include fluids.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Breast discolouration, Peripheral coldness, Thrombosis, Vaccination site discolouration
Clinical narrative: Blood clots; Tiny dots are showing up on arm of injection site; One larger dot on breast; Cold feeling in arm; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 THROMBOSIS (Blood clots) (seriousness criterion medically significant), VACCINATION SITE DISCOLOURATION (Tiny dots are showing up on arm of injection site), BREAST DISCOLOURATION (One larger dot on breast) and PERIPHERAL COLDNESS (Cold feeling in arm). At the time of the report, THROMBOSIS (Blood clots), VACCINATION SITE DISCOLOURATION (Tiny dots are showing up on arm of injection site), BREAST DISCOLOURATION (One larger dot on breast) and PERIPHERAL COLDNESS (Cold feeling in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.   Company Comment   Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Eclampsia, Exposure during pregnancy, Intentional product use issue
Clinical narrative: eclampsia; Deep vein thrombosis on her right leg/ blood clot; scheduled for second shot on 09-Jun-2021 but did not receive due to complications with pregnancy; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ECLAMPSIA (eclampsia) and DEEP VEIN THROMBOSIS (Deep vein thrombosis on her right leg/ blood clot) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included NIFEDIPINE (PROCARDIA [NIFEDIPINE]) and LEVOFLOXACIN (LOVENOX [LEVOFLOXACIN]) for an unknown indication.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 20-May-2021. On 12-May-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 09-Jun-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (scheduled for second shot on 09-Jun-2021 but did not receive due to complications with pregnancy). On an unknown date, the patient experienced ECLAMPSIA (eclampsia) (seriousness criterion medically significant) and DEEP VEIN THROMBOSIS (Deep vein thrombosis on her right leg/ blood clot) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 12-May-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. On 09-Jun-2021, INTENTIONAL PRODUCT USE ISSUE (scheduled for second shot on 09-Jun-2021 but did not receive due to complications with pregnancy) had resolved. At the time of the report, ECLAMPSIA (eclampsia) and DEEP VEIN THROMBOSIS (Deep vein thrombosis on her right leg/ blood clot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  The reporter stated that while screening for 2nd dose that was scheduled for 09-Jun-2021, patient checked yes for blood thinner and blood clot.  Company Comment  This is a case of product exposure during pregnancy and intentional product use issue with associated AEs of eclampsia and deep vein thrombosis reported for this 40-year-old female. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: This is a case of product exposure during pregnancy and intentional product use issue with associated AEs of eclampsia and deep vein thrombosis reported for this 40-year-old female. Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Peripheral swelling, Thrombosis, Ultrasound scan
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant), PERIPHERAL SWELLING (leg swollen) and CHEST DISCOMFORT (pressure in chest). At the time of the report, THROMBOSIS (blood clots), PERIPHERAL SWELLING (leg swollen) and CHEST DISCOMFORT (pressure in chest) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: abnormal (abnormal) Blood clots. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On an unknown date, a couple weeks after vaccination, the patient experienced THROMBOSIS (blood clots) (seriousness criteria medically significant), PERIPHERAL SWELLING (leg swollen) and CHEST DISCOMFORT (pressure in chest). Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Loss of consciousness, Vaccination site haemorrhage
Clinical narrative: Like he was going to pass out; Weakness; Cold sweat; The vaccinator pulled out the needle, blood came out and ran down his arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Like he was going to pass out) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Passed out (Patient has history of passing out when blood drawn from right arm as it usually hits a nerve).   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Like he was going to pass out) (seriousness criterion medically significant), ASTHENIA (Weakness), COLD SWEAT (Cold sweat) and VACCINATION SITE HAEMORRHAGE (The vaccinator pulled out the needle, blood came out and ran down his arm). At the time of the report, LOSS OF CONSCIOUSNESS (Like he was going to pass out), ASTHENIA (Weakness), COLD SWEAT (Cold sweat) and VACCINATION SITE HAEMORRHAGE (The vaccinator pulled out the needle, blood came out and ran down his arm) outcome was unknown.            Patient has drank water & ate M&M to relieve the  symptoms.   No relevant concomitant medications were reported.      Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's history of 'passing out when he gets blood drawn on his right arm because they usually hit a nerve' is a confounding factor that may play a possible contributory role.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were provided.  It was reported that a person died after receiving a COVID-19 vaccine. No further details were provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pericarditis, Presyncope, Vaccination complication, Vertigo
Clinical narrative: chest pain over left side of the sternum when touched the area is very painful...pericarditis; Vertigo symptom/my head was spinning so badly; started to throw up profusely; dizziness was so bad; first time I am experiencing a reaction; about to pass out; This spontaneous case was reported by a dentist and describes the occurrence of PERICARDITIS (developed chest pain over left side of the sternum when touched the area is very painful, so I strongly believe its pericarditis) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced DIZZINESS (The dizziness was so bad, I thought that, "I am going to die"), VACCINATION COMPLICATION (this was the first time I am experiencing a reaction ) and PRESYNCOPE (about to pass out). On 06-Jun-2021 at 2:00 AM, the patient experienced VERTIGO (Vertigo symptom/my head was spinning so badly) and VOMITING (started to throw up profusely). On 06-Jun-2021 at 4:00 PM, the patient experienced PERICARDITIS (developed chest pain over left side of the sternum when touched the area is very painful, so I strongly believe its pericarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (very sick). The patient was treated with IBUPROFEN for Pericarditis, at a dose of 1 dosage form, unknown. On 06-Jun-2021, VERTIGO (Vertigo symptom/my head was spinning so badly), DIZZINESS (The dizziness was so bad, I thought that, "I am going to die"), PRESYNCOPE (about to pass out) and VOMITING (started to throw up profusely) had resolved. At the time of the report, PERICARDITIS (developed chest pain over left side of the sternum when touched the area is very painful, so I strongly believe its pericarditis) had not resolved and ILLNESS (very sick) outcome was unknown.     The outcome of the event of VACCINATION COMPLICATION (this was the first time I am experiencing a reaction ) was resolved.   mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter noted he never had any adverse reaction after taking any medications before and this was the first time he was experiencing a reaction. He reported to be a healthy person before and now after receiving the Moderna vaccine, he is very sick. The reporter stated that he "will not take the 2nd dose of Moderna vaccine."; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: chest pain over left side of the sternum when touched the area is very painful...pericarditis; Vertigo symptom/my head was spinning so badly; started to throw up profusely; dizziness was so bad; first time I am experiencing a reaction; about to pass out; This spontaneous case was reported by a dentist and describes the occurrence of PERICARDITIS (developed chest pain over left side of the sternum when touched the area is very painful, so I strongly believe its pericarditis) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced DIZZINESS (The dizziness was so bad, I thought that, "I am going to die"), VACCINATION COMPLICATION (this was the first time I am experiencing a reaction ) and PRESYNCOPE (about to pass out). On 06-Jun-2021 at 2:00 AM, the patient experienced VERTIGO (Vertigo symptom/my head was spinning so badly) and VOMITING (started to throw up profusely). On 06-Jun-2021 at 4:00 PM, the patient experienced PERICARDITIS (developed chest pain over left side of the sternum when touched the area is very painful, so I strongly believe its pericarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (very sick). The patient was treated with IBUPROFEN for Pericarditis, at a dose of 1 dosage form, unknown. On 06-Jun-2021, VERTIGO (Vertigo symptom/my head was spinning so badly), DIZZINESS (The dizziness was so bad, I thought that, "I am going to die"), PRESYNCOPE (about to pass out) and VOMITING (started to throw up profusely) had resolved. At the time of the report, PERICARDITIS (developed chest pain over left side of the sternum when touched the area is very painful, so I strongly believe its pericarditis) had not resolved and ILLNESS (very sick) outcome was unknown.     The outcome of the event of VACCINATION COMPLICATION (this was the first time I am experiencing a reaction ) was resolved.   mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter noted he never had any adverse reaction after taking any medications before and this was the first time he was experiencing a reaction. He reported to be a healthy person before and now after receiving the Moderna vaccine, he is very sick. The reporter stated that he "will not take the 2nd dose of Moderna vaccine."; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac flutter, Cardiac stress test, Chest pain, Electrocardiogram
Clinical narrative: Racing of heart; Stabbing in heart; Flutter once in a while; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Racing of heart) and CHEST PAIN (Stabbing in heart) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PALPITATIONS (Racing of heart) (seriousness criterion hospitalization), CHEST PAIN (Stabbing in heart) (seriousness criterion hospitalization) and CARDIAC FLUTTER (Flutter once in a while). The patient was hospitalized for 1 day due to CHEST PAIN and PALPITATIONS. They discharged her and told her to follow up with PCP. Her PCP did stress test and EKG on her and the results were normal. She did tell her PCP that she received the vaccine. She was not taking any medication before the possible adverse events. She was not started on any new medications after the vaccine. She is calling because the adverse events such as flutter once in a while, racing of heart are still ongoing. They happen occasionally.At the time of the report, PALPITATIONS (Racing of heart) and CARDIAC FLUTTER (Flutter once in a while) had not resolved and CHEST PAIN (Stabbing in heart) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Cardiac stress test: normal (normal) normal. In April 2021, Electrocardiogram: normal (normal) normal.         No relevant concomitant medications were reported.  On 01APR2021, the patient felt racing of heart and described the intensity as "stabbing in heart." Two weeks later she was hospitalized over night. The patient was not given any treatment or medications at the hospital and was told to follow-up with her PCP. Blood was drawn for 8 hours for lab work, the results of which were not provided.   This case was linked to MOD-2021-219135 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Date of birth corrected; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Racing of heart; Stabbing in heart; Flutter once in a while; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Racing of heart) and CHEST PAIN (Stabbing in heart) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PALPITATIONS (Racing of heart) (seriousness criterion hospitalization), CHEST PAIN (Stabbing in heart) (seriousness criterion hospitalization) and CARDIAC FLUTTER (Flutter once in a while). The patient was hospitalized for 1 day due to CHEST PAIN and PALPITATIONS. They discharged her and told her to follow up with PCP. Her PCP did stress test and EKG on her and the results were normal. She did tell her PCP that she received the vaccine. She was not taking any medication before the possible adverse events. She was not started on any new medications after the vaccine. She is calling because the adverse events such as flutter once in a while, racing of heart are still ongoing. They happen occasionally.At the time of the report, PALPITATIONS (Racing of heart) and CARDIAC FLUTTER (Flutter once in a while) had not resolved and CHEST PAIN (Stabbing in heart) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Cardiac stress test: normal (normal) normal. In April 2021, Electrocardiogram: normal (normal) normal.         No relevant concomitant medications were reported.  On 01APR2021, the patient felt racing of heart and described the intensity as "stabbing in heart." Two weeks later she was hospitalized over night. The patient was not given any treatment or medications at the hospital and was told to follow-up with her PCP. Blood was drawn for 8 hours for lab work, the results of which were not provided.   This case was linked to MOD-2021-219135 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Date of birth corrected; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Drug reaction with eosinophilia and systemic symptoms
Clinical narrative: hospitalized for 7 days with DRESS syndrome; This spontaneous case was reported by a consumer and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (hospitalized for 7 days with DRESS syndrome) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (hospitalized for 7 days with DRESS syndrome) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 7 days due to DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS. At the time of the report, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (hospitalized for 7 days with DRESS syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.; 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke like symptoms; This spontaneous case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke like symptoms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 031B21A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high (Controlled blood pressure).   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke like symptoms) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Treatment information was not provided.  Company Comment   This case concerns a 57-year-old female hospitalized with a serious unexpected event of cerebrovascular accident. Event onset with unknown latency after mRNA-1273. Based on 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-2021-219208 (Patient Link).; Sender's Comments: This case concerns a 57-year-old female hospitalized with a serious unexpected event of cerebrovascular accident. Event onset with unknown latency after mRNA-1273. Based on 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Visual field defect
Clinical narrative: patient has lost peripheral vision and can not drive anymore.; Patient has had about 8 strokes from the date of administration of the vaccine till date; This spontaneous case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (Patient has had about 8 strokes from the date of administration of the vaccine till date) and VISUAL FIELD DEFECT (patient has lost peripheral vision and can not drive anymore.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Patient has had about 8 strokes from the date of administration of the vaccine till date) (seriousness criterion medically significant). On an unknown date, the patient experienced VISUAL FIELD DEFECT (patient has lost peripheral vision and can not drive anymore.) (seriousness criterion disability). At the time of the report, CEREBROVASCULAR ACCIDENT (Patient has had about 8 strokes from the date of administration of the vaccine till date) and VISUAL FIELD DEFECT (patient has lost peripheral vision and can not drive anymore.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has had about eight strokes from the date of vaccine administration till date of report. The patient had their blood pressure controlled and had not yet taken the second dose. She is unable to drive.  Concomitant products were not provided/unknown. Treatment was reported as palliative care.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   This case was linked to MOD21-109853 (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 events, a causal relationship cannot be excluded
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Possible blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Possible blood clot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced THROMBOSIS (Possible blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Possible blood clot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications and treatment details were not provided.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: I got pneumonia following my first dose of this vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (I got pneumonia following my first dose of this vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (I got pneumonia following my first dose of this vaccine) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (I got pneumonia following my first dose of this vaccine) 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 unknown.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the event has been provided at this time. 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in jaw, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: RA flares; General body pain; Swelling; Jawpain; Tiredness; Swelling of feet; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RA flares), PAIN (General body pain), SWELLING (Swelling), PAIN IN JAW (Jawpain), FATIGUE (Tiredness) and PERIPHERAL SWELLING (Swelling of feet) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product SARILUMAB (KEVZARA) solution for injection for Rheumatoid arthritis.    No medical history was reported.  Concomitant products included PREDNISONE for an unknown indication.   On 15-Jul-2019, the patient started SARILUMAB (KEVZARA) (Subcutaneous) 200 mg. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced RHEUMATOID ARTHRITIS (RA flares) (seriousness criterion medically significant), PAIN (General body pain) (seriousness criterion medically significant), SWELLING (Swelling) (seriousness criterion medically significant), PAIN IN JAW (Jawpain) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling of feet) (seriousness criterion medically significant). The patient was treated with PREDNISONE at a dose of 20 mg, 4 pills for 3 days; PREDNISONE at a dose of 3 pills for 3 days; PREDNISONE at a dose of 2 pills for 3 days and PREDNISONE at a dose of 1 pill for 3 days. On 14-Jun-2021, RHEUMATOID ARTHRITIS (RA flares), PAIN (General body pain), SWELLING (Swelling), PAIN IN JAW (Jawpain), FATIGUE (Tiredness) and PERIPHERAL SWELLING (Swelling of feet) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-219927 (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 events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: RA flares; General body pain; Swelling; Jawpain; Tiredness; Swelling of feet; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RA flares), PAIN (General body pain), SWELLING (Swelling), PAIN IN JAW (Jawpain), FATIGUE (Tiredness) and PERIPHERAL SWELLING (Swelling of feet) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product SARILUMAB (KEVZARA) solution for injection for Rheumatoid arthritis.    No medical history was reported.  Concomitant products included PREDNISONE for an unknown indication.   On 15-Jul-2019, the patient started SARILUMAB (KEVZARA) (Subcutaneous) 200 mg. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced RHEUMATOID ARTHRITIS (RA flares) (seriousness criterion medically significant), PAIN (General body pain) (seriousness criterion medically significant), SWELLING (Swelling) (seriousness criterion medically significant), PAIN IN JAW (Jawpain) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling of feet) (seriousness criterion medically significant). The patient was treated with PREDNISONE at a dose of 20 mg, 4 pills for 3 days; PREDNISONE at a dose of 3 pills for 3 days; PREDNISONE at a dose of 2 pills for 3 days and PREDNISONE at a dose of 1 pill for 3 days. On 14-Jun-2021, RHEUMATOID ARTHRITIS (RA flares), PAIN (General body pain), SWELLING (Swelling), PAIN IN JAW (Jawpain), FATIGUE (Tiredness) and PERIPHERAL SWELLING (Swelling of feet) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-219927 (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 events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Brain oedema, Feeling abnormal
Clinical narrative: brain swelling; I feel like I am dieing/Why is it killing me; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I feel like I am dieing/Why is it killing me) and BRAIN OEDEMA (brain swelling) 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 07-Apr-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 (I feel like I am dieing/Why is it killing me) (seriousness criteria hospitalization and life threatening) and BRAIN OEDEMA (brain swelling) (seriousness criteria hospitalization and medically significant). At the time of the report, FEELING ABNORMAL (I feel like I am dieing/Why is it killing me) and BRAIN OEDEMA (brain swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was mentioned  No treatment medication information was mentioned  no any additional information was mentioned patient had a feel like I am dieing and  brain swelling to Patient reported that he experienced a feeling like he was dieing and was informed about brain swelling. He was in hospital and visited several doctors.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been  requested.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: flutters; 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 CARDIAC FLUTTER (flutters) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (flutters) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (flutters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not 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-2021-216256 (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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Carpal tunnel syndrome, Diarrhoea, Fatigue, Haemorrhoids
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031B2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease. The patient's past medical history included Pain in hip since 2019, Osteopenia, Stenosis, Femur fracture and Back surgery. Concurrent medical conditions included Alcohol use (occasionally) since 1959. Concomitant products included BUDESONIDE (ENTOCORT) for Crohn's disease, COBAMAMIDE (VITAMIN B12 [COBAMAMIDE]) for an unknown indication. In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK,1 in 2 Weeks. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2020, the patient experienced CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome). In February 2021, the patient experienced SWELLING (Swelling). On 12-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant). In April 2021, the patient experienced FATIGUE (Tiredness). In 2021, the patient experienced PAIN IN EXTREMITY (Hand pain). On an unknown date, the patient experienced HAEMORRHOIDS (Hemorrhoids), PAIN (Pain), OSTEOARTHRITIS (Osteoarthritis), ABDOMINAL PAIN UPPER (Stomach cramps) and DIARRHOEA (Diarrhea). The patient was treated with COLESTIPOL at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis), HAEMORRHOIDS (Hemorrhoids), SWELLING (Swelling), PAIN (Pain), PAIN IN EXTREMITY (Hand pain), OSTEOARTHRITIS (Osteoarthritis), ABDOMINAL PAIN UPPER (Stomach cramps) and DIARRHOEA (Diarrhea) outcome was unknown, CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome) had not resolved and FATIGUE (Tiredness) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding the events has been provided at this time.  Further information has been requested. This case was linked to MOD-2021-219975 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.