chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Transient ischaemic attack, Vaccination site erythema, Vaccination site pain
Clinical narrative: Transient ischemic Attack; Double vision; Sore injection site; Red injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischemic Attack) and DIPLOPIA (Double vision) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site) and VACCINATION SITE ERYTHEMA (Red injection site). On 02-Apr-2021, the patient experienced DIPLOPIA (Double vision) (seriousness criterion medically significant). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischemic Attack) (seriousness criterion medically significant). On 01-Apr-2021, VACCINATION SITE PAIN (Sore injection site) and VACCINATION SITE ERYTHEMA (Red injection site) had resolved. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischemic Attack) and DIPLOPIA (Double vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator.  Treatment of these events included aspirin, Lipitor and Plavix.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Vaccination complication
Clinical narrative: Massive stroke; After second vaccination, immediately felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Massive stroke) in a 54-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.     The patient's past medical history included No adverse event (Medical history not provided.). Concomitant products included DIAZEPAM (VALIUM), ONDANSETRON (ZOFRAN [ONDANSETRON]), ATORVASTATIN CALCIUM (LIPITOR) and LISINOPRIL for an unknown indication.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION COMPLICATION (After second vaccination, immediately felt terrible). On 28-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Massive stroke) (seriousness criteria hospitalization and disability). At the time of the report, CEREBROVASCULAR ACCIDENT (Massive stroke) and VACCINATION COMPLICATION (After second vaccination, immediately felt terrible) outcome was unknown.            Treatment included t pack clot bursting stroke medication.  Stroke has affected the patient's vestibular system and balance and has caused vertigo, she is now crippled. These symptoms are ongoing and similar to what the reporter experienced  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Feeling abnormal, Somnolence, Vertigo
Clinical narrative: Vertigo came back stronger (After SECOND Shot); a little Sleepy; Afraid to go to bed at nights; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Vertigo came back stronger (After SECOND Shot)), SOMNOLENCE (a little Sleepy) and FEELING ABNORMAL (Afraid to go to bed at nights) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VERTIGO (Vertigo came back stronger (After SECOND Shot)) (seriousness criterion hospitalization), SOMNOLENCE (a little Sleepy) (seriousness criterion hospitalization) and FEELING ABNORMAL (Afraid to go to bed at nights) (seriousness criterion hospitalization). At the time of the report, VERTIGO (Vertigo came back stronger (After SECOND Shot)) had not resolved and SOMNOLENCE (a little Sleepy) and FEELING ABNORMAL (Afraid to go to bed at nights) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Normal.         Concomitant product use was not reported. On an unspecified date, an EKG was performed (results not reported).The patient did not receive any treatment.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   This case was linked to MOD-2021-066561 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chronic obstructive pulmonary disease, Headache, Hypertension, Illness, Nausea
Clinical narrative: Chronic obstructive pulmonary disease exacerbation; Hypertension; Reaction to COVID vaccine; Really sick; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease exacerbation), HYPERTENSION (Hypertension) and VACCINATION COMPLICATION (Reaction to COVID vaccine) in a 67-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.    Co-suspect product included non-company product TREPROSTINIL SODIUM for Secondary pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension and Chronic obstructive pulmonary disease. Concomitant products included TADALAFIL for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and TREPROSTINIL SODIUM (Respiratory) at an unspecified dose four times per day. On an unknown date, TREPROSTINIL SODIUM (Respiratory) dosage was changed to 72 mcg and TREPROSTINIL SODIUM (Respiratory) dosage was changed to 60 mcg. On 25-Mar-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease exacerbation) (seriousness criterion hospitalization), HYPERTENSION (Hypertension) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (Reaction to COVID vaccine) (seriousness criterion hospitalization). On an unknown date, the patient experienced ILLNESS (Really sick), NAUSEA (Nausea) and HEADACHE (Headache). The patient was hospitalized from 25-Mar-2021 to 28-Mar-2021 due to CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPERTENSION and VACCINATION COMPLICATION. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease exacerbation), HYPERTENSION (Hypertension), VACCINATION COMPLICATION (Reaction to COVID vaccine), ILLNESS (Really sick), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Description: On an unreported date, the patient had decreased treprostinil sodium breaths from 12 to 10 breaths (off label use).  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination complication
Clinical narrative: Chronic obstructive pulmonary disease exacerbation; Hypertension; Reaction to COVID vaccine; Really sick; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease exacerbation), HYPERTENSION (Hypertension) and VACCINATION COMPLICATION (Reaction to COVID vaccine) in a 67-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.    Co-suspect product included non-company product TREPROSTINIL SODIUM for Secondary pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension and Chronic obstructive pulmonary disease. Concomitant products included TADALAFIL for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and TREPROSTINIL SODIUM (Respiratory) at an unspecified dose four times per day. On an unknown date, TREPROSTINIL SODIUM (Respiratory) dosage was changed to 72 mcg and TREPROSTINIL SODIUM (Respiratory) dosage was changed to 60 mcg. On 25-Mar-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease exacerbation) (seriousness criterion hospitalization), HYPERTENSION (Hypertension) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (Reaction to COVID vaccine) (seriousness criterion hospitalization). On an unknown date, the patient experienced ILLNESS (Really sick), NAUSEA (Nausea) and HEADACHE (Headache). The patient was hospitalized from 25-Mar-2021 to 28-Mar-2021 due to CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPERTENSION and VACCINATION COMPLICATION. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease exacerbation), HYPERTENSION (Hypertension), VACCINATION COMPLICATION (Reaction to COVID vaccine), ILLNESS (Really sick), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Description: On an unreported date, the patient had decreased treprostinil sodium breaths from 12 to 10 breaths (off label use).  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Illness, Injection site induration, Ocular hyperaemia
Clinical narrative: Arm bleed a lot; Like a big red reaction around it; Redness started spreading covering the top of her arm; Felt of kind of sick; It's still lumping; Got really really red; Her eye (left eye on the same side of the injection) was all red like bloodshot red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Arm bleed a lot) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included METOPROLOL, HYDROCHLOROTHIAZIDE, VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and ZINC for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced OCULAR HYPERAEMIA (Her eye (left eye on the same side of the injection) was all red like bloodshot red). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Arm bleed a lot) (seriousness criterion medically significant), HYPERSENSITIVITY (Like a big red reaction around it), ERYTHEMA (Redness started spreading covering the top of her arm), ILLNESS (Felt of kind of sick), INJECTION SITE INDURATION (It's still lumping) and VACCINATION SITE ERYTHEMA (Got really really red). At the time of the report, VACCINATION SITE HAEMORRHAGE (Arm bleed a lot), HYPERSENSITIVITY (Like a big red reaction around it), ERYTHEMA (Redness started spreading covering the top of her arm), OCULAR HYPERAEMIA (Her eye (left eye on the same side of the injection) was all red like bloodshot red), ILLNESS (Felt of kind of sick), INJECTION SITE INDURATION (It's still lumping) and VACCINATION SITE ERYTHEMA (Got really really red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included paracetamol.  Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded.  Vaccination site erythema is consistent with the product known safety profile; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded.  Vaccination site erythema is consistent with the product known safety profile
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site haemorrhage
Clinical narrative: Arm bleed a lot; Like a big red reaction around it; Redness started spreading covering the top of her arm; Felt of kind of sick; It's still lumping; Got really really red; Her eye (left eye on the same side of the injection) was all red like bloodshot red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Arm bleed a lot) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included METOPROLOL, HYDROCHLOROTHIAZIDE, VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and ZINC for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced OCULAR HYPERAEMIA (Her eye (left eye on the same side of the injection) was all red like bloodshot red). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Arm bleed a lot) (seriousness criterion medically significant), HYPERSENSITIVITY (Like a big red reaction around it), ERYTHEMA (Redness started spreading covering the top of her arm), ILLNESS (Felt of kind of sick), INJECTION SITE INDURATION (It's still lumping) and VACCINATION SITE ERYTHEMA (Got really really red). At the time of the report, VACCINATION SITE HAEMORRHAGE (Arm bleed a lot), HYPERSENSITIVITY (Like a big red reaction around it), ERYTHEMA (Redness started spreading covering the top of her arm), OCULAR HYPERAEMIA (Her eye (left eye on the same side of the injection) was all red like bloodshot red), ILLNESS (Felt of kind of sick), INJECTION SITE INDURATION (It's still lumping) and VACCINATION SITE ERYTHEMA (Got really really red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included paracetamol.  Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded.  Vaccination site erythema is consistent with the product known safety profile; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded.  Vaccination site erythema is consistent with the product known safety profile
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac failure, Product dose omission issue
Clinical narrative: Patient was admitted to the hospital for Heart Failure and was discharged; Readmitted to the hospital for second time for heart related complications; Patient was scheduled to receive the second dose on 02Apr2021 but due to medical complications will not be able to receive the dose as scheduled; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Patient was admitted to the hospital for Heart Failure and was discharged) and CARDIAC DISORDER (Readmitted to the hospital for second time for heart related complications) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse drug reaction (No reported medical history).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE (Patient was admitted to the hospital for Heart Failure and was discharged) (seriousness criterion hospitalization), CARDIAC DISORDER (Readmitted to the hospital for second time for heart related complications) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Patient was scheduled to receive the second dose on 02Apr2021 but due to medical complications will not be able to receive the dose as scheduled). At the time of the report, CARDIAC FAILURE (Patient was admitted to the hospital for Heart Failure and was discharged), CARDIAC DISORDER (Readmitted to the hospital for second time for heart related complications) and PRODUCT DOSE OMISSION ISSUE (Patient was scheduled to receive the second dose on 02Apr2021 but due to medical complications will not be able to receive the dose as scheduled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported. Concomitant product use was not provided by the reporter.  Limited information regarding the events of cardiac failure and cardiac disorder has been provided at this time and a causal relationship cannot be excluded.  This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error; Sender's Comments: Limited information regarding the events of cardiac failure and cardiac disorder has been provided at this time and a causal relationship cannot be excluded.  This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Transient Ischemic Attack; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient Ischemic Attack) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient Ischemic Attack) (seriousness criterion medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient Ischemic Attack) outcome was unknown. Not Provided          Treatment included none 1 week after the first dose she had a Transient Ischemic Attack. Company comment: There is not enough information to assess the causal association of the reported event with the administration of mRNA-1273 . Critical details such as the patient's medical history,, concomitant medication and any relevant diagnostic or clinical report is lacking. Additional information has been requested; Sender's Comments: There is not enough information to assess the causal association of the reported event with the administration of mRNA-1273 . Critical details such as the patient's medical history,, concomitant medication and any relevant diagnostic or clinical report is lacking. Additional information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Ear discomfort, Headache, Hyperhidrosis, Hypotension
Clinical narrative: clogged ears; injcetion site rash; She almost fainted; She was nauseated and wanted to vomit; Sweating; blood pressure went low/down; pale; Fever; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (She almost fainted) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN (Body ache), PYREXIA (Fever) and HEADACHE (Headache). On 04-Apr-2021, the patient experienced SYNCOPE (She almost fainted) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating), HYPOTENSION (blood pressure went low/down), PALLOR (pale) and NAUSEA (She was nauseated and wanted to vomit). On an unknown date, the patient experienced EAR DISCOMFORT (clogged ears) and VACCINATION SITE RASH (injcetion site rash). At the time of the report, SYNCOPE (She almost fainted), PAIN (Body ache), HYPERHIDROSIS (Sweating), HYPOTENSION (blood pressure went low/down), PALLOR (pale), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (She was nauseated and wanted to vomit) outcome was unknown and EAR DISCOMFORT (clogged ears) and VACCINATION SITE RASH (injcetion site rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Blood pressure measurement: Low.         Tylenol was used as treatment medication. Concomitant medications was not reported.   This case was linked to MOD-2021-067463, US-MODERNATX, INC.-MOD-2021-067463 (E2B Linked Report).; Sender's Comments:  MOD-2021-067463:First Dose Case US-MODERNATX, INC.-MOD-2021-067463:Second dose case
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pallor, Pyrexia, Syncope
Clinical narrative: clogged ears; injcetion site rash; She almost fainted; She was nauseated and wanted to vomit; Sweating; blood pressure went low/down; pale; Fever; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (She almost fainted) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN (Body ache), PYREXIA (Fever) and HEADACHE (Headache). On 04-Apr-2021, the patient experienced SYNCOPE (She almost fainted) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating), HYPOTENSION (blood pressure went low/down), PALLOR (pale) and NAUSEA (She was nauseated and wanted to vomit). On an unknown date, the patient experienced EAR DISCOMFORT (clogged ears) and VACCINATION SITE RASH (injcetion site rash). At the time of the report, SYNCOPE (She almost fainted), PAIN (Body ache), HYPERHIDROSIS (Sweating), HYPOTENSION (blood pressure went low/down), PALLOR (pale), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (She was nauseated and wanted to vomit) outcome was unknown and EAR DISCOMFORT (clogged ears) and VACCINATION SITE RASH (injcetion site rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Blood pressure measurement: Low.         Tylenol was used as treatment medication. Concomitant medications was not reported.   This case was linked to MOD-2021-067463, US-MODERNATX, INC.-MOD-2021-067463 (E2B Linked Report).; Sender's Comments:  MOD-2021-067463:First Dose Case US-MODERNATX, INC.-MOD-2021-067463:Second dose case
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: clogged ears; injcetion site rash; She almost fainted; She was nauseated and wanted to vomit; Sweating; blood pressure went low/down; pale; Fever; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (She almost fainted) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN (Body ache), PYREXIA (Fever) and HEADACHE (Headache). On 04-Apr-2021, the patient experienced SYNCOPE (She almost fainted) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating), HYPOTENSION (blood pressure went low/down), PALLOR (pale) and NAUSEA (She was nauseated and wanted to vomit). On an unknown date, the patient experienced EAR DISCOMFORT (clogged ears) and VACCINATION SITE RASH (injcetion site rash). At the time of the report, SYNCOPE (She almost fainted), PAIN (Body ache), HYPERHIDROSIS (Sweating), HYPOTENSION (blood pressure went low/down), PALLOR (pale), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (She was nauseated and wanted to vomit) outcome was unknown and EAR DISCOMFORT (clogged ears) and VACCINATION SITE RASH (injcetion site rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Blood pressure measurement: Low.         Tylenol was used as treatment medication. Concomitant medications was not reported.   This case was linked to MOD-2021-067463, US-MODERNATX, INC.-MOD-2021-067463 (E2B Linked Report).; Sender's Comments:  MOD-2021-067463:First Dose Case US-MODERNATX, INC.-MOD-2021-067463:Second dose case
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Thrombosis
Clinical narrative: her left leg was swollen; two red clots on left leg; right feet was hurting; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (two red clots on left leg) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (her left leg was swollen), THROMBOSIS (two red clots on left leg) (seriousness criterion medically significant) and PAIN IN EXTREMITY (right feet was hurting). At the time of the report, PERIPHERAL SWELLING (her left leg was swollen), THROMBOSIS (two red clots on left leg) and PAIN IN EXTREMITY (right feet was hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Fatigue
Clinical narrative: Lung congestion; Felt like pneumonia; pain in arm; lower Back pain; Weakness; Upper respiratory tract congestion; Felt terrified; two spiked fever; alot of joint pain; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Lung congestion) and PNEUMONIA (Felt like pneumonia) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (twice). Concomitant products included TRAMADOL for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PULMONARY CONGESTION (Lung congestion) (seriousness criterion medically significant), PNEUMONIA (Felt like pneumonia) (seriousness criterion medically significant), PAIN IN EXTREMITY (pain in arm), BACK PAIN (lower Back pain), ASTHENIA (Weakness), UPPER RESPIRATORY TRACT CONGESTION (Upper respiratory tract congestion), PSYCHOLOGICAL TRAUMA (Felt terrified), PYREXIA (two spiked fever), ARTHRALGIA (alot of joint pain), CHILLS (Chills) and FATIGUE (Tired). At the time of the report, PULMONARY CONGESTION (Lung congestion), PNEUMONIA (Felt like pneumonia), PAIN IN EXTREMITY (pain in arm), BACK PAIN (lower Back pain), ASTHENIA (Weakness), UPPER RESPIRATORY TRACT CONGESTION (Upper respiratory tract congestion), PSYCHOLOGICAL TRAUMA (Felt terrified), PYREXIA (two spiked fever), ARTHRALGIA (alot of joint pain), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pneumonia, Psychological trauma, Pulmonary congestion, Pyrexia
Clinical narrative: Lung congestion; Felt like pneumonia; pain in arm; lower Back pain; Weakness; Upper respiratory tract congestion; Felt terrified; two spiked fever; alot of joint pain; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Lung congestion) and PNEUMONIA (Felt like pneumonia) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (twice). Concomitant products included TRAMADOL for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PULMONARY CONGESTION (Lung congestion) (seriousness criterion medically significant), PNEUMONIA (Felt like pneumonia) (seriousness criterion medically significant), PAIN IN EXTREMITY (pain in arm), BACK PAIN (lower Back pain), ASTHENIA (Weakness), UPPER RESPIRATORY TRACT CONGESTION (Upper respiratory tract congestion), PSYCHOLOGICAL TRAUMA (Felt terrified), PYREXIA (two spiked fever), ARTHRALGIA (alot of joint pain), CHILLS (Chills) and FATIGUE (Tired). At the time of the report, PULMONARY CONGESTION (Lung congestion), PNEUMONIA (Felt like pneumonia), PAIN IN EXTREMITY (pain in arm), BACK PAIN (lower Back pain), ASTHENIA (Weakness), UPPER RESPIRATORY TRACT CONGESTION (Upper respiratory tract congestion), PSYCHOLOGICAL TRAUMA (Felt terrified), PYREXIA (two spiked fever), ARTHRALGIA (alot of joint pain), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Upper respiratory tract congestion
Clinical narrative: Lung congestion; Felt like pneumonia; pain in arm; lower Back pain; Weakness; Upper respiratory tract congestion; Felt terrified; two spiked fever; alot of joint pain; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Lung congestion) and PNEUMONIA (Felt like pneumonia) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (twice). Concomitant products included TRAMADOL for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PULMONARY CONGESTION (Lung congestion) (seriousness criterion medically significant), PNEUMONIA (Felt like pneumonia) (seriousness criterion medically significant), PAIN IN EXTREMITY (pain in arm), BACK PAIN (lower Back pain), ASTHENIA (Weakness), UPPER RESPIRATORY TRACT CONGESTION (Upper respiratory tract congestion), PSYCHOLOGICAL TRAUMA (Felt terrified), PYREXIA (two spiked fever), ARTHRALGIA (alot of joint pain), CHILLS (Chills) and FATIGUE (Tired). At the time of the report, PULMONARY CONGESTION (Lung congestion), PNEUMONIA (Felt like pneumonia), PAIN IN EXTREMITY (pain in arm), BACK PAIN (lower Back pain), ASTHENIA (Weakness), UPPER RESPIRATORY TRACT CONGESTION (Upper respiratory tract congestion), PSYCHOLOGICAL TRAUMA (Felt terrified), PYREXIA (two spiked fever), ARTHRALGIA (alot of joint pain), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood urine present, Discomfort, Haematochezia
Clinical narrative: Blood in stool; Stomach Pain; Blood in Urine; Uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool), ABDOMINAL PAIN UPPER (Stomach Pain) and BLOOD URINE PRESENT (Blood in Urine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HAEMATOCHEZIA (Blood in stool) (seriousness criterion intervention required), ABDOMINAL PAIN UPPER (Stomach Pain) (seriousness criterion intervention required), BLOOD URINE PRESENT (Blood in Urine) (seriousness criterion intervention required) and DISCOMFORT (Uncomfortable). At the time of the report, HAEMATOCHEZIA (Blood in stool), BLOOD URINE PRESENT (Blood in Urine) and DISCOMFORT (Uncomfortable) outcome was unknown and ABDOMINAL PAIN UPPER (Stomach Pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Patient went to ER and was treated there on 01Apr2021.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Scleritis allergic
Clinical narrative: Rash on her arm that is 5 to 6 inch lenghty by 3 inch wide; Nodular Scleritis in left eye; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SCLERITIS ALLERGIC (Nodular Scleritis in left eye) in a 33-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.     Concurrent medical conditions included Food allergy (Patient is allergic to shell fish, food color food dye and many artificial products).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced SCLERITIS ALLERGIC (Nodular Scleritis in left eye) (seriousness criterion medically significant). On an unknown date, the patient experienced RASH (Rash on her arm that is 5 to 6 inch lenghty by 3 inch wide). At the time of the report, SCLERITIS ALLERGIC (Nodular Scleritis in left eye) and RASH (Rash on her arm that is 5 to 6 inch lenghty by 3 inch wide) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was interrupted on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information is not provided.  Treatment medication prescribed was an anti-inflammatory and the patient developed a reaction to the anti-inflammatory and then was prescribed a steroid prednisone and that was effective in helping the nodular scleritis.   The patient was recommended not to take the second dose of the Moderna  covid-19 vaccination.; 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. No follow up is possible.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Electrocardiogram, Fatigue, Feeling cold, Heart rate increased
Clinical narrative: passed out 24 hours after the first shot; heartrate went to 99; freezing; chills off and on; wiped out; freezing ,chills off and on; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication, TRIAMCINOLONE ACETONIDE (NASACORT), FLUTICASONE PROPIONATE (FLOVENT), LISINOPRIL and PRAVASTATIN.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) (seriousness criterion medically significant), HEART RATE INCREASED (heartrate went to 99), FEELING COLD (freezing; chills off and on), FATIGUE (wiped out) and CHILLS (freezing ,chills off and on). On 30-Mar-2021, LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) had resolved. On 06-Apr-2021, FEELING COLD (freezing; chills off and on), FATIGUE (wiped out) and CHILLS (freezing ,chills off and on) had resolved. At the time of the report, HEART RATE INCREASED (heartrate went to 99) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: (Inconclusive) result not mentioned.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included as EKG and discontinued Glipizide.  Company comment:This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected heart rate increased, feeling cold, and expected fatigue, chills. 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 MOD21-070319, US-MODERNATX, INC.-MOD-2021-068543 (E2B Linked Report).; Sender's Comments: This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected heart rate increased, feeling cold, and expected fatigue, chills. 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. MOD21-070319: US-MODERNATX, INC.-MOD-2021-068543:wife case
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out 24 hours after the first shot; heartrate went to 99; freezing; chills off and on; wiped out; freezing ,chills off and on; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication, TRIAMCINOLONE ACETONIDE (NASACORT), FLUTICASONE PROPIONATE (FLOVENT), LISINOPRIL and PRAVASTATIN.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) (seriousness criterion medically significant), HEART RATE INCREASED (heartrate went to 99), FEELING COLD (freezing; chills off and on), FATIGUE (wiped out) and CHILLS (freezing ,chills off and on). On 30-Mar-2021, LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) had resolved. On 06-Apr-2021, FEELING COLD (freezing; chills off and on), FATIGUE (wiped out) and CHILLS (freezing ,chills off and on) had resolved. At the time of the report, HEART RATE INCREASED (heartrate went to 99) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: (Inconclusive) result not mentioned.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included as EKG and discontinued Glipizide.  Company comment:This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected heart rate increased, feeling cold, and expected fatigue, chills. 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 MOD21-070319, US-MODERNATX, INC.-MOD-2021-068543 (E2B Linked Report).; Sender's Comments: This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected heart rate increased, feeling cold, and expected fatigue, chills. 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. MOD21-070319: US-MODERNATX, INC.-MOD-2021-068543:wife case
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Inappropriate schedule of product administration, Seizure
Clinical narrative: Seizures; fall; was scheduled for his 2nd dose on 29-Mar-2021 but did not receive it due to him being in the hospital; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizures) and FALL (fall) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizure (Has a history of a stroke and seizure for the past 2 years.) and Stroke.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced SEIZURE (Seizures) (seriousness criterion hospitalization) and FALL (fall) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (was scheduled for his 2nd dose on 29-Mar-2021 but did not receive it due to him being in the hospital). The patient was hospitalized on 27-Mar-2021 due to FALL and SEIZURE. At the time of the report, SEIZURE (Seizures), FALL (fall) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (was scheduled for his 2nd dose on 29-Mar-2021 but did not receive it due to him being in the hospital) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.  The patient has been hospitalized since. He was waiting to go to rehab but was uncooperative. No fractures were noted.