chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle contracture, Nausea, Pain in extremity, Paraesthesia, Sensory disturbance
Clinical narrative: Guillain-Barre syndrome; Pericarditis; Fainted once; Thought i had a seizure; Chest pain that went away as fast as it came; Gastrointestinal symptoms; Nosebleed; Dizziness; arm hurts; Arm pain in injection arm; Extreme headache; Chills all over the body; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once) and SEIZURE (Thought i had a seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), SYNCOPE (Fainted once) (seriousness criterion medically significant), SEIZURE (Thought i had a seizure) (seriousness criterion medically significant), CHEST PAIN (Chest pain that went away as fast as it came), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once), SEIZURE (Thought i had a seizure), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body) outcome was unknown and CHEST PAIN (Chest pain that went away as fast as it came) had resolved.            Concomitant medication and treatment information were not reported.  It was reported that the patient went to the hospital three times. The patient can not walk now and has permanent issues  Action taken with mRNA-1273 in response to the event was Not Applicable  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler, X-ray
Clinical narrative: Guillain-Barre syndrome; Pericarditis; Fainted once; Thought i had a seizure; Chest pain that went away as fast as it came; Gastrointestinal symptoms; Nosebleed; Dizziness; arm hurts; Arm pain in injection arm; Extreme headache; Chills all over the body; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once) and SEIZURE (Thought i had a seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), SYNCOPE (Fainted once) (seriousness criterion medically significant), SEIZURE (Thought i had a seizure) (seriousness criterion medically significant), CHEST PAIN (Chest pain that went away as fast as it came), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once), SEIZURE (Thought i had a seizure), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body) outcome was unknown and CHEST PAIN (Chest pain that went away as fast as it came) had resolved.            Concomitant medication and treatment information were not reported.  It was reported that the patient went to the hospital three times. The patient can not walk now and has permanent issues  Action taken with mRNA-1273 in response to the event was Not Applicable  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Dizziness, Epistaxis, Gastrointestinal disorder
Clinical narrative: Guillain-Barre syndrome; Pericarditis; Fainted once; Thought i had a seizure; Chest pain that went away as fast as it came; Gastrointestinal symptoms; Nosebleed; Dizziness; arm hurts; Arm pain in injection arm; Extreme headache; Chills all over the body; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once) and SEIZURE (Thought i had a seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), SYNCOPE (Fainted once) (seriousness criterion medically significant), SEIZURE (Thought i had a seizure) (seriousness criterion medically significant), CHEST PAIN (Chest pain that went away as fast as it came), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once), SEIZURE (Thought i had a seizure), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body) outcome was unknown and CHEST PAIN (Chest pain that went away as fast as it came) had resolved.            Concomitant medication and treatment information were not reported.  It was reported that the patient went to the hospital three times. The patient can not walk now and has permanent issues  Action taken with mRNA-1273 in response to the event was Not Applicable  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Headache, Pain in extremity, Pericarditis, Seizure
Clinical narrative: Guillain-Barre syndrome; Pericarditis; Fainted once; Thought i had a seizure; Chest pain that went away as fast as it came; Gastrointestinal symptoms; Nosebleed; Dizziness; arm hurts; Arm pain in injection arm; Extreme headache; Chills all over the body; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once) and SEIZURE (Thought i had a seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), SYNCOPE (Fainted once) (seriousness criterion medically significant), SEIZURE (Thought i had a seizure) (seriousness criterion medically significant), CHEST PAIN (Chest pain that went away as fast as it came), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once), SEIZURE (Thought i had a seizure), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body) outcome was unknown and CHEST PAIN (Chest pain that went away as fast as it came) had resolved.            Concomitant medication and treatment information were not reported.  It was reported that the patient went to the hospital three times. The patient can not walk now and has permanent issues  Action taken with mRNA-1273 in response to the event was Not Applicable  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Vaccination site pain
Clinical narrative: Guillain-Barre syndrome; Pericarditis; Fainted once; Thought i had a seizure; Chest pain that went away as fast as it came; Gastrointestinal symptoms; Nosebleed; Dizziness; arm hurts; Arm pain in injection arm; Extreme headache; Chills all over the body; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once) and SEIZURE (Thought i had a seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), SYNCOPE (Fainted once) (seriousness criterion medically significant), SEIZURE (Thought i had a seizure) (seriousness criterion medically significant), CHEST PAIN (Chest pain that went away as fast as it came), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once), SEIZURE (Thought i had a seizure), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body) outcome was unknown and CHEST PAIN (Chest pain that went away as fast as it came) had resolved.            Concomitant medication and treatment information were not reported.  It was reported that the patient went to the hospital three times. The patient can not walk now and has permanent issues  Action taken with mRNA-1273 in response to the event was Not Applicable  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Atrial fibrillation, Biopsy heart normal, Bronchitis, Cardioversion
Clinical narrative: Pericardial effusion, requiring pericardial window 4/16/2021.  Recurrent effusion with Constrictive/restrictive pericarditis, requiring pericardiectomy 6/22/21.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Cough, Feeling abnormal, Intensive care, Pericarditis
Clinical narrative: Pericardial effusion, requiring pericardial window 4/16/2021.  Recurrent effusion with Constrictive/restrictive pericarditis, requiring pericardiectomy 6/22/21.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thoracic operation, Viral infection
Clinical narrative: Pericardial effusion, requiring pericardial window 4/16/2021.  Recurrent effusion with Constrictive/restrictive pericarditis, requiring pericardiectomy 6/22/21.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram abnormal, Pericardial effusion, Pericardial excision, Pericarditis constrictive
Clinical narrative: Pericardial effusion, requiring pericardial window 4/16/2021.  Recurrent effusion with Constrictive/restrictive pericarditis, requiring pericardiectomy 6/22/21.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Chills, Echocardiogram, Electrocardiogram, Headache
Clinical narrative: Sent to ER and placed in ICU for 7 days with Myocarditis; This is a spontaneous report from a contactable consumer (parent). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04Jun2021 09:00 AM (Batch/Lot Number: EW0186) (at age of 15 years old) as 2ND DOSE, SINGLE for covid-19 immunisation at Hospital. The patient medical history was not reported. No known allergies for the patient. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previous took first dose of Pfizer COVID 19 vaccine on 14May2021 at 09:00 AM administered in left arm (lot number=ER8736) for covid-19 immunisation and no reaction on previous exposure to drug. The patient was sent to ER and placed in ICU for 7 days with myocarditis on 06Jun2021 with outcome of not recovered. The event was resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The treatment for event included IV prednisone. Since the vaccination, the patient performed Nasal Swab covid test on 07Jun2021 with negative result. The reporter classified the event as serious for seriousness criteria-Life threatening and Caused/prolonged hospitalization.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, Nausea, Troponin increased, Vomiting
Clinical narrative: Sent to ER and placed in ICU for 7 days with Myocarditis; This is a spontaneous report from a contactable consumer (parent). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04Jun2021 09:00 AM (Batch/Lot Number: EW0186) (at age of 15 years old) as 2ND DOSE, SINGLE for covid-19 immunisation at Hospital. The patient medical history was not reported. No known allergies for the patient. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previous took first dose of Pfizer COVID 19 vaccine on 14May2021 at 09:00 AM administered in left arm (lot number=ER8736) for covid-19 immunisation and no reaction on previous exposure to drug. The patient was sent to ER and placed in ICU for 7 days with myocarditis on 06Jun2021 with outcome of not recovered. The event was resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The treatment for event included IV prednisone. Since the vaccination, the patient performed Nasal Swab covid test on 07Jun2021 with negative result. The reporter classified the event as serious for seriousness criteria-Life threatening and Caused/prolonged hospitalization.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Pain, Troponin I increased
Clinical narrative: Sent to ER and placed in ICU for 7 days with Myocarditis; This is a spontaneous report from a contactable consumer (parent). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04Jun2021 09:00 AM (Batch/Lot Number: EW0186) (at age of 15 years old) as 2ND DOSE, SINGLE for covid-19 immunisation at Hospital. The patient medical history was not reported. No known allergies for the patient. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previous took first dose of Pfizer COVID 19 vaccine on 14May2021 at 09:00 AM administered in left arm (lot number=ER8736) for covid-19 immunisation and no reaction on previous exposure to drug. The patient was sent to ER and placed in ICU for 7 days with myocarditis on 06Jun2021 with outcome of not recovered. The event was resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The treatment for event included IV prednisone. Since the vaccination, the patient performed Nasal Swab covid test on 07Jun2021 with negative result. The reporter classified the event as serious for seriousness criteria-Life threatening and Caused/prolonged hospitalization.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Laboratory test, Myocarditis, Pericarditis
Clinical narrative: Sent to ER and placed in ICU for 7 days with Myocarditis; This is a spontaneous report from a contactable consumer (parent). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04Jun2021 09:00 AM (Batch/Lot Number: EW0186) (at age of 15 years old) as 2ND DOSE, SINGLE for covid-19 immunisation at Hospital. The patient medical history was not reported. No known allergies for the patient. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previous took first dose of Pfizer COVID 19 vaccine on 14May2021 at 09:00 AM administered in left arm (lot number=ER8736) for covid-19 immunisation and no reaction on previous exposure to drug. The patient was sent to ER and placed in ICU for 7 days with myocarditis on 06Jun2021 with outcome of not recovered. The event was resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The treatment for event included IV prednisone. Since the vaccination, the patient performed Nasal Swab covid test on 07Jun2021 with negative result. The reporter classified the event as serious for seriousness criteria-Life threatening and Caused/prolonged hospitalization.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin increased, Vomiting
Clinical narrative: Sent to ER and placed in ICU for 7 days with Myocarditis; This is a spontaneous report from a contactable consumer (parent). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04Jun2021 09:00 AM (Batch/Lot Number: EW0186) (at age of 15 years old) as 2ND DOSE, SINGLE for covid-19 immunisation at Hospital. The patient medical history was not reported. No known allergies for the patient. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previous took first dose of Pfizer COVID 19 vaccine on 14May2021 at 09:00 AM administered in left arm (lot number=ER8736) for covid-19 immunisation and no reaction on previous exposure to drug. The patient was sent to ER and placed in ICU for 7 days with myocarditis on 06Jun2021 with outcome of not recovered. The event was resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The treatment for event included IV prednisone. Since the vaccination, the patient performed Nasal Swab covid test on 07Jun2021 with negative result. The reporter classified the event as serious for seriousness criteria-Life threatening and Caused/prolonged hospitalization.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, SARS-CoV-2 test
Clinical narrative: Sent to ER and placed in ICU for 7 days with Myocarditis; This is a spontaneous report from a contactable consumer (parent). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04Jun2021 09:00 AM (Batch/Lot Number: EW0186) (at age of 15 years old) as 2ND DOSE, SINGLE for covid-19 immunisation at Hospital. The patient medical history was not reported. No known allergies for the patient. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previous took first dose of Pfizer COVID 19 vaccine on 14May2021 at 09:00 AM administered in left arm (lot number=ER8736) for covid-19 immunisation and no reaction on previous exposure to drug. The patient was sent to ER and placed in ICU for 7 days with myocarditis on 06Jun2021 with outcome of not recovered. The event was resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The treatment for event included IV prednisone. Since the vaccination, the patient performed Nasal Swab covid test on 07Jun2021 with negative result. The reporter classified the event as serious for seriousness criteria-Life threatening and Caused/prolonged hospitalization.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Brain natriuretic peptide normal, Chest pain, Immunoglobulin therapy, Inflammatory marker increased, Magnetic resonance imaging heart
Clinical narrative: Sent to ER and placed in ICU for 7 days with Myocarditis; This is a spontaneous report from a contactable consumer (parent). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04Jun2021 09:00 AM (Batch/Lot Number: EW0186) (at age of 15 years old) as 2ND DOSE, SINGLE for covid-19 immunisation at Hospital. The patient medical history was not reported. No known allergies for the patient. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previous took first dose of Pfizer COVID 19 vaccine on 14May2021 at 09:00 AM administered in left arm (lot number=ER8736) for covid-19 immunisation and no reaction on previous exposure to drug. The patient was sent to ER and placed in ICU for 7 days with myocarditis on 06Jun2021 with outcome of not recovered. The event was resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The treatment for event included IV prednisone. Since the vaccination, the patient performed Nasal Swab covid test on 07Jun2021 with negative result. The reporter classified the event as serious for seriousness criteria-Life threatening and Caused/prolonged hospitalization.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocardial oedema, Myocarditis, N-terminal prohormone brain natriuretic peptide increased, Nausea, Troponin I increased
Clinical narrative: Sent to ER and placed in ICU for 7 days with Myocarditis; This is a spontaneous report from a contactable consumer (parent). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04Jun2021 09:00 AM (Batch/Lot Number: EW0186) (at age of 15 years old) as 2ND DOSE, SINGLE for covid-19 immunisation at Hospital. The patient medical history was not reported. No known allergies for the patient. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previous took first dose of Pfizer COVID 19 vaccine on 14May2021 at 09:00 AM administered in left arm (lot number=ER8736) for covid-19 immunisation and no reaction on previous exposure to drug. The patient was sent to ER and placed in ICU for 7 days with myocarditis on 06Jun2021 with outcome of not recovered. The event was resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The treatment for event included IV prednisone. Since the vaccination, the patient performed Nasal Swab covid test on 07Jun2021 with negative result. The reporter classified the event as serious for seriousness criteria-Life threatening and Caused/prolonged hospitalization.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin T increased, Troponin increased, Vomiting
Clinical narrative: Sent to ER and placed in ICU for 7 days with Myocarditis; This is a spontaneous report from a contactable consumer (parent). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04Jun2021 09:00 AM (Batch/Lot Number: EW0186) (at age of 15 years old) as 2ND DOSE, SINGLE for covid-19 immunisation at Hospital. The patient medical history was not reported. No known allergies for the patient. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previous took first dose of Pfizer COVID 19 vaccine on 14May2021 at 09:00 AM administered in left arm (lot number=ER8736) for covid-19 immunisation and no reaction on previous exposure to drug. The patient was sent to ER and placed in ICU for 7 days with myocarditis on 06Jun2021 with outcome of not recovered. The event was resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The treatment for event included IV prednisone. Since the vaccination, the patient performed Nasal Swab covid test on 07Jun2021 with negative result. The reporter classified the event as serious for seriousness criteria-Life threatening and Caused/prolonged hospitalization.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Colitis, Computerised tomogram abnormal, Dizziness, Gastrointestinal haemorrhage
Clinical narrative: Nearly passed out twice; Passing blood clots; GI bleed; Severe body aches; Fatigue; Abdominal pain; Nausea; Vomiting; Fever; Diarrhea; Dehydration; Colitis; This is a spontaneous report from a contactable Nurse (patient) reported for herself.  A 42-year-old female patient (not Pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) at 42-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 03Jun2021 06:30 PM (Lot Number: EW0179) as dose 2, single for covid-19 immunisation in Clinic. Medical history included hypertension, anxiety, seasonal allergy, asthma, Known allergies to Cephalosporin. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications received within 2 weeks included spironolactone; irbesartan; buspirone hydrochloride (BUSPAR); silybum marianum (MILK THISTLE), all taken for an unspecified indication, start and stop date were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took miralax and experienced Allergy, lisinopril and experienced Allergy, venlafaxine and experienced Allergy, patient previously took first dose of BNT162B2 (Brand: Pfizer, Lot number: EW0177) into left arm on 13May2021 06:30 PM at 42 years old for COVID-19 immunization. Patient experienced Severe body aches, fatigue, abdominal pain, nausea/vomiting, fever, nearly passed out twice, diarrhea followed by passing blood clots, dehydration, treated in ER twice. Once for dehydration, second for colitis with GI bleed. Event Start Date was 03Jun2021 09:00 PM. the adverse event result in Emergency room/department or urgent care. treatment received for the adverse event included IV fluids, antibiotics, and antiemetic. Outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case, however, a possible contributory role of the suspect drug to the reported events "Nearly passed out twice, Passing blood clots and GI bleed" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haematochezia, Nausea, Thrombosis, Vomiting
Clinical narrative: Nearly passed out twice; Passing blood clots; GI bleed; Severe body aches; Fatigue; Abdominal pain; Nausea; Vomiting; Fever; Diarrhea; Dehydration; Colitis; This is a spontaneous report from a contactable Nurse (patient) reported for herself.  A 42-year-old female patient (not Pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) at 42-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 03Jun2021 06:30 PM (Lot Number: EW0179) as dose 2, single for covid-19 immunisation in Clinic. Medical history included hypertension, anxiety, seasonal allergy, asthma, Known allergies to Cephalosporin. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications received within 2 weeks included spironolactone; irbesartan; buspirone hydrochloride (BUSPAR); silybum marianum (MILK THISTLE), all taken for an unspecified indication, start and stop date were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took miralax and experienced Allergy, lisinopril and experienced Allergy, venlafaxine and experienced Allergy, patient previously took first dose of BNT162B2 (Brand: Pfizer, Lot number: EW0177) into left arm on 13May2021 06:30 PM at 42 years old for COVID-19 immunization. Patient experienced Severe body aches, fatigue, abdominal pain, nausea/vomiting, fever, nearly passed out twice, diarrhea followed by passing blood clots, dehydration, treated in ER twice. Once for dehydration, second for colitis with GI bleed. Event Start Date was 03Jun2021 09:00 PM. the adverse event result in Emergency room/department or urgent care. treatment received for the adverse event included IV fluids, antibiotics, and antiemetic. Outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case, however, a possible contributory role of the suspect drug to the reported events "Nearly passed out twice, Passing blood clots and GI bleed" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Colitis, Dehydration, Diarrhoea, Fatigue
Clinical narrative: Nearly passed out twice; Passing blood clots; GI bleed; Severe body aches; Fatigue; Abdominal pain; Nausea; Vomiting; Fever; Diarrhea; Dehydration; Colitis; This is a spontaneous report from a contactable Nurse (patient) reported for herself.  A 42-year-old female patient (not Pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) at 42-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 03Jun2021 06:30 PM (Lot Number: EW0179) as dose 2, single for covid-19 immunisation in Clinic. Medical history included hypertension, anxiety, seasonal allergy, asthma, Known allergies to Cephalosporin. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications received within 2 weeks included spironolactone; irbesartan; buspirone hydrochloride (BUSPAR); silybum marianum (MILK THISTLE), all taken for an unspecified indication, start and stop date were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took miralax and experienced Allergy, lisinopril and experienced Allergy, venlafaxine and experienced Allergy, patient previously took first dose of BNT162B2 (Brand: Pfizer, Lot number: EW0177) into left arm on 13May2021 06:30 PM at 42 years old for COVID-19 immunization. Patient experienced Severe body aches, fatigue, abdominal pain, nausea/vomiting, fever, nearly passed out twice, diarrhea followed by passing blood clots, dehydration, treated in ER twice. Once for dehydration, second for colitis with GI bleed. Event Start Date was 03Jun2021 09:00 PM. the adverse event result in Emergency room/department or urgent care. treatment received for the adverse event included IV fluids, antibiotics, and antiemetic. Outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case, however, a possible contributory role of the suspect drug to the reported events "Nearly passed out twice, Passing blood clots and GI bleed" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal haemorrhage, Loss of consciousness, Nausea, Pain, Pyrexia
Clinical narrative: Nearly passed out twice; Passing blood clots; GI bleed; Severe body aches; Fatigue; Abdominal pain; Nausea; Vomiting; Fever; Diarrhea; Dehydration; Colitis; This is a spontaneous report from a contactable Nurse (patient) reported for herself.  A 42-year-old female patient (not Pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) at 42-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 03Jun2021 06:30 PM (Lot Number: EW0179) as dose 2, single for covid-19 immunisation in Clinic. Medical history included hypertension, anxiety, seasonal allergy, asthma, Known allergies to Cephalosporin. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications received within 2 weeks included spironolactone; irbesartan; buspirone hydrochloride (BUSPAR); silybum marianum (MILK THISTLE), all taken for an unspecified indication, start and stop date were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took miralax and experienced Allergy, lisinopril and experienced Allergy, venlafaxine and experienced Allergy, patient previously took first dose of BNT162B2 (Brand: Pfizer, Lot number: EW0177) into left arm on 13May2021 06:30 PM at 42 years old for COVID-19 immunization. Patient experienced Severe body aches, fatigue, abdominal pain, nausea/vomiting, fever, nearly passed out twice, diarrhea followed by passing blood clots, dehydration, treated in ER twice. Once for dehydration, second for colitis with GI bleed. Event Start Date was 03Jun2021 09:00 PM. the adverse event result in Emergency room/department or urgent care. treatment received for the adverse event included IV fluids, antibiotics, and antiemetic. Outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case, however, a possible contributory role of the suspect drug to the reported events "Nearly passed out twice, Passing blood clots and GI bleed" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis, Vomiting
Clinical narrative: Nearly passed out twice; Passing blood clots; GI bleed; Severe body aches; Fatigue; Abdominal pain; Nausea; Vomiting; Fever; Diarrhea; Dehydration; Colitis; This is a spontaneous report from a contactable Nurse (patient) reported for herself.  A 42-year-old female patient (not Pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) at 42-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 03Jun2021 06:30 PM (Lot Number: EW0179) as dose 2, single for covid-19 immunisation in Clinic. Medical history included hypertension, anxiety, seasonal allergy, asthma, Known allergies to Cephalosporin. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications received within 2 weeks included spironolactone; irbesartan; buspirone hydrochloride (BUSPAR); silybum marianum (MILK THISTLE), all taken for an unspecified indication, start and stop date were not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took miralax and experienced Allergy, lisinopril and experienced Allergy, venlafaxine and experienced Allergy, patient previously took first dose of BNT162B2 (Brand: Pfizer, Lot number: EW0177) into left arm on 13May2021 06:30 PM at 42 years old for COVID-19 immunization. Patient experienced Severe body aches, fatigue, abdominal pain, nausea/vomiting, fever, nearly passed out twice, diarrhea followed by passing blood clots, dehydration, treated in ER twice. Once for dehydration, second for colitis with GI bleed. Event Start Date was 03Jun2021 09:00 PM. the adverse event result in Emergency room/department or urgent care. treatment received for the adverse event included IV fluids, antibiotics, and antiemetic. Outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case, however, a possible contributory role of the suspect drug to the reported events "Nearly passed out twice, Passing blood clots and GI bleed" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Condition aggravated, Death, Headache
Clinical narrative: No symptoms day of vaccine (Thursday); next day feeling somewhat malaise (Friday), following day no complaints (Saturday), next day found in bed passed away.  Pt always healthy, no childhood past medical hx, active is sports, band, martial arts; no heart or other known medical problems (history provided by mother).
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Death, Malaise, Pathology test, Toxicologic test
Clinical narrative: No symptoms day of vaccine (Thursday); next day feeling somewhat malaise (Friday), following day no complaints (Saturday), next day found in bed passed away.  Pt always healthy, no childhood past medical hx, active is sports, band, martial arts; no heart or other known medical problems (history provided by mother).
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: No symptoms day of vaccine (Thursday); next day feeling somewhat malaise (Friday), following day no complaints (Saturday), next day found in bed passed away.  Pt always healthy, no childhood past medical hx, active is sports, band, martial arts; no heart or other known medical problems (history provided by mother).
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Echocardiogram, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: Patient experienced fever and chills day following vaccine. On day two after receiving vaccine, patient developed chest pain and presented to ED. Work up concerning for myocarditis due to chest pain in the setting of ECG changes and troponin elevation. Chest pain resolved prior to discharge from the hospital and patient was back to baseline.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Patient experienced fever and chills day following vaccine. On day two after receiving vaccine, patient developed chest pain and presented to ED. Work up concerning for myocarditis due to chest pain in the setting of ECG changes and troponin elevation. Chest pain resolved prior to discharge from the hospital and patient was back to baseline.