chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction, Seizure
Clinical narrative: heart attack; seizure; This is a spontaneous report from a contactable pharmacist (parent). A 15-years-old non-pregnant female patient (reporter's daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Fa7485), via intramuscular route of administration, administered in left arm on 04Aug2021 at 03:15 (at the age of 15-Years-old) as dose 1, single for COVID-19 immunization. Medical history included undiagnosed mild anxiety and mild depression; both from an unknown start or stop dates. Concomitant medications within 2 weeks of vaccination included cranberry, cyanocobalamin (B12 [CYANOCOBALAMIN]) and sennoside a+b (SENNOSIDES) 25mg a few days prior; all taken for an unspecified indication, start and stop date were not reported. No known allergies and no past drug events. Prior to vaccination, patient was not diagnosed with COVID-19 and not received any other vaccines within 4 weeks. It was unknown that since the vaccination the patient was tested for COVID-19. On 07Aug2021 at 13:45, the patient experienced heart attack and seizure. Cardiopulmonary resuscitation (CPR) was performed. 911 called and paramedic took over and took her to the emergency room (ER). Patient moved to Intensive Care Unit (ICU) and is still in the hospital waiting to be moved to  hospital for more tests and possible defibrillator placement. The patient was hospitalized for heart attack and seizure for 7 days. The adverse events were considered as serious with seriousness criteria of hospitalization, life threatening and disability or permanent damage. The adverse event was resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of heart attack and seizure included CPR, resuscitation, hospitalization, continuous monitoring, respiratory, antibiotics (for aspirate). The outcome of the reported events was recovering at the time of report.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Myocardial infarction , Seizure  and suspect drug BNT162B2 cannot be excluded  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 identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Heart rate increased, Pain
Clinical narrative: Increased Resting Heart rate (~+20BPM); Sharp chest Pains on 3 occasions; Difficulty Breathing; This is a spontaneous report from a contactable consumer reporting for himself. This 37-year-old male patient received on 26Jul2021 16:00 at the age of 37-years first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ew0186) as single dose in the arm left for Covid-19 immunization. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, he has not been tested for COVID-19. On 26Jul2021 21:00, the patient had Increased Resting Heart rate (~+20BPM), Sharp chest Pains on 3 occasions, Difficulty Breathing. No treatment was provided. Outcome was recovering. The case was reported as non serious.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Increased Resting Heart rate (~+20BPM); Sharp chest Pains on 3 occasions; Difficulty Breathing; This is a spontaneous report from a contactable consumer reporting for himself. This 37-year-old male patient received on 26Jul2021 16:00 at the age of 37-years first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ew0186) as single dose in the arm left for Covid-19 immunization. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, he has not been tested for COVID-19. On 26Jul2021 21:00, the patient had Increased Resting Heart rate (~+20BPM), Sharp chest Pains on 3 occasions, Difficulty Breathing. No treatment was provided. Outcome was recovering. The case was reported as non serious.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Death, Fatigue
Clinical narrative: Very very sick; In bed for several days; flu-like symptoms; Headache; Fatigue; Died in their sleep; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (Died in their sleep) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-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 ILLNESS (Very very sick), MOBILITY DECREASED (In bed for several days), INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (Headache) and FATIGUE (Fatigue). The patient died on 30-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ILLNESS (Very very sick), MOBILITY DECREASED (In bed for several days), INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.  The caller was calling on behalf of their son who died on 30Jul2021.  The patient received first dose of Moderna COVID-19 vaccine on 22Jun2021 and second on 16Jul2021. The caller stated the patient received the second dose early. The caller did not know which arm the vaccine was given in.  The caller stated after receiving the second dose the patient became very very sick, the patient was in bed for several days, they had flu-like symptoms, a headache, and fatigue.  The caller confirmed patient seemed to get better however then the patient died in their sleep on 30Jul2021.  The caller did not know if the patient took anything to help with the symptoms experienced and confirmed the patient was not taking any daily medications.  Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286489 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. However, 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.; Reported Cause(s) of Death: Unknown cause of death
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Fatigue, Headache, Illness, Influenza like illness
Clinical narrative: Very very sick; In bed for several days; flu-like symptoms; Headache; Fatigue; Died in their sleep; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (Died in their sleep) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-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 ILLNESS (Very very sick), MOBILITY DECREASED (In bed for several days), INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (Headache) and FATIGUE (Fatigue). The patient died on 30-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ILLNESS (Very very sick), MOBILITY DECREASED (In bed for several days), INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.  The caller was calling on behalf of their son who died on 30Jul2021.  The patient received first dose of Moderna COVID-19 vaccine on 22Jun2021 and second on 16Jul2021. The caller stated the patient received the second dose early. The caller did not know which arm the vaccine was given in.  The caller stated after receiving the second dose the patient became very very sick, the patient was in bed for several days, they had flu-like symptoms, a headache, and fatigue.  The caller confirmed patient seemed to get better however then the patient died in their sleep on 30Jul2021.  The caller did not know if the patient took anything to help with the symptoms experienced and confirmed the patient was not taking any daily medications.  Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286489 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. However, 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.; Reported Cause(s) of Death: Unknown cause of death
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mobility decreased
Clinical narrative: Very very sick; In bed for several days; flu-like symptoms; Headache; Fatigue; Died in their sleep; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (Died in their sleep) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-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 ILLNESS (Very very sick), MOBILITY DECREASED (In bed for several days), INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (Headache) and FATIGUE (Fatigue). The patient died on 30-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ILLNESS (Very very sick), MOBILITY DECREASED (In bed for several days), INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.  The caller was calling on behalf of their son who died on 30Jul2021.  The patient received first dose of Moderna COVID-19 vaccine on 22Jun2021 and second on 16Jul2021. The caller stated the patient received the second dose early. The caller did not know which arm the vaccine was given in.  The caller stated after receiving the second dose the patient became very very sick, the patient was in bed for several days, they had flu-like symptoms, a headache, and fatigue.  The caller confirmed patient seemed to get better however then the patient died in their sleep on 30Jul2021.  The caller did not know if the patient took anything to help with the symptoms experienced and confirmed the patient was not taking any daily medications.  Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286489 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. However, 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.; Reported Cause(s) of Death: Unknown cause of death
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Death, Fatigue, Headache, Illness
Clinical narrative: Very very sick; In bed for several days; flu-like symptoms; Headache; Fatigue; Died in their sleep; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (Died in their sleep) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-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 ILLNESS (Very very sick), MOBILITY DECREASED (In bed for several days), INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (Headache) and FATIGUE (Fatigue). The patient died on 30-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ILLNESS (Very very sick), MOBILITY DECREASED (In bed for several days), INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.  The caller was calling on behalf of their son who died on 30Jul2021.  The patient received first dose of Moderna COVID-19 vaccine on 22Jun2021 and second on 16Jul2021. The caller stated the patient received the second dose early. The caller did not know which arm the vaccine was given in.  The caller stated after receiving the second dose the patient became very very sick, the patient was in bed for several days, they had flu-like symptoms, a headache, and fatigue.  The caller confirmed patient seemed to get better however then the patient died in their sleep on 30Jul2021.  The caller did not know if the patient took anything to help with the symptoms experienced and confirmed the patient was not taking any daily medications.  Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286489 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. However, 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.; Reported Cause(s) of Death: Unknown cause of death
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Influenza like illness, Mobility decreased
Clinical narrative: Very very sick; In bed for several days; flu-like symptoms; Headache; Fatigue; Died in their sleep; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (Died in their sleep) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-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 ILLNESS (Very very sick), MOBILITY DECREASED (In bed for several days), INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (Headache) and FATIGUE (Fatigue). The patient died on 30-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ILLNESS (Very very sick), MOBILITY DECREASED (In bed for several days), INFLUENZA LIKE ILLNESS (flu-like symptoms), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.  The caller was calling on behalf of their son who died on 30Jul2021.  The patient received first dose of Moderna COVID-19 vaccine on 22Jun2021 and second on 16Jul2021. The caller stated the patient received the second dose early. The caller did not know which arm the vaccine was given in.  The caller stated after receiving the second dose the patient became very very sick, the patient was in bed for several days, they had flu-like symptoms, a headache, and fatigue.  The caller confirmed patient seemed to get better however then the patient died in their sleep on 30Jul2021.  The caller did not know if the patient took anything to help with the symptoms experienced and confirmed the patient was not taking any daily medications.  Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286489 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. However, 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.; Reported Cause(s) of Death: Unknown cause of death
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: 19 yr old healthy male, on no medications, cleared several years in a row for sports activity. Within 14 hours of receiving the first dose, patient reported having a severe head ache and body aches. Within 16-18 hours he reports  having chest pain that increased with deep breath, then severe chest pain by the morning of 8/15 that decreased with use of Ibuprofen. Crescendo left chest pain, left arm pain, and  mid sternal pain. ED and hospital visit on 8/16 at 9 am due to severe chest pain. Troponin of 905, ST elevation on EKG with right ventricular hypertrophy. Diagnosis of myocarditis. Cardiology visit on 8/26 who noted myocarditis, probable pericarditis, and pleuritis with auscultation of right rub.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Auscultation, Chest pain, Electrocardiogram ST segment elevation, Headache, Myocarditis
Clinical narrative: 19 yr old healthy male, on no medications, cleared several years in a row for sports activity. Within 14 hours of receiving the first dose, patient reported having a severe head ache and body aches. Within 16-18 hours he reports  having chest pain that increased with deep breath, then severe chest pain by the morning of 8/15 that decreased with use of Ibuprofen. Crescendo left chest pain, left arm pain, and  mid sternal pain. ED and hospital visit on 8/16 at 9 am due to severe chest pain. Troponin of 905, ST elevation on EKG with right ventricular hypertrophy. Diagnosis of myocarditis. Cardiology visit on 8/26 who noted myocarditis, probable pericarditis, and pleuritis with auscultation of right rub.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Painful respiration, Pericarditis, Pleurisy
Clinical narrative: 19 yr old healthy male, on no medications, cleared several years in a row for sports activity. Within 14 hours of receiving the first dose, patient reported having a severe head ache and body aches. Within 16-18 hours he reports  having chest pain that increased with deep breath, then severe chest pain by the morning of 8/15 that decreased with use of Ibuprofen. Crescendo left chest pain, left arm pain, and  mid sternal pain. ED and hospital visit on 8/16 at 9 am due to severe chest pain. Troponin of 905, ST elevation on EKG with right ventricular hypertrophy. Diagnosis of myocarditis. Cardiology visit on 8/26 who noted myocarditis, probable pericarditis, and pleuritis with auscultation of right rub.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Right ventricular hypertrophy, Troponin
Clinical narrative: 19 yr old healthy male, on no medications, cleared several years in a row for sports activity. Within 14 hours of receiving the first dose, patient reported having a severe head ache and body aches. Within 16-18 hours he reports  having chest pain that increased with deep breath, then severe chest pain by the morning of 8/15 that decreased with use of Ibuprofen. Crescendo left chest pain, left arm pain, and  mid sternal pain. ED and hospital visit on 8/16 at 9 am due to severe chest pain. Troponin of 905, ST elevation on EKG with right ventricular hypertrophy. Diagnosis of myocarditis. Cardiology visit on 8/26 who noted myocarditis, probable pericarditis, and pleuritis with auscultation of right rub.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Dyspnoea, Fatigue
Clinical narrative: Little bit of dizziness; Feeling pretty fatigued; Muscles were sore and aching; Left arm was fairly sore at injection spot; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EYO584) via an unspecified route of administration in the left arm on 30Jul2021 at 11:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included guillain barre syndrome, hypothyroidism, alopecia, esophageal acid reflux (acid reflux), anxiety, PTSD (post-traumatic stress disorder), DiD (dissociative identity disorder). The patient had known allergies to pollen and grass (spring grasses). Concomitant medications included pregabalin (LYRICA), fluoxetine hydrochloride (PROZAC), quetiapine fumarate (SEROQUEL), omeprazole (MANUFACTURER UNKNOWN) and levothyroxine sodium (SYNTHROID) from an unknown dates, for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Jul2021 at 13:30, the patient left arm was fairly sore at injection spot. After a little over 24 hours, on 31Jul2021, the patient felt pretty fatigued, muscles were sore, aching and experienced little bit of dizziness. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm was fairly sore at injection spot, little bit of dizziness, pretty fatigued and muscles were sore and aching was not resolved at the time of this report.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Little bit of dizziness; Feeling pretty fatigued; Muscles were sore and aching; Left arm was fairly sore at injection spot; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EYO584) via an unspecified route of administration in the left arm on 30Jul2021 at 11:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included guillain barre syndrome, hypothyroidism, alopecia, esophageal acid reflux (acid reflux), anxiety, PTSD (post-traumatic stress disorder), DiD (dissociative identity disorder). The patient had known allergies to pollen and grass (spring grasses). Concomitant medications included pregabalin (LYRICA), fluoxetine hydrochloride (PROZAC), quetiapine fumarate (SEROQUEL), omeprazole (MANUFACTURER UNKNOWN) and levothyroxine sodium (SYNTHROID) from an unknown dates, for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Jul2021 at 13:30, the patient left arm was fairly sore at injection spot. After a little over 24 hours, on 31Jul2021, the patient felt pretty fatigued, muscles were sore, aching and experienced little bit of dizziness. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm was fairly sore at injection spot, little bit of dizziness, pretty fatigued and muscles were sore and aching was not resolved at the time of this report.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Cardiac flutter, Chest pain, Chills
Clinical narrative: Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died.; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Apr2021 (Lot Number: ER8729) (at the age of 79-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Mar2021 (Lot Number: EP7534) as single dose for covid-19 immunisation. No other vaccine in four weeks. The patient had no covid prior vaccination and unknown if covid tested post vaccination. Other medical history Healthy prior to vaccine. Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died. The adverse event start date on 07Apr2021 and event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), patient died. Treatment was received and event treatment doctor visits, labs, hospitalization and operations. The patient died on 13Aug2021. An autopsy was not performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Diarrhoea, Dyspnoea, Fatigue, Headache
Clinical narrative: Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died.; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Apr2021 (Lot Number: ER8729) (at the age of 79-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Mar2021 (Lot Number: EP7534) as single dose for covid-19 immunisation. No other vaccine in four weeks. The patient had no covid prior vaccination and unknown if covid tested post vaccination. Other medical history Healthy prior to vaccine. Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died. The adverse event start date on 07Apr2021 and event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), patient died. Treatment was received and event treatment doctor visits, labs, hospitalization and operations. The patient died on 13Aug2021. An autopsy was not performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Injection site erythema, Injection site swelling, Jaundice, Malaise
Clinical narrative: Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died.; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Apr2021 (Lot Number: ER8729) (at the age of 79-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Mar2021 (Lot Number: EP7534) as single dose for covid-19 immunisation. No other vaccine in four weeks. The patient had no covid prior vaccination and unknown if covid tested post vaccination. Other medical history Healthy prior to vaccine. Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died. The adverse event start date on 07Apr2021 and event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), patient died. Treatment was received and event treatment doctor visits, labs, hospitalization and operations. The patient died on 13Aug2021. An autopsy was not performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Palpitations, Pancreatitis, Pyrexia
Clinical narrative: Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died.; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Apr2021 (Lot Number: ER8729) (at the age of 79-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Mar2021 (Lot Number: EP7534) as single dose for covid-19 immunisation. No other vaccine in four weeks. The patient had no covid prior vaccination and unknown if covid tested post vaccination. Other medical history Healthy prior to vaccine. Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died. The adverse event start date on 07Apr2021 and event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), patient died. Treatment was received and event treatment doctor visits, labs, hospitalization and operations. The patient died on 13Aug2021. An autopsy was not performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died.; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Apr2021 (Lot Number: ER8729) (at the age of 79-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Mar2021 (Lot Number: EP7534) as single dose for covid-19 immunisation. No other vaccine in four weeks. The patient had no covid prior vaccination and unknown if covid tested post vaccination. Other medical history Healthy prior to vaccine. Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died. The adverse event start date on 07Apr2021 and event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), patient died. Treatment was received and event treatment doctor visits, labs, hospitalization and operations. The patient died on 13Aug2021. An autopsy was not performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died.; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Apr2021 (Lot Number: ER8729) (at the age of 79-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Mar2021 (Lot Number: EP7534) as single dose for covid-19 immunisation. No other vaccine in four weeks. The patient had no covid prior vaccination and unknown if covid tested post vaccination. Other medical history Healthy prior to vaccine. Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died. The adverse event start date on 07Apr2021 and event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), patient died. Treatment was received and event treatment doctor visits, labs, hospitalization and operations. The patient died on 13Aug2021. An autopsy was not performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Had almost all of listed side effects listed on Pfizers website; filed report, continued process of diagnosis, was hospitalized and died.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Fatigue, Hallucination, Heavy menstrual bleeding, Narcolepsy
Clinical narrative: Extreme worsening of Narcolepsy; Extreme worsening of Narcolepsy; very frequent cataplexy; very frequent cataplexy; Hallucinations; Breakthrough blood clots between menstrual cycle; Excessive daytime sleepiness; night terrors; sleep paralysis; Breakthrough blood clots between menstrual cycle; This is a spontaneous report from a contactable consumer. This 27-year-old non-pregnant female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 02Aug2021 as dose 1, single for covid-19 immunisation. Patient's known allergies were allergic to Macrobid, Morphine, Thiuram Mix, Gold, Gluten, Dairy, Eggs. Other medical history: Narcolepsy (Type 1 with Cataplexy), Endometriosis. Other medications in two weeks: Armodafinil 250mg, Bupropion XL 150mg, Zyrtec. No other vaccine in four weeks. No Covid prior vaccination and post vaccination. On 02Aug2021 at 17:00, the patient experienced extreme worsening of Narcolepsy (Type 1, with Cataplexy), with symptoms: excessive daytime sleepiness, very frequent cataplexy, night terrors, hallucinations, sleep paralysis. She also experienced breakthrough blood clots between menstrual cycle. Adverse events resulted in doctor or other healthcare professional office/clinic visit. She did not receive any treatment. The outcome of all events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep paralysis, Sleep terror, Somnolence
Clinical narrative: Extreme worsening of Narcolepsy; Extreme worsening of Narcolepsy; very frequent cataplexy; very frequent cataplexy; Hallucinations; Breakthrough blood clots between menstrual cycle; Excessive daytime sleepiness; night terrors; sleep paralysis; Breakthrough blood clots between menstrual cycle; This is a spontaneous report from a contactable consumer. This 27-year-old non-pregnant female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 02Aug2021 as dose 1, single for covid-19 immunisation. Patient's known allergies were allergic to Macrobid, Morphine, Thiuram Mix, Gold, Gluten, Dairy, Eggs. Other medical history: Narcolepsy (Type 1 with Cataplexy), Endometriosis. Other medications in two weeks: Armodafinil 250mg, Bupropion XL 150mg, Zyrtec. No other vaccine in four weeks. No Covid prior vaccination and post vaccination. On 02Aug2021 at 17:00, the patient experienced extreme worsening of Narcolepsy (Type 1, with Cataplexy), with symptoms: excessive daytime sleepiness, very frequent cataplexy, night terrors, hallucinations, sleep paralysis. She also experienced breakthrough blood clots between menstrual cycle. Adverse events resulted in doctor or other healthcare professional office/clinic visit. She did not receive any treatment. The outcome of all events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cataplexy, Disease recurrence, Hallucination, Intermenstrual bleeding, Menstrual disorder
Clinical narrative: Extreme worsening of Narcolepsy; Extreme worsening of Narcolepsy; very frequent cataplexy; very frequent cataplexy; Hallucinations; Breakthrough blood clots between menstrual cycle; Excessive daytime sleepiness; night terrors; sleep paralysis; Breakthrough blood clots between menstrual cycle; This is a spontaneous report from a contactable consumer. This 27-year-old non-pregnant female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 02Aug2021 as dose 1, single for covid-19 immunisation. Patient's known allergies were allergic to Macrobid, Morphine, Thiuram Mix, Gold, Gluten, Dairy, Eggs. Other medical history: Narcolepsy (Type 1 with Cataplexy), Endometriosis. Other medications in two weeks: Armodafinil 250mg, Bupropion XL 150mg, Zyrtec. No other vaccine in four weeks. No Covid prior vaccination and post vaccination. On 02Aug2021 at 17:00, the patient experienced extreme worsening of Narcolepsy (Type 1, with Cataplexy), with symptoms: excessive daytime sleepiness, very frequent cataplexy, night terrors, hallucinations, sleep paralysis. She also experienced breakthrough blood clots between menstrual cycle. Adverse events resulted in doctor or other healthcare professional office/clinic visit. She did not receive any treatment. The outcome of all events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Narcolepsy, Sleep paralysis, Sleep terror, Somnolence
Clinical narrative: Extreme worsening of Narcolepsy; Extreme worsening of Narcolepsy; very frequent cataplexy; very frequent cataplexy; Hallucinations; Breakthrough blood clots between menstrual cycle; Excessive daytime sleepiness; night terrors; sleep paralysis; Breakthrough blood clots between menstrual cycle; This is a spontaneous report from a contactable consumer. This 27-year-old non-pregnant female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 02Aug2021 as dose 1, single for covid-19 immunisation. Patient's known allergies were allergic to Macrobid, Morphine, Thiuram Mix, Gold, Gluten, Dairy, Eggs. Other medical history: Narcolepsy (Type 1 with Cataplexy), Endometriosis. Other medications in two weeks: Armodafinil 250mg, Bupropion XL 150mg, Zyrtec. No other vaccine in four weeks. No Covid prior vaccination and post vaccination. On 02Aug2021 at 17:00, the patient experienced extreme worsening of Narcolepsy (Type 1, with Cataplexy), with symptoms: excessive daytime sleepiness, very frequent cataplexy, night terrors, hallucinations, sleep paralysis. She also experienced breakthrough blood clots between menstrual cycle. Adverse events resulted in doctor or other healthcare professional office/clinic visit. She did not receive any treatment. The outcome of all events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest discomfort, Cough, Dizziness, Dyspnoea
Clinical narrative: Chest heavy; heart rate up; weakness; feel like I'm inhaling water through my nose; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself). A 26-year-old adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 09Aug2021 at 12:00 AM (at the age of 26-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient had no covid prior vaccination. The patient concomitant medications included unspecified Vitamins. No other vaccine in four weeks. On 09Aug2021 at 12:00 AM, after the vaccination, the patient experienced Chest heavy, heart rate up, weakness and feel like inhaling water through her nose. No treatment was received to treat the events. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 05Aug2021. The patient outcome of the events was Not resolved at the time of this report.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Heart rate increased, Nasal discomfort, Oropharyngeal pain
Clinical narrative: Chest heavy; heart rate up; weakness; feel like I'm inhaling water through my nose; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself). A 26-year-old adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 09Aug2021 at 12:00 AM (at the age of 26-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient had no covid prior vaccination. The patient concomitant medications included unspecified Vitamins. No other vaccine in four weeks. On 09Aug2021 at 12:00 AM, after the vaccination, the patient experienced Chest heavy, heart rate up, weakness and feel like inhaling water through her nose. No treatment was received to treat the events. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 05Aug2021. The patient outcome of the events was Not resolved at the time of this report.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest discomfort, Feeling abnormal, Heart rate increased, SARS-CoV-2 test
Clinical narrative: Chest heavy; heart rate up; weakness; feel like I'm inhaling water through my nose; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself). A 26-year-old adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 09Aug2021 at 12:00 AM (at the age of 26-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient had no covid prior vaccination. The patient concomitant medications included unspecified Vitamins. No other vaccine in four weeks. On 09Aug2021 at 12:00 AM, after the vaccination, the patient experienced Chest heavy, heart rate up, weakness and feel like inhaling water through her nose. No treatment was received to treat the events. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 05Aug2021. The patient outcome of the events was Not resolved at the time of this report.  Information on the lot/batch number has been requested.