chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Atrial flutter, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, and felt better.  About 12 hours later she had a headache and took some Aleve.  She woke up the next morning with a severe headache and chest pain that was excruciating.  Her daughter took her to the hospital and did multiple tests and said that she had a pronounced inflammatory response to the vaccine and developed a pericardial effusion and pericarditis.  They sent her home with steroids and Colchicine.  They did not want to put her on NSAIDS due to possible ulcers.  She all the COVID symptoms, and had severe pain still.  Her daughter 3 weeks later took her to the cardiologist.  She had an EKG and Echo and now was in atrial flutter due to the response to the vaccine.  She was then sent to the ER again, and went there twice.  He has put her on medications and now is doing better, she is still weak and has to take Colchicine for 3 months, is on blood thinners and now has sleep issues.  They also put her on some hypertensive medications to make sure that she does not go back into atrial flutter.  She is now back in sinus rhythm.  She was advised not to get the 2nd vaccine due to the reactions from the first one.     She was admitted the first time for 4 days and then 2 trips to the ER and then another admission for 4 more days, so a total of 10 days in the hospital.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Pain, Pericardial effusion, Pericarditis
Clinical narrative: She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, and felt better.  About 12 hours later she had a headache and took some Aleve.  She woke up the next morning with a severe headache and chest pain that was excruciating.  Her daughter took her to the hospital and did multiple tests and said that she had a pronounced inflammatory response to the vaccine and developed a pericardial effusion and pericarditis.  They sent her home with steroids and Colchicine.  They did not want to put her on NSAIDS due to possible ulcers.  She all the COVID symptoms, and had severe pain still.  Her daughter 3 weeks later took her to the cardiologist.  She had an EKG and Echo and now was in atrial flutter due to the response to the vaccine.  She was then sent to the ER again, and went there twice.  He has put her on medications and now is doing better, she is still weak and has to take Colchicine for 3 months, is on blood thinners and now has sleep issues.  They also put her on some hypertensive medications to make sure that she does not go back into atrial flutter.  She is now back in sinus rhythm.  She was advised not to get the 2nd vaccine due to the reactions from the first one.     She was admitted the first time for 4 days and then 2 trips to the ER and then another admission for 4 more days, so a total of 10 days in the hospital.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Sleep disorder, Systemic inflammatory response syndrome
Clinical narrative: She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, and felt better.  About 12 hours later she had a headache and took some Aleve.  She woke up the next morning with a severe headache and chest pain that was excruciating.  Her daughter took her to the hospital and did multiple tests and said that she had a pronounced inflammatory response to the vaccine and developed a pericardial effusion and pericarditis.  They sent her home with steroids and Colchicine.  They did not want to put her on NSAIDS due to possible ulcers.  She all the COVID symptoms, and had severe pain still.  Her daughter 3 weeks later took her to the cardiologist.  She had an EKG and Echo and now was in atrial flutter due to the response to the vaccine.  She was then sent to the ER again, and went there twice.  He has put her on medications and now is doing better, she is still weak and has to take Colchicine for 3 months, is on blood thinners and now has sleep issues.  They also put her on some hypertensive medications to make sure that she does not go back into atrial flutter.  She is now back in sinus rhythm.  She was advised not to get the 2nd vaccine due to the reactions from the first one.     She was admitted the first time for 4 days and then 2 trips to the ER and then another admission for 4 more days, so a total of 10 days in the hospital.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Atrial flutter, Brain natriuretic peptide increased, C-reactive protein increased, Computerised tomogram aorta, Echocardiogram
Clinical narrative: She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, and felt better.  About 12 hours later she had a headache and took some Aleve.  She woke up the next morning with a severe headache and chest pain that was excruciating.  Her daughter took her to the hospital and did multiple tests and said that she had a pronounced inflammatory response to the vaccine and developed a pericardial effusion and pericarditis.  They sent her home with steroids and Colchicine.  They did not want to put her on NSAIDS due to possible ulcers.  She all the COVID symptoms, and had severe pain still.  Her daughter 3 weeks later took her to the cardiologist.  She had an EKG and Echo and now was in atrial flutter due to the response to the vaccine.  She was then sent to the ER again, and went there twice.  He has put her on medications and now is doing better, she is still weak and has to take Colchicine for 3 months, is on blood thinners and now has sleep issues.  They also put her on some hypertensive medications to make sure that she does not go back into atrial flutter.  She is now back in sinus rhythm.  She was advised not to get the 2nd vaccine due to the reactions from the first one.     She was admitted the first time for 4 days and then 2 trips to the ER and then another admission for 4 more days, so a total of 10 days in the hospital.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ejection fraction normal, Pericardial effusion, Pericarditis, Red blood cell sedimentation rate increased
Clinical narrative: She received the vaccine, she went to bed after she was tired for about an hour in the afternoon, and felt better.  About 12 hours later she had a headache and took some Aleve.  She woke up the next morning with a severe headache and chest pain that was excruciating.  Her daughter took her to the hospital and did multiple tests and said that she had a pronounced inflammatory response to the vaccine and developed a pericardial effusion and pericarditis.  They sent her home with steroids and Colchicine.  They did not want to put her on NSAIDS due to possible ulcers.  She all the COVID symptoms, and had severe pain still.  Her daughter 3 weeks later took her to the cardiologist.  She had an EKG and Echo and now was in atrial flutter due to the response to the vaccine.  She was then sent to the ER again, and went there twice.  He has put her on medications and now is doing better, she is still weak and has to take Colchicine for 3 months, is on blood thinners and now has sleep issues.  They also put her on some hypertensive medications to make sure that she does not go back into atrial flutter.  She is now back in sinus rhythm.  She was advised not to get the 2nd vaccine due to the reactions from the first one.     She was admitted the first time for 4 days and then 2 trips to the ER and then another admission for 4 more days, so a total of 10 days in the hospital.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Fall, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Found on floor pale, diaphoretic, unconscious approximately 3 minutes. Suddenly became alert on first attempt to rouse. Noted 5 cm reddened area on forehead as result of fall and hitting a plastic trash can. Orient X3 and aware that she had lost consciousness during syncopal episode. denies similar reactions in the past. Rapid Response called. Ice pack to forehead. 1135 BP 104/66 HR 66 SpO2 99% Assisted to sitting 1140 BP 108/70 HR 72 SpO2 99%   Sent to ED.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Fall, Head injury, Hyperhidrosis, Loss of consciousness
Clinical narrative: Found on floor pale, diaphoretic, unconscious approximately 3 minutes. Suddenly became alert on first attempt to rouse. Noted 5 cm reddened area on forehead as result of fall and hitting a plastic trash can. Orient X3 and aware that she had lost consciousness during syncopal episode. denies similar reactions in the past. Rapid Response called. Ice pack to forehead. 1135 BP 104/66 HR 66 SpO2 99% Assisted to sitting 1140 BP 108/70 HR 72 SpO2 99%   Sent to ED.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pallor, Syncope, Vital signs measurement
Clinical narrative: Found on floor pale, diaphoretic, unconscious approximately 3 minutes. Suddenly became alert on first attempt to rouse. Noted 5 cm reddened area on forehead as result of fall and hitting a plastic trash can. Orient X3 and aware that she had lost consciousness during syncopal episode. denies similar reactions in the past. Rapid Response called. Ice pack to forehead. 1135 BP 104/66 HR 66 SpO2 99% Assisted to sitting 1140 BP 108/70 HR 72 SpO2 99%   Sent to ED.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Incoherent, Injection site pain, Liver function test abnormal, Malaise
Clinical narrative: Became less coherent; Nausea; Headache; Throwing up; Heart was racing; Heart shut down; Kidney shut down; Liver was not functioning/liver shut down; Condition deteriorated; passed; Couldn't talk; Soreness at shot location; feeling not so great; This spontaneous report was received from a consumer via social media, who was the father of a 39-year-old female patient who experienced heart shut down (cardiac failure), kidney shut down (renal failure), liver was not functioning/liver shut down (hepatic failure), condition deteriorated (general physical heath deterioration), became less coherent (incoherent), couldn't talk (aphasia), heart was racing (palpitations), nausea, headache, vomiting, started  feeling not so great (vaccine complication), and soreness at shot location (injection site pain).   The patient had no known medical history.  Concomitant product use was not provided.  On 01-Feb-2001, one day before the onset of the events, this patient was administered their second planned dose of mRNA-1273 (Lot/Batch number: Not provided) for prophylaxis of COVID-19 infection.  On 01 Feb 2021, the patient experienced soreness at shot location.  That evening she started feeling "not so great."  On 02-Feb-2020, the day after vaccination,  She complained she was drinking lots of fluids, but was not urinating, and she had a headache and nausea. She spent 02 and 03 Feb 2021 in bed. She felt a little better on 03 Feb 2021.   On 04 Feb 2021, the patient's heart began racing and she felt like she needed to get to the emergency room, for which her father took her. As soon as they arrived, she began throwing up.  A blood test showed she was "very, very sick" and her liver was not functioning.  She then became less coherent.  On 04 Feb 2021 in the evening, she was transported to a trauma center for a liver transplant.  Attempts to stabilize her for the liver transplant failed and her condition deteriorated.   On the morning of 05 Feb 2021, the patient couldn't talk and her condition worsened throughout the day. Her father reported, her liver, kidney and heart shut down. At 9:00 that night, 30 hours after first arriving to the hospital, the patient passed away.  Action taken with the drug in response to the events is not applicable.  The patient died on 05 Feb 2021.  The autopsy was performed and the results were pending at the time of this report.    The outcome for the events renal failure, hepatic failure and heart failure was considered as unknown.; Reporter's Comments: This is a case of death in a 39-year-old male subject with unknown medical history of, who died 4 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Urinary retention, Vomiting
Clinical narrative: Became less coherent; Nausea; Headache; Throwing up; Heart was racing; Heart shut down; Kidney shut down; Liver was not functioning/liver shut down; Condition deteriorated; passed; Couldn't talk; Soreness at shot location; feeling not so great; This spontaneous report was received from a consumer via social media, who was the father of a 39-year-old female patient who experienced heart shut down (cardiac failure), kidney shut down (renal failure), liver was not functioning/liver shut down (hepatic failure), condition deteriorated (general physical heath deterioration), became less coherent (incoherent), couldn't talk (aphasia), heart was racing (palpitations), nausea, headache, vomiting, started  feeling not so great (vaccine complication), and soreness at shot location (injection site pain).   The patient had no known medical history.  Concomitant product use was not provided.  On 01-Feb-2001, one day before the onset of the events, this patient was administered their second planned dose of mRNA-1273 (Lot/Batch number: Not provided) for prophylaxis of COVID-19 infection.  On 01 Feb 2021, the patient experienced soreness at shot location.  That evening she started feeling "not so great."  On 02-Feb-2020, the day after vaccination,  She complained she was drinking lots of fluids, but was not urinating, and she had a headache and nausea. She spent 02 and 03 Feb 2021 in bed. She felt a little better on 03 Feb 2021.   On 04 Feb 2021, the patient's heart began racing and she felt like she needed to get to the emergency room, for which her father took her. As soon as they arrived, she began throwing up.  A blood test showed she was "very, very sick" and her liver was not functioning.  She then became less coherent.  On 04 Feb 2021 in the evening, she was transported to a trauma center for a liver transplant.  Attempts to stabilize her for the liver transplant failed and her condition deteriorated.   On the morning of 05 Feb 2021, the patient couldn't talk and her condition worsened throughout the day. Her father reported, her liver, kidney and heart shut down. At 9:00 that night, 30 hours after first arriving to the hospital, the patient passed away.  Action taken with the drug in response to the events is not applicable.  The patient died on 05 Feb 2021.  The autopsy was performed and the results were pending at the time of this report.    The outcome for the events renal failure, hepatic failure and heart failure was considered as unknown.; Reporter's Comments: This is a case of death in a 39-year-old male subject with unknown medical history of, who died 4 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Cardiac failure, Death, General physical health deterioration, Headache
Clinical narrative: Became less coherent; Nausea; Headache; Throwing up; Heart was racing; Heart shut down; Kidney shut down; Liver was not functioning/liver shut down; Condition deteriorated; passed; Couldn't talk; Soreness at shot location; feeling not so great; This spontaneous report was received from a consumer via social media, who was the father of a 39-year-old female patient who experienced heart shut down (cardiac failure), kidney shut down (renal failure), liver was not functioning/liver shut down (hepatic failure), condition deteriorated (general physical heath deterioration), became less coherent (incoherent), couldn't talk (aphasia), heart was racing (palpitations), nausea, headache, vomiting, started  feeling not so great (vaccine complication), and soreness at shot location (injection site pain).   The patient had no known medical history.  Concomitant product use was not provided.  On 01-Feb-2001, one day before the onset of the events, this patient was administered their second planned dose of mRNA-1273 (Lot/Batch number: Not provided) for prophylaxis of COVID-19 infection.  On 01 Feb 2021, the patient experienced soreness at shot location.  That evening she started feeling "not so great."  On 02-Feb-2020, the day after vaccination,  She complained she was drinking lots of fluids, but was not urinating, and she had a headache and nausea. She spent 02 and 03 Feb 2021 in bed. She felt a little better on 03 Feb 2021.   On 04 Feb 2021, the patient's heart began racing and she felt like she needed to get to the emergency room, for which her father took her. As soon as they arrived, she began throwing up.  A blood test showed she was "very, very sick" and her liver was not functioning.  She then became less coherent.  On 04 Feb 2021 in the evening, she was transported to a trauma center for a liver transplant.  Attempts to stabilize her for the liver transplant failed and her condition deteriorated.   On the morning of 05 Feb 2021, the patient couldn't talk and her condition worsened throughout the day. Her father reported, her liver, kidney and heart shut down. At 9:00 that night, 30 hours after first arriving to the hospital, the patient passed away.  Action taken with the drug in response to the events is not applicable.  The patient died on 05 Feb 2021.  The autopsy was performed and the results were pending at the time of this report.    The outcome for the events renal failure, hepatic failure and heart failure was considered as unknown.; Reporter's Comments: This is a case of death in a 39-year-old male subject with unknown medical history of, who died 4 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatic failure, Incoherent, Nausea, Palpitations, Renal failure
Clinical narrative: Became less coherent; Nausea; Headache; Throwing up; Heart was racing; Heart shut down; Kidney shut down; Liver was not functioning/liver shut down; Condition deteriorated; passed; Couldn't talk; Soreness at shot location; feeling not so great; This spontaneous report was received from a consumer via social media, who was the father of a 39-year-old female patient who experienced heart shut down (cardiac failure), kidney shut down (renal failure), liver was not functioning/liver shut down (hepatic failure), condition deteriorated (general physical heath deterioration), became less coherent (incoherent), couldn't talk (aphasia), heart was racing (palpitations), nausea, headache, vomiting, started  feeling not so great (vaccine complication), and soreness at shot location (injection site pain).   The patient had no known medical history.  Concomitant product use was not provided.  On 01-Feb-2001, one day before the onset of the events, this patient was administered their second planned dose of mRNA-1273 (Lot/Batch number: Not provided) for prophylaxis of COVID-19 infection.  On 01 Feb 2021, the patient experienced soreness at shot location.  That evening she started feeling "not so great."  On 02-Feb-2020, the day after vaccination,  She complained she was drinking lots of fluids, but was not urinating, and she had a headache and nausea. She spent 02 and 03 Feb 2021 in bed. She felt a little better on 03 Feb 2021.   On 04 Feb 2021, the patient's heart began racing and she felt like she needed to get to the emergency room, for which her father took her. As soon as they arrived, she began throwing up.  A blood test showed she was "very, very sick" and her liver was not functioning.  She then became less coherent.  On 04 Feb 2021 in the evening, she was transported to a trauma center for a liver transplant.  Attempts to stabilize her for the liver transplant failed and her condition deteriorated.   On the morning of 05 Feb 2021, the patient couldn't talk and her condition worsened throughout the day. Her father reported, her liver, kidney and heart shut down. At 9:00 that night, 30 hours after first arriving to the hospital, the patient passed away.  Action taken with the drug in response to the events is not applicable.  The patient died on 05 Feb 2021.  The autopsy was performed and the results were pending at the time of this report.    The outcome for the events renal failure, hepatic failure and heart failure was considered as unknown.; Reporter's Comments: This is a case of death in a 39-year-old male subject with unknown medical history of, who died 4 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication, Vaccination site pain, Vomiting
Clinical narrative: Became less coherent; Nausea; Headache; Throwing up; Heart was racing; Heart shut down; Kidney shut down; Liver was not functioning/liver shut down; Condition deteriorated; passed; Couldn't talk; Soreness at shot location; feeling not so great; This spontaneous report was received from a consumer via social media, who was the father of a 39-year-old female patient who experienced heart shut down (cardiac failure), kidney shut down (renal failure), liver was not functioning/liver shut down (hepatic failure), condition deteriorated (general physical heath deterioration), became less coherent (incoherent), couldn't talk (aphasia), heart was racing (palpitations), nausea, headache, vomiting, started  feeling not so great (vaccine complication), and soreness at shot location (injection site pain).   The patient had no known medical history.  Concomitant product use was not provided.  On 01-Feb-2001, one day before the onset of the events, this patient was administered their second planned dose of mRNA-1273 (Lot/Batch number: Not provided) for prophylaxis of COVID-19 infection.  On 01 Feb 2021, the patient experienced soreness at shot location.  That evening she started feeling "not so great."  On 02-Feb-2020, the day after vaccination,  She complained she was drinking lots of fluids, but was not urinating, and she had a headache and nausea. She spent 02 and 03 Feb 2021 in bed. She felt a little better on 03 Feb 2021.   On 04 Feb 2021, the patient's heart began racing and she felt like she needed to get to the emergency room, for which her father took her. As soon as they arrived, she began throwing up.  A blood test showed she was "very, very sick" and her liver was not functioning.  She then became less coherent.  On 04 Feb 2021 in the evening, she was transported to a trauma center for a liver transplant.  Attempts to stabilize her for the liver transplant failed and her condition deteriorated.   On the morning of 05 Feb 2021, the patient couldn't talk and her condition worsened throughout the day. Her father reported, her liver, kidney and heart shut down. At 9:00 that night, 30 hours after first arriving to the hospital, the patient passed away.  Action taken with the drug in response to the events is not applicable.  The patient died on 05 Feb 2021.  The autopsy was performed and the results were pending at the time of this report.    The outcome for the events renal failure, hepatic failure and heart failure was considered as unknown.; Reporter's Comments: This is a case of death in a 39-year-old male subject with unknown medical history of, who died 4 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Hypotension
Clinical narrative: atrial fibrillation; This is a spontaneous report from a contactable consumer (consumer). An 86-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 14Feb2021 11:00 (at the age of 86-years-old), at single dose for COVID-19 immunisation.  Medical history included diabetes and high blood pressure. The patient had also Covid prior vaccination. The patient had no known allergy. Concomitant medications included linagliptin (TRADJENTA), insulin glargine (LANTUS), glimepiride and carvedilol (COREG).  The patient experienced atrial fibrillation on 15Feb2021 at 15:00.  The patient visit emergency room and was hospitalized for 1 days.  The event was treated with antiarrhythmic and anticoagulant drugs. The outcome of event was recovering.  Information on the lot/batch number has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation
Clinical narrative: atrial fibrillation; This is a spontaneous report from a contactable consumer (consumer). An 86-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 14Feb2021 11:00 (at the age of 86-years-old), at single dose for COVID-19 immunisation.  Medical history included diabetes and high blood pressure. The patient had also Covid prior vaccination. The patient had no known allergy. Concomitant medications included linagliptin (TRADJENTA), insulin glargine (LANTUS), glimepiride and carvedilol (COREG).  The patient experienced atrial fibrillation on 15Feb2021 at 15:00.  The patient visit emergency room and was hospitalized for 1 days.  The event was treated with antiarrhythmic and anticoagulant drugs. The outcome of event was recovering.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coagulation test abnormal, Coagulopathy, Computerised tomogram abnormal, Haemorrhage intracranial, Head injury
Clinical narrative: Brain Death; found to have mixed spontaneous SAH with subsequent trauma; Coagulopathy with hematemesis; Platelets values 160 historical baseline/130 (on arrival to ER)/80/ 70/Patient death; Patient arrived at hospital after fall (within 12 hours of vaccination); hematuria; This is a spontaneous report from a contactable physician. A 74-years-old male patient received first dose of BNT162B2 (Solution for injection, Lot Number: EN6203, Expiration date: Not provided), administered intramuscularly (Anatomical location: Arm left) on 28Feb2021 15:00 as single dose for COVID-19 immunisation. The patient medical history included benign prostatic hyperplasia (BPH). Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) via unknown route of administration for unspecified indication and finasteride via unknown route of administration for an unspecified indication. It was reported that patient had no prior vaccination and covid was not tested. It was reported that patient arrived at hospital after fall (within 12 hours of vaccination), found to have mixed spontaneous Subarachnoid hemorrhage (SAH) with subsequent trauma, Coagulopathy with hematemesis and hematuria. Platelets values 160 historical baseline less than 130 (on arrival to ER) then to less than 80 less than70 and Patient died . The patient underwent lab tests and procedures on 27Feb2021, which included platelet count of 160 historical baseline/130 (on arrival to ER) less than 80 to less than70. Therapeutic measures were taken as a result of brain death, SAH, hematemesis, Platelets decreased, Fall, Hematuria with Platelets, Fresh Frozen Plasma. The patient died on 28Feb2021, Outcome of all events were fatal. Autopsy was not performed.; Sender's Comments: The events fall, subarachnoid hemorrhage, hematamesis, hematuria and brain death are assessed as possibly related to the suspect drug ( bnt162b2 )  based on strong temporal association, but have to ascertain the onset of these events, as it is mentioned the lab test and procedures were done on 27Feb2021 and the patient took the vaccine ( bnt162b2 ) on 28Feb2021.. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the product is evaluated as part of  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.; Reported Cause(s) of Death: Brain Death
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Laboratory test, Syncope
Clinical narrative: Brain Death; found to have mixed spontaneous SAH with subsequent trauma; Coagulopathy with hematemesis; Platelets values 160 historical baseline/130 (on arrival to ER)/80/ 70/Patient death; Patient arrived at hospital after fall (within 12 hours of vaccination); hematuria; This is a spontaneous report from a contactable physician. A 74-years-old male patient received first dose of BNT162B2 (Solution for injection, Lot Number: EN6203, Expiration date: Not provided), administered intramuscularly (Anatomical location: Arm left) on 28Feb2021 15:00 as single dose for COVID-19 immunisation. The patient medical history included benign prostatic hyperplasia (BPH). Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) via unknown route of administration for unspecified indication and finasteride via unknown route of administration for an unspecified indication. It was reported that patient had no prior vaccination and covid was not tested. It was reported that patient arrived at hospital after fall (within 12 hours of vaccination), found to have mixed spontaneous Subarachnoid hemorrhage (SAH) with subsequent trauma, Coagulopathy with hematemesis and hematuria. Platelets values 160 historical baseline less than 130 (on arrival to ER) then to less than 80 less than70 and Patient died . The patient underwent lab tests and procedures on 27Feb2021, which included platelet count of 160 historical baseline/130 (on arrival to ER) less than 80 to less than70. Therapeutic measures were taken as a result of brain death, SAH, hematemesis, Platelets decreased, Fall, Hematuria with Platelets, Fresh Frozen Plasma. The patient died on 28Feb2021, Outcome of all events were fatal. Autopsy was not performed.; Sender's Comments: The events fall, subarachnoid hemorrhage, hematamesis, hematuria and brain death are assessed as possibly related to the suspect drug ( bnt162b2 )  based on strong temporal association, but have to ascertain the onset of these events, as it is mentioned the lab test and procedures were done on 27Feb2021 and the patient took the vaccine ( bnt162b2 ) on 28Feb2021.. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the product is evaluated as part of  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.; Reported Cause(s) of Death: Brain Death
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain death, Fall, Haematemesis, Haematuria, Platelet count
Clinical narrative: Brain Death; found to have mixed spontaneous SAH with subsequent trauma; Coagulopathy with hematemesis; Platelets values 160 historical baseline/130 (on arrival to ER)/80/ 70/Patient death; Patient arrived at hospital after fall (within 12 hours of vaccination); hematuria; This is a spontaneous report from a contactable physician. A 74-years-old male patient received first dose of BNT162B2 (Solution for injection, Lot Number: EN6203, Expiration date: Not provided), administered intramuscularly (Anatomical location: Arm left) on 28Feb2021 15:00 as single dose for COVID-19 immunisation. The patient medical history included benign prostatic hyperplasia (BPH). Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) via unknown route of administration for unspecified indication and finasteride via unknown route of administration for an unspecified indication. It was reported that patient had no prior vaccination and covid was not tested. It was reported that patient arrived at hospital after fall (within 12 hours of vaccination), found to have mixed spontaneous Subarachnoid hemorrhage (SAH) with subsequent trauma, Coagulopathy with hematemesis and hematuria. Platelets values 160 historical baseline less than 130 (on arrival to ER) then to less than 80 less than70 and Patient died . The patient underwent lab tests and procedures on 27Feb2021, which included platelet count of 160 historical baseline/130 (on arrival to ER) less than 80 to less than70. Therapeutic measures were taken as a result of brain death, SAH, hematemesis, Platelets decreased, Fall, Hematuria with Platelets, Fresh Frozen Plasma. The patient died on 28Feb2021, Outcome of all events were fatal. Autopsy was not performed.; Sender's Comments: The events fall, subarachnoid hemorrhage, hematamesis, hematuria and brain death are assessed as possibly related to the suspect drug ( bnt162b2 )  based on strong temporal association, but have to ascertain the onset of these events, as it is mentioned the lab test and procedures were done on 27Feb2021 and the patient took the vaccine ( bnt162b2 ) on 28Feb2021.. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the product is evaluated as part of  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.; Reported Cause(s) of Death: Brain Death
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Subarachnoid haemorrhage
Clinical narrative: Brain Death; found to have mixed spontaneous SAH with subsequent trauma; Coagulopathy with hematemesis; Platelets values 160 historical baseline/130 (on arrival to ER)/80/ 70/Patient death; Patient arrived at hospital after fall (within 12 hours of vaccination); hematuria; This is a spontaneous report from a contactable physician. A 74-years-old male patient received first dose of BNT162B2 (Solution for injection, Lot Number: EN6203, Expiration date: Not provided), administered intramuscularly (Anatomical location: Arm left) on 28Feb2021 15:00 as single dose for COVID-19 immunisation. The patient medical history included benign prostatic hyperplasia (BPH). Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) via unknown route of administration for unspecified indication and finasteride via unknown route of administration for an unspecified indication. It was reported that patient had no prior vaccination and covid was not tested. It was reported that patient arrived at hospital after fall (within 12 hours of vaccination), found to have mixed spontaneous Subarachnoid hemorrhage (SAH) with subsequent trauma, Coagulopathy with hematemesis and hematuria. Platelets values 160 historical baseline less than 130 (on arrival to ER) then to less than 80 less than70 and Patient died . The patient underwent lab tests and procedures on 27Feb2021, which included platelet count of 160 historical baseline/130 (on arrival to ER) less than 80 to less than70. Therapeutic measures were taken as a result of brain death, SAH, hematemesis, Platelets decreased, Fall, Hematuria with Platelets, Fresh Frozen Plasma. The patient died on 28Feb2021, Outcome of all events were fatal. Autopsy was not performed.; Sender's Comments: The events fall, subarachnoid hemorrhage, hematamesis, hematuria and brain death are assessed as possibly related to the suspect drug ( bnt162b2 )  based on strong temporal association, but have to ascertain the onset of these events, as it is mentioned the lab test and procedures were done on 27Feb2021 and the patient took the vaccine ( bnt162b2 ) on 28Feb2021.. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the product is evaluated as part of  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.; Reported Cause(s) of Death: Brain Death
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea, Nausea, Rash erythematous, Rash pruritic
Clinical narrative: Patient reported mild itching of arms at the time of injection.  Was monitored for 30-45 minutes at the clinic and patient contacted MD via phone.  MD advised patient to take Zyrtec and report to ER if symptoms worsened/difficulty breathing or swelling of throat/lips/face.  Patient reports that approximately one hour after the injection, she began having a rash, throat tightness and shortness of breath.  Arrived at ER and was treated with at steroid.  Was advised by MD to abstain from receiving dose #2 of the Moderna Vaccine.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: Patient reported mild itching of arms at the time of injection.  Was monitored for 30-45 minutes at the clinic and patient contacted MD via phone.  MD advised patient to take Zyrtec and report to ER if symptoms worsened/difficulty breathing or swelling of throat/lips/face.  Patient reports that approximately one hour after the injection, she began having a rash, throat tightness and shortness of breath.  Arrived at ER and was treated with at steroid.  Was advised by MD to abstain from receiving dose #2 of the Moderna Vaccine.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Immediate post-injection reaction, Pruritus, Rash, Throat tightness
Clinical narrative: Patient reported mild itching of arms at the time of injection.  Was monitored for 30-45 minutes at the clinic and patient contacted MD via phone.  MD advised patient to take Zyrtec and report to ER if symptoms worsened/difficulty breathing or swelling of throat/lips/face.  Patient reports that approximately one hour after the injection, she began having a rash, throat tightness and shortness of breath.  Arrived at ER and was treated with at steroid.  Was advised by MD to abstain from receiving dose #2 of the Moderna Vaccine.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aortic valve incompetence, Cardiovascular evaluation, Dyspnoea
Clinical narrative: Aortic heart valve was leaking badly; Shortness of breath; Sore shoulder/Sore joints; Tiredness; Fever; This is a spontaneous report from a contactable consumer. This consumer reported an 81-year-old male patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on 21Feb2021 at 14:30 (age at vaccination: 81-years) at a single dose in the left arm for COVID-19 immunization. Medical history included Barrett's esophagus and prior heart valve replacements. Concomitant medications included aminobenzoic acid, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (VITAMIN B COMPLEX [AMINOBENZOIC ACID;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FOLIC ACID;INOSITOL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]); VITAMIN D3; ubidecarenone (CO Q10); doxazosin; metoprolol; apixaban; dofetilide; topiramate; simvastatin; and probiotic. The patient was not diagnosed with COVID-19 prior vaccination. The patient previously took Xarelto and Keppra and experienced allergies; first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) on 30Jan2021 (age: 81-years) in the right arm for COVID-19 immunization. On 23Feb2021, the patient experienced sore shoulder/sore joints, tiredness, and fever. On 24Feb2021, the patient had shortness of breath. On 25Feb2021, the patient's aortic heart valve was leaking badly. The events resulted to emergency room visit and hospitalization for 13 days (date unspecified). The events were considered life threatening illness (immediate risk of death from the events). Patient had two stents, a TAVR heart valve, and unspecified medications as treatment for the events. The patient underwent lab test which included COVID test with negative result on 26Feb2021. The outcome of the events was recovered on an unspecified date.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aortic valve disease, Arthralgia, Dyspnoea, Fatigue, Pyrexia
Clinical narrative: Aortic heart valve was leaking badly; Shortness of breath; Sore shoulder/Sore joints; Tiredness; Fever; This is a spontaneous report from a contactable consumer. This consumer reported an 81-year-old male patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on 21Feb2021 at 14:30 (age at vaccination: 81-years) at a single dose in the left arm for COVID-19 immunization. Medical history included Barrett's esophagus and prior heart valve replacements. Concomitant medications included aminobenzoic acid, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (VITAMIN B COMPLEX [AMINOBENZOIC ACID;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FOLIC ACID;INOSITOL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]); VITAMIN D3; ubidecarenone (CO Q10); doxazosin; metoprolol; apixaban; dofetilide; topiramate; simvastatin; and probiotic. The patient was not diagnosed with COVID-19 prior vaccination. The patient previously took Xarelto and Keppra and experienced allergies; first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) on 30Jan2021 (age: 81-years) in the right arm for COVID-19 immunization. On 23Feb2021, the patient experienced sore shoulder/sore joints, tiredness, and fever. On 24Feb2021, the patient had shortness of breath. On 25Feb2021, the patient's aortic heart valve was leaking badly. The events resulted to emergency room visit and hospitalization for 13 days (date unspecified). The events were considered life threatening illness (immediate risk of death from the events). Patient had two stents, a TAVR heart valve, and unspecified medications as treatment for the events. The patient underwent lab test which included COVID test with negative result on 26Feb2021. The outcome of the events was recovered on an unspecified date.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Aortic heart valve was leaking badly; Shortness of breath; Sore shoulder/Sore joints; Tiredness; Fever; This is a spontaneous report from a contactable consumer. This consumer reported an 81-year-old male patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on 21Feb2021 at 14:30 (age at vaccination: 81-years) at a single dose in the left arm for COVID-19 immunization. Medical history included Barrett's esophagus and prior heart valve replacements. Concomitant medications included aminobenzoic acid, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (VITAMIN B COMPLEX [AMINOBENZOIC ACID;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FOLIC ACID;INOSITOL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]); VITAMIN D3; ubidecarenone (CO Q10); doxazosin; metoprolol; apixaban; dofetilide; topiramate; simvastatin; and probiotic. The patient was not diagnosed with COVID-19 prior vaccination. The patient previously took Xarelto and Keppra and experienced allergies; first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) on 30Jan2021 (age: 81-years) in the right arm for COVID-19 immunization. On 23Feb2021, the patient experienced sore shoulder/sore joints, tiredness, and fever. On 24Feb2021, the patient had shortness of breath. On 25Feb2021, the patient's aortic heart valve was leaking badly. The events resulted to emergency room visit and hospitalization for 13 days (date unspecified). The events were considered life threatening illness (immediate risk of death from the events). Patient had two stents, a TAVR heart valve, and unspecified medications as treatment for the events. The patient underwent lab test which included COVID test with negative result on 26Feb2021. The outcome of the events was recovered on an unspecified date.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immune thrombocytopenia, Petechiae, Platelet count decreased, Purpura
Clinical narrative: rare condition Immune Thrombocytopenia (ITT); platelets decreased; A spontaneous report  was received from a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced low platelets and rare condition Immune Thrombocytopenia (ITT).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25-FEB-2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 012A21A) intramuscularly on left upper arm for prophylaxis of COVID-19 infection. On an unspecified date, in the same week after receiving the vaccine, the patient had been for a dermatologist appointment and her blood work showed low level of platelets. On an unspecified date, the patient went to hematologist and was diagnosed with rare condition Immune Thrombocytopenia (ITT) which caused patient bruises and red spots on mostly knee down. The patient was treated with steroid medication.  The seriousness criteria for the events low platelets and rare condition Immune Thrombocytopenia (ITT) was considered as medically significant.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events low platelets and rare condition Immune Thrombocytopenia (ITT) was unknown.  The reporter did not provide the assessment for the event, rare condition Immune Thrombocytopenia (ITT).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.