chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Hypoaesthesia oral, Oral mucosal eruption, Rash, Swelling face
Clinical narrative: face swollen/ facial swelling; rash; chest pain; tongue/ mouth started to go numb; rash tongue; rash mouth; This is a spontaneous report from a contactable consumer (patient). This 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) on 16Mar2021 03:45 PM in left arm at single dose for COVID-19 immunisation. Medical history included Fabry's disease, kidney disease, known allergies: penicillin. No covid prior vaccination. Concomitant medications in two weeks included clopidogrel, agalsidase beta (FABRAZYME), atorvastatin, nortriptyline hydrochloride (NORTRIPTYLIN). The patient did not receive other vaccine in four weeks. No covid tested post vaccination. The patient experienced face swollen, rash 30 minutes after injection at 04:30 PM on 16Mar2021, two diphenhydramine hydrochloride (BENADRYL) were taken at home before heading to ER (emergency room), arrived to ER with chest pain, facial swelling and rash tongue/ mouth started to go numb around 2 hrs past injection. The events resulted in emergency room/department or urgent care, hospitalization, the patient was hospitalization for two days. The patient received treatment as Albuterol (salbutamol) nebulizer, famotidine (PEPCID), solumedrol nitroglyce for the events. Outcome of the events was recovered.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tongue eruption
Clinical narrative: face swollen/ facial swelling; rash; chest pain; tongue/ mouth started to go numb; rash tongue; rash mouth; This is a spontaneous report from a contactable consumer (patient). This 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) on 16Mar2021 03:45 PM in left arm at single dose for COVID-19 immunisation. Medical history included Fabry's disease, kidney disease, known allergies: penicillin. No covid prior vaccination. Concomitant medications in two weeks included clopidogrel, agalsidase beta (FABRAZYME), atorvastatin, nortriptyline hydrochloride (NORTRIPTYLIN). The patient did not receive other vaccine in four weeks. No covid tested post vaccination. The patient experienced face swollen, rash 30 minutes after injection at 04:30 PM on 16Mar2021, two diphenhydramine hydrochloride (BENADRYL) were taken at home before heading to ER (emergency room), arrived to ER with chest pain, facial swelling and rash tongue/ mouth started to go numb around 2 hrs past injection. The events resulted in emergency room/department or urgent care, hospitalization, the patient was hospitalization for two days. The patient received treatment as Albuterol (salbutamol) nebulizer, famotidine (PEPCID), solumedrol nitroglyce for the events. Outcome of the events was recovered.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rheumatic disorder, Swelling, Swelling face, Swollen tongue
Clinical narrative: Swelling of face and tongue and hives. DAY 2 SEVERE itching around 3lbows and hands that traveled through both arms, swelling in face again and neck, swollen under eye, the next 2 days are variations of the above except for the swollen eye
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Pruritus, Swelling, Swelling face, Swollen tongue
Clinical narrative: Swelling of face and tongue and hives. DAY 2 SEVERE itching around 3lbows and hands that traveled through both arms, swelling in face again and neck, swollen under eye, the next 2 days are variations of the above except for the swollen eye
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Swelling of face and tongue and hives. DAY 2 SEVERE itching around 3lbows and hands that traveled through both arms, swelling in face again and neck, swollen under eye, the next 2 days are variations of the above except for the swollen eye
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain stem stroke, Chest pain, Dyspnoea, Endotracheal intubation, Thrombosis
Clinical narrative: difficulty walking, speaking, seeing; difficulty walking, speaking, seeing; difficulty walking, speaking, seeing; blood clot in brain; vomiting; dizzy; weakness; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular, on 10Mar2021 14:00, as single dose, for covid-19 immunisation, at a physician's office. Medical history included heart disorder. It was unknown if the patient has allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks. On 12Mar2021 at 07:00, the patient experienced difficulty walking, speaking, seeing, and had blood clot in brain. She spent 6 days in the intensive care unit (ICU) and went home (unspecified dates). On an unspecified date in Mar2021, the patient fell ill again and was vomiting, dizzy and had weakness. She was back in the hospital on an unspecified date. The patient has been in the hospital for a total of 12 days at the time of the report. All events resulted to emergency room visit and hospitalization. It was reported that that all events were life-threatening (immediate risk of death from events). Treatment for the events included "possible antibiotics, no diagnosis". The outcome of the events was not recovered.  Information on lot number/batch number has been requested.; Sender's Comments: Based on the available information and temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and all events. However, patient's underlying medical condition of unspecified degree heart disorder, may also have causal relationship to the events. The case will be reassessed if relevant additional medical information becomes available.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral, Angiogram pulmonary, Basilar artery thrombosis, Computerised tomogram head, Ischaemic stroke
Clinical narrative: difficulty walking, speaking, seeing; difficulty walking, speaking, seeing; difficulty walking, speaking, seeing; blood clot in brain; vomiting; dizzy; weakness; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular, on 10Mar2021 14:00, as single dose, for covid-19 immunisation, at a physician's office. Medical history included heart disorder. It was unknown if the patient has allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks. On 12Mar2021 at 07:00, the patient experienced difficulty walking, speaking, seeing, and had blood clot in brain. She spent 6 days in the intensive care unit (ICU) and went home (unspecified dates). On an unspecified date in Mar2021, the patient fell ill again and was vomiting, dizzy and had weakness. She was back in the hospital on an unspecified date. The patient has been in the hospital for a total of 12 days at the time of the report. All events resulted to emergency room visit and hospitalization. It was reported that that all events were life-threatening (immediate risk of death from events). Treatment for the events included "possible antibiotics, no diagnosis". The outcome of the events was not recovered.  Information on lot number/batch number has been requested.; Sender's Comments: Based on the available information and temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and all events. However, patient's underlying medical condition of unspecified degree heart disorder, may also have causal relationship to the events. The case will be reassessed if relevant additional medical information becomes available.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Cerebral thrombosis, Dizziness, Gait disturbance, Speech disorder
Clinical narrative: difficulty walking, speaking, seeing; difficulty walking, speaking, seeing; difficulty walking, speaking, seeing; blood clot in brain; vomiting; dizzy; weakness; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular, on 10Mar2021 14:00, as single dose, for covid-19 immunisation, at a physician's office. Medical history included heart disorder. It was unknown if the patient has allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks. On 12Mar2021 at 07:00, the patient experienced difficulty walking, speaking, seeing, and had blood clot in brain. She spent 6 days in the intensive care unit (ICU) and went home (unspecified dates). On an unspecified date in Mar2021, the patient fell ill again and was vomiting, dizzy and had weakness. She was back in the hospital on an unspecified date. The patient has been in the hospital for a total of 12 days at the time of the report. All events resulted to emergency room visit and hospitalization. It was reported that that all events were life-threatening (immediate risk of death from events). Treatment for the events included "possible antibiotics, no diagnosis". The outcome of the events was not recovered.  Information on lot number/batch number has been requested.; Sender's Comments: Based on the available information and temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and all events. However, patient's underlying medical condition of unspecified degree heart disorder, may also have causal relationship to the events. The case will be reassessed if relevant additional medical information becomes available.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Visual acuity reduced, Vomiting
Clinical narrative: difficulty walking, speaking, seeing; difficulty walking, speaking, seeing; difficulty walking, speaking, seeing; blood clot in brain; vomiting; dizzy; weakness; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular, on 10Mar2021 14:00, as single dose, for covid-19 immunisation, at a physician's office. Medical history included heart disorder. It was unknown if the patient has allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks. On 12Mar2021 at 07:00, the patient experienced difficulty walking, speaking, seeing, and had blood clot in brain. She spent 6 days in the intensive care unit (ICU) and went home (unspecified dates). On an unspecified date in Mar2021, the patient fell ill again and was vomiting, dizzy and had weakness. She was back in the hospital on an unspecified date. The patient has been in the hospital for a total of 12 days at the time of the report. All events resulted to emergency room visit and hospitalization. It was reported that that all events were life-threatening (immediate risk of death from events). Treatment for the events included "possible antibiotics, no diagnosis". The outcome of the events was not recovered.  Information on lot number/batch number has been requested.; Sender's Comments: Based on the available information and temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and all events. However, patient's underlying medical condition of unspecified degree heart disorder, may also have causal relationship to the events. The case will be reassessed if relevant additional medical information becomes available.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Brain death, Brain herniation, Cerebral haematoma, Cerebral haemorrhage
Clinical narrative: DEATH NOS; WORSENING HEADACHE; LEFT-SIDED WEAKNESS; DRY HEAVES; HEADACHE; THROMBOCYTOPENIA; This spontaneous report  was received from The Food and Drug Administration (FDA) via a Company representative and concerned a 45-year old female. The patient's weight, height, and medical history were not reported. The patient was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose, vaccination site and start therapy date were not reported for the prevention of COVID-19 infection. No concomitant medications were reported.  On an unspecified date (6-7 days post vaccination), the patient developed a headache (captured as non-serious).  On an unspecified date (eleven (11) days post vaccination), the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A computerized tomography (CT) and computed tomography angiography (CTA) revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  No other details were provided. The patient died 18 days post vaccination. The immediate cause of death was not reported. It was unspecified if an autopsy was performed. The patient died (death nos), and outcome for the events of left-sided weakness, worsening headache, thrombocytopenia, dry heaves, and headache was not reported. This report was serious (Death, Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 This report received from FDA reported a 45-year-old female patient who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died 18 days later. Medical history and concomitant medications were not reported.  It was reported that 6-7 days post vaccination, the patient developed a headache.  11 days post vaccination, the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A CT/CTA revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  The patient died a week later (18 days post vaccination). No information was provided regarding the cause of death. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: DEATH NOS
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral mass effect, Cerebral venous thrombosis, Cerebral ventricle dilatation, Computerised tomogram head abnormal, Endotracheal intubation
Clinical narrative: DEATH NOS; WORSENING HEADACHE; LEFT-SIDED WEAKNESS; DRY HEAVES; HEADACHE; THROMBOCYTOPENIA; This spontaneous report  was received from The Food and Drug Administration (FDA) via a Company representative and concerned a 45-year old female. The patient's weight, height, and medical history were not reported. The patient was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose, vaccination site and start therapy date were not reported for the prevention of COVID-19 infection. No concomitant medications were reported.  On an unspecified date (6-7 days post vaccination), the patient developed a headache (captured as non-serious).  On an unspecified date (eleven (11) days post vaccination), the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A computerized tomography (CT) and computed tomography angiography (CTA) revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  No other details were provided. The patient died 18 days post vaccination. The immediate cause of death was not reported. It was unspecified if an autopsy was performed. The patient died (death nos), and outcome for the events of left-sided weakness, worsening headache, thrombocytopenia, dry heaves, and headache was not reported. This report was serious (Death, Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 This report received from FDA reported a 45-year-old female patient who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died 18 days later. Medical history and concomitant medications were not reported.  It was reported that 6-7 days post vaccination, the patient developed a headache.  11 days post vaccination, the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A CT/CTA revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  The patient died a week later (18 days post vaccination). No information was provided regarding the cause of death. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: DEATH NOS
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Hemiparesis, Mental status changes, Posturing, Retching
Clinical narrative: DEATH NOS; WORSENING HEADACHE; LEFT-SIDED WEAKNESS; DRY HEAVES; HEADACHE; THROMBOCYTOPENIA; This spontaneous report  was received from The Food and Drug Administration (FDA) via a Company representative and concerned a 45-year old female. The patient's weight, height, and medical history were not reported. The patient was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose, vaccination site and start therapy date were not reported for the prevention of COVID-19 infection. No concomitant medications were reported.  On an unspecified date (6-7 days post vaccination), the patient developed a headache (captured as non-serious).  On an unspecified date (eleven (11) days post vaccination), the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A computerized tomography (CT) and computed tomography angiography (CTA) revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  No other details were provided. The patient died 18 days post vaccination. The immediate cause of death was not reported. It was unspecified if an autopsy was performed. The patient died (death nos), and outcome for the events of left-sided weakness, worsening headache, thrombocytopenia, dry heaves, and headache was not reported. This report was serious (Death, Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 This report received from FDA reported a 45-year-old female patient who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died 18 days later. Medical history and concomitant medications were not reported.  It was reported that 6-7 days post vaccination, the patient developed a headache.  11 days post vaccination, the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A CT/CTA revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  The patient died a week later (18 days post vaccination). No information was provided regarding the cause of death. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: DEATH NOS
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia
Clinical narrative: DEATH NOS; WORSENING HEADACHE; LEFT-SIDED WEAKNESS; DRY HEAVES; HEADACHE; THROMBOCYTOPENIA; This spontaneous report  was received from The Food and Drug Administration (FDA) via a Company representative and concerned a 45-year old female. The patient's weight, height, and medical history were not reported. The patient was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose, vaccination site and start therapy date were not reported for the prevention of COVID-19 infection. No concomitant medications were reported.  On an unspecified date (6-7 days post vaccination), the patient developed a headache (captured as non-serious).  On an unspecified date (eleven (11) days post vaccination), the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A computerized tomography (CT) and computed tomography angiography (CTA) revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  No other details were provided. The patient died 18 days post vaccination. The immediate cause of death was not reported. It was unspecified if an autopsy was performed. The patient died (death nos), and outcome for the events of left-sided weakness, worsening headache, thrombocytopenia, dry heaves, and headache was not reported. This report was serious (Death, Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 This report received from FDA reported a 45-year-old female patient who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died 18 days later. Medical history and concomitant medications were not reported.  It was reported that 6-7 days post vaccination, the patient developed a headache.  11 days post vaccination, the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A CT/CTA revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  The patient died a week later (18 days post vaccination). No information was provided regarding the cause of death. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: DEATH NOS
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram, Computerised tomogram, Death, Headache, Hemiparesis
Clinical narrative: DEATH NOS; WORSENING HEADACHE; LEFT-SIDED WEAKNESS; DRY HEAVES; HEADACHE; THROMBOCYTOPENIA; This spontaneous report  was received from The Food and Drug Administration (FDA) via a Company representative and concerned a 45-year old female. The patient's weight, height, and medical history were not reported. The patient was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose, vaccination site and start therapy date were not reported for the prevention of COVID-19 infection. No concomitant medications were reported.  On an unspecified date (6-7 days post vaccination), the patient developed a headache (captured as non-serious).  On an unspecified date (eleven (11) days post vaccination), the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A computerized tomography (CT) and computed tomography angiography (CTA) revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  No other details were provided. The patient died 18 days post vaccination. The immediate cause of death was not reported. It was unspecified if an autopsy was performed. The patient died (death nos), and outcome for the events of left-sided weakness, worsening headache, thrombocytopenia, dry heaves, and headache was not reported. This report was serious (Death, Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 This report received from FDA reported a 45-year-old female patient who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died 18 days later. Medical history and concomitant medications were not reported.  It was reported that 6-7 days post vaccination, the patient developed a headache.  11 days post vaccination, the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A CT/CTA revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  The patient died a week later (18 days post vaccination). No information was provided regarding the cause of death. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: DEATH NOS
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count, Retching, Thrombocytopenia
Clinical narrative: DEATH NOS; WORSENING HEADACHE; LEFT-SIDED WEAKNESS; DRY HEAVES; HEADACHE; THROMBOCYTOPENIA; This spontaneous report  was received from The Food and Drug Administration (FDA) via a Company representative and concerned a 45-year old female. The patient's weight, height, and medical history were not reported. The patient was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose, vaccination site and start therapy date were not reported for the prevention of COVID-19 infection. No concomitant medications were reported.  On an unspecified date (6-7 days post vaccination), the patient developed a headache (captured as non-serious).  On an unspecified date (eleven (11) days post vaccination), the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A computerized tomography (CT) and computed tomography angiography (CTA) revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  No other details were provided. The patient died 18 days post vaccination. The immediate cause of death was not reported. It was unspecified if an autopsy was performed. The patient died (death nos), and outcome for the events of left-sided weakness, worsening headache, thrombocytopenia, dry heaves, and headache was not reported. This report was serious (Death, Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 This report received from FDA reported a 45-year-old female patient who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died 18 days later. Medical history and concomitant medications were not reported.  It was reported that 6-7 days post vaccination, the patient developed a headache.  11 days post vaccination, the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A CT/CTA revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  The patient died a week later (18 days post vaccination). No information was provided regarding the cause of death. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: DEATH NOS
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Headache
Clinical narrative: DEATH NOS; WORSENING HEADACHE; LEFT-SIDED WEAKNESS; DRY HEAVES; HEADACHE; THROMBOCYTOPENIA; This spontaneous report  was received from The Food and Drug Administration (FDA) via a Company representative and concerned a 45-year old female. The patient's weight, height, and medical history were not reported. The patient was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose, vaccination site and start therapy date were not reported for the prevention of COVID-19 infection. No concomitant medications were reported.  On an unspecified date (6-7 days post vaccination), the patient developed a headache (captured as non-serious).  On an unspecified date (eleven (11) days post vaccination), the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A computerized tomography (CT) and computed tomography angiography (CTA) revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  No other details were provided. The patient died 18 days post vaccination. The immediate cause of death was not reported. It was unspecified if an autopsy was performed. The patient died (death nos), and outcome for the events of left-sided weakness, worsening headache, thrombocytopenia, dry heaves, and headache was not reported. This report was serious (Death, Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 This report received from FDA reported a 45-year-old female patient who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died 18 days later. Medical history and concomitant medications were not reported.  It was reported that 6-7 days post vaccination, the patient developed a headache.  11 days post vaccination, the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A CT/CTA revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  The patient died a week later (18 days post vaccination). No information was provided regarding the cause of death. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: DEATH NOS
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Death
Clinical narrative: DEATH NOS; WORSENING HEADACHE; LEFT-SIDED WEAKNESS; DRY HEAVES; HEADACHE; THROMBOCYTOPENIA; This spontaneous report  was received from The Food and Drug Administration (FDA) via a Company representative and concerned a 45-year old female. The patient's weight, height, and medical history were not reported. The patient was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose, vaccination site and start therapy date were not reported for the prevention of COVID-19 infection. No concomitant medications were reported.  On an unspecified date (6-7 days post vaccination), the patient developed a headache (captured as non-serious).  On an unspecified date (eleven (11) days post vaccination), the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A computerized tomography (CT) and computed tomography angiography (CTA) revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  No other details were provided. The patient died 18 days post vaccination. The immediate cause of death was not reported. It was unspecified if an autopsy was performed. The patient died (death nos), and outcome for the events of left-sided weakness, worsening headache, thrombocytopenia, dry heaves, and headache was not reported. This report was serious (Death, Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 This report received from FDA reported a 45-year-old female patient who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died 18 days later. Medical history and concomitant medications were not reported.  It was reported that 6-7 days post vaccination, the patient developed a headache.  11 days post vaccination, the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A CT/CTA revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  The patient died a week later (18 days post vaccination). No information was provided regarding the cause of death. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: DEATH NOS
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram abnormal, Angiogram cerebral abnormal, Antinuclear antibody negative, Blood fibrinogen decreased, Brain death
Clinical narrative: DEATH NOS; WORSENING HEADACHE; LEFT-SIDED WEAKNESS; DRY HEAVES; HEADACHE; THROMBOCYTOPENIA; This spontaneous report  was received from The Food and Drug Administration (FDA) via a Company representative and concerned a 45-year old female. The patient's weight, height, and medical history were not reported. The patient was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose, vaccination site and start therapy date were not reported for the prevention of COVID-19 infection. No concomitant medications were reported.  On an unspecified date (6-7 days post vaccination), the patient developed a headache (captured as non-serious).  On an unspecified date (eleven (11) days post vaccination), the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A computerized tomography (CT) and computed tomography angiography (CTA) revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  No other details were provided. The patient died 18 days post vaccination. The immediate cause of death was not reported. It was unspecified if an autopsy was performed. The patient died (death nos), and outcome for the events of left-sided weakness, worsening headache, thrombocytopenia, dry heaves, and headache was not reported. This report was serious (Death, Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 This report received from FDA reported a 45-year-old female patient who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died 18 days later. Medical history and concomitant medications were not reported.  It was reported that 6-7 days post vaccination, the patient developed a headache.  11 days post vaccination, the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A CT/CTA revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  The patient died a week later (18 days post vaccination). No information was provided regarding the cause of death. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: DEATH NOS
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Computerised tomogram head abnormal, Death, Feeling abnormal, Fibrin D dimer increased
Clinical narrative: DEATH NOS; WORSENING HEADACHE; LEFT-SIDED WEAKNESS; DRY HEAVES; HEADACHE; THROMBOCYTOPENIA; This spontaneous report  was received from The Food and Drug Administration (FDA) via a Company representative and concerned a 45-year old female. The patient's weight, height, and medical history were not reported. The patient was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose, vaccination site and start therapy date were not reported for the prevention of COVID-19 infection. No concomitant medications were reported.  On an unspecified date (6-7 days post vaccination), the patient developed a headache (captured as non-serious).  On an unspecified date (eleven (11) days post vaccination), the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A computerized tomography (CT) and computed tomography angiography (CTA) revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  No other details were provided. The patient died 18 days post vaccination. The immediate cause of death was not reported. It was unspecified if an autopsy was performed. The patient died (death nos), and outcome for the events of left-sided weakness, worsening headache, thrombocytopenia, dry heaves, and headache was not reported. This report was serious (Death, Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 This report received from FDA reported a 45-year-old female patient who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died 18 days later. Medical history and concomitant medications were not reported.  It was reported that 6-7 days post vaccination, the patient developed a headache.  11 days post vaccination, the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A CT/CTA revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  The patient died a week later (18 days post vaccination). No information was provided regarding the cause of death. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: DEATH NOS
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Gene mutation identification test negative, Headache, Lethargy, Nausea, Platelet count decreased
Clinical narrative: DEATH NOS; WORSENING HEADACHE; LEFT-SIDED WEAKNESS; DRY HEAVES; HEADACHE; THROMBOCYTOPENIA; This spontaneous report  was received from The Food and Drug Administration (FDA) via a Company representative and concerned a 45-year old female. The patient's weight, height, and medical history were not reported. The patient was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose, vaccination site and start therapy date were not reported for the prevention of COVID-19 infection. No concomitant medications were reported.  On an unspecified date (6-7 days post vaccination), the patient developed a headache (captured as non-serious).  On an unspecified date (eleven (11) days post vaccination), the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A computerized tomography (CT) and computed tomography angiography (CTA) revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  No other details were provided. The patient died 18 days post vaccination. The immediate cause of death was not reported. It was unspecified if an autopsy was performed. The patient died (death nos), and outcome for the events of left-sided weakness, worsening headache, thrombocytopenia, dry heaves, and headache was not reported. This report was serious (Death, Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 This report received from FDA reported a 45-year-old female patient who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died 18 days later. Medical history and concomitant medications were not reported.  It was reported that 6-7 days post vaccination, the patient developed a headache.  11 days post vaccination, the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A CT/CTA revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  The patient died a week later (18 days post vaccination). No information was provided regarding the cause of death. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: DEATH NOS
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia, Transverse sinus thrombosis
Clinical narrative: DEATH NOS; WORSENING HEADACHE; LEFT-SIDED WEAKNESS; DRY HEAVES; HEADACHE; THROMBOCYTOPENIA; This spontaneous report  was received from The Food and Drug Administration (FDA) via a Company representative and concerned a 45-year old female. The patient's weight, height, and medical history were not reported. The patient was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose, vaccination site and start therapy date were not reported for the prevention of COVID-19 infection. No concomitant medications were reported.  On an unspecified date (6-7 days post vaccination), the patient developed a headache (captured as non-serious).  On an unspecified date (eleven (11) days post vaccination), the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A computerized tomography (CT) and computed tomography angiography (CTA) revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  No other details were provided. The patient died 18 days post vaccination. The immediate cause of death was not reported. It was unspecified if an autopsy was performed. The patient died (death nos), and outcome for the events of left-sided weakness, worsening headache, thrombocytopenia, dry heaves, and headache was not reported. This report was serious (Death, Hospitalization Caused/Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 This report received from FDA reported a 45-year-old female patient who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and died 18 days later. Medical history and concomitant medications were not reported.  It was reported that 6-7 days post vaccination, the patient developed a headache.  11 days post vaccination, the patient presented to the hospital with left-sided weakness, dry heaves, and worsening headache. A CT/CTA revealed cortical vein thrombosis involving the right transverse and sigmoid sinus, tentorial herniation, and massive intracerebral hemorrhage. She also had thrombocytopenia (value not reported).  The patient died a week later (18 days post vaccination). No information was provided regarding the cause of death. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: DEATH NOS
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Blood test, Chills, Computerised tomogram normal, Impaired driving ability
Clinical narrative: flu like symptoms; Severe Vertigo; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 06Jan2021 (Batch/Lot Number: EL0142) as SINGLE DOSE for covid-19 immunisation. Medical history included High Cholesterol and allergies: Latex from an unknown date and unknown if ongoing. The patient has no Covid prior vaccination. The patient was vaccinated in a hospital. It was reported that there was no other vaccine in four weeks. The patient previously received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) first dose via unspecified route of administration (lot number: EK5750) on 18Dec2020 09:30 AM at the Left arm for COVID-19 immunization. Concomitant medication included (also reported as Other medications in two weeks) omeprazole; lisinopril; and fenofibrate; all taken for an unspecified indication, start and stop date were not reported. It was reported that "3 days after 2nd shot I had flu like symptoms 4 weeks after 2nd shot, I developed Severe Vertigo while on duty, taken to ER and am still off duty because of it (5 weeks as of this report). I have followed up with PCP, ENT & Neurologist, all show no signs of ear infection or any trauma or damage that would set this off." The events were reported to occurred on 13Feb2021 at 02:15 am. The outcome of the events was not recovered. The events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care; Disability or permanent damage. Treatment was initiated which includes: MRI, MRA, CT, CT with Contrast, Vestibular Rehabil. The patient was tested for covid post vaccination (nasal swab) on 13Feb2021 with negative result.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Impaired work ability, Magnetic resonance imaging, Nausea, Pain, Pyrexia
Clinical narrative: flu like symptoms; Severe Vertigo; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 06Jan2021 (Batch/Lot Number: EL0142) as SINGLE DOSE for covid-19 immunisation. Medical history included High Cholesterol and allergies: Latex from an unknown date and unknown if ongoing. The patient has no Covid prior vaccination. The patient was vaccinated in a hospital. It was reported that there was no other vaccine in four weeks. The patient previously received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) first dose via unspecified route of administration (lot number: EK5750) on 18Dec2020 09:30 AM at the Left arm for COVID-19 immunization. Concomitant medication included (also reported as Other medications in two weeks) omeprazole; lisinopril; and fenofibrate; all taken for an unspecified indication, start and stop date were not reported. It was reported that "3 days after 2nd shot I had flu like symptoms 4 weeks after 2nd shot, I developed Severe Vertigo while on duty, taken to ER and am still off duty because of it (5 weeks as of this report). I have followed up with PCP, ENT & Neurologist, all show no signs of ear infection or any trauma or damage that would set this off." The events were reported to occurred on 13Feb2021 at 02:15 am. The outcome of the events was not recovered. The events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care; Disability or permanent damage. Treatment was initiated which includes: MRI, MRA, CT, CT with Contrast, Vestibular Rehabil. The patient was tested for covid post vaccination (nasal swab) on 13Feb2021 with negative result.