chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Blood test normal, Body temperature increased, Chest X-ray normal, Electrocardiogram normal
Clinical narrative: palpitations; Heart rate was 138 and was 98 when released; Body temperature was 101; BP was 148/95 and was 138/87 when released; Potassium was low 3.5; Total Bilirubin was high 1.1; WBC high 12.4; RDW high 14.4; This is a spontaneous report from a contactable consumer (patient). A 53-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3184, Expiration date; Not reported), via intramuscular route in right arm on 27Aug2021 at 18:00 (at the age of 53-years-old) as dose 2, single for COVID-19 immunization in a pharmacy/drug store. The patient's medical history was reported as none. The patient's family history included massive heart attack for both father (62-years-old) and brother (58-years-old) who died due to this problem and the sister (60-years-old) died due to massive stroke. There were no concomitant medications reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0180, Expiration date; Not reported), via intramuscular route in right arm on 06Aug2021 at 18:00 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization and experienced swollen lymph nodes. No prior vaccinations were reported. The patient experienced palpitations on 28Aug2021 at 13:30. This event required emergency room (ER) visit. The patient received treatment with metoprolol (LOPRESSOR) and the heart rate (HR) still spikes but not on any medications for it. It's better. On 28Aug2021, the patient's total bilirubin was 1.1 (high); potassium was 3.5 (low); blood pressure (BP) was 148/95 and was 138/87 when released; blood test for cardiac enzymes was negative; heart rate was 138, and was 98 when released; body temperature was 101; red cell distribution width was 14.4 (high) and white blood cell count (WBC) was 12.4 (high). The event palpitations was considered as an important medical event. The outcome of palpitations was recovering while the outcome of other events was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Parosmia
Clinical narrative: palpitations; Heart rate was 138 and was 98 when released; Body temperature was 101; BP was 148/95 and was 138/87 when released; Potassium was low 3.5; Total Bilirubin was high 1.1; WBC high 12.4; RDW high 14.4; This is a spontaneous report from a contactable consumer (patient). A 53-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3184, Expiration date; Not reported), via intramuscular route in right arm on 27Aug2021 at 18:00 (at the age of 53-years-old) as dose 2, single for COVID-19 immunization in a pharmacy/drug store. The patient's medical history was reported as none. The patient's family history included massive heart attack for both father (62-years-old) and brother (58-years-old) who died due to this problem and the sister (60-years-old) died due to massive stroke. There were no concomitant medications reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0180, Expiration date; Not reported), via intramuscular route in right arm on 06Aug2021 at 18:00 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization and experienced swollen lymph nodes. No prior vaccinations were reported. The patient experienced palpitations on 28Aug2021 at 13:30. This event required emergency room (ER) visit. The patient received treatment with metoprolol (LOPRESSOR) and the heart rate (HR) still spikes but not on any medications for it. It's better. On 28Aug2021, the patient's total bilirubin was 1.1 (high); potassium was 3.5 (low); blood pressure (BP) was 148/95 and was 138/87 when released; blood test for cardiac enzymes was negative; heart rate was 138, and was 98 when released; body temperature was 101; red cell distribution width was 14.4 (high) and white blood cell count (WBC) was 12.4 (high). The event palpitations was considered as an important medical event. The outcome of palpitations was recovering while the outcome of other events was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Body temperature, Heart rate
Clinical narrative: palpitations; Heart rate was 138 and was 98 when released; Body temperature was 101; BP was 148/95 and was 138/87 when released; Potassium was low 3.5; Total Bilirubin was high 1.1; WBC high 12.4; RDW high 14.4; This is a spontaneous report from a contactable consumer (patient). A 53-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3184, Expiration date; Not reported), via intramuscular route in right arm on 27Aug2021 at 18:00 (at the age of 53-years-old) as dose 2, single for COVID-19 immunization in a pharmacy/drug store. The patient's medical history was reported as none. The patient's family history included massive heart attack for both father (62-years-old) and brother (58-years-old) who died due to this problem and the sister (60-years-old) died due to massive stroke. There were no concomitant medications reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0180, Expiration date; Not reported), via intramuscular route in right arm on 06Aug2021 at 18:00 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization and experienced swollen lymph nodes. No prior vaccinations were reported. The patient experienced palpitations on 28Aug2021 at 13:30. This event required emergency room (ER) visit. The patient received treatment with metoprolol (LOPRESSOR) and the heart rate (HR) still spikes but not on any medications for it. It's better. On 28Aug2021, the patient's total bilirubin was 1.1 (high); potassium was 3.5 (low); blood pressure (BP) was 148/95 and was 138/87 when released; blood test for cardiac enzymes was negative; heart rate was 138, and was 98 when released; body temperature was 101; red cell distribution width was 14.4 (high) and white blood cell count (WBC) was 12.4 (high). The event palpitations was considered as an important medical event. The outcome of palpitations was recovering while the outcome of other events was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Palpitations, Pyrexia
Clinical narrative: palpitations; Heart rate was 138 and was 98 when released; Body temperature was 101; BP was 148/95 and was 138/87 when released; Potassium was low 3.5; Total Bilirubin was high 1.1; WBC high 12.4; RDW high 14.4; This is a spontaneous report from a contactable consumer (patient). A 53-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3184, Expiration date; Not reported), via intramuscular route in right arm on 27Aug2021 at 18:00 (at the age of 53-years-old) as dose 2, single for COVID-19 immunization in a pharmacy/drug store. The patient's medical history was reported as none. The patient's family history included massive heart attack for both father (62-years-old) and brother (58-years-old) who died due to this problem and the sister (60-years-old) died due to massive stroke. There were no concomitant medications reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0180, Expiration date; Not reported), via intramuscular route in right arm on 06Aug2021 at 18:00 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization and experienced swollen lymph nodes. No prior vaccinations were reported. The patient experienced palpitations on 28Aug2021 at 13:30. This event required emergency room (ER) visit. The patient received treatment with metoprolol (LOPRESSOR) and the heart rate (HR) still spikes but not on any medications for it. It's better. On 28Aug2021, the patient's total bilirubin was 1.1 (high); potassium was 3.5 (low); blood pressure (BP) was 148/95 and was 138/87 when released; blood test for cardiac enzymes was negative; heart rate was 138, and was 98 when released; body temperature was 101; red cell distribution width was 14.4 (high) and white blood cell count (WBC) was 12.4 (high). The event palpitations was considered as an important medical event. The outcome of palpitations was recovering while the outcome of other events was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Fall, Feeling hot, Gait disturbance, Hypokinesia
Clinical narrative: Events: Unstable gait, itchy/burning/tingling/redness in hands up to wrists, tingling in toes, muscles weakness in both arms and thighs, weakness in lower back, constant falling ending in using a walker. No Current Treatments
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Movement disorder, Muscle fatigue, Pain, Paralysis
Clinical narrative: Events: Unstable gait, itchy/burning/tingling/redness in hands up to wrists, tingling in toes, muscles weakness in both arms and thighs, weakness in lower back, constant falling ending in using a walker. No Current Treatments
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Burning sensation, Chest X-ray, Electromyogram
Clinical narrative: Events: Unstable gait, itchy/burning/tingling/redness in hands up to wrists, tingling in toes, muscles weakness in both arms and thighs, weakness in lower back, constant falling ending in using a walker. No Current Treatments
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Fall, Gait disturbance, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: Events: Unstable gait, itchy/burning/tingling/redness in hands up to wrists, tingling in toes, muscles weakness in both arms and thighs, weakness in lower back, constant falling ending in using a walker. No Current Treatments
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia, Pruritus, Walking aid user
Clinical narrative: Events: Unstable gait, itchy/burning/tingling/redness in hands up to wrists, tingling in toes, muscles weakness in both arms and thighs, weakness in lower back, constant falling ending in using a walker. No Current Treatments
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Blood test, Chest X-ray, Dry mouth, Dyspnoea
Clinical narrative: asthma attack; Sweating; elevated heart rate; itchy mouth shortly after 2nd dose; trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 26Aug2021 (Batch/Lot Number: EW0181) at the age of 36-years-old as dose 2, single for covid-19 immunisation. Medical history included life threatening anaphylaxis after allergy shot (3 day hospitalization), known allergy- penicillin, stone fruit, dogs, cats, weeds, grass and trees. The patient is not pregnant at the time of vaccination. Concomitant medications included sertraline; doxycycline (DOXICILINA); fluticasone propionate (FLONASE ALLERGY RELIEF); montelukast sodium (SINGULAIR) and cetirizine hydrochloride (ZYRAC) all taken for an unspecified indication, start and stop date were not reported. The patient previously received dose 1 of bnt162b2 (lot number: EW0181) on 04Aug2021 administered n the right arm for Covid-19 immunization. On 26Aug2021, the patient experienced asthma attack, sweating, elevated heart rate, itchy mouth shortly after 2nd dose and trouble breathing. The events required emergency room/department or urgent care visit. The patient was administered IV steroids and Benadryl. The events were assessed serious, medically significant. The outcome of t events was recovered on unspecified date.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Heart rate increased, Hyperhidrosis, Rash macular, Tremor
Clinical narrative: asthma attack; Sweating; elevated heart rate; itchy mouth shortly after 2nd dose; trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 26Aug2021 (Batch/Lot Number: EW0181) at the age of 36-years-old as dose 2, single for covid-19 immunisation. Medical history included life threatening anaphylaxis after allergy shot (3 day hospitalization), known allergy- penicillin, stone fruit, dogs, cats, weeds, grass and trees. The patient is not pregnant at the time of vaccination. Concomitant medications included sertraline; doxycycline (DOXICILINA); fluticasone propionate (FLONASE ALLERGY RELIEF); montelukast sodium (SINGULAIR) and cetirizine hydrochloride (ZYRAC) all taken for an unspecified indication, start and stop date were not reported. The patient previously received dose 1 of bnt162b2 (lot number: EW0181) on 04Aug2021 administered n the right arm for Covid-19 immunization. On 26Aug2021, the patient experienced asthma attack, sweating, elevated heart rate, itchy mouth shortly after 2nd dose and trouble breathing. The events required emergency room/department or urgent care visit. The patient was administered IV steroids and Benadryl. The events were assessed serious, medically significant. The outcome of t events was recovered on unspecified date.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Dyspnoea, Heart rate increased, Hyperhidrosis, Oral pruritus
Clinical narrative: asthma attack; Sweating; elevated heart rate; itchy mouth shortly after 2nd dose; trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 26Aug2021 (Batch/Lot Number: EW0181) at the age of 36-years-old as dose 2, single for covid-19 immunisation. Medical history included life threatening anaphylaxis after allergy shot (3 day hospitalization), known allergy- penicillin, stone fruit, dogs, cats, weeds, grass and trees. The patient is not pregnant at the time of vaccination. Concomitant medications included sertraline; doxycycline (DOXICILINA); fluticasone propionate (FLONASE ALLERGY RELIEF); montelukast sodium (SINGULAIR) and cetirizine hydrochloride (ZYRAC) all taken for an unspecified indication, start and stop date were not reported. The patient previously received dose 1 of bnt162b2 (lot number: EW0181) on 04Aug2021 administered n the right arm for Covid-19 immunization. On 26Aug2021, the patient experienced asthma attack, sweating, elevated heart rate, itchy mouth shortly after 2nd dose and trouble breathing. The events required emergency room/department or urgent care visit. The patient was administered IV steroids and Benadryl. The events were assessed serious, medically significant. The outcome of t events was recovered on unspecified date.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: 24 hours after my 2nd shot, I woke up to Hives on my body. My lips and eyelids began to swell, and so did my throat. We went to the ER and they sent me home with benadryl. The following day I woke up with an even worse rash from the top of my head, groin, all over my torso, and the bottom of my feet. It spread quickly and aggressively. I was admitted to the ER and as the rash spread to the inside of my mouth and face, they gave me my first Epi- Shot. It seemed to calm down, but about 20 minutes later it flared up again. I received another Epi- Shot. About an hour later, the same thing happened and I received my third Epi-Shot. I was admitted to the ICU for further monitoring. The rash continued to spread, and every four hours they were giving me steroid, and benadryl. Around 4am the first night I had another flare up and I received my fourth Epi- shot. The next day my rash was still spreading, and getting worse. I started to figure out that there was PEG in the moderna shot, and PEG in all the medications they were giving me. I began to refuse the medication and demanded they try something new. They gave me a different steroid, and a different antihistamine. Day 3 I began to stabilize,  and they moved me to a regular room. I spent 2 days in a regular hospital room for further monitoring. I was released after day 5 on an insane regime of antihistamines, and steroids. Now I suffer from high blood pressure, and an allergy to PEG and Polyexythanol.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Eye swelling, Hypersensitivity, Hypertension, Intensive care
Clinical narrative: 24 hours after my 2nd shot, I woke up to Hives on my body. My lips and eyelids began to swell, and so did my throat. We went to the ER and they sent me home with benadryl. The following day I woke up with an even worse rash from the top of my head, groin, all over my torso, and the bottom of my feet. It spread quickly and aggressively. I was admitted to the ER and as the rash spread to the inside of my mouth and face, they gave me my first Epi- Shot. It seemed to calm down, but about 20 minutes later it flared up again. I received another Epi- Shot. About an hour later, the same thing happened and I received my third Epi-Shot. I was admitted to the ICU for further monitoring. The rash continued to spread, and every four hours they were giving me steroid, and benadryl. Around 4am the first night I had another flare up and I received my fourth Epi- shot. The next day my rash was still spreading, and getting worse. I started to figure out that there was PEG in the moderna shot, and PEG in all the medications they were giving me. I began to refuse the medication and demanded they try something new. They gave me a different steroid, and a different antihistamine. Day 3 I began to stabilize,  and they moved me to a regular room. I spent 2 days in a regular hospital room for further monitoring. I was released after day 5 on an insane regime of antihistamines, and steroids. Now I suffer from high blood pressure, and an allergy to PEG and Polyexythanol.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Oral mucosal eruption, Pharyngeal swelling, Rash, Urticaria
Clinical narrative: 24 hours after my 2nd shot, I woke up to Hives on my body. My lips and eyelids began to swell, and so did my throat. We went to the ER and they sent me home with benadryl. The following day I woke up with an even worse rash from the top of my head, groin, all over my torso, and the bottom of my feet. It spread quickly and aggressively. I was admitted to the ER and as the rash spread to the inside of my mouth and face, they gave me my first Epi- Shot. It seemed to calm down, but about 20 minutes later it flared up again. I received another Epi- Shot. About an hour later, the same thing happened and I received my third Epi-Shot. I was admitted to the ICU for further monitoring. The rash continued to spread, and every four hours they were giving me steroid, and benadryl. Around 4am the first night I had another flare up and I received my fourth Epi- shot. The next day my rash was still spreading, and getting worse. I started to figure out that there was PEG in the moderna shot, and PEG in all the medications they were giving me. I began to refuse the medication and demanded they try something new. They gave me a different steroid, and a different antihistamine. Day 3 I began to stabilize,  and they moved me to a regular room. I spent 2 days in a regular hospital room for further monitoring. I was released after day 5 on an insane regime of antihistamines, and steroids. Now I suffer from high blood pressure, and an allergy to PEG and Polyexythanol.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Lip pruritus, Lip swelling
Clinical narrative: She was almost died; severe dizziness; chest pain; my arm hurt (where she received the injection); itchy tongue; lips swelled; still very tired; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on 16Aug2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 53 years). The patient medical history and concomitant medications was not reported. The patient previously took Cipro (Ciprofloxacin) and Bactrim and experienced allergy. On an unspecified date in Aug2021, it was reported that, the patient experienced had a bad reaction: severe dizziness, chest pain, itchy tongue, lips swelled, still very tired, her arm was hurt (where she received the injection) and she was almost died. The outcome of the events severe dizziness, chest pain and her arm was hurt (where she received the injection) was not recovered. The outcome of the events itchy tongue, lips swelled, still very tired and she was almost died was unknown.   Follow-up attempts completed. No further information was expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Near death experience, Pallor, Tongue pruritus
Clinical narrative: She was almost died; severe dizziness; chest pain; my arm hurt (where she received the injection); itchy tongue; lips swelled; still very tired; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on 16Aug2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 53 years). The patient medical history and concomitant medications was not reported. The patient previously took Cipro (Ciprofloxacin) and Bactrim and experienced allergy. On an unspecified date in Aug2021, it was reported that, the patient experienced had a bad reaction: severe dizziness, chest pain, itchy tongue, lips swelled, still very tired, her arm was hurt (where she received the injection) and she was almost died. The outcome of the events severe dizziness, chest pain and her arm was hurt (where she received the injection) was not recovered. The outcome of the events itchy tongue, lips swelled, still very tired and she was almost died was unknown.   Follow-up attempts completed. No further information was expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Lip swelling, Near death experience
Clinical narrative: She was almost died; severe dizziness; chest pain; my arm hurt (where she received the injection); itchy tongue; lips swelled; still very tired; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on 16Aug2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 53 years). The patient medical history and concomitant medications was not reported. The patient previously took Cipro (Ciprofloxacin) and Bactrim and experienced allergy. On an unspecified date in Aug2021, it was reported that, the patient experienced had a bad reaction: severe dizziness, chest pain, itchy tongue, lips swelled, still very tired, her arm was hurt (where she received the injection) and she was almost died. The outcome of the events severe dizziness, chest pain and her arm was hurt (where she received the injection) was not recovered. The outcome of the events itchy tongue, lips swelled, still very tired and she was almost died was unknown.   Follow-up attempts completed. No further information was expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue pruritus, Vaccination site pain
Clinical narrative: She was almost died; severe dizziness; chest pain; my arm hurt (where she received the injection); itchy tongue; lips swelled; still very tired; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on 16Aug2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 53 years). The patient medical history and concomitant medications was not reported. The patient previously took Cipro (Ciprofloxacin) and Bactrim and experienced allergy. On an unspecified date in Aug2021, it was reported that, the patient experienced had a bad reaction: severe dizziness, chest pain, itchy tongue, lips swelled, still very tired, her arm was hurt (where she received the injection) and she was almost died. The outcome of the events severe dizziness, chest pain and her arm was hurt (where she received the injection) was not recovered. The outcome of the events itchy tongue, lips swelled, still very tired and she was almost died was unknown.   Follow-up attempts completed. No further information was expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Activated partial thromboplastin time shortened, Antibody test positive, Anticoagulant therapy, Blood fibrinogen decreased
Clinical narrative: CVST; This spontaneous report was received from a consumer (the patient's brother-in-law) and concerned a 37 year-old female patient. The patient's weight and height were not reported, nor was her medical history, mother of 2 year-old child and a 5 year-old child. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number not reported), dose, vaccination date and anatomical site of administration not reported, for prophylactic vaccination. The batch number was not reported and will be requested. No concomitant medications were reported. On 06-SEP-2021, approximately 1 week post-vaccination, the reporter contacted the company to report that the patient had experienced cerebral venous sinus thrombosis (CVST), was fighting for her life 'confirmed that night, a direct reaction to your vaccine', and that the patient's prognosis was dire. The patient had been hospitalized on an unspecified date. On 15:52 hours on 07-SEP-2021, the reporter contacted the company again to report that life support for the patient was to be discontinued in 38 minutes. It was not reported if life support was subsequently withdrawn and if the patient had died. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The outcomes of CVST was not reported. This report was serious (life-threatening, caused/prolonged hospitalization).; Sender's Comments: V0: This spontaneous report received from a consumer (the patient's brother-in-law) concerned a 37-year-old female patient who experienced CVST approximately 1 week after vaccine. Medical history and concomitant medications were not reported. Approximately 1 week after vaccine, the reporter contacted the company to report that the patient had experienced cerebral venous sinus thrombosis (CVST), was fighting for her life 'confirmed that night, a direct reaction to your vaccine', and that the patient's prospects were dire. The patient had been hospitalized on an unspecified date. Laboratory values, including platelet count, d dimer and anti-PF4 antibodies were not provided. The following day, the reporter contacted the company again to report that life support for the patient was to be discontinued in 38 minutes. It was not reported if life support was subsequently withdrawn or if the patient had died. Information is limited in this case, and the occurrence of CVST could represent background incidence of such events in the general population. It was not reported whether there was thrombocytopenia or other risk factors. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood lactate dehydrogenase normal, Brain death, Cerebral haemorrhage, Computerised tomogram head abnormal, Craniotomy
Clinical narrative: CVST; This spontaneous report was received from a consumer (the patient's brother-in-law) and concerned a 37 year-old female patient. The patient's weight and height were not reported, nor was her medical history, mother of 2 year-old child and a 5 year-old child. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number not reported), dose, vaccination date and anatomical site of administration not reported, for prophylactic vaccination. The batch number was not reported and will be requested. No concomitant medications were reported. On 06-SEP-2021, approximately 1 week post-vaccination, the reporter contacted the company to report that the patient had experienced cerebral venous sinus thrombosis (CVST), was fighting for her life 'confirmed that night, a direct reaction to your vaccine', and that the patient's prognosis was dire. The patient had been hospitalized on an unspecified date. On 15:52 hours on 07-SEP-2021, the reporter contacted the company again to report that life support for the patient was to be discontinued in 38 minutes. It was not reported if life support was subsequently withdrawn and if the patient had died. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The outcomes of CVST was not reported. This report was serious (life-threatening, caused/prolonged hospitalization).; Sender's Comments: V0: This spontaneous report received from a consumer (the patient's brother-in-law) concerned a 37-year-old female patient who experienced CVST approximately 1 week after vaccine. Medical history and concomitant medications were not reported. Approximately 1 week after vaccine, the reporter contacted the company to report that the patient had experienced cerebral venous sinus thrombosis (CVST), was fighting for her life 'confirmed that night, a direct reaction to your vaccine', and that the patient's prospects were dire. The patient had been hospitalized on an unspecified date. Laboratory values, including platelet count, d dimer and anti-PF4 antibodies were not provided. The following day, the reporter contacted the company again to report that life support for the patient was to be discontinued in 38 minutes. It was not reported if life support was subsequently withdrawn or if the patient had died. Information is limited in this case, and the occurrence of CVST could represent background incidence of such events in the general population. It was not reported whether there was thrombocytopenia or other risk factors. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Death, Fibrin D dimer increased, Haemoglobin normal, Haemostasis, Haptoglobin normal
Clinical narrative: CVST; This spontaneous report was received from a consumer (the patient's brother-in-law) and concerned a 37 year-old female patient. The patient's weight and height were not reported, nor was her medical history, mother of 2 year-old child and a 5 year-old child. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number not reported), dose, vaccination date and anatomical site of administration not reported, for prophylactic vaccination. The batch number was not reported and will be requested. No concomitant medications were reported. On 06-SEP-2021, approximately 1 week post-vaccination, the reporter contacted the company to report that the patient had experienced cerebral venous sinus thrombosis (CVST), was fighting for her life 'confirmed that night, a direct reaction to your vaccine', and that the patient's prognosis was dire. The patient had been hospitalized on an unspecified date. On 15:52 hours on 07-SEP-2021, the reporter contacted the company again to report that life support for the patient was to be discontinued in 38 minutes. It was not reported if life support was subsequently withdrawn and if the patient had died. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The outcomes of CVST was not reported. This report was serious (life-threatening, caused/prolonged hospitalization).; Sender's Comments: V0: This spontaneous report received from a consumer (the patient's brother-in-law) concerned a 37-year-old female patient who experienced CVST approximately 1 week after vaccine. Medical history and concomitant medications were not reported. Approximately 1 week after vaccine, the reporter contacted the company to report that the patient had experienced cerebral venous sinus thrombosis (CVST), was fighting for her life 'confirmed that night, a direct reaction to your vaccine', and that the patient's prospects were dire. The patient had been hospitalized on an unspecified date. Laboratory values, including platelet count, d dimer and anti-PF4 antibodies were not provided. The following day, the reporter contacted the company again to report that life support for the patient was to be discontinued in 38 minutes. It was not reported if life support was subsequently withdrawn or if the patient had died. Information is limited in this case, and the occurrence of CVST could represent background incidence of such events in the general population. It was not reported whether there was thrombocytopenia or other risk factors. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Heparin-induced thrombocytopenia test positive, Immunoglobulin therapy, Infarction, International normalised ratio increased
Clinical narrative: CVST; This spontaneous report was received from a consumer (the patient's brother-in-law) and concerned a 37 year-old female patient. The patient's weight and height were not reported, nor was her medical history, mother of 2 year-old child and a 5 year-old child. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number not reported), dose, vaccination date and anatomical site of administration not reported, for prophylactic vaccination. The batch number was not reported and will be requested. No concomitant medications were reported. On 06-SEP-2021, approximately 1 week post-vaccination, the reporter contacted the company to report that the patient had experienced cerebral venous sinus thrombosis (CVST), was fighting for her life 'confirmed that night, a direct reaction to your vaccine', and that the patient's prognosis was dire. The patient had been hospitalized on an unspecified date. On 15:52 hours on 07-SEP-2021, the reporter contacted the company again to report that life support for the patient was to be discontinued in 38 minutes. It was not reported if life support was subsequently withdrawn and if the patient had died. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The outcomes of CVST was not reported. This report was serious (life-threatening, caused/prolonged hospitalization).; Sender's Comments: V0: This spontaneous report received from a consumer (the patient's brother-in-law) concerned a 37-year-old female patient who experienced CVST approximately 1 week after vaccine. Medical history and concomitant medications were not reported. Approximately 1 week after vaccine, the reporter contacted the company to report that the patient had experienced cerebral venous sinus thrombosis (CVST), was fighting for her life 'confirmed that night, a direct reaction to your vaccine', and that the patient's prospects were dire. The patient had been hospitalized on an unspecified date. Laboratory values, including platelet count, d dimer and anti-PF4 antibodies were not provided. The following day, the reporter contacted the company again to report that life support for the patient was to be discontinued in 38 minutes. It was not reported if life support was subsequently withdrawn or if the patient had died. Information is limited in this case, and the occurrence of CVST could represent background incidence of such events in the general population. It was not reported whether there was thrombocytopenia or other risk factors. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Intracranial pressure increased, Neurological decompensation, Ovarian vein thrombosis, Platelet count decreased, Prothrombin time prolonged
Clinical narrative: CVST; This spontaneous report was received from a consumer (the patient's brother-in-law) and concerned a 37 year-old female patient. The patient's weight and height were not reported, nor was her medical history, mother of 2 year-old child and a 5 year-old child. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number not reported), dose, vaccination date and anatomical site of administration not reported, for prophylactic vaccination. The batch number was not reported and will be requested. No concomitant medications were reported. On 06-SEP-2021, approximately 1 week post-vaccination, the reporter contacted the company to report that the patient had experienced cerebral venous sinus thrombosis (CVST), was fighting for her life 'confirmed that night, a direct reaction to your vaccine', and that the patient's prognosis was dire. The patient had been hospitalized on an unspecified date. On 15:52 hours on 07-SEP-2021, the reporter contacted the company again to report that life support for the patient was to be discontinued in 38 minutes. It was not reported if life support was subsequently withdrawn and if the patient had died. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The outcomes of CVST was not reported. This report was serious (life-threatening, caused/prolonged hospitalization).; Sender's Comments: V0: This spontaneous report received from a consumer (the patient's brother-in-law) concerned a 37-year-old female patient who experienced CVST approximately 1 week after vaccine. Medical history and concomitant medications were not reported. Approximately 1 week after vaccine, the reporter contacted the company to report that the patient had experienced cerebral venous sinus thrombosis (CVST), was fighting for her life 'confirmed that night, a direct reaction to your vaccine', and that the patient's prospects were dire. The patient had been hospitalized on an unspecified date. Laboratory values, including platelet count, d dimer and anti-PF4 antibodies were not provided. The following day, the reporter contacted the company again to report that life support for the patient was to be discontinued in 38 minutes. It was not reported if life support was subsequently withdrawn or if the patient had died. Information is limited in this case, and the occurrence of CVST could represent background incidence of such events in the general population. It was not reported whether there was thrombocytopenia or other risk factors. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Renal vein thrombosis, Thrombocytopenia, Transfusion, Ventricular drainage, White blood cell count increased
Clinical narrative: CVST; This spontaneous report was received from a consumer (the patient's brother-in-law) and concerned a 37 year-old female patient. The patient's weight and height were not reported, nor was her medical history, mother of 2 year-old child and a 5 year-old child. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number not reported), dose, vaccination date and anatomical site of administration not reported, for prophylactic vaccination. The batch number was not reported and will be requested. No concomitant medications were reported. On 06-SEP-2021, approximately 1 week post-vaccination, the reporter contacted the company to report that the patient had experienced cerebral venous sinus thrombosis (CVST), was fighting for her life 'confirmed that night, a direct reaction to your vaccine', and that the patient's prognosis was dire. The patient had been hospitalized on an unspecified date. On 15:52 hours on 07-SEP-2021, the reporter contacted the company again to report that life support for the patient was to be discontinued in 38 minutes. It was not reported if life support was subsequently withdrawn and if the patient had died. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The outcomes of CVST was not reported. This report was serious (life-threatening, caused/prolonged hospitalization).; Sender's Comments: V0: This spontaneous report received from a consumer (the patient's brother-in-law) concerned a 37-year-old female patient who experienced CVST approximately 1 week after vaccine. Medical history and concomitant medications were not reported. Approximately 1 week after vaccine, the reporter contacted the company to report that the patient had experienced cerebral venous sinus thrombosis (CVST), was fighting for her life 'confirmed that night, a direct reaction to your vaccine', and that the patient's prospects were dire. The patient had been hospitalized on an unspecified date. Laboratory values, including platelet count, d dimer and anti-PF4 antibodies were not provided. The following day, the reporter contacted the company again to report that life support for the patient was to be discontinued in 38 minutes. It was not reported if life support was subsequently withdrawn or if the patient had died. Information is limited in this case, and the occurrence of CVST could represent background incidence of such events in the general population. It was not reported whether there was thrombocytopenia or other risk factors. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Withdrawal of life support
Clinical narrative: CVST; This spontaneous report was received from a consumer (the patient's brother-in-law) and concerned a 37 year-old female patient. The patient's weight and height were not reported, nor was her medical history, mother of 2 year-old child and a 5 year-old child. The patient received COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number not reported), dose, vaccination date and anatomical site of administration not reported, for prophylactic vaccination. The batch number was not reported and will be requested. No concomitant medications were reported. On 06-SEP-2021, approximately 1 week post-vaccination, the reporter contacted the company to report that the patient had experienced cerebral venous sinus thrombosis (CVST), was fighting for her life 'confirmed that night, a direct reaction to your vaccine', and that the patient's prognosis was dire. The patient had been hospitalized on an unspecified date. On 15:52 hours on 07-SEP-2021, the reporter contacted the company again to report that life support for the patient was to be discontinued in 38 minutes. It was not reported if life support was subsequently withdrawn and if the patient had died. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The outcomes of CVST was not reported. This report was serious (life-threatening, caused/prolonged hospitalization).; Sender's Comments: V0: This spontaneous report received from a consumer (the patient's brother-in-law) concerned a 37-year-old female patient who experienced CVST approximately 1 week after vaccine. Medical history and concomitant medications were not reported. Approximately 1 week after vaccine, the reporter contacted the company to report that the patient had experienced cerebral venous sinus thrombosis (CVST), was fighting for her life 'confirmed that night, a direct reaction to your vaccine', and that the patient's prospects were dire. The patient had been hospitalized on an unspecified date. Laboratory values, including platelet count, d dimer and anti-PF4 antibodies were not provided. The following day, the reporter contacted the company again to report that life support for the patient was to be discontinued in 38 minutes. It was not reported if life support was subsequently withdrawn or if the patient had died. Information is limited in this case, and the occurrence of CVST could represent background incidence of such events in the general population. It was not reported whether there was thrombocytopenia or other risk factors. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. Additional information has been requested.