chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pulmonary embolism, Ultrasound scan
Clinical narrative: blacked out; broke my nose; concussion; DVT; pulmonary embolisms; pain in the calf; minor risk of blood clot in surgery/blood clot was found; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 (also reported as 26Feb2021) 13:00 (Batch/Lot Number: em9810) as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: Lactose intolerant. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (lot number: em9810) on 04Feb2021 13:15 in left arm for COVID-19 immunization. On 26Feb2021 08:00, it was reported "after receiving my second Pfizer vaccine, I blacked out/lost consciousness, broke my nose, and had a concussion. I had maxillofacial surgery the next day to fix his nose. The surgeon informed him that there is a minor risk of blood clot in surgery, but he was not given an anticoagulant. Also on 26Feb2021 08:00, the patient experienced DVT, and pulmonary embolism. The patient was hospitalized from 26Feb2021 to an unspecified date. On Friday, 2Apr2021, Caller went to the hospital because of pain in the calf, and a blood clot was found. He was scanned with CT on lungs and blood clots were also found. Caller mentioned he had "deep vein thrombosis" and "pulmonary embolisms". He was given Lovenox and discharged on 4Apr2021. Caller is currently on anticoagulant Eliquis. 5 weeks later, the patient developed DVT, and now have pulmonary embolisms. The doctor has no way of deciding if the patient should stay on the anticoagulant for the standard time period, or if I will need it for the rest of my life." The events were assessed as serious. The patient was treated with surgery and anti-coagulants. The outcome of the events pain in the calf, and minor risk of blood clot in surgery/blood clot was found was unknown while recovering for the other events.  Follow-up information requested.
Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Anticoagulant therapy, Computerised tomogram thorax abnormal, Concussion, Deep vein thrombosis, Facial bones fracture
Clinical narrative: blacked out; broke my nose; concussion; DVT; pulmonary embolisms; pain in the calf; minor risk of blood clot in surgery/blood clot was found; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 (also reported as 26Feb2021) 13:00 (Batch/Lot Number: em9810) as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: Lactose intolerant. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (lot number: em9810) on 04Feb2021 13:15 in left arm for COVID-19 immunization. On 26Feb2021 08:00, it was reported "after receiving my second Pfizer vaccine, I blacked out/lost consciousness, broke my nose, and had a concussion. I had maxillofacial surgery the next day to fix his nose. The surgeon informed him that there is a minor risk of blood clot in surgery, but he was not given an anticoagulant. Also on 26Feb2021 08:00, the patient experienced DVT, and pulmonary embolism. The patient was hospitalized from 26Feb2021 to an unspecified date. On Friday, 2Apr2021, Caller went to the hospital because of pain in the calf, and a blood clot was found. He was scanned with CT on lungs and blood clots were also found. Caller mentioned he had "deep vein thrombosis" and "pulmonary embolisms". He was given Lovenox and discharged on 4Apr2021. Caller is currently on anticoagulant Eliquis. 5 weeks later, the patient developed DVT, and now have pulmonary embolisms. The doctor has no way of deciding if the patient should stay on the anticoagulant for the standard time period, or if I will need it for the rest of my life." The events were assessed as serious. The patient was treated with surgery and anti-coagulants. The outcome of the events pain in the calf, and minor risk of blood clot in surgery/blood clot was found was unknown while recovering for the other events.  Follow-up information requested.
Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Loss of consciousness, Maxillofacial operation, Pain in extremity, Pulmonary embolism, Pulmonary thrombosis
Clinical narrative: blacked out; broke my nose; concussion; DVT; pulmonary embolisms; pain in the calf; minor risk of blood clot in surgery/blood clot was found; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 (also reported as 26Feb2021) 13:00 (Batch/Lot Number: em9810) as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: Lactose intolerant. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (lot number: em9810) on 04Feb2021 13:15 in left arm for COVID-19 immunization. On 26Feb2021 08:00, it was reported "after receiving my second Pfizer vaccine, I blacked out/lost consciousness, broke my nose, and had a concussion. I had maxillofacial surgery the next day to fix his nose. The surgeon informed him that there is a minor risk of blood clot in surgery, but he was not given an anticoagulant. Also on 26Feb2021 08:00, the patient experienced DVT, and pulmonary embolism. The patient was hospitalized from 26Feb2021 to an unspecified date. On Friday, 2Apr2021, Caller went to the hospital because of pain in the calf, and a blood clot was found. He was scanned with CT on lungs and blood clots were also found. Caller mentioned he had "deep vein thrombosis" and "pulmonary embolisms". He was given Lovenox and discharged on 4Apr2021. Caller is currently on anticoagulant Eliquis. 5 weeks later, the patient developed DVT, and now have pulmonary embolisms. The doctor has no way of deciding if the patient should stay on the anticoagulant for the standard time period, or if I will need it for the rest of my life." The events were assessed as serious. The patient was treated with surgery and anti-coagulants. The outcome of the events pain in the calf, and minor risk of blood clot in surgery/blood clot was found was unknown while recovering for the other events.  Follow-up information requested.
Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Thrombosis
Clinical narrative: blacked out; broke my nose; concussion; DVT; pulmonary embolisms; pain in the calf; minor risk of blood clot in surgery/blood clot was found; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 (also reported as 26Feb2021) 13:00 (Batch/Lot Number: em9810) as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: Lactose intolerant. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (lot number: em9810) on 04Feb2021 13:15 in left arm for COVID-19 immunization. On 26Feb2021 08:00, it was reported "after receiving my second Pfizer vaccine, I blacked out/lost consciousness, broke my nose, and had a concussion. I had maxillofacial surgery the next day to fix his nose. The surgeon informed him that there is a minor risk of blood clot in surgery, but he was not given an anticoagulant. Also on 26Feb2021 08:00, the patient experienced DVT, and pulmonary embolism. The patient was hospitalized from 26Feb2021 to an unspecified date. On Friday, 2Apr2021, Caller went to the hospital because of pain in the calf, and a blood clot was found. He was scanned with CT on lungs and blood clots were also found. Caller mentioned he had "deep vein thrombosis" and "pulmonary embolisms". He was given Lovenox and discharged on 4Apr2021. Caller is currently on anticoagulant Eliquis. 5 weeks later, the patient developed DVT, and now have pulmonary embolisms. The doctor has no way of deciding if the patient should stay on the anticoagulant for the standard time period, or if I will need it for the rest of my life." The events were assessed as serious. The patient was treated with surgery and anti-coagulants. The outcome of the events pain in the calf, and minor risk of blood clot in surgery/blood clot was found was unknown while recovering for the other events.  Follow-up information requested.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Swelling face
Clinical narrative: Minor swelling of the face; Flushing of the face; This case was received via  FDA VAERS (Reference number: 410179) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This regulatory authority case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Minor swelling of the face) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Reaction to previous exposure to any vaccine.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced SWELLING FACE (Minor swelling of the face) (seriousness criterion medically significant) and FLUSHING (Flushing of the face). On 05-Apr-2021, SWELLING FACE (Minor swelling of the face) and FLUSHING (Flushing of the face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product used was not provided by the reporter. Patient was sent to the Emergency Department. Treatment for the events included prednisone, famotidine and diphenhydramine. The events resolved and the patient was discharged home the same day.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Age: 31.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Chest pain, Injection site pain
Clinical narrative: CHEST PAIN/CHEST TIGHTNESS; BLOOD PRESSURE HIGH; This spontaneous report received from a pharmacist concerned a 31 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 06-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the patient experienced chest pain/chest tightness and blood pressure high. On 05-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 147/104 mmHg at 08:30, 138/84 mmHg at 11:30 and 134/74 mmHg at 13:00. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain/chest tightness and blood pressure high was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210410658-covid-19 vaccine ad26.cov2.s-chest pain/chest tightness, blood pressure high. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 31.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Chest pain, Hypertension
Clinical narrative: CHEST PAIN/CHEST TIGHTNESS; BLOOD PRESSURE HIGH; This spontaneous report received from a pharmacist concerned a 31 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 06-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the patient experienced chest pain/chest tightness and blood pressure high. On 05-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 147/104 mmHg at 08:30, 138/84 mmHg at 11:30 and 134/74 mmHg at 13:00. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain/chest tightness and blood pressure high was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210410658-covid-19 vaccine ad26.cov2.s-chest pain/chest tightness, blood pressure high. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Malaise, Nausea, Physical examination, Seizure
Clinical narrative: Sweating profusely, passed out 2 times in 15 min at Walgreens. Diagnosed vaso Vega syncope after a day In the hospital. Was told ?it just happens? 1 week later still weak, foggy head, headache, muscle aches
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Electrocardiogram normal, Feeling abnormal, Full blood count normal, Headache
Clinical narrative: Sweating profusely, passed out 2 times in 15 min at Walgreens. Diagnosed vaso Vega syncope after a day In the hospital. Was told ?it just happens? 1 week later still weak, foggy head, headache, muscle aches
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Myalgia, Syncope, Urine analysis normal
Clinical narrative: Sweating profusely, passed out 2 times in 15 min at Walgreens. Diagnosed vaso Vega syncope after a day In the hospital. Was told ?it just happens? 1 week later still weak, foggy head, headache, muscle aches
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Cerebrovascular accident, Encephalopathy, Hemiparesis, Pain
Clinical narrative: had a massive stroke during the night 2 days after receiving her vaccine.  She was taken by ambulance to the hospital and died 8 days later.   She never regained consciousness.    reported pain in her knee - she thought she sprained it while walking.  reported "not feeling well" on the day on Wednesday (3/31).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory acidosis, Troponin increased, Urinary tract infection
Clinical narrative: had a massive stroke during the night 2 days after receiving her vaccine.  She was taken by ambulance to the hospital and died 8 days later.   She never regained consciousness.    reported pain in her knee - she thought she sprained it while walking.  reported "not feeling well" on the day on Wednesday (3/31).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cerebrovascular accident, Death, Magnetic resonance imaging, Malaise
Clinical narrative: had a massive stroke during the night 2 days after receiving her vaccine.  She was taken by ambulance to the hospital and died 8 days later.   She never regained consciousness.    reported pain in her knee - she thought she sprained it while walking.  reported "not feeling well" on the day on Wednesday (3/31).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan brain
Clinical narrative: had a massive stroke during the night 2 days after receiving her vaccine.  She was taken by ambulance to the hospital and died 8 days later.   She never regained consciousness.    reported pain in her knee - she thought she sprained it while walking.  reported "not feeling well" on the day on Wednesday (3/31).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Multiple sclerosis
Clinical narrative: INCREASED SPASTICITY, GRAB AND TWIST IN SPINAL CORD,  FELT DISABLED, SEVER PAIN 10 TIMES MORE THAN MULTIPLE SCLEROSIS; WEAKNESS; LOW GRADE FEVER; NAUSEA; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included generally healthy secondary progressive multiple sclerosis, non smoker, non alcoholic, and bladder issue, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. The patient takes medications for multiple sclerosis regularly. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 11:30 in left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced increased spasticity, grab and twist in spinal cord, felt disabled, sever pain 10 times more than multiple sclerosis. On 05-APR-2021, the subject experienced weakness. On 05-APR-2021, the subject experienced low grade fever. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, was recovering from nausea, and weakness, and had not recovered from increased spasticity, grab and twist in spinal cord, felt disabled, sever pain 10 times more than multiple sclerosis. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Muscle spasticity, Nausea, Pyrexia
Clinical narrative: INCREASED SPASTICITY, GRAB AND TWIST IN SPINAL CORD,  FELT DISABLED, SEVER PAIN 10 TIMES MORE THAN MULTIPLE SCLEROSIS; WEAKNESS; LOW GRADE FEVER; NAUSEA; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included generally healthy secondary progressive multiple sclerosis, non smoker, non alcoholic, and bladder issue, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. The patient takes medications for multiple sclerosis regularly. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 11:30 in left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced increased spasticity, grab and twist in spinal cord, felt disabled, sever pain 10 times more than multiple sclerosis. On 05-APR-2021, the subject experienced weakness. On 05-APR-2021, the subject experienced low grade fever. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, was recovering from nausea, and weakness, and had not recovered from increased spasticity, grab and twist in spinal cord, felt disabled, sever pain 10 times more than multiple sclerosis. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain, Cerebral venous sinus thrombosis, Chills, Headache
Clinical narrative: CEREBRAL VENOUS SINUS THROMBOSIS; PORTAL VEIN THROMBOSIS; PULMONARY EMBOLISM; THROMBOCYTOPENIA; This spontaneous report was received from a physician and included additional information obtained via telephone follow up on 12-APR-2021. The patient is a 26 year-old female, and reported to be overweight (weight/BMI unknown) but physically active (a gym instructor).   She has no history or family history of clotting disorder. She is not on any medication or birth control pills. The patient received 1 dose of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) on an unspecified date.  Approximately 1 week following vaccination, she developed a severe headache and visited the emergency department. The patient was given paracetamol and benadryl and sent home. The patient continued to have headaches.  Approximately another week later, the patient developed abdominal discomfort and rapid heart rate and was seen in the hospital. Laboratory evaluation revealed  platelet count of 120,000 (thrombocytopenia), elevated D-Dimer (level unknown) and normal fibrinogen (level unknown).  Covid-19 infection was ruled out (exact test unknown).  Diagnostic scans showed cerebral cavernous sinus thrombosis (coded to cerebral venous sinus thrombosis), portal vein thrombosis and pulmonary embolism. Initial treatment with heparin was stopped and IVIG administered  after lab result showed positive antibodies to platelet factor 4 (level 3.0).  Platelet count was reported to have started increasing prior to IVIG administration.  The patient spent 1-1.5 weeks in the hospital and was released home on oral anticoagulants. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of portal vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, thrombocytopenia was recovering. This report was serious (Hospitalized/ Other Medically Important Condition).; Sender's Comments: V0:  This case concerns a 26-year-old obese female subject who developed a cerebral venous cavernous sinus thrombosis, portal vein thrombosis and pulmonary embolism with reduced platelet count, elevated D-Dimer and positive anti-PF4 antibodies approximately one to two weeks post vaccination with Janssen COVID-19 vaccine.  Initial symptoms of headache occurred 1 week following vaccination, with subsequent abdominal symptoms and diagnosis/treatment approximately 2 weeks following vaccination.  The patient had no known medical history of thrombotic disorder, was not on other medications and Covid-19 infection was reportedly ruled out during hospital admission.  She appeared to have responded well to treatment with IVIG and oral anticoagulation and is recovering. Additional follow up information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heparin-induced thrombocytopenia test positive, Immunoglobulin therapy, Intensive care, Nausea, Pain
Clinical narrative: CEREBRAL VENOUS SINUS THROMBOSIS; PORTAL VEIN THROMBOSIS; PULMONARY EMBOLISM; THROMBOCYTOPENIA; This spontaneous report was received from a physician and included additional information obtained via telephone follow up on 12-APR-2021. The patient is a 26 year-old female, and reported to be overweight (weight/BMI unknown) but physically active (a gym instructor).   She has no history or family history of clotting disorder. She is not on any medication or birth control pills. The patient received 1 dose of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) on an unspecified date.  Approximately 1 week following vaccination, she developed a severe headache and visited the emergency department. The patient was given paracetamol and benadryl and sent home. The patient continued to have headaches.  Approximately another week later, the patient developed abdominal discomfort and rapid heart rate and was seen in the hospital. Laboratory evaluation revealed  platelet count of 120,000 (thrombocytopenia), elevated D-Dimer (level unknown) and normal fibrinogen (level unknown).  Covid-19 infection was ruled out (exact test unknown).  Diagnostic scans showed cerebral cavernous sinus thrombosis (coded to cerebral venous sinus thrombosis), portal vein thrombosis and pulmonary embolism. Initial treatment with heparin was stopped and IVIG administered  after lab result showed positive antibodies to platelet factor 4 (level 3.0).  Platelet count was reported to have started increasing prior to IVIG administration.  The patient spent 1-1.5 weeks in the hospital and was released home on oral anticoagulants. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of portal vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, thrombocytopenia was recovering. This report was serious (Hospitalized/ Other Medically Important Condition).; Sender's Comments: V0:  This case concerns a 26-year-old obese female subject who developed a cerebral venous cavernous sinus thrombosis, portal vein thrombosis and pulmonary embolism with reduced platelet count, elevated D-Dimer and positive anti-PF4 antibodies approximately one to two weeks post vaccination with Janssen COVID-19 vaccine.  Initial symptoms of headache occurred 1 week following vaccination, with subsequent abdominal symptoms and diagnosis/treatment approximately 2 weeks following vaccination.  The patient had no known medical history of thrombotic disorder, was not on other medications and Covid-19 infection was reportedly ruled out during hospital admission.  She appeared to have responded well to treatment with IVIG and oral anticoagulation and is recovering. Additional follow up information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Portal vein thrombosis, Pulmonary embolism, Pyrexia, Vomiting
Clinical narrative: CEREBRAL VENOUS SINUS THROMBOSIS; PORTAL VEIN THROMBOSIS; PULMONARY EMBOLISM; THROMBOCYTOPENIA; This spontaneous report was received from a physician and included additional information obtained via telephone follow up on 12-APR-2021. The patient is a 26 year-old female, and reported to be overweight (weight/BMI unknown) but physically active (a gym instructor).   She has no history or family history of clotting disorder. She is not on any medication or birth control pills. The patient received 1 dose of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) on an unspecified date.  Approximately 1 week following vaccination, she developed a severe headache and visited the emergency department. The patient was given paracetamol and benadryl and sent home. The patient continued to have headaches.  Approximately another week later, the patient developed abdominal discomfort and rapid heart rate and was seen in the hospital. Laboratory evaluation revealed  platelet count of 120,000 (thrombocytopenia), elevated D-Dimer (level unknown) and normal fibrinogen (level unknown).  Covid-19 infection was ruled out (exact test unknown).  Diagnostic scans showed cerebral cavernous sinus thrombosis (coded to cerebral venous sinus thrombosis), portal vein thrombosis and pulmonary embolism. Initial treatment with heparin was stopped and IVIG administered  after lab result showed positive antibodies to platelet factor 4 (level 3.0).  Platelet count was reported to have started increasing prior to IVIG administration.  The patient spent 1-1.5 weeks in the hospital and was released home on oral anticoagulants. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of portal vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, thrombocytopenia was recovering. This report was serious (Hospitalized/ Other Medically Important Condition).; Sender's Comments: V0:  This case concerns a 26-year-old obese female subject who developed a cerebral venous cavernous sinus thrombosis, portal vein thrombosis and pulmonary embolism with reduced platelet count, elevated D-Dimer and positive anti-PF4 antibodies approximately one to two weeks post vaccination with Janssen COVID-19 vaccine.  Initial symptoms of headache occurred 1 week following vaccination, with subsequent abdominal symptoms and diagnosis/treatment approximately 2 weeks following vaccination.  The patient had no known medical history of thrombotic disorder, was not on other medications and Covid-19 infection was reportedly ruled out during hospital admission.  She appeared to have responded well to treatment with IVIG and oral anticoagulation and is recovering. Additional follow up information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood fibrinogen, COVID-19, Cerebral venous sinus thrombosis, Fibrin D dimer increased, Platelet count
Clinical narrative: CEREBRAL VENOUS SINUS THROMBOSIS; PORTAL VEIN THROMBOSIS; PULMONARY EMBOLISM; THROMBOCYTOPENIA; This spontaneous report was received from a physician and included additional information obtained via telephone follow up on 12-APR-2021. The patient is a 26 year-old female, and reported to be overweight (weight/BMI unknown) but physically active (a gym instructor).   She has no history or family history of clotting disorder. She is not on any medication or birth control pills. The patient received 1 dose of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) on an unspecified date.  Approximately 1 week following vaccination, she developed a severe headache and visited the emergency department. The patient was given paracetamol and benadryl and sent home. The patient continued to have headaches.  Approximately another week later, the patient developed abdominal discomfort and rapid heart rate and was seen in the hospital. Laboratory evaluation revealed  platelet count of 120,000 (thrombocytopenia), elevated D-Dimer (level unknown) and normal fibrinogen (level unknown).  Covid-19 infection was ruled out (exact test unknown).  Diagnostic scans showed cerebral cavernous sinus thrombosis (coded to cerebral venous sinus thrombosis), portal vein thrombosis and pulmonary embolism. Initial treatment with heparin was stopped and IVIG administered  after lab result showed positive antibodies to platelet factor 4 (level 3.0).  Platelet count was reported to have started increasing prior to IVIG administration.  The patient spent 1-1.5 weeks in the hospital and was released home on oral anticoagulants. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of portal vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, thrombocytopenia was recovering. This report was serious (Hospitalized/ Other Medically Important Condition).; Sender's Comments: V0:  This case concerns a 26-year-old obese female subject who developed a cerebral venous cavernous sinus thrombosis, portal vein thrombosis and pulmonary embolism with reduced platelet count, elevated D-Dimer and positive anti-PF4 antibodies approximately one to two weeks post vaccination with Janssen COVID-19 vaccine.  Initial symptoms of headache occurred 1 week following vaccination, with subsequent abdominal symptoms and diagnosis/treatment approximately 2 weeks following vaccination.  The patient had no known medical history of thrombotic disorder, was not on other medications and Covid-19 infection was reportedly ruled out during hospital admission.  She appeared to have responded well to treatment with IVIG and oral anticoagulation and is recovering. Additional follow up information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet factor 4, Portal vein thrombosis, Pulmonary embolism, Scan, Thrombocytopenia
Clinical narrative: CEREBRAL VENOUS SINUS THROMBOSIS; PORTAL VEIN THROMBOSIS; PULMONARY EMBOLISM; THROMBOCYTOPENIA; This spontaneous report was received from a physician and included additional information obtained via telephone follow up on 12-APR-2021. The patient is a 26 year-old female, and reported to be overweight (weight/BMI unknown) but physically active (a gym instructor).   She has no history or family history of clotting disorder. She is not on any medication or birth control pills. The patient received 1 dose of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) on an unspecified date.  Approximately 1 week following vaccination, she developed a severe headache and visited the emergency department. The patient was given paracetamol and benadryl and sent home. The patient continued to have headaches.  Approximately another week later, the patient developed abdominal discomfort and rapid heart rate and was seen in the hospital. Laboratory evaluation revealed  platelet count of 120,000 (thrombocytopenia), elevated D-Dimer (level unknown) and normal fibrinogen (level unknown).  Covid-19 infection was ruled out (exact test unknown).  Diagnostic scans showed cerebral cavernous sinus thrombosis (coded to cerebral venous sinus thrombosis), portal vein thrombosis and pulmonary embolism. Initial treatment with heparin was stopped and IVIG administered  after lab result showed positive antibodies to platelet factor 4 (level 3.0).  Platelet count was reported to have started increasing prior to IVIG administration.  The patient spent 1-1.5 weeks in the hospital and was released home on oral anticoagulants. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of portal vein thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, thrombocytopenia was recovering. This report was serious (Hospitalized/ Other Medically Important Condition).; Sender's Comments: V0:  This case concerns a 26-year-old obese female subject who developed a cerebral venous cavernous sinus thrombosis, portal vein thrombosis and pulmonary embolism with reduced platelet count, elevated D-Dimer and positive anti-PF4 antibodies approximately one to two weeks post vaccination with Janssen COVID-19 vaccine.  Initial symptoms of headache occurred 1 week following vaccination, with subsequent abdominal symptoms and diagnosis/treatment approximately 2 weeks following vaccination.  The patient had no known medical history of thrombotic disorder, was not on other medications and Covid-19 infection was reportedly ruled out during hospital admission.  She appeared to have responded well to treatment with IVIG and oral anticoagulation and is recovering. Additional follow up information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Dysphagia, Nausea
Clinical narrative: POSTNASAL DRIP; DRY COUGH; DIFFICULTY BREATHING; TIGHTNESS IN CHEST; RINGING IN BOTH EARS; DIZZINESS; NAUSEA; FEVER; BODY ACHE; HOT AND COLD SWEATS; JOINT PAIN; CHILLS; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: not reported) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced hot and cold sweats. On 06-APR-2021, the subject experienced joint pain. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. Treatment medications included: ibuprofen, and paracetamol. On 06-APR-2021 09:55, the subject experienced difficulty breathing. On 06-APR-2021 09:55, the subject experienced tightness in chest. On 06-APR-2021 09:55, the subject experienced ringing in both ears. On 06-APR-2021 09:55, the subject experienced dizziness. On 06-APR-2021 09:55, the subject experienced nausea. On 08-APR-2021, the subject experienced postnasal drip. On 08-APR-2021, the subject experienced dry cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, tightness in chest, dizziness, body ache, hot and cold sweats, joint pain, chills, nausea, and fever on 07-APR-2021, and had not recovered from ringing in both ears, postnasal drip, and dry cough. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: POSTNASAL DRIP; DRY COUGH; DIFFICULTY BREATHING; TIGHTNESS IN CHEST; RINGING IN BOTH EARS; DIZZINESS; NAUSEA; FEVER; BODY ACHE; HOT AND COLD SWEATS; JOINT PAIN; CHILLS; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: not reported) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced hot and cold sweats. On 06-APR-2021, the subject experienced joint pain. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. Treatment medications included: ibuprofen, and paracetamol. On 06-APR-2021 09:55, the subject experienced difficulty breathing. On 06-APR-2021 09:55, the subject experienced tightness in chest. On 06-APR-2021 09:55, the subject experienced ringing in both ears. On 06-APR-2021 09:55, the subject experienced dizziness. On 06-APR-2021 09:55, the subject experienced nausea. On 08-APR-2021, the subject experienced postnasal drip. On 08-APR-2021, the subject experienced dry cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, tightness in chest, dizziness, body ache, hot and cold sweats, joint pain, chills, nausea, and fever on 07-APR-2021, and had not recovered from ringing in both ears, postnasal drip, and dry cough. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Cough, Dizziness
Clinical narrative: POSTNASAL DRIP; DRY COUGH; DIFFICULTY BREATHING; TIGHTNESS IN CHEST; RINGING IN BOTH EARS; DIZZINESS; NAUSEA; FEVER; BODY ACHE; HOT AND COLD SWEATS; JOINT PAIN; CHILLS; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: not reported) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced hot and cold sweats. On 06-APR-2021, the subject experienced joint pain. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. Treatment medications included: ibuprofen, and paracetamol. On 06-APR-2021 09:55, the subject experienced difficulty breathing. On 06-APR-2021 09:55, the subject experienced tightness in chest. On 06-APR-2021 09:55, the subject experienced ringing in both ears. On 06-APR-2021 09:55, the subject experienced dizziness. On 06-APR-2021 09:55, the subject experienced nausea. On 08-APR-2021, the subject experienced postnasal drip. On 08-APR-2021, the subject experienced dry cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, tightness in chest, dizziness, body ache, hot and cold sweats, joint pain, chills, nausea, and fever on 07-APR-2021, and had not recovered from ringing in both ears, postnasal drip, and dry cough. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Nausea, Pain, Pyrexia
Clinical narrative: POSTNASAL DRIP; DRY COUGH; DIFFICULTY BREATHING; TIGHTNESS IN CHEST; RINGING IN BOTH EARS; DIZZINESS; NAUSEA; FEVER; BODY ACHE; HOT AND COLD SWEATS; JOINT PAIN; CHILLS; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: not reported) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced hot and cold sweats. On 06-APR-2021, the subject experienced joint pain. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. Treatment medications included: ibuprofen, and paracetamol. On 06-APR-2021 09:55, the subject experienced difficulty breathing. On 06-APR-2021 09:55, the subject experienced tightness in chest. On 06-APR-2021 09:55, the subject experienced ringing in both ears. On 06-APR-2021 09:55, the subject experienced dizziness. On 06-APR-2021 09:55, the subject experienced nausea. On 08-APR-2021, the subject experienced postnasal drip. On 08-APR-2021, the subject experienced dry cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, tightness in chest, dizziness, body ache, hot and cold sweats, joint pain, chills, nausea, and fever on 07-APR-2021, and had not recovered from ringing in both ears, postnasal drip, and dry cough. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Upper-airway cough syndrome
Clinical narrative: POSTNASAL DRIP; DRY COUGH; DIFFICULTY BREATHING; TIGHTNESS IN CHEST; RINGING IN BOTH EARS; DIZZINESS; NAUSEA; FEVER; BODY ACHE; HOT AND COLD SWEATS; JOINT PAIN; CHILLS; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: not reported) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced hot and cold sweats. On 06-APR-2021, the subject experienced joint pain. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. Treatment medications included: ibuprofen, and paracetamol. On 06-APR-2021 09:55, the subject experienced difficulty breathing. On 06-APR-2021 09:55, the subject experienced tightness in chest. On 06-APR-2021 09:55, the subject experienced ringing in both ears. On 06-APR-2021 09:55, the subject experienced dizziness. On 06-APR-2021 09:55, the subject experienced nausea. On 08-APR-2021, the subject experienced postnasal drip. On 08-APR-2021, the subject experienced dry cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, tightness in chest, dizziness, body ache, hot and cold sweats, joint pain, chills, nausea, and fever on 07-APR-2021, and had not recovered from ringing in both ears, postnasal drip, and dry cough. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Brain natriuretic peptide, Chest pain, Dyspnoea, Fatigue
Clinical narrative: Went to ER and was diagnosed with bilateral pulmonary emboli; Pain on left lung/torso/Severe pain on Left lung/torso, pain starting at collar bone down the torso; increased difficulty breathing; Vomiting; fever 99.2/fever 99.6; Tired; Nausea; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER 8727), via an unspecified route of administration, at the age of 46 years, administered on the left arm on 23Mar2021 10:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to PCN from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC) and fluoxetine (FLUOXETINE); both taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicilin and experienced drug hypersensitivity. The patient went to ER and was diagnosed with bilateral pulmonary emboli on 23Mar2021 21:30, pain on left lung/torso/severe pain on left lung/torso, pain starting at collar bone down the torso on 23Mar2021 21:30, increased difficulty breathing on 23Mar2021 21:30, nausea, vomiting, fever 99.2/ 99.6, tired on 23Mar2021 21:30. The patient underwent lab tests and procedures which included body temperature: 99.2 on Mar2021, body temperature: 99.6 on Mar2021, sars-cov-2 test: negative on 01Apr2021. Therapeutic measures (Eliquis (blood thinners)) were taken as a result of the events. The events were reported as Life threatening. The outcome of the events was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Full blood count, Glomerular filtration rate, Haemoptysis, Injection site pain
Clinical narrative: Went to ER and was diagnosed with bilateral pulmonary emboli; Pain on left lung/torso/Severe pain on Left lung/torso, pain starting at collar bone down the torso; increased difficulty breathing; Vomiting; fever 99.2/fever 99.6; Tired; Nausea; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER 8727), via an unspecified route of administration, at the age of 46 years, administered on the left arm on 23Mar2021 10:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to PCN from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC) and fluoxetine (FLUOXETINE); both taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicilin and experienced drug hypersensitivity. The patient went to ER and was diagnosed with bilateral pulmonary emboli on 23Mar2021 21:30, pain on left lung/torso/severe pain on left lung/torso, pain starting at collar bone down the torso on 23Mar2021 21:30, increased difficulty breathing on 23Mar2021 21:30, nausea, vomiting, fever 99.2/ 99.6, tired on 23Mar2021 21:30. The patient underwent lab tests and procedures which included body temperature: 99.2 on Mar2021, body temperature: 99.6 on Mar2021, sars-cov-2 test: negative on 01Apr2021. Therapeutic measures (Eliquis (blood thinners)) were taken as a result of the events. The events were reported as Life threatening. The outcome of the events was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Nausea, Pregnancy test urine, Prothrombin time, Pulmonary embolism
Clinical narrative: Went to ER and was diagnosed with bilateral pulmonary emboli; Pain on left lung/torso/Severe pain on Left lung/torso, pain starting at collar bone down the torso; increased difficulty breathing; Vomiting; fever 99.2/fever 99.6; Tired; Nausea; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER 8727), via an unspecified route of administration, at the age of 46 years, administered on the left arm on 23Mar2021 10:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to PCN from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC) and fluoxetine (FLUOXETINE); both taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicilin and experienced drug hypersensitivity. The patient went to ER and was diagnosed with bilateral pulmonary emboli on 23Mar2021 21:30, pain on left lung/torso/severe pain on left lung/torso, pain starting at collar bone down the torso on 23Mar2021 21:30, increased difficulty breathing on 23Mar2021 21:30, nausea, vomiting, fever 99.2/ 99.6, tired on 23Mar2021 21:30. The patient underwent lab tests and procedures which included body temperature: 99.2 on Mar2021, body temperature: 99.6 on Mar2021, sars-cov-2 test: negative on 01Apr2021. Therapeutic measures (Eliquis (blood thinners)) were taken as a result of the events. The events were reported as Life threatening. The outcome of the events was recovering.