chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Hypoaesthesia, Peripheral swelling
Clinical narrative: BLOOD CLOT IN LUNG; BILATERAL FEET AND HAND NUMB; BILATERAL HANDS AND LEGS SWOLLEN; SLEPT FOR 6 HOURS AFTER SHOT; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 285 pounds, and height was 56 inches. The patient's concurrent conditions included high blood pressure, depression, diabetes, flea bites allergy, peanut allergy, alcohol consumer, non smoker, heart disorder, nerve pain, mood disorder, fluid retention and pain. He had no known drug allergies. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, 1 in total administered to right deltoid on 09-APR-2021 for prophylactic vaccination. Concomitant medications included hydralazine 25mg BID (twice a day) for blood pressure, metformin hydrochloride 500mg BID for diabetes, Baby Aspirin (acetylsalicylic acid) EC (enteric coated) for heart disorder, escitalopram 10mg daily for mood disorder, gabapentin 100mg TID for nerve pain, and celecoxib 200mg 1 tablet a day as needed for pain. olmesartan medoxomil 40mg daily for blood pressure, amlodipine besilate 10mg daily for blood pressure, furosemide 40mg daily for fluid retention, potassium chloride ER (extended release) 20 Meq TID (thrice a day) and metoprolol succinate ER 50mg daily for an unknown indication.  On the same day vaccination, the patient slept for 6 hours after shot and was tired. On 16-APR-2021, the patient experienced bilateral hands and legs swollen. On 19-APR-2021, the patient had bilateral feet and hands numb. On 21-APR-2021, he went to the emergency room (ER) and was hospitalized. He had following test done. Covid-19 test and EKG (electrocardiogram) results not provided, sonagram of legs showed no blood clots, computerized tomography (CAT) scan found blood clots in lungs. He was put on IV fluids and oxygen. He had blood clots in lungs, he could not specify if both lungs had it. He was discharged the next day without oxygen. He was put on Eliquis (apixaban) 5mg BID for 3 months. He was hospitalized for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours after shot, and tired on 09-APR-2021, had not recovered from bilateral hands and legs swollen, and bilateral feet and hand numb, and the outcome of blood clot in lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210554313- COVID-19 VACCINE AD26.COV2.S- blood clot in lung,  bilateral hands and legs swollen and bilateral feet and hand numb. 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: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pulmonary thrombosis, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: BLOOD CLOT IN LUNG; BILATERAL FEET AND HAND NUMB; BILATERAL HANDS AND LEGS SWOLLEN; SLEPT FOR 6 HOURS AFTER SHOT; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 285 pounds, and height was 56 inches. The patient's concurrent conditions included high blood pressure, depression, diabetes, flea bites allergy, peanut allergy, alcohol consumer, non smoker, heart disorder, nerve pain, mood disorder, fluid retention and pain. He had no known drug allergies. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, 1 in total administered to right deltoid on 09-APR-2021 for prophylactic vaccination. Concomitant medications included hydralazine 25mg BID (twice a day) for blood pressure, metformin hydrochloride 500mg BID for diabetes, Baby Aspirin (acetylsalicylic acid) EC (enteric coated) for heart disorder, escitalopram 10mg daily for mood disorder, gabapentin 100mg TID for nerve pain, and celecoxib 200mg 1 tablet a day as needed for pain. olmesartan medoxomil 40mg daily for blood pressure, amlodipine besilate 10mg daily for blood pressure, furosemide 40mg daily for fluid retention, potassium chloride ER (extended release) 20 Meq TID (thrice a day) and metoprolol succinate ER 50mg daily for an unknown indication.  On the same day vaccination, the patient slept for 6 hours after shot and was tired. On 16-APR-2021, the patient experienced bilateral hands and legs swollen. On 19-APR-2021, the patient had bilateral feet and hands numb. On 21-APR-2021, he went to the emergency room (ER) and was hospitalized. He had following test done. Covid-19 test and EKG (electrocardiogram) results not provided, sonagram of legs showed no blood clots, computerized tomography (CAT) scan found blood clots in lungs. He was put on IV fluids and oxygen. He had blood clots in lungs, he could not specify if both lungs had it. He was discharged the next day without oxygen. He was put on Eliquis (apixaban) 5mg BID for 3 months. He was hospitalized for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours after shot, and tired on 09-APR-2021, had not recovered from bilateral hands and legs swollen, and bilateral feet and hand numb, and the outcome of blood clot in lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210554313- COVID-19 VACCINE AD26.COV2.S- blood clot in lung,  bilateral hands and legs swollen and bilateral feet and hand numb. 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: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Full blood count, Hypertension, Lacrimation increased
Clinical narrative: BLOOD CLOT IN LUNG; BILATERAL FEET AND HAND NUMB; BILATERAL HANDS AND LEGS SWOLLEN; SLEPT FOR 6 HOURS AFTER SHOT; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 285 pounds, and height was 56 inches. The patient's concurrent conditions included high blood pressure, depression, diabetes, flea bites allergy, peanut allergy, alcohol consumer, non smoker, heart disorder, nerve pain, mood disorder, fluid retention and pain. He had no known drug allergies. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, 1 in total administered to right deltoid on 09-APR-2021 for prophylactic vaccination. Concomitant medications included hydralazine 25mg BID (twice a day) for blood pressure, metformin hydrochloride 500mg BID for diabetes, Baby Aspirin (acetylsalicylic acid) EC (enteric coated) for heart disorder, escitalopram 10mg daily for mood disorder, gabapentin 100mg TID for nerve pain, and celecoxib 200mg 1 tablet a day as needed for pain. olmesartan medoxomil 40mg daily for blood pressure, amlodipine besilate 10mg daily for blood pressure, furosemide 40mg daily for fluid retention, potassium chloride ER (extended release) 20 Meq TID (thrice a day) and metoprolol succinate ER 50mg daily for an unknown indication.  On the same day vaccination, the patient slept for 6 hours after shot and was tired. On 16-APR-2021, the patient experienced bilateral hands and legs swollen. On 19-APR-2021, the patient had bilateral feet and hands numb. On 21-APR-2021, he went to the emergency room (ER) and was hospitalized. He had following test done. Covid-19 test and EKG (electrocardiogram) results not provided, sonagram of legs showed no blood clots, computerized tomography (CAT) scan found blood clots in lungs. He was put on IV fluids and oxygen. He had blood clots in lungs, he could not specify if both lungs had it. He was discharged the next day without oxygen. He was put on Eliquis (apixaban) 5mg BID for 3 months. He was hospitalized for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours after shot, and tired on 09-APR-2021, had not recovered from bilateral hands and legs swollen, and bilateral feet and hand numb, and the outcome of blood clot in lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210554313- COVID-19 VACCINE AD26.COV2.S- blood clot in lung,  bilateral hands and legs swollen and bilateral feet and hand numb. 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: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Ultrasound scan, Vision blurred
Clinical narrative: BLOOD CLOT IN LUNG; BILATERAL FEET AND HAND NUMB; BILATERAL HANDS AND LEGS SWOLLEN; SLEPT FOR 6 HOURS AFTER SHOT; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 285 pounds, and height was 56 inches. The patient's concurrent conditions included high blood pressure, depression, diabetes, flea bites allergy, peanut allergy, alcohol consumer, non smoker, heart disorder, nerve pain, mood disorder, fluid retention and pain. He had no known drug allergies. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, 1 in total administered to right deltoid on 09-APR-2021 for prophylactic vaccination. Concomitant medications included hydralazine 25mg BID (twice a day) for blood pressure, metformin hydrochloride 500mg BID for diabetes, Baby Aspirin (acetylsalicylic acid) EC (enteric coated) for heart disorder, escitalopram 10mg daily for mood disorder, gabapentin 100mg TID for nerve pain, and celecoxib 200mg 1 tablet a day as needed for pain. olmesartan medoxomil 40mg daily for blood pressure, amlodipine besilate 10mg daily for blood pressure, furosemide 40mg daily for fluid retention, potassium chloride ER (extended release) 20 Meq TID (thrice a day) and metoprolol succinate ER 50mg daily for an unknown indication.  On the same day vaccination, the patient slept for 6 hours after shot and was tired. On 16-APR-2021, the patient experienced bilateral hands and legs swollen. On 19-APR-2021, the patient had bilateral feet and hands numb. On 21-APR-2021, he went to the emergency room (ER) and was hospitalized. He had following test done. Covid-19 test and EKG (electrocardiogram) results not provided, sonagram of legs showed no blood clots, computerized tomography (CAT) scan found blood clots in lungs. He was put on IV fluids and oxygen. He had blood clots in lungs, he could not specify if both lungs had it. He was discharged the next day without oxygen. He was put on Eliquis (apixaban) 5mg BID for 3 months. He was hospitalized for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours after shot, and tired on 09-APR-2021, had not recovered from bilateral hands and legs swollen, and bilateral feet and hand numb, and the outcome of blood clot in lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210554313- COVID-19 VACCINE AD26.COV2.S- blood clot in lung,  bilateral hands and legs swollen and bilateral feet and hand numb. 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: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Fatigue, Hypoaesthesia, Peripheral swelling
Clinical narrative: BLOOD CLOT IN LUNG; BILATERAL FEET AND HAND NUMB; BILATERAL HANDS AND LEGS SWOLLEN; SLEPT FOR 6 HOURS AFTER SHOT; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 285 pounds, and height was 56 inches. The patient's concurrent conditions included high blood pressure, depression, diabetes, flea bites allergy, peanut allergy, alcohol consumer, non smoker, heart disorder, nerve pain, mood disorder, fluid retention and pain. He had no known drug allergies. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, 1 in total administered to right deltoid on 09-APR-2021 for prophylactic vaccination. Concomitant medications included hydralazine 25mg BID (twice a day) for blood pressure, metformin hydrochloride 500mg BID for diabetes, Baby Aspirin (acetylsalicylic acid) EC (enteric coated) for heart disorder, escitalopram 10mg daily for mood disorder, gabapentin 100mg TID for nerve pain, and celecoxib 200mg 1 tablet a day as needed for pain. olmesartan medoxomil 40mg daily for blood pressure, amlodipine besilate 10mg daily for blood pressure, furosemide 40mg daily for fluid retention, potassium chloride ER (extended release) 20 Meq TID (thrice a day) and metoprolol succinate ER 50mg daily for an unknown indication.  On the same day vaccination, the patient slept for 6 hours after shot and was tired. On 16-APR-2021, the patient experienced bilateral hands and legs swollen. On 19-APR-2021, the patient had bilateral feet and hands numb. On 21-APR-2021, he went to the emergency room (ER) and was hospitalized. He had following test done. Covid-19 test and EKG (electrocardiogram) results not provided, sonagram of legs showed no blood clots, computerized tomography (CAT) scan found blood clots in lungs. He was put on IV fluids and oxygen. He had blood clots in lungs, he could not specify if both lungs had it. He was discharged the next day without oxygen. He was put on Eliquis (apixaban) 5mg BID for 3 months. He was hospitalized for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours after shot, and tired on 09-APR-2021, had not recovered from bilateral hands and legs swollen, and bilateral feet and hand numb, and the outcome of blood clot in lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210554313- COVID-19 VACCINE AD26.COV2.S- blood clot in lung,  bilateral hands and legs swollen and bilateral feet and hand numb. 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: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pulmonary thrombosis, SARS-CoV-2 test, Somnolence, Ultrasound scan
Clinical narrative: BLOOD CLOT IN LUNG; BILATERAL FEET AND HAND NUMB; BILATERAL HANDS AND LEGS SWOLLEN; SLEPT FOR 6 HOURS AFTER SHOT; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 285 pounds, and height was 56 inches. The patient's concurrent conditions included high blood pressure, depression, diabetes, flea bites allergy, peanut allergy, alcohol consumer, non smoker, heart disorder, nerve pain, mood disorder, fluid retention and pain. He had no known drug allergies. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, 1 in total administered to right deltoid on 09-APR-2021 for prophylactic vaccination. Concomitant medications included hydralazine 25mg BID (twice a day) for blood pressure, metformin hydrochloride 500mg BID for diabetes, Baby Aspirin (acetylsalicylic acid) EC (enteric coated) for heart disorder, escitalopram 10mg daily for mood disorder, gabapentin 100mg TID for nerve pain, and celecoxib 200mg 1 tablet a day as needed for pain. olmesartan medoxomil 40mg daily for blood pressure, amlodipine besilate 10mg daily for blood pressure, furosemide 40mg daily for fluid retention, potassium chloride ER (extended release) 20 Meq TID (thrice a day) and metoprolol succinate ER 50mg daily for an unknown indication.  On the same day vaccination, the patient slept for 6 hours after shot and was tired. On 16-APR-2021, the patient experienced bilateral hands and legs swollen. On 19-APR-2021, the patient had bilateral feet and hands numb. On 21-APR-2021, he went to the emergency room (ER) and was hospitalized. He had following test done. Covid-19 test and EKG (electrocardiogram) results not provided, sonagram of legs showed no blood clots, computerized tomography (CAT) scan found blood clots in lungs. He was put on IV fluids and oxygen. He had blood clots in lungs, he could not specify if both lungs had it. He was discharged the next day without oxygen. He was put on Eliquis (apixaban) 5mg BID for 3 months. He was hospitalized for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours after shot, and tired on 09-APR-2021, had not recovered from bilateral hands and legs swollen, and bilateral feet and hand numb, and the outcome of blood clot in lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210554313- COVID-19 VACCINE AD26.COV2.S- blood clot in lung,  bilateral hands and legs swollen and bilateral feet and hand numb. 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: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Computerised tomogram, Electrocardiogram, Heart rate, Hypoaesthesia
Clinical narrative: BLOOD CLOT IN LUNG; BILATERAL FEET AND HAND NUMB; BILATERAL HANDS AND LEGS SWOLLEN; SLEPT FOR 6 HOURS AFTER SHOT; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 285 pounds, and height was 56 inches. The patient's concurrent conditions included high blood pressure, depression, diabetes, flea bites allergy, peanut allergy, alcohol consumer, non smoker, heart disorder, nerve pain, mood disorder, fluid retention and pain. He had no known drug allergies. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, 1 in total administered to right deltoid on 09-APR-2021 for prophylactic vaccination. Concomitant medications included hydralazine 25mg BID (twice a day) for blood pressure, metformin hydrochloride 500mg BID for diabetes, Baby Aspirin (acetylsalicylic acid) EC (enteric coated) for heart disorder, escitalopram 10mg daily for mood disorder, gabapentin 100mg TID for nerve pain, and celecoxib 200mg 1 tablet a day as needed for pain. olmesartan medoxomil 40mg daily for blood pressure, amlodipine besilate 10mg daily for blood pressure, furosemide 40mg daily for fluid retention, potassium chloride ER (extended release) 20 Meq TID (thrice a day) and metoprolol succinate ER 50mg daily for an unknown indication.  On the same day vaccination, the patient slept for 6 hours after shot and was tired. On 16-APR-2021, the patient experienced bilateral hands and legs swollen. On 19-APR-2021, the patient had bilateral feet and hands numb. On 21-APR-2021, he went to the emergency room (ER) and was hospitalized. He had following test done. Covid-19 test and EKG (electrocardiogram) results not provided, sonagram of legs showed no blood clots, computerized tomography (CAT) scan found blood clots in lungs. He was put on IV fluids and oxygen. He had blood clots in lungs, he could not specify if both lungs had it. He was discharged the next day without oxygen. He was put on Eliquis (apixaban) 5mg BID for 3 months. He was hospitalized for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours after shot, and tired on 09-APR-2021, had not recovered from bilateral hands and legs swollen, and bilateral feet and hand numb, and the outcome of blood clot in lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210554313- COVID-19 VACCINE AD26.COV2.S- blood clot in lung,  bilateral hands and legs swollen and bilateral feet and hand numb. 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: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Pulmonary thrombosis, SARS-CoV-2 test, Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOT IN LUNG; BILATERAL FEET AND HAND NUMB; BILATERAL HANDS AND LEGS SWOLLEN; SLEPT FOR 6 HOURS AFTER SHOT; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 285 pounds, and height was 56 inches. The patient's concurrent conditions included high blood pressure, depression, diabetes, flea bites allergy, peanut allergy, alcohol consumer, non smoker, heart disorder, nerve pain, mood disorder, fluid retention and pain. He had no known drug allergies. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, 1 in total administered to right deltoid on 09-APR-2021 for prophylactic vaccination. Concomitant medications included hydralazine 25mg BID (twice a day) for blood pressure, metformin hydrochloride 500mg BID for diabetes, Baby Aspirin (acetylsalicylic acid) EC (enteric coated) for heart disorder, escitalopram 10mg daily for mood disorder, gabapentin 100mg TID for nerve pain, and celecoxib 200mg 1 tablet a day as needed for pain. olmesartan medoxomil 40mg daily for blood pressure, amlodipine besilate 10mg daily for blood pressure, furosemide 40mg daily for fluid retention, potassium chloride ER (extended release) 20 Meq TID (thrice a day) and metoprolol succinate ER 50mg daily for an unknown indication.  On the same day vaccination, the patient slept for 6 hours after shot and was tired. On 16-APR-2021, the patient experienced bilateral hands and legs swollen. On 19-APR-2021, the patient had bilateral feet and hands numb. On 21-APR-2021, he went to the emergency room (ER) and was hospitalized. He had following test done. Covid-19 test and EKG (electrocardiogram) results not provided, sonagram of legs showed no blood clots, computerized tomography (CAT) scan found blood clots in lungs. He was put on IV fluids and oxygen. He had blood clots in lungs, he could not specify if both lungs had it. He was discharged the next day without oxygen. He was put on Eliquis (apixaban) 5mg BID for 3 months. He was hospitalized for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours after shot, and tired on 09-APR-2021, had not recovered from bilateral hands and legs swollen, and bilateral feet and hand numb, and the outcome of blood clot in lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210554313- COVID-19 VACCINE AD26.COV2.S- blood clot in lung,  bilateral hands and legs swollen and bilateral feet and hand numb. 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: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, high piercing tone heard constantly in ears; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at 47-years-old, dose 2 via an unspecified route of administration, administered in left arm on 25Apr2021 at 03:15 PM (Lot Number: EWO172) as single dose for Covid-19 immunisation. Medical history included allergic to dust and mold, fungal infection from an unknown date and unknown if ongoing. The patient was not diagnosed with Covid-19 prior to vaccination and not Covid-19 tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included fluconazol taken for yeast infection and antibiotic (unspecified) for UTI, start and stop date were not reported.  The patient previously took the first dose of bnt162b2 on 03Apr2021 at 03:30 PM (lot number: EP7533), on the left arm, for Covid-19 immunisation. The patient experienced tinnitus, high piercing tone heard constantly in ears on 29Apr2021 with outcome of not recovered. The patient was treated of ear flush, prednisone, and acetyl Lcarnitine. The event resulted in emergency room visit and was assessed as serious due to disability. Information on Lot/Batch number was available. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling, Ultrasound scan abnormal
Clinical narrative: Patient developed a deep vein thrombosis approximately one month after receipt of vaccine.  Of note, was on an oral contraceptive prior to this.  No other history of VTE or smoking, or other coagulation disorders in family.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Ultrasound scan abnormal, Ultrasound scan normal
Clinical narrative: Patient developed a deep vein thrombosis approximately one month after receipt of vaccine.  Of note, was on an oral contraceptive prior to this.  No other history of VTE or smoking, or other coagulation disorders in family.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Convalescent plasma transfusion, Cough
Clinical narrative: First  dose given 2/9/2021 see further information below. Date of death 5/16/2021.  Hospital 5/8/2021 to 5/16/2021
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Dyspnoea, Hypoxia, Mechanical ventilation, SARS-CoV-2 test positive
Clinical narrative: First  dose given 2/9/2021 see further information below. Date of death 5/16/2021.  Hospital 5/8/2021 to 5/16/2021
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: First  dose given 2/9/2021 see further information below. Date of death 5/16/2021.  Hospital 5/8/2021 to 5/16/2021
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: First  dose given 2/9/2021 see further information below. Date of death 5/16/2021.  Hospital 5/8/2021 to 5/16/2021
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Dyspnoea, Malaise, Myocardial infarction, Thrombosis
Clinical narrative: DEATH; COULDNT WALK; SWOLLEN LEGS; COULDNT TASTE; COULDNT SWALLOW; SHORTNESS OF BREATH; This spontaneous report received from a parent and concerned a 66-year-old a Not Hispanic or Latino Asian female patient. The patient's weight was not reported and height was 62 inches. The patient's past medical history included overweight. Patient was non-alcoholic, and non-smoker. Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and expiry: unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  In May-2021, afterwards or sometime around, the patient could not walk, had swollen legs, could not taste, could not swallow and had shortness breath. On an unspecified date in MAY-2021, the patient died from an unknown cause. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: Covid-19 Vaccine ad26.Cov2.S-Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Death, Dysphagia, Dyspnoea, Gait inability
Clinical narrative: DEATH; COULDNT WALK; SWOLLEN LEGS; COULDNT TASTE; COULDNT SWALLOW; SHORTNESS OF BREATH; This spontaneous report received from a parent and concerned a 66-year-old a Not Hispanic or Latino Asian female patient. The patient's weight was not reported and height was 62 inches. The patient's past medical history included overweight. Patient was non-alcoholic, and non-smoker. Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and expiry: unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  In May-2021, afterwards or sometime around, the patient could not walk, had swollen legs, could not taste, could not swallow and had shortness breath. On an unspecified date in MAY-2021, the patient died from an unknown cause. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: Covid-19 Vaccine ad26.Cov2.S-Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: DEATH; COULDNT WALK; SWOLLEN LEGS; COULDNT TASTE; COULDNT SWALLOW; SHORTNESS OF BREATH; This spontaneous report received from a parent and concerned a 66-year-old a Not Hispanic or Latino Asian female patient. The patient's weight was not reported and height was 62 inches. The patient's past medical history included overweight. Patient was non-alcoholic, and non-smoker. Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and expiry: unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  In May-2021, afterwards or sometime around, the patient could not walk, had swollen legs, could not taste, could not swallow and had shortness breath. On an unspecified date in MAY-2021, the patient died from an unknown cause. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: Covid-19 Vaccine ad26.Cov2.S-Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Echocardiogram, Echocardiogram normal, Implantable cardiac monitor insertion, Ischaemic stroke
Clinical narrative: Patient called and stated she had a stroke approximately 3 weeks after second vaccination.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Ultrasound Doppler
Clinical narrative: Patient called and stated she had a stroke approximately 3 weeks after second vaccination.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Patient called and stated she had a stroke approximately 3 weeks after second vaccination.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dyspnoea, Throat tightness
Clinical narrative: Patient developed swelling in her throat and tongue within the 15 minute waiting time.. Nurses at the clinic administered an Epi-pen treatment and told us to go immediately to the emergency room. Patient was examined, monitored, and treated with three different drugs. We were at the ER for approximately two and a half hours.  About four hours later she complained about similar symptoms and we returned to the ER. she was again examined, monitored, and treated again with one drug. The second visit was for approximately and hour and a half.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: Patient developed swelling in her throat and tongue within the 15 minute waiting time.. Nurses at the clinic administered an Epi-pen treatment and told us to go immediately to the emergency room. Patient was examined, monitored, and treated with three different drugs. We were at the ER for approximately two and a half hours.  About four hours later she complained about similar symptoms and we returned to the ER. she was again examined, monitored, and treated again with one drug. The second visit was for approximately and hour and a half.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Aortic thrombosis, Blood fibrinogen normal, Fibrin D dimer increased, Flank pain
Clinical narrative: BLOOD CLOT IN BRAIN; BLOOD CLOT IN RIGHT LUNG; BLOOD CLOT IN STOMACH AND NECK; This spontaneous report received from a patient concerned a 64-year-old, female.  The patient's height, and weight were not reported. The patient's past medical history included tendonitis in right shoulder, surgeries on right shoulder and concurrent conditions included arthritis in right shoulder, non-smoker, abstains from alcohol, and seasonal allergies, and other pre-existing medical conditions included the normal wear and tear on her body at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, one total, administered on 04-MAY-2021 at the right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The Patient reported that on 04-MAY-2021, after vaccination, she began feeling unwell with a low grade fever, her highest body temperature was 102F. She experienced headache that she initially felt on the right side of her head but could not determine the source for sure. On 14-MAY-2021, she coughed up blood, but she didn't think anything of it and continued her normal routine then on 15-MAY-2021, she coughed up more blood but it had some phlegm in it, so she went to the ER (emergency room) on 18-MAY-2021. She received a Computerized axial tomography (CAT) scan of her chest which showed blood clots in her right lung. She got a secondary CAT scan and blood clots were found in her stomach, brain and in her neck. She was admitted to hospital on 19-MAY-2021.  The Patient was reportedly hospitalized for 6 days and was supposedly discharged on 24/May/2021. For treatment, she was receiving an Intravenous (IV) blood thinner but later changed to an oral blood thinner. She was also receiving Tramadol for pain. She was receiving other medications when first admitted but could not recall specific names. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in brain, blood clot in right lung, and blood clot in stomach and neck. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210546778-covid-19 vaccine ad26.cov2.s- blood clot in brain, blood clot in right lung, and blood clot in stomach and neck. This events are considered unassessable. The events 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 events.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemoptysis, Headache, Heparin-induced thrombocytopenia test positive, Immunoglobulin therapy, Pain in extremity
Clinical narrative: BLOOD CLOT IN BRAIN; BLOOD CLOT IN RIGHT LUNG; BLOOD CLOT IN STOMACH AND NECK; This spontaneous report received from a patient concerned a 64-year-old, female.  The patient's height, and weight were not reported. The patient's past medical history included tendonitis in right shoulder, surgeries on right shoulder and concurrent conditions included arthritis in right shoulder, non-smoker, abstains from alcohol, and seasonal allergies, and other pre-existing medical conditions included the normal wear and tear on her body at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, one total, administered on 04-MAY-2021 at the right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The Patient reported that on 04-MAY-2021, after vaccination, she began feeling unwell with a low grade fever, her highest body temperature was 102F. She experienced headache that she initially felt on the right side of her head but could not determine the source for sure. On 14-MAY-2021, she coughed up blood, but she didn't think anything of it and continued her normal routine then on 15-MAY-2021, she coughed up more blood but it had some phlegm in it, so she went to the ER (emergency room) on 18-MAY-2021. She received a Computerized axial tomography (CAT) scan of her chest which showed blood clots in her right lung. She got a secondary CAT scan and blood clots were found in her stomach, brain and in her neck. She was admitted to hospital on 19-MAY-2021.  The Patient was reportedly hospitalized for 6 days and was supposedly discharged on 24/May/2021. For treatment, she was receiving an Intravenous (IV) blood thinner but later changed to an oral blood thinner. She was also receiving Tramadol for pain. She was receiving other medications when first admitted but could not recall specific names. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in brain, blood clot in right lung, and blood clot in stomach and neck. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210546778-covid-19 vaccine ad26.cov2.s- blood clot in brain, blood clot in right lung, and blood clot in stomach and neck. This events are considered unassessable. The events 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 events.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Pulmonary embolism, Thrombocytopenia
Clinical narrative: BLOOD CLOT IN BRAIN; BLOOD CLOT IN RIGHT LUNG; BLOOD CLOT IN STOMACH AND NECK; This spontaneous report received from a patient concerned a 64-year-old, female.  The patient's height, and weight were not reported. The patient's past medical history included tendonitis in right shoulder, surgeries on right shoulder and concurrent conditions included arthritis in right shoulder, non-smoker, abstains from alcohol, and seasonal allergies, and other pre-existing medical conditions included the normal wear and tear on her body at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, one total, administered on 04-MAY-2021 at the right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The Patient reported that on 04-MAY-2021, after vaccination, she began feeling unwell with a low grade fever, her highest body temperature was 102F. She experienced headache that she initially felt on the right side of her head but could not determine the source for sure. On 14-MAY-2021, she coughed up blood, but she didn't think anything of it and continued her normal routine then on 15-MAY-2021, she coughed up more blood but it had some phlegm in it, so she went to the ER (emergency room) on 18-MAY-2021. She received a Computerized axial tomography (CAT) scan of her chest which showed blood clots in her right lung. She got a secondary CAT scan and blood clots were found in her stomach, brain and in her neck. She was admitted to hospital on 19-MAY-2021.  The Patient was reportedly hospitalized for 6 days and was supposedly discharged on 24/May/2021. For treatment, she was receiving an Intravenous (IV) blood thinner but later changed to an oral blood thinner. She was also receiving Tramadol for pain. She was receiving other medications when first admitted but could not recall specific names. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in brain, blood clot in right lung, and blood clot in stomach and neck. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210546778-covid-19 vaccine ad26.cov2.s- blood clot in brain, blood clot in right lung, and blood clot in stomach and neck. This events are considered unassessable. The events 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 events.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Cerebral thrombosis, Computerised tomogram, Pulmonary thrombosis, Thrombosis
Clinical narrative: BLOOD CLOT IN BRAIN; BLOOD CLOT IN RIGHT LUNG; BLOOD CLOT IN STOMACH AND NECK; This spontaneous report received from a patient concerned a 64-year-old, female.  The patient's height, and weight were not reported. The patient's past medical history included tendonitis in right shoulder, surgeries on right shoulder and concurrent conditions included arthritis in right shoulder, non-smoker, abstains from alcohol, and seasonal allergies, and other pre-existing medical conditions included the normal wear and tear on her body at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, one total, administered on 04-MAY-2021 at the right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The Patient reported that on 04-MAY-2021, after vaccination, she began feeling unwell with a low grade fever, her highest body temperature was 102F. She experienced headache that she initially felt on the right side of her head but could not determine the source for sure. On 14-MAY-2021, she coughed up blood, but she didn't think anything of it and continued her normal routine then on 15-MAY-2021, she coughed up more blood but it had some phlegm in it, so she went to the ER (emergency room) on 18-MAY-2021. She received a Computerized axial tomography (CAT) scan of her chest which showed blood clots in her right lung. She got a secondary CAT scan and blood clots were found in her stomach, brain and in her neck. She was admitted to hospital on 19-MAY-2021.  The Patient was reportedly hospitalized for 6 days and was supposedly discharged on 24/May/2021. For treatment, she was receiving an Intravenous (IV) blood thinner but later changed to an oral blood thinner. She was also receiving Tramadol for pain. She was receiving other medications when first admitted but could not recall specific names. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in brain, blood clot in right lung, and blood clot in stomach and neck. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210546778-covid-19 vaccine ad26.cov2.s- blood clot in brain, blood clot in right lung, and blood clot in stomach and neck. This events are considered unassessable. The events 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 events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Headache, Pain in extremity, Palpitations
Clinical narrative: PULMONARY EMBOLISM; DEEP VEIN THROMBOSIS ON LEGS AND RIGHT ARM; FAST HEART RATE; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to penicillin, non alcohol user, and non smoker. The patient had no drug abuse or illicit drug usage and allergy to vactrum. The patient experienced drug allergy when treated with hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1A0501A expiry: UNKNOWN) dose was not reported, 1 in total administered at left arm on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient had heart rate and she went to emergency room and was sent home with unspecified medication. On 21-AMY-2021, the patient was admitted with pulmonary embolism and deep vein thrombosis on legs and right arm. Patient was discharged on Eliquis for 6 month. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pulmonary embolism, and fast heart rate, and the outcome of deep vein thrombosis on legs and right arm was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210554600-COVID-19 VACCINE AD26.COV2.S-pulmonary embolism, deep vein thrombosis on legs and right arm. 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).