chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Chest pain, Diarrhoea, Dizziness, Feeling jittery
Clinical narrative: ELEVATED HEART RATE; CHEST PAIN; FELT FAINT; BODY ACHES; STOMACH UPSET; DIARRHEA; FELT JITTERY; HEADACHE; NAUSEA; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 55 year old white male. The patient's height, and weight were not reported. The patient's past medical history included both knees replacement, both hips replacement, and heart attack, and concurrent conditions included heart problems, circulation problems, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 at 10:15 to left arm for prophylactic vaccination. Concomitant medications included warfarin (5mg) for blood thinner, atorvastatin (80mg), baclofen (10mg), furosemide (40mg, 1 to 2 daily), glyceryl trinitrate, losartan (25mg), midodrine (5mg), oxycodone hydrochloride/paracetamol, potassium, and promethazine (25mg). On 08-APR-2021, the patient had heart rate issue after 45 minutes of vaccine administration, while driving to home and went to sleep for 2 hours. The patient felt faint, body aches, stomach upset, diarrhea, headache, nausea, sore arm at injection site and felt jittery. He told vaccination provider that he was on a blood thinner (warfarin 5mg), and had heart and circulation problems. He also took lorazepam (1mg) as treatment for jitters, which was not helpful for it. His heart rate had been fluctuating down to low 70's and up to 100's since he received the vaccine. On 09-APR-2021, he called his nurse about heart rate and nurse advised him to visit to emergency room (ER) if he experience chest pains. On 10-Apr-2021 at 09:00, the patient visited emergency room due to worsening of the elevated heart rate, and chest pain. The patient felt like he had another heart attack. The patient was admitted to the cardiac floor and medicine was provided to stabilize the heart rate. The patient was hospitalized for 2 days and discharged on 11-APR-2021 with the improvement of heart rate on prescribed medicines and advised if heart rate passed 90 to 100 to went back or felt flutter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt faint, body aches, stomach upset, diarrhea, nausea, and sore arm at injection site on 10-APR-2021, was recovering from elevated heart rate, had not recovered from headache, and felt jittery, and the outcome of chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210420626-covid-19 vaccine ad26.cov2.s-Elevated heart rate, Chest pain. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Injection site pain, Nausea
Clinical narrative: ELEVATED HEART RATE; CHEST PAIN; FELT FAINT; BODY ACHES; STOMACH UPSET; DIARRHEA; FELT JITTERY; HEADACHE; NAUSEA; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 55 year old white male. The patient's height, and weight were not reported. The patient's past medical history included both knees replacement, both hips replacement, and heart attack, and concurrent conditions included heart problems, circulation problems, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 at 10:15 to left arm for prophylactic vaccination. Concomitant medications included warfarin (5mg) for blood thinner, atorvastatin (80mg), baclofen (10mg), furosemide (40mg, 1 to 2 daily), glyceryl trinitrate, losartan (25mg), midodrine (5mg), oxycodone hydrochloride/paracetamol, potassium, and promethazine (25mg). On 08-APR-2021, the patient had heart rate issue after 45 minutes of vaccine administration, while driving to home and went to sleep for 2 hours. The patient felt faint, body aches, stomach upset, diarrhea, headache, nausea, sore arm at injection site and felt jittery. He told vaccination provider that he was on a blood thinner (warfarin 5mg), and had heart and circulation problems. He also took lorazepam (1mg) as treatment for jitters, which was not helpful for it. His heart rate had been fluctuating down to low 70's and up to 100's since he received the vaccine. On 09-APR-2021, he called his nurse about heart rate and nurse advised him to visit to emergency room (ER) if he experience chest pains. On 10-Apr-2021 at 09:00, the patient visited emergency room due to worsening of the elevated heart rate, and chest pain. The patient felt like he had another heart attack. The patient was admitted to the cardiac floor and medicine was provided to stabilize the heart rate. The patient was hospitalized for 2 days and discharged on 11-APR-2021 with the improvement of heart rate on prescribed medicines and advised if heart rate passed 90 to 100 to went back or felt flutter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt faint, body aches, stomach upset, diarrhea, nausea, and sore arm at injection site on 10-APR-2021, was recovering from elevated heart rate, had not recovered from headache, and felt jittery, and the outcome of chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210420626-covid-19 vaccine ad26.cov2.s-Elevated heart rate, Chest pain. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: ELEVATED HEART RATE; CHEST PAIN; FELT FAINT; BODY ACHES; STOMACH UPSET; DIARRHEA; FELT JITTERY; HEADACHE; NAUSEA; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 55 year old white male. The patient's height, and weight were not reported. The patient's past medical history included both knees replacement, both hips replacement, and heart attack, and concurrent conditions included heart problems, circulation problems, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 at 10:15 to left arm for prophylactic vaccination. Concomitant medications included warfarin (5mg) for blood thinner, atorvastatin (80mg), baclofen (10mg), furosemide (40mg, 1 to 2 daily), glyceryl trinitrate, losartan (25mg), midodrine (5mg), oxycodone hydrochloride/paracetamol, potassium, and promethazine (25mg). On 08-APR-2021, the patient had heart rate issue after 45 minutes of vaccine administration, while driving to home and went to sleep for 2 hours. The patient felt faint, body aches, stomach upset, diarrhea, headache, nausea, sore arm at injection site and felt jittery. He told vaccination provider that he was on a blood thinner (warfarin 5mg), and had heart and circulation problems. He also took lorazepam (1mg) as treatment for jitters, which was not helpful for it. His heart rate had been fluctuating down to low 70's and up to 100's since he received the vaccine. On 09-APR-2021, he called his nurse about heart rate and nurse advised him to visit to emergency room (ER) if he experience chest pains. On 10-Apr-2021 at 09:00, the patient visited emergency room due to worsening of the elevated heart rate, and chest pain. The patient felt like he had another heart attack. The patient was admitted to the cardiac floor and medicine was provided to stabilize the heart rate. The patient was hospitalized for 2 days and discharged on 11-APR-2021 with the improvement of heart rate on prescribed medicines and advised if heart rate passed 90 to 100 to went back or felt flutter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt faint, body aches, stomach upset, diarrhea, nausea, and sore arm at injection site on 10-APR-2021, was recovering from elevated heart rate, had not recovered from headache, and felt jittery, and the outcome of chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210420626-covid-19 vaccine ad26.cov2.s-Elevated heart rate, Chest pain. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Headache, Intensive care, International normalised ratio increased, Magnetic resonance imaging head abnormal
Clinical narrative: Headache began 4/8/2021,  2 weeks after receipt of Janssen. Presented to ER and CT/MRI showed cerebral blood clots.  Hospital attempted to remove blood clots surgically which failed. Patient was transferred to hospital in another city for plasmapheresis on 4/18.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Prothrombin time prolonged, Scan with contrast abnormal, Superior sagittal sinus thrombosis, Transverse sinus thrombosis
Clinical narrative: Headache began 4/8/2021,  2 weeks after receipt of Janssen. Presented to ER and CT/MRI showed cerebral blood clots.  Hospital attempted to remove blood clots surgically which failed. Patient was transferred to hospital in another city for plasmapheresis on 4/18.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Venogram abnormal, Vomiting
Clinical narrative: Headache began 4/8/2021,  2 weeks after receipt of Janssen. Presented to ER and CT/MRI showed cerebral blood clots.  Hospital attempted to remove blood clots surgically which failed. Patient was transferred to hospital in another city for plasmapheresis on 4/18.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache
Clinical narrative: Headache began 4/8/2021,  2 weeks after receipt of Janssen. Presented to ER and CT/MRI showed cerebral blood clots.  Hospital attempted to remove blood clots surgically which failed. Patient was transferred to hospital in another city for plasmapheresis on 4/18.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral venous thrombosis, Computerised tomogram abnormal, Headache, Magnetic resonance imaging abnormal, Plasmapheresis
Clinical narrative: Headache began 4/8/2021,  2 weeks after receipt of Janssen. Presented to ER and CT/MRI showed cerebral blood clots.  Hospital attempted to remove blood clots surgically which failed. Patient was transferred to hospital in another city for plasmapheresis on 4/18.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Surgical failure
Clinical narrative: Headache began 4/8/2021,  2 weeks after receipt of Janssen. Presented to ER and CT/MRI showed cerebral blood clots.  Hospital attempted to remove blood clots surgically which failed. Patient was transferred to hospital in another city for plasmapheresis on 4/18.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Headache, International normalised ratio, Magnetic resonance imaging, Magnetic resonance imaging head
Clinical narrative: Headache began 4/8/2021,  2 weeks after receipt of Janssen. Presented to ER and CT/MRI showed cerebral blood clots.  Hospital attempted to remove blood clots surgically which failed. Patient was transferred to hospital in another city for plasmapheresis on 4/18.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count, Prothrombin time, Vomiting
Clinical narrative: Headache began 4/8/2021,  2 weeks after receipt of Janssen. Presented to ER and CT/MRI showed cerebral blood clots.  Hospital attempted to remove blood clots surgically which failed. Patient was transferred to hospital in another city for plasmapheresis on 4/18.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Computerised tomogram, Dyspnoea, Fatigue
Clinical narrative: BLOOD CLOT IN BOTH LUNGS; EXTREME FATIGUE; This spontaneous report received from reporter via company representative via the VAERS (Vaccine Adverse Event Reporting System)concerned a 64 year old white, not hispanic or latino male patient. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies to medications, food or other products. The patient did not had other illnesses at the time of vaccination and up to one month prior. The patient did not had adverse event after any previous vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 17-MAR-2021 10:30 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included colesevelam hydrochloride, ibuprofen, losartan, omeprazole, potassium chloride, and trazodone. On 22-MAR-2021 12:00, the patient experienced blood clot in both lungs and extreme fatigue. The patient experienced severe pain in chest, trouble breathing within 5 days of vaccination and was on blood thinners to help get rid of the clots. On an unspecified date in MAR-2021 the patient was admitted to the hospital. On an unspecified date in MAR-2021, laboratory data included: CT scan (computed tomography) (NR: not provided) Not reported, chest X-ray (NR: not provided) not reported, and diagnostic ultrasound (NR: not provided) not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in both lungs, and extreme fatigue. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0:  This 64-year-old white (non-Hispanic/Latino) male patient was hospitalized for blood cloth in both lungs with associated extreme fatigue 5 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  No pre-existing medical conditions, no known allergies, no previous vaccine reaction, no acute illness within a month prior to vaccination.  Symptoms reported to have started as chest pain and trouble breathing.  No laboratory/diagnostic tests result were reported.  The patient was start on unspecified blood thinners.  The events have not recovered.  Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information is requested
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOT IN BOTH LUNGS; EXTREME FATIGUE; This spontaneous report received from reporter via company representative via the VAERS (Vaccine Adverse Event Reporting System)concerned a 64 year old white, not hispanic or latino male patient. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies to medications, food or other products. The patient did not had other illnesses at the time of vaccination and up to one month prior. The patient did not had adverse event after any previous vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 17-MAR-2021 10:30 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included colesevelam hydrochloride, ibuprofen, losartan, omeprazole, potassium chloride, and trazodone. On 22-MAR-2021 12:00, the patient experienced blood clot in both lungs and extreme fatigue. The patient experienced severe pain in chest, trouble breathing within 5 days of vaccination and was on blood thinners to help get rid of the clots. On an unspecified date in MAR-2021 the patient was admitted to the hospital. On an unspecified date in MAR-2021, laboratory data included: CT scan (computed tomography) (NR: not provided) Not reported, chest X-ray (NR: not provided) not reported, and diagnostic ultrasound (NR: not provided) not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in both lungs, and extreme fatigue. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0:  This 64-year-old white (non-Hispanic/Latino) male patient was hospitalized for blood cloth in both lungs with associated extreme fatigue 5 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  No pre-existing medical conditions, no known allergies, no previous vaccine reaction, no acute illness within a month prior to vaccination.  Symptoms reported to have started as chest pain and trouble breathing.  No laboratory/diagnostic tests result were reported.  The patient was start on unspecified blood thinners.  The events have not recovered.  Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information is requested
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram, Fatigue, Pulmonary thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOT IN BOTH LUNGS; EXTREME FATIGUE; This spontaneous report received from reporter via company representative via the VAERS (Vaccine Adverse Event Reporting System)concerned a 64 year old white, not hispanic or latino male patient. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies to medications, food or other products. The patient did not had other illnesses at the time of vaccination and up to one month prior. The patient did not had adverse event after any previous vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 17-MAR-2021 10:30 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included colesevelam hydrochloride, ibuprofen, losartan, omeprazole, potassium chloride, and trazodone. On 22-MAR-2021 12:00, the patient experienced blood clot in both lungs and extreme fatigue. The patient experienced severe pain in chest, trouble breathing within 5 days of vaccination and was on blood thinners to help get rid of the clots. On an unspecified date in MAR-2021 the patient was admitted to the hospital. On an unspecified date in MAR-2021, laboratory data included: CT scan (computed tomography) (NR: not provided) Not reported, chest X-ray (NR: not provided) not reported, and diagnostic ultrasound (NR: not provided) not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in both lungs, and extreme fatigue. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0:  This 64-year-old white (non-Hispanic/Latino) male patient was hospitalized for blood cloth in both lungs with associated extreme fatigue 5 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  No pre-existing medical conditions, no known allergies, no previous vaccine reaction, no acute illness within a month prior to vaccination.  Symptoms reported to have started as chest pain and trouble breathing.  No laboratory/diagnostic tests result were reported.  The patient was start on unspecified blood thinners.  The events have not recovered.  Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information is requested
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: Patient had ED visit / hospitalization within 6 weeks of receiving COVID vaccine.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient had ED visit / hospitalization within 6 weeks of receiving COVID vaccine.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. First event occurred on 3/7/2021 and second was 3/13/2021.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Death, Malaise, Unresponsive to stimuli, Vomiting
Clinical narrative: DEATH; FELT UNWELL AFTER RECEIVING VACCINE; This spontaneous report received from a patient via a company representative concerned a 21 years old  male. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-APR-2021, after vaccination the patient felt unwell and went to rest. Patient was found dead due to unspecified cause in his room later that day on 12-APR-2021 by his roommate. An autopsy was performed on an unspecified date.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 12-APR-2021, and the outcome of felt unwell after receiving vaccine was not reported. 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: CAUSE UNKNOWN DEATH
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Malaise
Clinical narrative: DEATH; FELT UNWELL AFTER RECEIVING VACCINE; This spontaneous report received from a patient via a company representative concerned a 21 years old  male. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-APR-2021, after vaccination the patient felt unwell and went to rest. Patient was found dead due to unspecified cause in his room later that day on 12-APR-2021 by his roommate. An autopsy was performed on an unspecified date.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 12-APR-2021, and the outcome of felt unwell after receiving vaccine was not reported. 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: CAUSE UNKNOWN DEATH
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Catheterisation cardiac, Chest pain, Headache, Magnetic resonance imaging, Nausea
Clinical narrative: CHEST PAIN; HIGH TROPONINS; This spontaneous report received from a consumer (via a company representative) concerned a 22 year old male. The reporter obtained the information from news/media. 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) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On 13-APR-2021, the patient experienced chest pain, and visited emergency room where he was on heparin drip. The patient was at hospital overnight due to high troponins and he had echocardiogram on 14-APR-2021 which was normal and the results of magnetic resonance imaging (MRI) scan was not provided.  At the time of this report, the patient was still in the hospital. The patient was scheduled for catheterization on the same day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and the outcome of high troponins was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: -Covid-19 vaccine ad26.cov2.s -Chest pain and High Troponins. 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Pulmonary oedema, Pyrexia, Vomiting
Clinical narrative: CHEST PAIN; HIGH TROPONINS; This spontaneous report received from a consumer (via a company representative) concerned a 22 year old male. The reporter obtained the information from news/media. 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) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On 13-APR-2021, the patient experienced chest pain, and visited emergency room where he was on heparin drip. The patient was at hospital overnight due to high troponins and he had echocardiogram on 14-APR-2021 which was normal and the results of magnetic resonance imaging (MRI) scan was not provided.  At the time of this report, the patient was still in the hospital. The patient was scheduled for catheterization on the same day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and the outcome of high troponins was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: -Covid-19 vaccine ad26.cov2.s -Chest pain and High Troponins. 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Echocardiogram, Magnetic resonance imaging, Troponin, Troponin increased
Clinical narrative: CHEST PAIN; HIGH TROPONINS; This spontaneous report received from a consumer (via a company representative) concerned a 22 year old male. The reporter obtained the information from news/media. 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) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On 13-APR-2021, the patient experienced chest pain, and visited emergency room where he was on heparin drip. The patient was at hospital overnight due to high troponins and he had echocardiogram on 14-APR-2021 which was normal and the results of magnetic resonance imaging (MRI) scan was not provided.  At the time of this report, the patient was still in the hospital. The patient was scheduled for catheterization on the same day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and the outcome of high troponins was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: -Covid-19 vaccine ad26.cov2.s -Chest pain and High Troponins. 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac assistance device user, Chest pain, Chills, Dizziness, Ejection fraction decreased
Clinical narrative: CHEST PAIN; HIGH TROPONINS; This spontaneous report received from a consumer (via a company representative) concerned a 22 year old male. The reporter obtained the information from news/media. 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) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On 13-APR-2021, the patient experienced chest pain, and visited emergency room where he was on heparin drip. The patient was at hospital overnight due to high troponins and he had echocardiogram on 14-APR-2021 which was normal and the results of magnetic resonance imaging (MRI) scan was not provided.  At the time of this report, the patient was still in the hospital. The patient was scheduled for catheterization on the same day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and the outcome of high troponins was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: -Covid-19 vaccine ad26.cov2.s -Chest pain and High Troponins. 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Laboratory test, Magnetic resonance imaging heart, Painful respiration, Troponin increased
Clinical narrative: CHEST PAIN; HIGH TROPONINS; This spontaneous report received from a consumer (via a company representative) concerned a 22 year old male. The reporter obtained the information from news/media. 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) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On 13-APR-2021, the patient experienced chest pain, and visited emergency room where he was on heparin drip. The patient was at hospital overnight due to high troponins and he had echocardiogram on 14-APR-2021 which was normal and the results of magnetic resonance imaging (MRI) scan was not provided.  At the time of this report, the patient was still in the hospital. The patient was scheduled for catheterization on the same day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and the outcome of high troponins was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: -Covid-19 vaccine ad26.cov2.s -Chest pain and High Troponins. 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: CHEST PAIN; HIGH TROPONINS; This spontaneous report received from a consumer (via a company representative) concerned a 22 year old male. The reporter obtained the information from news/media. 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) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On 13-APR-2021, the patient experienced chest pain, and visited emergency room where he was on heparin drip. The patient was at hospital overnight due to high troponins and he had echocardiogram on 14-APR-2021 which was normal and the results of magnetic resonance imaging (MRI) scan was not provided.  At the time of this report, the patient was still in the hospital. The patient was scheduled for catheterization on the same day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and the outcome of high troponins was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: -Covid-19 vaccine ad26.cov2.s -Chest pain and High Troponins. 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).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: PNEUMONIA; ALLERGY-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, 1 total, administered on 13-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, ten days later vaccination the subject experienced coughing, allergy-like symptoms and fatigue.  On 01-APR-2021, the patient visited Healthcare Professional where she was diagnosed pneumonia and was prescribed antibiotics and nebulizer. On 06-APR-2021, Laboratory data included: SARS-CoV-2 test (NR: not provided) Negative (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from allergy-like symptoms and pneumonia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210427853-covid-19 vaccine ad26.cov2. s-pneumonia. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, X-ray abnormal
Clinical narrative: PNEUMONIA; ALLERGY-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, 1 total, administered on 13-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, ten days later vaccination the subject experienced coughing, allergy-like symptoms and fatigue.  On 01-APR-2021, the patient visited Healthcare Professional where she was diagnosed pneumonia and was prescribed antibiotics and nebulizer. On 06-APR-2021, Laboratory data included: SARS-CoV-2 test (NR: not provided) Negative (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from allergy-like symptoms and pneumonia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210427853-covid-19 vaccine ad26.cov2. s-pneumonia. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Pneumonia, SARS-CoV-2 test
Clinical narrative: PNEUMONIA; ALLERGY-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, 1 total, administered on 13-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, ten days later vaccination the subject experienced coughing, allergy-like symptoms and fatigue.  On 01-APR-2021, the patient visited Healthcare Professional where she was diagnosed pneumonia and was prescribed antibiotics and nebulizer. On 06-APR-2021, Laboratory data included: SARS-CoV-2 test (NR: not provided) Negative (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from allergy-like symptoms and pneumonia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210427853-covid-19 vaccine ad26.cov2. s-pneumonia. This event is considered unassessable. The event 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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Death, Fatigue, Pyrexia
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of 63 years age. The patient's height, and weight were not reported. The patient had no known allergies.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, 1 total dose administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications include chronic medications to treat high cholesterol and hypothyroidism.  On 18-MAR-2021, the patient developed fever, chills, fatigue and loss of appetite. Later, her SARS-CoV-2 test was performed. On 22-MAR-2021, SARS-CoV-2 tested positive (coded- Confirmed Covid-19 infection). In the following week, fever and chills was recovered, but fatigue and loss of appetite remained. The health care professional (HCP) recommended to stay home unless he had trouble breathing. On 29-MAR-2021, the patient passed away due to confirmed covid-19 infection. It was not reported if the 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 - COVID-19 Infection. This event is considered Unassessable. The event 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.; Reported Cause(s) of Death: COVID-19 INFECTION
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of 63 years age. The patient's height, and weight were not reported. The patient had no known allergies.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, 1 total dose administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications include chronic medications to treat high cholesterol and hypothyroidism.  On 18-MAR-2021, the patient developed fever, chills, fatigue and loss of appetite. Later, her SARS-CoV-2 test was performed. On 22-MAR-2021, SARS-CoV-2 tested positive (coded- Confirmed Covid-19 infection). In the following week, fever and chills was recovered, but fatigue and loss of appetite remained. The health care professional (HCP) recommended to stay home unless he had trouble breathing. On 29-MAR-2021, the patient passed away due to confirmed covid-19 infection. It was not reported if the 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 - COVID-19 Infection. This event is considered Unassessable. The event 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.; Reported Cause(s) of Death: COVID-19 INFECTION
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of 63 years age. The patient's height, and weight were not reported. The patient had no known allergies.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, 1 total dose administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications include chronic medications to treat high cholesterol and hypothyroidism.  On 18-MAR-2021, the patient developed fever, chills, fatigue and loss of appetite. Later, her SARS-CoV-2 test was performed. On 22-MAR-2021, SARS-CoV-2 tested positive (coded- Confirmed Covid-19 infection). In the following week, fever and chills was recovered, but fatigue and loss of appetite remained. The health care professional (HCP) recommended to stay home unless he had trouble breathing. On 29-MAR-2021, the patient passed away due to confirmed covid-19 infection. It was not reported if the 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 - COVID-19 Infection. This event is considered Unassessable. The event 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.; Reported Cause(s) of Death: COVID-19 INFECTION
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: 02/24/2021  Guillain Barre' Syndrome  04/19/2021  Renal Failure with other complications
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: 02/24/2021  Guillain Barre' Syndrome  04/19/2021  Renal Failure with other complications
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Renal failure, Ultrasound scan, X-ray
Clinical narrative: 02/24/2021  Guillain Barre' Syndrome  04/19/2021  Renal Failure with other complications
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer normal, Full blood count normal, Hypoaesthesia, Paraesthesia
Clinical narrative: Fingers on left hand began tingling around 30 minutes or so after shot.  While riding home in the car, both the numbness, heaviness feeling in my arm and the tingling worsened.  Then a strong sensation went up the left side of my neck and into the left side of my face where my face started tingling.  That was so powerful and unexpected it caused me to gasp and grab the side of my neck.  My husband turned the car around and we returned to the hospital where they took the information and had me sit for a while checking back a few times.   My arm, fingers, neck and face continued to feel numb and heavy with my face and fingers tingling.    After no improvement and some escalation as it ebbed and flowed, I had an April 12 appointment with Dr at Medical Center.  Some blood work was done afterwards.  A PT appt. is set for April 29th.  It has been more than two weeks now and unfortunately, the numbness, heaviness and tingling continue.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dyspnoea, Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: Fingers on left hand began tingling around 30 minutes or so after shot.  While riding home in the car, both the numbness, heaviness feeling in my arm and the tingling worsened.  Then a strong sensation went up the left side of my neck and into the left side of my face where my face started tingling.  That was so powerful and unexpected it caused me to gasp and grab the side of my neck.  My husband turned the car around and we returned to the hospital where they took the information and had me sit for a while checking back a few times.   My arm, fingers, neck and face continued to feel numb and heavy with my face and fingers tingling.    After no improvement and some escalation as it ebbed and flowed, I had an April 12 appointment with Dr at Medical Center.  Some blood work was done afterwards.  A PT appt. is set for April 29th.  It has been more than two weeks now and unfortunately, the numbness, heaviness and tingling continue.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Chills, Contusion, Dyspnoea
Clinical narrative: Shortness of breath, low oxygen level, dyspnea, elevated HR, increased bruising.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Fibrin D dimer normal, Full blood count normal, Headache, Hyperhidrosis
Clinical narrative: Shortness of breath, low oxygen level, dyspnea, elevated HR, increased bruising.