chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain oedema, Cerebrovascular accident, Deep vein thrombosis, Hemiplegia, Immunology test
Clinical narrative: VACCINE INDUCED THROMBOCYTOPENIA; PNEUMONIA; CEREBRAL EDEMA; LEFT SIDED PARALYSIS (LEFT HEMIPARESIS); BILATERAL DEEP VENOUS THROMBOSIS IN LOWER EXTREMITIES; CLOTS IN LEFT ARM; BILATERAL PULMONARY EMBOLISM; STROKE/STROKE IN AORTA; This spontaneous report received from a health care professional concerned a 48 year old white male of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced stroke/stroke in aorta, and was hospitalized. On 17-AUG-2021, the patient experienced clots in left arm, bilateral deep venous thrombosis in lower extremities and bilateral pulmonary embolism. Patient was treated with Argatroban, and intravenous immunoglobulin and patient's condition improved. In AUG-2021, Laboratory data included: ELISA (enzyme linked immunoassay) positive, Platelet count while admitted was 32000 and Platelet factor 4 (Anti-Platelet Factor 4) 0.486, positive abnormal. On an unspecified date, patient was diagnosed with vaccine induced thrombocytopenia and afterwards developed pneumonia, left hemiparesis and cerebral edema. The patient had left sided paralysis as on 21-SEP-2021. Patient spent 2 weeks in ICU and was now in physical rehabilitation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke/stroke in aorta, and bilateral pulmonary embolism, and the outcome of clots in left arm, pneumonia, bilateral deep venous thrombosis in lower extremities, vaccine induced thrombocytopenia, cerebral edema and left sided paralysis (left hemiparesis) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210938399-covid-19 vaccine ad26.cov2.s- stroke/stroke in aorta, pneumonia, cerebral edema, left sided paralysis (left hemiparesis). 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).  20210938399-covid-19 vaccine ad26.cov2.s-bilateral deep venous thrombosis in lower extremities, bilateral pulmonary embolism, clots in left arm, vaccine induced thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet factor 4, Pneumonia, Pulmonary embolism, Thrombocytopenia, Thrombosis
Clinical narrative: VACCINE INDUCED THROMBOCYTOPENIA; PNEUMONIA; CEREBRAL EDEMA; LEFT SIDED PARALYSIS (LEFT HEMIPARESIS); BILATERAL DEEP VENOUS THROMBOSIS IN LOWER EXTREMITIES; CLOTS IN LEFT ARM; BILATERAL PULMONARY EMBOLISM; STROKE/STROKE IN AORTA; This spontaneous report received from a health care professional concerned a 48 year old white male of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced stroke/stroke in aorta, and was hospitalized. On 17-AUG-2021, the patient experienced clots in left arm, bilateral deep venous thrombosis in lower extremities and bilateral pulmonary embolism. Patient was treated with Argatroban, and intravenous immunoglobulin and patient's condition improved. In AUG-2021, Laboratory data included: ELISA (enzyme linked immunoassay) positive, Platelet count while admitted was 32000 and Platelet factor 4 (Anti-Platelet Factor 4) 0.486, positive abnormal. On an unspecified date, patient was diagnosed with vaccine induced thrombocytopenia and afterwards developed pneumonia, left hemiparesis and cerebral edema. The patient had left sided paralysis as on 21-SEP-2021. Patient spent 2 weeks in ICU and was now in physical rehabilitation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke/stroke in aorta, and bilateral pulmonary embolism, and the outcome of clots in left arm, pneumonia, bilateral deep venous thrombosis in lower extremities, vaccine induced thrombocytopenia, cerebral edema and left sided paralysis (left hemiparesis) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210938399-covid-19 vaccine ad26.cov2.s- stroke/stroke in aorta, pneumonia, cerebral edema, left sided paralysis (left hemiparesis). 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).  20210938399-covid-19 vaccine ad26.cov2.s-bilateral deep venous thrombosis in lower extremities, bilateral pulmonary embolism, clots in left arm, vaccine induced thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Brain oedema, Carotid artery thrombosis, Cerebrovascular accident, Computerised tomogram thorax abnormal
Clinical narrative: VACCINE INDUCED THROMBOCYTOPENIA; PNEUMONIA; CEREBRAL EDEMA; LEFT SIDED PARALYSIS (LEFT HEMIPARESIS); BILATERAL DEEP VENOUS THROMBOSIS IN LOWER EXTREMITIES; CLOTS IN LEFT ARM; BILATERAL PULMONARY EMBOLISM; STROKE/STROKE IN AORTA; This spontaneous report received from a health care professional concerned a 48 year old white male of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced stroke/stroke in aorta, and was hospitalized. On 17-AUG-2021, the patient experienced clots in left arm, bilateral deep venous thrombosis in lower extremities and bilateral pulmonary embolism. Patient was treated with Argatroban, and intravenous immunoglobulin and patient's condition improved. In AUG-2021, Laboratory data included: ELISA (enzyme linked immunoassay) positive, Platelet count while admitted was 32000 and Platelet factor 4 (Anti-Platelet Factor 4) 0.486, positive abnormal. On an unspecified date, patient was diagnosed with vaccine induced thrombocytopenia and afterwards developed pneumonia, left hemiparesis and cerebral edema. The patient had left sided paralysis as on 21-SEP-2021. Patient spent 2 weeks in ICU and was now in physical rehabilitation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke/stroke in aorta, and bilateral pulmonary embolism, and the outcome of clots in left arm, pneumonia, bilateral deep venous thrombosis in lower extremities, vaccine induced thrombocytopenia, cerebral edema and left sided paralysis (left hemiparesis) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210938399-covid-19 vaccine ad26.cov2.s- stroke/stroke in aorta, pneumonia, cerebral edema, left sided paralysis (left hemiparesis). 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).  20210938399-covid-19 vaccine ad26.cov2.s-bilateral deep venous thrombosis in lower extremities, bilateral pulmonary embolism, clots in left arm, vaccine induced thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coronary artery thrombosis, Deep vein thrombosis, Hemiparesis, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: VACCINE INDUCED THROMBOCYTOPENIA; PNEUMONIA; CEREBRAL EDEMA; LEFT SIDED PARALYSIS (LEFT HEMIPARESIS); BILATERAL DEEP VENOUS THROMBOSIS IN LOWER EXTREMITIES; CLOTS IN LEFT ARM; BILATERAL PULMONARY EMBOLISM; STROKE/STROKE IN AORTA; This spontaneous report received from a health care professional concerned a 48 year old white male of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced stroke/stroke in aorta, and was hospitalized. On 17-AUG-2021, the patient experienced clots in left arm, bilateral deep venous thrombosis in lower extremities and bilateral pulmonary embolism. Patient was treated with Argatroban, and intravenous immunoglobulin and patient's condition improved. In AUG-2021, Laboratory data included: ELISA (enzyme linked immunoassay) positive, Platelet count while admitted was 32000 and Platelet factor 4 (Anti-Platelet Factor 4) 0.486, positive abnormal. On an unspecified date, patient was diagnosed with vaccine induced thrombocytopenia and afterwards developed pneumonia, left hemiparesis and cerebral edema. The patient had left sided paralysis as on 21-SEP-2021. Patient spent 2 weeks in ICU and was now in physical rehabilitation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke/stroke in aorta, and bilateral pulmonary embolism, and the outcome of clots in left arm, pneumonia, bilateral deep venous thrombosis in lower extremities, vaccine induced thrombocytopenia, cerebral edema and left sided paralysis (left hemiparesis) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210938399-covid-19 vaccine ad26.cov2.s- stroke/stroke in aorta, pneumonia, cerebral edema, left sided paralysis (left hemiparesis). 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).  20210938399-covid-19 vaccine ad26.cov2.s-bilateral deep venous thrombosis in lower extremities, bilateral pulmonary embolism, clots in left arm, vaccine induced thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pneumonia, Pulmonary embolism, Tachycardia, Thrombectomy, Thrombosis with thrombocytopenia syndrome
Clinical narrative: VACCINE INDUCED THROMBOCYTOPENIA; PNEUMONIA; CEREBRAL EDEMA; LEFT SIDED PARALYSIS (LEFT HEMIPARESIS); BILATERAL DEEP VENOUS THROMBOSIS IN LOWER EXTREMITIES; CLOTS IN LEFT ARM; BILATERAL PULMONARY EMBOLISM; STROKE/STROKE IN AORTA; This spontaneous report received from a health care professional concerned a 48 year old white male of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced stroke/stroke in aorta, and was hospitalized. On 17-AUG-2021, the patient experienced clots in left arm, bilateral deep venous thrombosis in lower extremities and bilateral pulmonary embolism. Patient was treated with Argatroban, and intravenous immunoglobulin and patient's condition improved. In AUG-2021, Laboratory data included: ELISA (enzyme linked immunoassay) positive, Platelet count while admitted was 32000 and Platelet factor 4 (Anti-Platelet Factor 4) 0.486, positive abnormal. On an unspecified date, patient was diagnosed with vaccine induced thrombocytopenia and afterwards developed pneumonia, left hemiparesis and cerebral edema. The patient had left sided paralysis as on 21-SEP-2021. Patient spent 2 weeks in ICU and was now in physical rehabilitation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke/stroke in aorta, and bilateral pulmonary embolism, and the outcome of clots in left arm, pneumonia, bilateral deep venous thrombosis in lower extremities, vaccine induced thrombocytopenia, cerebral edema and left sided paralysis (left hemiparesis) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210938399-covid-19 vaccine ad26.cov2.s- stroke/stroke in aorta, pneumonia, cerebral edema, left sided paralysis (left hemiparesis). 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).  20210938399-covid-19 vaccine ad26.cov2.s-bilateral deep venous thrombosis in lower extremities, bilateral pulmonary embolism, clots in left arm, vaccine induced thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: VACCINE INDUCED THROMBOCYTOPENIA; PNEUMONIA; CEREBRAL EDEMA; LEFT SIDED PARALYSIS (LEFT HEMIPARESIS); BILATERAL DEEP VENOUS THROMBOSIS IN LOWER EXTREMITIES; CLOTS IN LEFT ARM; BILATERAL PULMONARY EMBOLISM; STROKE/STROKE IN AORTA; This spontaneous report received from a health care professional concerned a 48 year old white male of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced stroke/stroke in aorta, and was hospitalized. On 17-AUG-2021, the patient experienced clots in left arm, bilateral deep venous thrombosis in lower extremities and bilateral pulmonary embolism. Patient was treated with Argatroban, and intravenous immunoglobulin and patient's condition improved. In AUG-2021, Laboratory data included: ELISA (enzyme linked immunoassay) positive, Platelet count while admitted was 32000 and Platelet factor 4 (Anti-Platelet Factor 4) 0.486, positive abnormal. On an unspecified date, patient was diagnosed with vaccine induced thrombocytopenia and afterwards developed pneumonia, left hemiparesis and cerebral edema. The patient had left sided paralysis as on 21-SEP-2021. Patient spent 2 weeks in ICU and was now in physical rehabilitation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke/stroke in aorta, and bilateral pulmonary embolism, and the outcome of clots in left arm, pneumonia, bilateral deep venous thrombosis in lower extremities, vaccine induced thrombocytopenia, cerebral edema and left sided paralysis (left hemiparesis) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210938399-covid-19 vaccine ad26.cov2.s- stroke/stroke in aorta, pneumonia, cerebral edema, left sided paralysis (left hemiparesis). 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).  20210938399-covid-19 vaccine ad26.cov2.s-bilateral deep venous thrombosis in lower extremities, bilateral pulmonary embolism, clots in left arm, vaccine induced thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Angiogram, Brain oedema, Carotid artery thrombosis, Cerebrovascular accident
Clinical narrative: VACCINE INDUCED THROMBOCYTOPENIA; PNEUMONIA; CEREBRAL EDEMA; LEFT SIDED PARALYSIS (LEFT HEMIPARESIS); BILATERAL DEEP VENOUS THROMBOSIS IN LOWER EXTREMITIES; CLOTS IN LEFT ARM; BILATERAL PULMONARY EMBOLISM; STROKE/STROKE IN AORTA; This spontaneous report received from a health care professional concerned a 48 year old white male of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced stroke/stroke in aorta, and was hospitalized. On 17-AUG-2021, the patient experienced clots in left arm, bilateral deep venous thrombosis in lower extremities and bilateral pulmonary embolism. Patient was treated with Argatroban, and intravenous immunoglobulin and patient's condition improved. In AUG-2021, Laboratory data included: ELISA (enzyme linked immunoassay) positive, Platelet count while admitted was 32000 and Platelet factor 4 (Anti-Platelet Factor 4) 0.486, positive abnormal. On an unspecified date, patient was diagnosed with vaccine induced thrombocytopenia and afterwards developed pneumonia, left hemiparesis and cerebral edema. The patient had left sided paralysis as on 21-SEP-2021. Patient spent 2 weeks in ICU and was now in physical rehabilitation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke/stroke in aorta, and bilateral pulmonary embolism, and the outcome of clots in left arm, pneumonia, bilateral deep venous thrombosis in lower extremities, vaccine induced thrombocytopenia, cerebral edema and left sided paralysis (left hemiparesis) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210938399-covid-19 vaccine ad26.cov2.s- stroke/stroke in aorta, pneumonia, cerebral edema, left sided paralysis (left hemiparesis). 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).  20210938399-covid-19 vaccine ad26.cov2.s-bilateral deep venous thrombosis in lower extremities, bilateral pulmonary embolism, clots in left arm, vaccine induced thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Computerised tomogram thorax, Computerised tomogram thorax abnormal, Coronary artery thrombosis, Deep vein thrombosis
Clinical narrative: VACCINE INDUCED THROMBOCYTOPENIA; PNEUMONIA; CEREBRAL EDEMA; LEFT SIDED PARALYSIS (LEFT HEMIPARESIS); BILATERAL DEEP VENOUS THROMBOSIS IN LOWER EXTREMITIES; CLOTS IN LEFT ARM; BILATERAL PULMONARY EMBOLISM; STROKE/STROKE IN AORTA; This spontaneous report received from a health care professional concerned a 48 year old white male of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced stroke/stroke in aorta, and was hospitalized. On 17-AUG-2021, the patient experienced clots in left arm, bilateral deep venous thrombosis in lower extremities and bilateral pulmonary embolism. Patient was treated with Argatroban, and intravenous immunoglobulin and patient's condition improved. In AUG-2021, Laboratory data included: ELISA (enzyme linked immunoassay) positive, Platelet count while admitted was 32000 and Platelet factor 4 (Anti-Platelet Factor 4) 0.486, positive abnormal. On an unspecified date, patient was diagnosed with vaccine induced thrombocytopenia and afterwards developed pneumonia, left hemiparesis and cerebral edema. The patient had left sided paralysis as on 21-SEP-2021. Patient spent 2 weeks in ICU and was now in physical rehabilitation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke/stroke in aorta, and bilateral pulmonary embolism, and the outcome of clots in left arm, pneumonia, bilateral deep venous thrombosis in lower extremities, vaccine induced thrombocytopenia, cerebral edema and left sided paralysis (left hemiparesis) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210938399-covid-19 vaccine ad26.cov2.s- stroke/stroke in aorta, pneumonia, cerebral edema, left sided paralysis (left hemiparesis). 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).  20210938399-covid-19 vaccine ad26.cov2.s-bilateral deep venous thrombosis in lower extremities, bilateral pulmonary embolism, clots in left arm, vaccine induced thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hemiparesis, Immunoglobulin therapy, Laboratory test, Platelet count, Platelet count decreased
Clinical narrative: VACCINE INDUCED THROMBOCYTOPENIA; PNEUMONIA; CEREBRAL EDEMA; LEFT SIDED PARALYSIS (LEFT HEMIPARESIS); BILATERAL DEEP VENOUS THROMBOSIS IN LOWER EXTREMITIES; CLOTS IN LEFT ARM; BILATERAL PULMONARY EMBOLISM; STROKE/STROKE IN AORTA; This spontaneous report received from a health care professional concerned a 48 year old white male of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced stroke/stroke in aorta, and was hospitalized. On 17-AUG-2021, the patient experienced clots in left arm, bilateral deep venous thrombosis in lower extremities and bilateral pulmonary embolism. Patient was treated with Argatroban, and intravenous immunoglobulin and patient's condition improved. In AUG-2021, Laboratory data included: ELISA (enzyme linked immunoassay) positive, Platelet count while admitted was 32000 and Platelet factor 4 (Anti-Platelet Factor 4) 0.486, positive abnormal. On an unspecified date, patient was diagnosed with vaccine induced thrombocytopenia and afterwards developed pneumonia, left hemiparesis and cerebral edema. The patient had left sided paralysis as on 21-SEP-2021. Patient spent 2 weeks in ICU and was now in physical rehabilitation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke/stroke in aorta, and bilateral pulmonary embolism, and the outcome of clots in left arm, pneumonia, bilateral deep venous thrombosis in lower extremities, vaccine induced thrombocytopenia, cerebral edema and left sided paralysis (left hemiparesis) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210938399-covid-19 vaccine ad26.cov2.s- stroke/stroke in aorta, pneumonia, cerebral edema, left sided paralysis (left hemiparesis). 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).  20210938399-covid-19 vaccine ad26.cov2.s-bilateral deep venous thrombosis in lower extremities, bilateral pulmonary embolism, clots in left arm, vaccine induced thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pneumonia, Pulmonary embolism, Tachycardia, Thrombectomy, Thrombocytopenia
Clinical narrative: VACCINE INDUCED THROMBOCYTOPENIA; PNEUMONIA; CEREBRAL EDEMA; LEFT SIDED PARALYSIS (LEFT HEMIPARESIS); BILATERAL DEEP VENOUS THROMBOSIS IN LOWER EXTREMITIES; CLOTS IN LEFT ARM; BILATERAL PULMONARY EMBOLISM; STROKE/STROKE IN AORTA; This spontaneous report received from a health care professional concerned a 48 year old white male of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced stroke/stroke in aorta, and was hospitalized. On 17-AUG-2021, the patient experienced clots in left arm, bilateral deep venous thrombosis in lower extremities and bilateral pulmonary embolism. Patient was treated with Argatroban, and intravenous immunoglobulin and patient's condition improved. In AUG-2021, Laboratory data included: ELISA (enzyme linked immunoassay) positive, Platelet count while admitted was 32000 and Platelet factor 4 (Anti-Platelet Factor 4) 0.486, positive abnormal. On an unspecified date, patient was diagnosed with vaccine induced thrombocytopenia and afterwards developed pneumonia, left hemiparesis and cerebral edema. The patient had left sided paralysis as on 21-SEP-2021. Patient spent 2 weeks in ICU and was now in physical rehabilitation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke/stroke in aorta, and bilateral pulmonary embolism, and the outcome of clots in left arm, pneumonia, bilateral deep venous thrombosis in lower extremities, vaccine induced thrombocytopenia, cerebral edema and left sided paralysis (left hemiparesis) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210938399-covid-19 vaccine ad26.cov2.s- stroke/stroke in aorta, pneumonia, cerebral edema, left sided paralysis (left hemiparesis). 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).  20210938399-covid-19 vaccine ad26.cov2.s-bilateral deep venous thrombosis in lower extremities, bilateral pulmonary embolism, clots in left arm, vaccine induced thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis, Ultrasound Doppler, Ultrasound Doppler abnormal
Clinical narrative: VACCINE INDUCED THROMBOCYTOPENIA; PNEUMONIA; CEREBRAL EDEMA; LEFT SIDED PARALYSIS (LEFT HEMIPARESIS); BILATERAL DEEP VENOUS THROMBOSIS IN LOWER EXTREMITIES; CLOTS IN LEFT ARM; BILATERAL PULMONARY EMBOLISM; STROKE/STROKE IN AORTA; This spontaneous report received from a health care professional concerned a 48 year old white male of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced stroke/stroke in aorta, and was hospitalized. On 17-AUG-2021, the patient experienced clots in left arm, bilateral deep venous thrombosis in lower extremities and bilateral pulmonary embolism. Patient was treated with Argatroban, and intravenous immunoglobulin and patient's condition improved. In AUG-2021, Laboratory data included: ELISA (enzyme linked immunoassay) positive, Platelet count while admitted was 32000 and Platelet factor 4 (Anti-Platelet Factor 4) 0.486, positive abnormal. On an unspecified date, patient was diagnosed with vaccine induced thrombocytopenia and afterwards developed pneumonia, left hemiparesis and cerebral edema. The patient had left sided paralysis as on 21-SEP-2021. Patient spent 2 weeks in ICU and was now in physical rehabilitation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke/stroke in aorta, and bilateral pulmonary embolism, and the outcome of clots in left arm, pneumonia, bilateral deep venous thrombosis in lower extremities, vaccine induced thrombocytopenia, cerebral edema and left sided paralysis (left hemiparesis) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210938399-covid-19 vaccine ad26.cov2.s- stroke/stroke in aorta, pneumonia, cerebral edema, left sided paralysis (left hemiparesis). 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).  20210938399-covid-19 vaccine ad26.cov2.s-bilateral deep venous thrombosis in lower extremities, bilateral pulmonary embolism, clots in left arm, vaccine induced thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Dysuria, Faecal elastase test
Clinical narrative: ABDOMINAL PAIN; POSSIBLE NEUROLOGICAL PROBLEM; WEAKNESS/WEAKNESS IN GIRDLE MAGNIFIED; MUSCULAR WEAKNESS; DIARRHEA; MUSCLE FELT ACHEY; LOWER LEG PAIN; MUSCLE FELT LIKE THEY NEED TO BE STRETCHED; PAINFUL URINATION; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 180 pounds, and height was 68 inches. The patient's concurrent conditions included: type 2 diabetes, non smoker, no alcohol use, alcohol allergy, and weakness in girdle, and other pre-existing medical conditions included: The patient did not have history of 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, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin calcium, and canagliflozin. On APR-2021, the patient experienced muscle felt like they need to be stretched. On APR-2021, the patient experienced lower leg pain. On APR-2021, the patient experienced muscle felt achey. On 10-APR-2021, the patient experienced diarrhea. On 16-APR-2021, the patient experienced muscular weakness. On 21-APR-2021, Laboratory data included: Duplex ultrasound (NR: not provided) did not had any significant results. On 02-AUG-2021, Laboratory data included: Urinalysis (NR: not provided) normal. On 02-AUG-2021, the patient experienced painful urination. On 03-SEP-2021, Laboratory data included: Complete blood count (NR: not provided) normal, Comprehensive metabolic panel (NR: not provided) normal, Fecal elastase test (NR: not provided) normal, Fibrin D dimer (NR: not provided) positive, Lipase (NR: not provided) normal, Plasma protein (NR: not provided) normal, Stool analysis (NR: not provided) normal, and Thyroid function test (NR: not provided) normal. On an unspecified date, the patient experienced abdominal pain, painful urination, possible neurological problem, and weakness/weakness in girdle magnified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, and muscular weakness, and the outcome of abdominal pain, weakness/weakness in girdle magnified, muscle felt achey, muscle felt like they need to be stretched, lower leg pain, painful urination and possible neurological problem was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Full blood count, Lipase, Metabolic function test, Muscle tightness
Clinical narrative: ABDOMINAL PAIN; POSSIBLE NEUROLOGICAL PROBLEM; WEAKNESS/WEAKNESS IN GIRDLE MAGNIFIED; MUSCULAR WEAKNESS; DIARRHEA; MUSCLE FELT ACHEY; LOWER LEG PAIN; MUSCLE FELT LIKE THEY NEED TO BE STRETCHED; PAINFUL URINATION; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 180 pounds, and height was 68 inches. The patient's concurrent conditions included: type 2 diabetes, non smoker, no alcohol use, alcohol allergy, and weakness in girdle, and other pre-existing medical conditions included: The patient did not have history of 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, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin calcium, and canagliflozin. On APR-2021, the patient experienced muscle felt like they need to be stretched. On APR-2021, the patient experienced lower leg pain. On APR-2021, the patient experienced muscle felt achey. On 10-APR-2021, the patient experienced diarrhea. On 16-APR-2021, the patient experienced muscular weakness. On 21-APR-2021, Laboratory data included: Duplex ultrasound (NR: not provided) did not had any significant results. On 02-AUG-2021, Laboratory data included: Urinalysis (NR: not provided) normal. On 02-AUG-2021, the patient experienced painful urination. On 03-SEP-2021, Laboratory data included: Complete blood count (NR: not provided) normal, Comprehensive metabolic panel (NR: not provided) normal, Fecal elastase test (NR: not provided) normal, Fibrin D dimer (NR: not provided) positive, Lipase (NR: not provided) normal, Plasma protein (NR: not provided) normal, Stool analysis (NR: not provided) normal, and Thyroid function test (NR: not provided) normal. On an unspecified date, the patient experienced abdominal pain, painful urination, possible neurological problem, and weakness/weakness in girdle magnified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, and muscular weakness, and the outcome of abdominal pain, weakness/weakness in girdle magnified, muscle felt achey, muscle felt like they need to be stretched, lower leg pain, painful urination and possible neurological problem was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Nervous system disorder, Pain in extremity, Protein total
Clinical narrative: ABDOMINAL PAIN; POSSIBLE NEUROLOGICAL PROBLEM; WEAKNESS/WEAKNESS IN GIRDLE MAGNIFIED; MUSCULAR WEAKNESS; DIARRHEA; MUSCLE FELT ACHEY; LOWER LEG PAIN; MUSCLE FELT LIKE THEY NEED TO BE STRETCHED; PAINFUL URINATION; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 180 pounds, and height was 68 inches. The patient's concurrent conditions included: type 2 diabetes, non smoker, no alcohol use, alcohol allergy, and weakness in girdle, and other pre-existing medical conditions included: The patient did not have history of 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, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin calcium, and canagliflozin. On APR-2021, the patient experienced muscle felt like they need to be stretched. On APR-2021, the patient experienced lower leg pain. On APR-2021, the patient experienced muscle felt achey. On 10-APR-2021, the patient experienced diarrhea. On 16-APR-2021, the patient experienced muscular weakness. On 21-APR-2021, Laboratory data included: Duplex ultrasound (NR: not provided) did not had any significant results. On 02-AUG-2021, Laboratory data included: Urinalysis (NR: not provided) normal. On 02-AUG-2021, the patient experienced painful urination. On 03-SEP-2021, Laboratory data included: Complete blood count (NR: not provided) normal, Comprehensive metabolic panel (NR: not provided) normal, Fecal elastase test (NR: not provided) normal, Fibrin D dimer (NR: not provided) positive, Lipase (NR: not provided) normal, Plasma protein (NR: not provided) normal, Stool analysis (NR: not provided) normal, and Thyroid function test (NR: not provided) normal. On an unspecified date, the patient experienced abdominal pain, painful urination, possible neurological problem, and weakness/weakness in girdle magnified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, and muscular weakness, and the outcome of abdominal pain, weakness/weakness in girdle magnified, muscle felt achey, muscle felt like they need to be stretched, lower leg pain, painful urination and possible neurological problem was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Stool analysis, Thyroid function test, Ultrasound Doppler, Urine analysis
Clinical narrative: ABDOMINAL PAIN; POSSIBLE NEUROLOGICAL PROBLEM; WEAKNESS/WEAKNESS IN GIRDLE MAGNIFIED; MUSCULAR WEAKNESS; DIARRHEA; MUSCLE FELT ACHEY; LOWER LEG PAIN; MUSCLE FELT LIKE THEY NEED TO BE STRETCHED; PAINFUL URINATION; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 180 pounds, and height was 68 inches. The patient's concurrent conditions included: type 2 diabetes, non smoker, no alcohol use, alcohol allergy, and weakness in girdle, and other pre-existing medical conditions included: The patient did not have history of 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, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin calcium, and canagliflozin. On APR-2021, the patient experienced muscle felt like they need to be stretched. On APR-2021, the patient experienced lower leg pain. On APR-2021, the patient experienced muscle felt achey. On 10-APR-2021, the patient experienced diarrhea. On 16-APR-2021, the patient experienced muscular weakness. On 21-APR-2021, Laboratory data included: Duplex ultrasound (NR: not provided) did not had any significant results. On 02-AUG-2021, Laboratory data included: Urinalysis (NR: not provided) normal. On 02-AUG-2021, the patient experienced painful urination. On 03-SEP-2021, Laboratory data included: Complete blood count (NR: not provided) normal, Comprehensive metabolic panel (NR: not provided) normal, Fecal elastase test (NR: not provided) normal, Fibrin D dimer (NR: not provided) positive, Lipase (NR: not provided) normal, Plasma protein (NR: not provided) normal, Stool analysis (NR: not provided) normal, and Thyroid function test (NR: not provided) normal. On an unspecified date, the patient experienced abdominal pain, painful urination, possible neurological problem, and weakness/weakness in girdle magnified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, and muscular weakness, and the outcome of abdominal pain, weakness/weakness in girdle magnified, muscle felt achey, muscle felt like they need to be stretched, lower leg pain, painful urination and possible neurological problem was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: SHE GOT FIRST DOSE OF THE PFIZER VACCINE AND GOT JOHNSON AND JOHNSON VACCINE 4 MONTHS AGO; This spontaneous report received from a patient and concerned a 67 year old female. The patient's weight was 101.15 kilograms, and height was 166 centimeters. The patient's past medical history included: pace maker for heart, and concurrent conditions included: stage 4 kidney failure, controlled high blood pressure, and depression. 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, administered on MAY-2021 for prophylactic vaccination. The batch number was reported and has been requested. Concomitant medications included rivaroxaban for blood thinner, and bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced she got first dose of the pfizer vaccine and got johnson and johnson vaccine 4 months ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of she got first dose of the pfizer vaccine and got johnson and johnson vaccine 4 months ago was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: NOT COUGHED AS HARSHLY AS BEFORE A MONTH AFTER RECEIVING VACCINE; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non smoker, asthmatic, and chronic cough, and other pre-existing medical conditions included: Patient had no known drug allergies and 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: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced not coughed as harshly as before a month after receiving vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not coughed as harshly as before a month after receiving vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: RARE CASES OF BLOOD CLOTS AFTER  THE VACCINE ADMINISTRATION; This spontaneous report received from a consumer concerned multiple patients of unspecified race, ethnic origin and age. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced rare cases of blood clots after the vaccine administration. It was reported that reporter knew rare cases where the people had blood clots after administration of Janssen covid-19 vaccine on an unspecified date The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rare cases of blood clots after the vaccine administration was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210943879-Covid-19 vaccine ad26.cov2.s-Rare cases of blood clots after the vaccine administration . 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: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a pharmacist through reports (from other doctors and nurses) concerned 6 or 7 patients. 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 expiry: unknown) dose, start therapy date were not reported, frequency time 1 total was administered 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.  The reporter stated that, on an unspecified date 6 or 7 patients died due to unknown cause of death after receiving the Janssen covid-19 vaccine around the time of the food and drug administration (FDA) pause of vaccine. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210943888-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